Regulatory Open Forum

Hi team,

I am working on this novel device for the vagina that has LED lights and a temperature sensor.  Management does not want to do clinical studies and wants to use a device that has no lights and temperature sensors as their predicate, but has the same intended use.  While I have advised that this will result in NSE, it is the path they want to take.  In any event, I have advised that the LED be mentioned as an illumination feature only, with no benefits.  That is only since they are unwilling to do any clinical studies.  That said, they are trying to push the boundaries on what claims they can make even when we list it as an illumination feature and the claims are cosmetic.  So, I pose the following questions:

1. Can they make claims that are cosmetic as it relates to the LED feature IF the 510(k) is cleared? 
2. Can such claims like the red lights and heat stimulate collagen and elastin production?
3. I suggested that the temperature sensors be a wellness feature only and not one that advises users on seeking medical attention etc. Simply to track vaginal moisture and aging of the vagina.  Is that an acceptable claim?
4. What can we say about heat? Heat to increase blood circulation - rejuvenating skin/tissue, increase lubrication?
5. Can we make any mention of resurfacing of the tissue?
6. What words should we avoid when making these claims?


Any help will do.

Thanks,
Laura 



------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

​Hi Laura.

I see several issues with your proposed claims when you don't have clinical evidence to back them up.  Almost every one of your claims proposed appears to relate to the structure or function of the body and therefore would likely be considered medical and not cosmetic.  The next obvious question is what is providing the heat source and why would you need to monitor temperature if the product is not meant to heat the tissue?  While it is possible to make cosmetic claims, why would a 510(k) be needed if none of the claims were medicinal/medical in nature?  Remember the definition of medical in this case - something that is use to diagnose, treat, mitigate, cure, or effect the structure or function of the body.  If the product is not doing any of these things, then a 510(k) is unnecessary.  I like to use the example of a hair dryer as a cosmetic device that is truly a cosmetic device.  There is no diagnosis, treatment, mitigation or cure related to this device and the impact on the hair is simply to dry excess water from the hair therefore it is not impact on the structure or the function.  Another good example of a cosmetic device is the brushes or applicators for makeup.  No diagnosis, treatment, mitigation or cure of anything here and the only purpose is to apply a color cosmetic to improve the appearance of the skin.  Neither of these items have ever been reviewed for safety or efficacy by FDA to my knowledge.

Sorry, I don't think that any of your proposed claims can possibly pass as cosmetics.  And again, if the product is cosmetic, do you really need a 510(k)?

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
------------------------------

Original Message:
Sent: 16-Aug-2017 12:04
From: LAURA HOSHUE
Subject: Claims & Rejuvenation of the Vagina

Hi team,

I am working on this novel device for the vagina that has LED lights and a temperature sensor.  Management does not want to do clinical studies and wants to use a device that has no lights and temperature sensors as their predicate, but has the same intended use.  While I have advised that this will result in NSE, it is the path they want to take.  In any event, I have advised that the LED be mentioned as an illumination feature only, with no benefits.  That is only since they are unwilling to do any clinical studies.  That said, they are trying to push the boundaries on what claims they can make even when we list it as an illumination feature and the claims are cosmetic.  So, I pose the following questions:

1. Can they make claims that are cosmetic as it relates to the LED feature IF the 510(k) is cleared?
2. Can such claims like the red lights and heat stimulate collagen and elastin production?
3. I suggested that the temperature sensors be a wellness feature only and not one that advises users on seeking medical attention etc. Simply to track vaginal moisture and aging of the vagina.  Is that an acceptable claim?
4. What can we say about heat? Heat to increase blood circulation - rejuvenating skin/tissue, increase lubrication?
5. Can we make any mention of resurfacing of the tissue?
6. What words should we avoid when making these claims?


Any help will do.

