Regulatory Open Forum

Dear all,

I'm getting confused on one point concerning reusable instrument sold sterile (single use) specifically for the drill bit.

From FDA classification, I found that drill bit which are class I 510 K exempt.

But  what happens when this device is sold sterile? Does it become a class II or it remain a class I witch required a 510 k?

Because I see on FDA access database a 510 K for a sterile drill bitt with a HWE code which is a 510 k exempt.

Please could you help me to understand.

Thank you in advance for your help.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hello,

I looked up the HWC product code which you referred to (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=4656) - this appears to be for a different device than what you are describing.  The HWC code refers to "Screw, Fixation, Bone" as described by 21 CFR 888.3040 "Smooth or threaded metallic bone fixation fastener".

I do not work in orthopedics, but I had a search in the FDA classification database for a drill bit and found the code "HTW" for "Bit, Drill" which is a 510(k) exempt, Class I device (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=4651).  The applicable regulation is 21 CFR 888.4540 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=888.4540).

Without knowing any more specifics, this code/regulation appears to be relevant to your product type.  Hope this helps!

-Liz

------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Manager-International
Irvine CA
United States
------------------------------

Original Message:
Sent: 11-Nov-2021 15:10
From: Nadine Adia
Subject: FDA classification for Drill bit sold sterile

Dear all,

I'm getting confused on one point concerning reusable instrument sold sterile (single use) specifically for the drill bit.

From FDA classification, I found that drill bit which are class I 510 K exempt.

But  what happens when this device is sold sterile? Does it become a class II or it remain a class I witch required a 510 k?

Because I see on FDA access database a 510 K for a sterile drill bitt with a HWC code which is a 510 k exempt.

Please could you help me to understand.

Thank you in advance for your help.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Thank you Elisabeth for your response. you are right ,It is a mistake in my message the code should be HWE instead of HWC, the edit was done.
Rgds​

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Original Message:
Sent: 11-Nov-2021 18:34
From: Elizabeth Goldstein
Subject: FDA classification for Drill bit sold sterile

Hello,

I looked up the HWC product code which you referred to (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=4656) - this appears to be for a different device than what you are describing.  The HWC code refers to "Screw, Fixation, Bone" as described by 21 CFR 888.3040 "Smooth or threaded metallic bone fixation fastener".

I do not work in orthopedics, but I had a search in the FDA classification database for a drill bit and found the code "HTW" for "Bit, Drill" which is a 510(k) exempt, Class I device (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=4651).  The applicable regulation is 21 CFR 888.4540 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=888.4540).

Without knowing any more specifics, this code/regulation appears to be relevant to your product type.  Hope this helps!

-Liz

------------------------------
Elizabeth Goldstein RAC
Regulatory Affairs Manager-International
Irvine CA
United States

Original Message:
Sent: 11-Nov-2021 15:10
From: Nadine Adia
Subject: FDA classification for Drill bit sold sterile

Dear all,

I'm getting confused on one point concerning reusable instrument sold sterile (single use) specifically for the drill bit.

From FDA classification, I found that drill bit which are class I 510 K exempt.

But  what happens when this device is sold sterile? Does it become a class II or it remain a class I witch required a 510 k?

Because I see on FDA access database a 510 K for a sterile drill bitt with a HWC code which is a 510 k exempt.

Please could you help me to understand.

Thank you in advance for your help.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hi Nadine,

Have you sent a request for an informal classification to CDRH? There are no costs involved. Although the opinion is non binding it can help clarify some fo the confusion. The response usually takes one to two weeks.

Contact CDRH Office of Compliance by email at:
DeviceDetermination@fda.hhs.gov
• Provide product description, draft labeling, and intended use

It should eliminate some of the guesswork.

------------------------------
[Robert] [Falcone] PhD, FTOPRA, FRAPS
------------------------------

Original Message:
Sent: 11-Nov-2021 15:10
From: Nadine Adia
Subject: FDA classification for Drill bit sold sterile

Dear all,

I'm getting confused on one point concerning reusable instrument sold sterile (single use) specifically for the drill bit.

From FDA classification, I found that drill bit which are class I 510 K exempt.

But  what happens when this device is sold sterile? Does it become a class II or it remain a class I witch required a 510 k?

Because I see on FDA access database a 510 K for a sterile drill bitt with a HWE code which is a 510 k exempt.

Please could you help me to understand.

Thank you in advance for your help.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hi Nadine,

I will second the suggestion to reach out to CDRH.  If you look through the detailed information on the devices that show up in the 510k database for ProCode HWE, you will see that some of them predate FDA's classification changes and some of them are part of systems that carry higher classifications.  At a glance, many of them appear to be specifically neuro, which would explain the 510k.

