Regulatory Open Forum

Dear Experts,

I really appreciate the responses i get to my queries whenever i post some questions.

I once again would appreciate the response if someone can assist that "which product category (FDA) will be suitable for the sterilizable oil for the reusable medical devices that protect devices from the potential rust and wear"? or such product can be exempted from the 510 (k).

I thank in advance to the community for support.

Best Regards,






------------------------------
Rabel Talpur
Freiburg
Germany
------------------------------

Hello Rabel,

Interesting question, I personally am not familiar with these type of products - new to me.  When looking at sterilisation products, sterilants, and sterilisation accessories many of these are Class II requiring a 510(k) with a couple being Unclassified.  A quick view of the database, I did not see anything straight away.  Maybe as part of the sterilisation process it could be considered in the "sterilant" bucket, but maybe it is just an accessory and not classified at all.  From my view, there could be a concern with left-over materials or residues which could pose a risk to the patient through contamination or irritation.  It would take some research to determine exact classification, but I might suggest inquiring with the FDA - is it a device or not? - process first.  You can do this through emailing US FDA at DeviceDetermination@fda.hhs.gov which they are fairly responsive https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device.  I am sure they have seen these type of products before and while it may not be described in one of the Product Codes or Regulation, they might already know where the product would be classified.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 11-Oct-2022 10:09
From: Rabel Talpur
Subject: FDA Product Category for sterilization Oil for reusable devcies

Dear Experts,

I really appreciate the responses i get to my queries whenever i post some questions.

I once again would appreciate the response if someone can assist that "which product category (FDA) will be suitable for the sterilizable oil for the reusable medical devices that protect devices from the potential rust and wear"? or such product can be exempted from the 510 (k).

I thank in advance to the community for support.

Best Regards,






------------------------------
Rabel Talpur
Freiburg
Germany
------------------------------

Hello Richard,

Thanks for providing the insight, i have reached out FDA as per your provided email above to identify right classification, there is no clear classification of such products (Oil, lubricants).

I will keep you updated here once i have assistance from FDA.

Best,

------------------------------
Rabel Talpur
Freiburg
Germany
------------------------------

Original Message:
Sent: 12-Oct-2022 04:16
From: Richard Vincins
Subject: FDA Product Category for sterilization Oil for reusable devcies

Hello Rabel,

Interesting question, I personally am not familiar with these type of products - new to me.  When looking at sterilisation products, sterilants, and sterilisation accessories many of these are Class II requiring a 510(k) with a couple being Unclassified.  A quick view of the database, I did not see anything straight away.  Maybe as part of the sterilisation process it could be considered in the "sterilant" bucket, but maybe it is just an accessory and not classified at all.  From my view, there could be a concern with left-over materials or residues which could pose a risk to the patient through contamination or irritation.  It would take some research to determine exact classification, but I might suggest inquiring with the FDA - is it a device or not? - process first.  You can do this through emailing US FDA at DeviceDetermination@fda.hhs.gov which they are fairly responsive https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device.  I am sure they have seen these type of products before and while it may not be described in one of the Product Codes or Regulation, they might already know where the product would be classified.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 11-Oct-2022 10:09
From: Rabel Talpur
Subject: FDA Product Category for sterilization Oil for reusable devcies

Dear Experts,

I really appreciate the responses i get to my queries whenever i post some questions.

I once again would appreciate the response if someone can assist that "which product category (FDA) will be suitable for the sterilizable oil for the reusable medical devices that protect devices from the potential rust and wear"? or such product can be exempted from the 510 (k).

I thank in advance to the community for support.

Best Regards,






------------------------------
Rabel Talpur
Freiburg
Germany
------------------------------

It is an interesting question, as there is certainly interest in having accessory lubricants that will survive sterile processing while not interfering with the device cleaning and sterilization, not exploding in the autoclave, and so on.

Mostly I see lubricants listed under the same product code as the specific device they are intended for.  For example,

Handpiece, air-powered, dental
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Handpiece, Air-Powered, Dental
Handpiece, Contra- And Right-Angle Attachment, Dental
Disinfector, medical devices
SCREWDRIVER
UNIT, OPERATIVE DENTAL
DRILL, BONE, POWERED
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
INSTRUMENTS, DENTAL HAND
TRAY, SURGICAL, INSTRUMENT
Unit, Operative Dental, Accessories
Cleaner, Ultrasonic, Medical Instrument
DRIVER, WIRE, AND BONE DRILL, MANUAL
Dermatome
Disinfector, Medical Devices
Drill, Bone, Powered
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Electrosurgical, Cutting & Coagulation & Accessories
HANDPIECE, AIR-POWERED, DENTAL
INSTRUMENT, CUTTING, ORTHOPEDIC
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
LARYNGOSCOPE, RIGID
Laparoscope, general & plastic surgery
Motor, Drill, Electric
Motor, Surgical Instrument, Ac-Powered
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT


------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 12-Oct-2022 09:10
From: Rabel Talpur
Subject: FDA Product Category for sterilization Oil for reusable devcies

Hello Richard,

Thanks for providing the insight, i have reached out FDA as per your provided email above to identify right classification, there is no clear classification of such products (Oil, lubricants).

I will keep you updated here once i have assistance from FDA.

Best,

------------------------------
Rabel Talpur
Freiburg
Germany

Original Message:
Sent: 12-Oct-2022 04:16
From: Richard Vincins
Subject: FDA Product Category for sterilization Oil for reusable devcies

Hello Rabel,

Interesting question, I personally am not familiar with these type of products - new to me.  When looking at sterilisation products, sterilants, and sterilisation accessories many of these are Class II requiring a 510(k) with a couple being Unclassified.  A quick view of the database, I did not see anything straight away.  Maybe as part of the sterilisation process it could be considered in the "sterilant" bucket, but maybe it is just an accessory and not classified at all.  From my view, there could be a concern with left-over materials or residues which could pose a risk to the patient through contamination or irritation.  It would take some research to determine exact classification, but I might suggest inquiring with the FDA - is it a device or not? - process first.  You can do this through emailing US FDA at DeviceDetermination@fda.hhs.gov which they are fairly responsive https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device.  I am sure they have seen these type of products before and while it may not be described in one of the Product Codes or Regulation, they might already know where the product would be classified.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 11-Oct-2022 10:09
From: Rabel Talpur
Subject: FDA Product Category for sterilization Oil for reusable devcies

Dear Experts,

I really appreciate the responses i get to my queries whenever i post some questions.

I once again would appreciate the response if someone can assist that "which product category (FDA) will be suitable for the sterilizable oil for the reusable medical devices that protect devices from the potential rust and wear"? or such product can be exempted from the 510 (k).

I thank in advance to the community for support.

Best Regards,






------------------------------
Rabel Talpur
Freiburg
Germany
------------------------------