Thanks,
Laura



------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Victor,

Thank you so much for that response.  The device also encompasses a Kegel exercise which is considered a medical device.  The predicate that they are proposing to use is their current Kegel device, and submit that one with the LED and temperature sensor feature as cosmetic features only.  The only reason it is a device is because it treats incontinence and sexual dysfunction, strengthens the pelvic floors etc.  The LED and temperature sensors are technological features for cosmetic purposes only.  

Based on your feedback, had we not had the Kegel part of the device and weren't treating anything and considering the anatomical site, you would sumise that a 510(k) would not be necessary? According to a guidance on general wellness devices, FDA considers devices that are invasive, with an energy source, indicated for intravaginal use, to still be under their purview and not considered a general wellness, low risk device. 

They are wanting to make a lot of claims with no studies, not wait for the ideal predicate that is currently under review, and push the limits.  

What a struggle.  

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 17-Aug-2017 08:31
From: Victor Mencarelli
Subject: Claims & Rejuvenation of the Vagina

​Hi Laura.

I see several issues with your proposed claims when you don't have clinical evidence to back them up.  Almost every one of your claims proposed appears to relate to the structure or function of the body and therefore would likely be considered medical and not cosmetic.  The next obvious question is what is providing the heat source and why would you need to monitor temperature if the product is not meant to heat the tissue?  While it is possible to make cosmetic claims, why would a 510(k) be needed if none of the claims were medicinal/medical in nature?  Remember the definition of medical in this case - something that is use to diagnose, treat, mitigate, cure, or effect the structure or function of the body.  If the product is not doing any of these things, then a 510(k) is unnecessary.  I like to use the example of a hair dryer as a cosmetic device that is truly a cosmetic device.  There is no diagnosis, treatment, mitigation or cure related to this device and the impact on the hair is simply to dry excess water from the hair therefore it is not impact on the structure or the function.  Another good example of a cosmetic device is the brushes or applicators for makeup.  No diagnosis, treatment, mitigation or cure of anything here and the only purpose is to apply a color cosmetic to improve the appearance of the skin.  Neither of these items have ever been reviewed for safety or efficacy by FDA to my knowledge.

Sorry, I don't think that any of your proposed claims can possibly pass as cosmetics.  And again, if the product is cosmetic, do you really need a 510(k)?

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States

Original Message:
Sent: 16-Aug-2017 12:04
From: LAURA HOSHUE
Subject: Claims & Rejuvenation of the Vagina

Hi team,

I am working on this novel device for the vagina that has LED lights and a temperature sensor.  Management does not want to do clinical studies and wants to use a device that has no lights and temperature sensors as their predicate, but has the same intended use.  While I have advised that this will result in NSE, it is the path they want to take.  In any event, I have advised that the LED be mentioned as an illumination feature only, with no benefits.  That is only since they are unwilling to do any clinical studies.  That said, they are trying to push the boundaries on what claims they can make even when we list it as an illumination feature and the claims are cosmetic.  So, I pose the following questions:

1. Can they make claims that are cosmetic as it relates to the LED feature IF the 510(k) is cleared?
2. Can such claims like the red lights and heat stimulate collagen and elastin production?
3. I suggested that the temperature sensors be a wellness feature only and not one that advises users on seeking medical attention etc. Simply to track vaginal moisture and aging of the vagina.  Is that an acceptable claim?
4. What can we say about heat? Heat to increase blood circulation - rejuvenating skin/tissue, increase lubrication?
5. Can we make any mention of resurfacing of the tissue?
6. What words should we avoid when making these claims?


Any help will do.

Thanks,
Laura



------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

​HI Laura

I highly recommend that you have a face to face presubmission meeting with the FDA on this matter.  If this product is treating incontinence, then it is a medical device and would require a 510(K) with clinical study.  .  If you are claiming vaginal rejuvenation, then it is a medical device and will require a deNovo application with a clinical study in order to gain that indication as there is no predicate device.

There are a lot of companies in this space now using laser, RF, and other modalities for treating these conditions.  They are NOT cosmetic treatments.  They are medical indications.