Be sure to include all of the information specific to your device when requesting classification feedback.  Is it part (accessory) of a system even if sold separately but intended to be used only with the system?  Is it intended/indicated for a specific use, procedure or patient population?  You describe your device as "reusable instrument sold sterile (single use)".  I'm assuming that's reusable on the same patient during a single procedure that does not require cleaning/sterilization in between, and if so, I would be specific on that.

As noted, their feedback is non-binding; however, the chances of their suggestion being accurate and defensible on your end increase if you give them the best possible description.

------------------------------
Robin Haden RAC
Sr. Regulatory Affairs Specialist
New Hill NC
United States
------------------------------

Original Message:
Sent: 12-Nov-2021 08:40
From: Robert Falcone
Subject: FDA classification for Drill bit sold sterile

Hi Nadine,

Have you sent a request for an informal classification to CDRH? There are no costs involved. Although the opinion is non binding it can help clarify some fo the confusion. The response usually takes one to two weeks.

Contact CDRH Office of Compliance by email at:
DeviceDetermination@fda.hhs.gov
• Provide product description, draft labeling, and intended use

It should eliminate some of the guesswork.

------------------------------
[Robert] [Falcone] PhD, FTOPRA, FRAPS

Original Message:
Sent: 11-Nov-2021 15:10
From: Nadine Adia
Subject: FDA classification for Drill bit sold sterile

Dear all,

I'm getting confused on one point concerning reusable instrument sold sterile (single use) specifically for the drill bit.

From FDA classification, I found that drill bit which are class I 510 K exempt.

But  what happens when this device is sold sterile? Does it become a class II or it remain a class I witch required a 510 k?

Because I see on FDA access database a 510 K for a sterile drill bitt with a HWE code which is a 510 k exempt.

Please could you help me to understand.

Thank you in advance for your help.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hi Nadine,

Suggest using the following format

We are in the process of exploring the idea of developing a medical device for 

 

• A brief description of the device, including the mechanisms you will use to accomplish your intended use

• Device Description: 
• Mechanism of Operation: 

• Intended use

• Any labeling claims you plan to make about your device

The more specific you are, the quicker the response.

Good Luck :)

------------------------------
[Robert] [Falcone] PhD, FTOPRA, FRAPS
------------------------------

Original Message:
Sent: 12-Nov-2021 09:55
From: J Robin Haden
Subject: FDA classification for Drill bit sold sterile

Hi Nadine,

I will second the suggestion to reach out to CDRH.  If you look through the detailed information on the devices that show up in the 510k database for ProCode HWE, you will see that some of them predate FDA's classification changes and some of them are part of systems that carry higher classifications.  At a glance, many of them appear to be specifically neuro, which would explain the 510k.

Be sure to include all of the information specific to your device when requesting classification feedback.  Is it part (accessory) of a system even if sold separately but intended to be used only with the system?  Is it intended/indicated for a specific use, procedure or patient population?  You describe your device as "reusable instrument sold sterile (single use)".  I'm assuming that's reusable on the same patient during a single procedure that does not require cleaning/sterilization in between, and if so, I would be specific on that.

As noted, their feedback is non-binding; however, the chances of their suggestion being accurate and defensible on your end increase if you give them the best possible description.

------------------------------
Robin Haden RAC
Sr. Regulatory Affairs Specialist
New Hill NC
United States

Original Message:
Sent: 12-Nov-2021 08:40
From: Robert Falcone
Subject: FDA classification for Drill bit sold sterile

Hi Nadine,

Have you sent a request for an informal classification to CDRH? There are no costs involved. Although the opinion is non binding it can help clarify some fo the confusion. The response usually takes one to two weeks.

Contact CDRH Office of Compliance by email at:
DeviceDetermination@fda.hhs.gov
• Provide product description, draft labeling, and intended use

It should eliminate some of the guesswork.

------------------------------
[Robert] [Falcone] PhD, FTOPRA, FRAPS

Original Message:
Sent: 11-Nov-2021 15:10
From: Nadine Adia
Subject: FDA classification for Drill bit sold sterile

Dear all,

I'm getting confused on one point concerning reusable instrument sold sterile (single use) specifically for the drill bit.

From FDA classification, I found that drill bit which are class I 510 K exempt.

But  what happens when this device is sold sterile? Does it become a class II or it remain a class I witch required a 510 k?

Because I see on FDA access database a 510 K for a sterile drill bitt with a HWE code which is a 510 k exempt.

Please could you help me to understand.