Connie


------------------------------
Connie Hoy
EVP Regulatory Affairs
Cynosure

United States
------------------------------

Original Message:
Sent: 17-Aug-2017 11:52
From: LAURA HOSHUE
Subject: Claims & Rejuvenation of the Vagina

Victor,

Thank you so much for that response.  The device also encompasses a Kegel exercise which is considered a medical device.  The predicate that they are proposing to use is their current Kegel device, and submit that one with the LED and temperature sensor feature as cosmetic features only.  The only reason it is a device is because it treats incontinence and sexual dysfunction, strengthens the pelvic floors etc.  The LED and temperature sensors are technological features for cosmetic purposes only.

Based on your feedback, had we not had the Kegel part of the device and weren't treating anything and considering the anatomical site, you would sumise that a 510(k) would not be necessary? According to a guidance on general wellness devices, FDA considers devices that are invasive, with an energy source, indicated for intravaginal use, to still be under their purview and not considered a general wellness, low risk device.

They are wanting to make a lot of claims with no studies, not wait for the ideal predicate that is currently under review, and push the limits.

What a struggle.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA

Original Message:
Sent: 17-Aug-2017 08:31
From: Victor Mencarelli
Subject: Claims & Rejuvenation of the Vagina

​Hi Laura.

I see several issues with your proposed claims when you don't have clinical evidence to back them up.  Almost every one of your claims proposed appears to relate to the structure or function of the body and therefore would likely be considered medical and not cosmetic.  The next obvious question is what is providing the heat source and why would you need to monitor temperature if the product is not meant to heat the tissue?  While it is possible to make cosmetic claims, why would a 510(k) be needed if none of the claims were medicinal/medical in nature?  Remember the definition of medical in this case - something that is use to diagnose, treat, mitigate, cure, or effect the structure or function of the body.  If the product is not doing any of these things, then a 510(k) is unnecessary.  I like to use the example of a hair dryer as a cosmetic device that is truly a cosmetic device.  There is no diagnosis, treatment, mitigation or cure related to this device and the impact on the hair is simply to dry excess water from the hair therefore it is not impact on the structure or the function.  Another good example of a cosmetic device is the brushes or applicators for makeup.  No diagnosis, treatment, mitigation or cure of anything here and the only purpose is to apply a color cosmetic to improve the appearance of the skin.  Neither of these items have ever been reviewed for safety or efficacy by FDA to my knowledge.

Sorry, I don't think that any of your proposed claims can possibly pass as cosmetics.  And again, if the product is cosmetic, do you really need a 510(k)?

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States

Original Message:
Sent: 16-Aug-2017 12:04
From: LAURA HOSHUE
Subject: Claims & Rejuvenation of the Vagina

Hi team,

I am working on this novel device for the vagina that has LED lights and a temperature sensor.  Management does not want to do clinical studies and wants to use a device that has no lights and temperature sensors as their predicate, but has the same intended use.  While I have advised that this will result in NSE, it is the path they want to take.  In any event, I have advised that the LED be mentioned as an illumination feature only, with no benefits.  That is only since they are unwilling to do any clinical studies.  That said, they are trying to push the boundaries on what claims they can make even when we list it as an illumination feature and the claims are cosmetic.  So, I pose the following questions:

1. Can they make claims that are cosmetic as it relates to the LED feature IF the 510(k) is cleared?
2. Can such claims like the red lights and heat stimulate collagen and elastin production?
3. I suggested that the temperature sensors be a wellness feature only and not one that advises users on seeking medical attention etc. Simply to track vaginal moisture and aging of the vagina.  Is that an acceptable claim?
4. What can we say about heat? Heat to increase blood circulation - rejuvenating skin/tissue, increase lubrication?
5. Can we make any mention of resurfacing of the tissue?
6. What words should we avoid when making these claims?


Any help will do.

Thanks,
Laura



------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Connie,

Thank you so much. I have established that it is a device and there is no way around it.  What I am struggling with, well not so much anymore, is identifying a suitable predicate with LED use for the vagina and there are none.  Laser products sure, but not LED light therapy.  LED is used on the face for wrinkles, it is used for stretch marks etc., but to date, nothing cleared or marketed, or even studied, that shows LED for that site.  I will certainly keep this group posted on where we go from here ultimately.


Regards,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 18-Aug-2017 07:11
From: Connie Hoy
Subject: Claims & Rejuvenation of the Vagina

​HI Laura

I highly recommend that you have a face to face presubmission meeting with the FDA on this matter.  If this product is treating incontinence, then it is a medical device and would require a 510(K) with clinical study.  .  If you are claiming vaginal rejuvenation, then it is a medical device and will require a deNovo application with a clinical study in order to gain that indication as there is no predicate device.

There are a lot of companies in this space now using laser, RF, and other modalities for treating these conditions.  They are NOT cosmetic treatments.  They are medical indications.

Connie


------------------------------
Connie Hoy
EVP Regulatory Affairs
Cynosure

United States

Original Message:
Sent: 17-Aug-2017 11:52
From: LAURA HOSHUE
Subject: Claims & Rejuvenation of the Vagina

Victor,

Thank you so much for that response.  The device also encompasses a Kegel exercise which is considered a medical device.  The predicate that they are proposing to use is their current Kegel device, and submit that one with the LED and temperature sensor feature as cosmetic features only.  The only reason it is a device is because it treats incontinence and sexual dysfunction, strengthens the pelvic floors etc.  The LED and temperature sensors are technological features for cosmetic purposes only.

Based on your feedback, had we not had the Kegel part of the device and weren't treating anything and considering the anatomical site, you would sumise that a 510(k) would not be necessary? According to a guidance on general wellness devices, FDA considers devices that are invasive, with an energy source, indicated for intravaginal use, to still be under their purview and not considered a general wellness, low risk device.

They are wanting to make a lot of claims with no studies, not wait for the ideal predicate that is currently under review, and push the limits.

What a struggle.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA

Original Message:
Sent: 17-Aug-2017 08:31
From: Victor Mencarelli
Subject: Claims & Rejuvenation of the Vagina

​Hi Laura.

I see several issues with your proposed claims when you don't have clinical evidence to back them up.  Almost every one of your claims proposed appears to relate to the structure or function of the body and therefore would likely be considered medical and not cosmetic.  The next obvious question is what is providing the heat source and why would you need to monitor temperature if the product is not meant to heat the tissue?  While it is possible to make cosmetic claims, why would a 510(k) be needed if none of the claims were medicinal/medical in nature?  Remember the definition of medical in this case - something that is use to diagnose, treat, mitigate, cure, or effect the structure or function of the body.  If the product is not doing any of these things, then a 510(k) is unnecessary.  I like to use the example of a hair dryer as a cosmetic device that is truly a cosmetic device.  There is no diagnosis, treatment, mitigation or cure related to this device and the impact on the hair is simply to dry excess water from the hair therefore it is not impact on the structure or the function.  Another good example of a cosmetic device is the brushes or applicators for makeup.  No diagnosis, treatment, mitigation or cure of anything here and the only purpose is to apply a color cosmetic to improve the appearance of the skin.  Neither of these items have ever been reviewed for safety or efficacy by FDA to my knowledge.

Sorry, I don't think that any of your proposed claims can possibly pass as cosmetics.  And again, if the product is cosmetic, do you really need a 510(k)?