Thank you in advance for your help.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hi Nadine,

I would echo Robin's comments in that (in my somewhat cursory review of the FDA website), the 510(k)s that include the HWE procode are "systems", of which the drill bit is a minor part.  It is used as a tool to insert the implantable portions of the system.  In my opinion, if you are marketing a stand-alone drill bit, the sterility status does not drive the 510(k) status, and as HWE is 510(k) exempt, no submission would be needed.  Note that HWE is not GMP exempt, so it is subject to design controls, DV&V testing, and sterilization validation.  I cannot envision marketing such a product for this intended use non-sterile unless accompanied by instructions for terminal sterilization at point of use.

If any questions remain, I would second Robert's suggestion to reach out to CDRH.

Regards,
James

------------------------------
James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
------------------------------

Original Message:
Sent: 12-Nov-2021 09:55
From: J Robin Haden
Subject: FDA classification for Drill bit sold sterile

Hi Nadine,

I will second the suggestion to reach out to CDRH.  If you look through the detailed information on the devices that show up in the 510k database for ProCode HWE, you will see that some of them predate FDA's classification changes and some of them are part of systems that carry higher classifications.  At a glance, many of them appear to be specifically neuro, which would explain the 510k.

Be sure to include all of the information specific to your device when requesting classification feedback.  Is it part (accessory) of a system even if sold separately but intended to be used only with the system?  Is it intended/indicated for a specific use, procedure or patient population?  You describe your device as "reusable instrument sold sterile (single use)".  I'm assuming that's reusable on the same patient during a single procedure that does not require cleaning/sterilization in between, and if so, I would be specific on that.

As noted, their feedback is non-binding; however, the chances of their suggestion being accurate and defensible on your end increase if you give them the best possible description.

------------------------------
Robin Haden RAC
Sr. Regulatory Affairs Specialist
New Hill NC
United States

Original Message:
Sent: 12-Nov-2021 08:40
From: Robert Falcone
Subject: FDA classification for Drill bit sold sterile

Hi Nadine,

Have you sent a request for an informal classification to CDRH? There are no costs involved. Although the opinion is non binding it can help clarify some fo the confusion. The response usually takes one to two weeks.

Contact CDRH Office of Compliance by email at:
DeviceDetermination@fda.hhs.gov
• Provide product description, draft labeling, and intended use

It should eliminate some of the guesswork.

------------------------------
[Robert] [Falcone] PhD, FTOPRA, FRAPS

Original Message:
Sent: 11-Nov-2021 15:10
From: Nadine Adia
Subject: FDA classification for Drill bit sold sterile

Dear all,

I'm getting confused on one point concerning reusable instrument sold sterile (single use) specifically for the drill bit.

From FDA classification, I found that drill bit which are class I 510 K exempt.

But  what happens when this device is sold sterile? Does it become a class II or it remain a class I witch required a 510 k?

Because I see on FDA access database a 510 K for a sterile drill bitt with a HWE code which is a 510 k exempt.

Please could you help me to understand.

Thank you in advance for your help.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Class I do not require design controls in the US with the exception of a very small list specified in 21 CFR 820.30. So Design Control elements like DV&V are not required. Still need to demonstrate safety/efficacy, just not with the rigor of DC.

------------------------------
Joshua Lust
RiskMitigated.com
------------------------------

Original Message:
Sent: 13-Nov-2021 09:31
From: James Bonds
Subject: FDA classification for Drill bit sold sterile

Hi Nadine,

I would echo Robin's comments in that (in my somewhat cursory review of the FDA website), the 510(k)s that include the HWE procode are "systems", of which the drill bit is a minor part.  It is used as a tool to insert the implantable portions of the system.  In my opinion, if you are marketing a stand-alone drill bit, the sterility status does not drive the 510(k) status, and as HWE is 510(k) exempt, no submission would be needed.  Note that HWE is not GMP exempt, so it is subject to design controls, DV&V testing, and sterilization validation.  I cannot envision marketing such a product for this intended use non-sterile unless accompanied by instructions for terminal sterilization at point of use.

If any questions remain, I would second Robert's suggestion to reach out to CDRH.

Regards,
James

------------------------------
James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States

Original Message:
Sent: 12-Nov-2021 09:55
From: J Robin Haden
Subject: FDA classification for Drill bit sold sterile

Hi Nadine,

I will second the suggestion to reach out to CDRH.  If you look through the detailed information on the devices that show up in the 510k database for ProCode HWE, you will see that some of them predate FDA's classification changes and some of them are part of systems that carry higher classifications.  At a glance, many of them appear to be specifically neuro, which would explain the 510k.