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States

Original Message:
Sent: 16-Aug-2017 12:04
From: LAURA HOSHUE
Subject: Claims & Rejuvenation of the Vagina

Hi team,

I am working on this novel device for the vagina that has LED lights and a temperature sensor.  Management does not want to do clinical studies and wants to use a device that has no lights and temperature sensors as their predicate, but has the same intended use.  While I have advised that this will result in NSE, it is the path they want to take.  In any event, I have advised that the LED be mentioned as an illumination feature only, with no benefits.  That is only since they are unwilling to do any clinical studies.  That said, they are trying to push the boundaries on what claims they can make even when we list it as an illumination feature and the claims are cosmetic.  So, I pose the following questions:

1. Can they make claims that are cosmetic as it relates to the LED feature IF the 510(k) is cleared?
2. Can such claims like the red lights and heat stimulate collagen and elastin production?
3. I suggested that the temperature sensors be a wellness feature only and not one that advises users on seeking medical attention etc. Simply to track vaginal moisture and aging of the vagina.  Is that an acceptable claim?
4. What can we say about heat? Heat to increase blood circulation - rejuvenating skin/tissue, increase lubrication?
5. Can we make any mention of resurfacing of the tissue?
6. What words should we avoid when making these claims?


Any help will do.

Thanks,
Laura



------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Look into how the LED claims for wrinkles evolved. They didn't have LEDs pre-1976 either, so it must have evolved from some other similar technology - lasers? RF? perhaps you can take the same approach they did, if you understand what it was.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Engineering
MN
------------------------------

Original Message:
Sent: 22-Aug-2017 12:44
From: LAURA HOSHUE
Subject: Claims & Rejuvenation of the Vagina

Connie,

Thank you so much. I have established that it is a device and there is no way around it.  What I am struggling with, well not so much anymore, is identifying a suitable predicate with LED use for the vagina and there are none.  Laser products sure, but not LED light therapy.  LED is used on the face for wrinkles, it is used for stretch marks etc., but to date, nothing cleared or marketed, or even studied, that shows LED for that site.  I will certainly keep this group posted on where we go from here ultimately.


Regards,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA

Original Message:
Sent: 18-Aug-2017 07:11
From: Connie Hoy
Subject: Claims & Rejuvenation of the Vagina

​HI Laura

I highly recommend that you have a face to face presubmission meeting with the FDA on this matter.  If this product is treating incontinence, then it is a medical device and would require a 510(K) with clinical study.  .  If you are claiming vaginal rejuvenation, then it is a medical device and will require a deNovo application with a clinical study in order to gain that indication as there is no predicate device.

There are a lot of companies in this space now using laser, RF, and other modalities for treating these conditions.  They are NOT cosmetic treatments.  They are medical indications.

Connie


------------------------------
Connie Hoy
EVP Regulatory Affairs
Cynosure

United States

Original Message:
Sent: 17-Aug-2017 11:52
From: LAURA HOSHUE
Subject: Claims & Rejuvenation of the Vagina

Victor,

Thank you so much for that response.  The device also encompasses a Kegel exercise which is considered a medical device.  The predicate that they are proposing to use is their current Kegel device, and submit that one with the LED and temperature sensor feature as cosmetic features only.  The only reason it is a device is because it treats incontinence and sexual dysfunction, strengthens the pelvic floors etc.  The LED and temperature sensors are technological features for cosmetic purposes only.

Based on your feedback, had we not had the Kegel part of the device and weren't treating anything and considering the anatomical site, you would sumise that a 510(k) would not be necessary? According to a guidance on general wellness devices, FDA considers devices that are invasive, with an energy source, indicated for intravaginal use, to still be under their purview and not considered a general wellness, low risk device.

They are wanting to make a lot of claims with no studies, not wait for the ideal predicate that is currently under review, and push the limits.

What a struggle.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA

Original Message:
Sent: 17-Aug-2017 08:31
From: Victor Mencarelli
Subject: Claims & Rejuvenation of the Vagina

​Hi Laura.

I see several issues with your proposed claims when you don't have clinical evidence to back them up.  Almost every one of your claims proposed appears to relate to the structure or function of the body and therefore would likely be considered medical and not cosmetic.  The next obvious question is what is providing the heat source and why would you need to monitor temperature if the product is not meant to heat the tissue?  While it is possible to make cosmetic claims, why would a 510(k) be needed if none of the claims were medicinal/medical in nature?  Remember the definition of medical in this case - something that is use to diagnose, treat, mitigate, cure, or effect the structure or function of the body.  If the product is not doing any of these things, then a 510(k) is unnecessary.  I like to use the example of a hair dryer as a cosmetic device that is truly a cosmetic device.  There is no diagnosis, treatment, mitigation or cure related to this device and the impact on the hair is simply to dry excess water from the hair therefore it is not impact on the structure or the function.  Another good example of a cosmetic device is the brushes or applicators for makeup.  No diagnosis, treatment, mitigation or cure of anything here and the only purpose is to apply a color cosmetic to improve the appearance of the skin.  Neither of these items have ever been reviewed for safety or efficacy by FDA to my knowledge.

Sorry, I don't think that any of your proposed claims can possibly pass as cosmetics.  And again, if the product is cosmetic, do you really need a 510(k)?

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States

Original Message:
Sent: 16-Aug-2017 12:04
From: LAURA HOSHUE
Subject: Claims & Rejuvenation of the Vagina

Hi team,

I am working on this novel device for the vagina that has LED lights and a temperature sensor.  Management does not want to do clinical studies and wants to use a device that has no lights and temperature sensors as their predicate, but has the same intended use.  While I have advised that this will result in NSE, it is the path they want to take.  In any event, I have advised that the LED be mentioned as an illumination feature only, with no benefits.  That is only since they are unwilling to do any clinical studies.  That said, they are trying to push the boundaries on what claims they can make even when we list it as an illumination feature and the claims are cosmetic.  So, I pose the following questions:

1. Can they make claims that are cosmetic as it relates to the LED feature IF the 510(k) is cleared?
2. Can such claims like the red lights and heat stimulate collagen and elastin production?
3. I suggested that the temperature sensors be a wellness feature only and not one that advises users on seeking medical attention etc. Simply to track vaginal moisture and aging of the vagina.  Is that an acceptable claim?
4. What can we say about heat? Heat to increase blood circulation - rejuvenating skin/tissue, increase lubrication?
5. Can we make any mention of resurfacing of the tissue?
6. What words should we avoid when making these claims?


Any help will do.

Thanks,
Laura



------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Yes thank you.  They evolved from lasers Ginger.  Thanks again.


Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 23-Aug-2017 10:26
From: Ginger Glaser
Subject: Claims & Rejuvenation of the Vagina

Look into how the LED claims for wrinkles evolved. They didn't have LEDs pre-1976 either, so it must have evolved from some other similar technology - lasers? RF? perhaps you can take the same approach they did, if you understand what it was.

g-

------------------------------
Ginger Glaser RAC
Vice-President, Engineering
MN

Original Message:
Sent: 22-Aug-2017 12:44
From: LAURA HOSHUE
Subject: Claims & Rejuvenation of the Vagina

Connie,

Thank you so much. I have established that it is a device and there is no way around it.  What I am struggling with, well not so much anymore, is identifying a suitable predicate with LED use for the vagina and there are none.  Laser products sure, but not LED light therapy.  LED is used on the face for wrinkles, it is used for stretch marks etc., but to date, nothing cleared or marketed, or even studied, that shows LED for that site.  I will certainly keep this group posted on where we go from here ultimately.


Regards,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA

Original Message:
Sent: 18-Aug-2017 07:11
From: Connie Hoy
Subject: Claims & Rejuvenation of the Vagina

​HI Laura

I highly recommend that you have a face to face presubmission meeting with the FDA on this matter.  If this product is treating incontinence, then it is a medical device and would require a 510(K) with clinical study.  .  If you are claiming vaginal rejuvenation, then it is a medical device and will require a deNovo application with a clinical study in order to gain that indication as there is no predicate device.

There are a lot of companies in this space now using laser, RF, and other modalities for treating these conditions.  They are NOT cosmetic treatments.  They are medical indications.