Be sure to include all of the information specific to your device when requesting classification feedback.  Is it part (accessory) of a system even if sold separately but intended to be used only with the system?  Is it intended/indicated for a specific use, procedure or patient population?  You describe your device as "reusable instrument sold sterile (single use)".  I'm assuming that's reusable on the same patient during a single procedure that does not require cleaning/sterilization in between, and if so, I would be specific on that.

As noted, their feedback is non-binding; however, the chances of their suggestion being accurate and defensible on your end increase if you give them the best possible description.

------------------------------
Robin Haden RAC
Sr. Regulatory Affairs Specialist
New Hill NC
United States

Original Message:
Sent: 12-Nov-2021 08:40
From: Robert Falcone
Subject: FDA classification for Drill bit sold sterile

Hi Nadine,

Have you sent a request for an informal classification to CDRH? There are no costs involved. Although the opinion is non binding it can help clarify some fo the confusion. The response usually takes one to two weeks.

Contact CDRH Office of Compliance by email at:
DeviceDetermination@fda.hhs.gov
• Provide product description, draft labeling, and intended use

It should eliminate some of the guesswork.

------------------------------
[Robert] [Falcone] PhD, FTOPRA, FRAPS

Original Message:
Sent: 11-Nov-2021 15:10
From: Nadine Adia
Subject: FDA classification for Drill bit sold sterile

Dear all,

I'm getting confused on one point concerning reusable instrument sold sterile (single use) specifically for the drill bit.

From FDA classification, I found that drill bit which are class I 510 K exempt.

But  what happens when this device is sold sterile? Does it become a class II or it remain a class I witch required a 510 k?

Because I see on FDA access database a 510 K for a sterile drill bitt with a HWE code which is a 510 k exempt.

Please could you help me to understand.

Thank you in advance for your help.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hi Nadine. 
It certainly gets confusing. I did a "simple search" on "drill bit."   Looks to me that your device is still Class 1 exempt. 

Additionally, I found this FDA power point to be helpful with regard to cleaning and sterilization. It also looks like your product code is not in the "required" 510(k) list.  https://www.fda.gov/media/141277/download 

------------------------------
Kimberly Rendon
Director RA AM NAM
Springfield PA
United States
------------------------------

Original Message:
Sent: 11-Nov-2021 15:10
From: Nadine Adia
Subject: FDA classification for Drill bit sold sterile

Dear all,

I'm getting confused on one point concerning reusable instrument sold sterile (single use) specifically for the drill bit.

From FDA classification, I found that drill bit which are class I 510 K exempt.

But  what happens when this device is sold sterile? Does it become a class II or it remain a class I witch required a 510 k?

Because I see on FDA access database a 510 K for a sterile drill bitt with a HWE code which is a 510 k exempt.

Please could you help me to understand.

Thank you in advance for your help.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hi Nadine,

Suggest making an informal request since a lot of assumptions are being made. There are no costs involved, and you get a determination/opinion from the regulatory agency overseeing medical devices. Be aware that CDRH may suggest proceeding with a 510K or a De Novo Application on some occasions.

------------------------------
[Robert] [Falcone] PhD, FTOPRA, FRAPS
------------------------------

Original Message:
Sent: 11-Nov-2021 15:10
From: Nadine Adia
Subject: FDA classification for Drill bit sold sterile

Dear all,

I'm getting confused on one point concerning reusable instrument sold sterile (single use) specifically for the drill bit.

From FDA classification, I found that drill bit which are class I 510 K exempt.

But  what happens when this device is sold sterile? Does it become a class II or it remain a class I witch required a 510 k?

Because I see on FDA access database a 510 K for a sterile drill bitt with a HWE code which is a 510 k exempt.

Please could you help me to understand.

Thank you in advance for your help.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Thank you so much all for your response very helpful. 
it appears in general from these exchanges that sterilization does not influence the risk class when the drills are sold standalone; the risk class remains class 1 (510 K exempt) following the amendment made by the FDA on the classification rules.
However, I have sent an email to the FDA as you recommended. I will keep you informed as soon as I have any information.

Thank you.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Original Message:
Sent: 11-Nov-2021 15:10
From: Nadine Adia
Subject: FDA classification for Drill bit sold sterile

Dear all,

I'm getting confused on one point concerning reusable instrument sold sterile (single use) specifically for the drill bit.

From FDA classification, I found that drill bit which are class I 510 K exempt.

But  what happens when this device is sold sterile? Does it become a class II or it remain a class I witch required a 510 k?

Because I see on FDA access database a 510 K for a sterile drill bitt with a HWE code which is a 510 k exempt.

Please could you help me to understand.

Thank you in advance for your help.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------