Connie


------------------------------
Connie Hoy
EVP Regulatory Affairs
Cynosure

United States

Original Message:
Sent: 17-Aug-2017 11:52
From: LAURA HOSHUE
Subject: Claims & Rejuvenation of the Vagina

Victor,

Thank you so much for that response.  The device also encompasses a Kegel exercise which is considered a medical device.  The predicate that they are proposing to use is their current Kegel device, and submit that one with the LED and temperature sensor feature as cosmetic features only.  The only reason it is a device is because it treats incontinence and sexual dysfunction, strengthens the pelvic floors etc.  The LED and temperature sensors are technological features for cosmetic purposes only.

Based on your feedback, had we not had the Kegel part of the device and weren't treating anything and considering the anatomical site, you would sumise that a 510(k) would not be necessary? According to a guidance on general wellness devices, FDA considers devices that are invasive, with an energy source, indicated for intravaginal use, to still be under their purview and not considered a general wellness, low risk device.

They are wanting to make a lot of claims with no studies, not wait for the ideal predicate that is currently under review, and push the limits.

What a struggle.

Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA

Original Message:
Sent: 17-Aug-2017 08:31
From: Victor Mencarelli
Subject: Claims & Rejuvenation of the Vagina

​Hi Laura.

I see several issues with your proposed claims when you don't have clinical evidence to back them up.  Almost every one of your claims proposed appears to relate to the structure or function of the body and therefore would likely be considered medical and not cosmetic.  The next obvious question is what is providing the heat source and why would you need to monitor temperature if the product is not meant to heat the tissue?  While it is possible to make cosmetic claims, why would a 510(k) be needed if none of the claims were medicinal/medical in nature?  Remember the definition of medical in this case - something that is use to diagnose, treat, mitigate, cure, or effect the structure or function of the body.  If the product is not doing any of these things, then a 510(k) is unnecessary.  I like to use the example of a hair dryer as a cosmetic device that is truly a cosmetic device.  There is no diagnosis, treatment, mitigation or cure related to this device and the impact on the hair is simply to dry excess water from the hair therefore it is not impact on the structure or the function.  Another good example of a cosmetic device is the brushes or applicators for makeup.  No diagnosis, treatment, mitigation or cure of anything here and the only purpose is to apply a color cosmetic to improve the appearance of the skin.  Neither of these items have ever been reviewed for safety or efficacy by FDA to my knowledge.

Sorry, I don't think that any of your proposed claims can possibly pass as cosmetics.  And again, if the product is cosmetic, do you really need a 510(k)?

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States

Original Message:
Sent: 16-Aug-2017 12:04
From: LAURA HOSHUE
Subject: Claims & Rejuvenation of the Vagina

Hi team,

I am working on this novel device for the vagina that has LED lights and a temperature sensor.  Management does not want to do clinical studies and wants to use a device that has no lights and temperature sensors as their predicate, but has the same intended use.  While I have advised that this will result in NSE, it is the path they want to take.  In any event, I have advised that the LED be mentioned as an illumination feature only, with no benefits.  That is only since they are unwilling to do any clinical studies.  That said, they are trying to push the boundaries on what claims they can make even when we list it as an illumination feature and the claims are cosmetic.  So, I pose the following questions:

1. Can they make claims that are cosmetic as it relates to the LED feature IF the 510(k) is cleared?
2. Can such claims like the red lights and heat stimulate collagen and elastin production?
3. I suggested that the temperature sensors be a wellness feature only and not one that advises users on seeking medical attention etc. Simply to track vaginal moisture and aging of the vagina.  Is that an acceptable claim?
4. What can we say about heat? Heat to increase blood circulation - rejuvenating skin/tissue, increase lubrication?
5. Can we make any mention of resurfacing of the tissue?
6. What words should we avoid when making these claims?


Any help will do.

Thanks,
Laura



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Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
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