Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

For 510(k) substantial equivalence to predicate and specifically the technological characteristics from a material perspective, is it sufficient to demonstrate physical equivalence or is it necessary to also demonstrate material composition equivalence? For example, if the new device is a tube that is implanted into a patient and but there is limited information available on the predicate 510(k) in relation to the material composition, is it sufficient to provide the dimensional characteristic comparison (length, OD, ID, tensile, etc.) to the predicate device or do you need to perform material testing (FTIR, etc), to determine the material content of the predicate in addition to biocompatibility, etc.? Is it acceptable to perform this type of reverse engineering for a 510(k) Substantial Equivalence?

Hello Anon,

For materials in the substantial equivalence discussion, try to be as detailed as possible, but in some cases the exact material composition may not be known.  However, using statements such as PVC or silicone may be sufficient as the US FDA does have the ability to review the predicate device 510(k) knowing the materials.  As an example, a tube implanted may be made of silicone, but the exact hardness and composition may not be known.  Describe in the substantial equivalence discussion the tubing from both devices are silicone which is a common material used, etc. etc.  Then within the subject device, your device, would describe the full characteristics of the tubing such as length, OD, ID, Durometer, and other performance characteristics.  In some cases, the basic material type and other characteristics might be listed in the predicate device 510(k) Summary, so this is a good source to use.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 04-Jul-2023 11:10
From: Anonymous Member
Subject: Substantial Equivalence - Technological Characteristics

This message was posted by a user wishing to remain anonymous

For 510(k) substantial equivalence to predicate and specifically the technological characteristics from a material perspective, is it sufficient to demonstrate physical equivalence or is it necessary to also demonstrate material composition equivalence? <o:p></o:p>For example, if the new device is a tube that is implanted into a patient and but there is limited information available on the predicate 510(k) in relation to the material composition, is it sufficient to provide the dimensional characteristic comparison (length, OD, ID, tensile, etc.) to the predicate device or do you need to perform material testing (FTIR, etc), to determine the material content of the predicate in addition to biocompatibility, etc.? Is it acceptable to perform this type of reverse engineering for a 510(k) Substantial Equivalence?<o:p></o:p>

Hello Anon

A key point to think about is whether material composition is a characteristic related to safety. It is certainly not necessary to use the same material as the predicate device to achieve the benefits of the intended use. The point of demonstrating substantial equivalence is that the technological characteristics do not present any new question related to "safety and effectiveness". In my view, if the material composition is a relevant factor for safety, then sufficient data should be provided to satisfy the expectation of safety and effectiveness.

Best regards.

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Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/
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Original Message:
Sent: 04-Jul-2023 11:10
From: Anonymous Member
Subject: Substantial Equivalence - Technological Characteristics

This message was posted by a user wishing to remain anonymous

For 510(k) substantial equivalence to predicate and specifically the technological characteristics from a material perspective, is it sufficient to demonstrate physical equivalence or is it necessary to also demonstrate material composition equivalence? <o:p></o:p>For example, if the new device is a tube that is implanted into a patient and but there is limited information available on the predicate 510(k) in relation to the material composition, is it sufficient to provide the dimensional characteristic comparison (length, OD, ID, tensile, etc.) to the predicate device or do you need to perform material testing (FTIR, etc), to determine the material content of the predicate in addition to biocompatibility, etc.? Is it acceptable to perform this type of reverse engineering for a 510(k) Substantial Equivalence?<o:p></o:p>

Hello Anon,

Generally, comparative assessment physical/technology attributes and performance testing, as well as intended use and indications for should be all that is required for your equivalence argument in the submission. 

You should not have to reverse engineer the predicate product for biocompatibility. Your own biocomp testing should be sufficient,  provided it is performed in a qualified lab, and testing endpoints are selected/justified based on your biocompatibility risk assessment (related to your device's material composition, manufacturing processes, and intended use).

FDA does not typically accept the argument that your device is composed of exactly the same materials as the predicate and therefore you  don't have to test your device for  biocompatibility.  This is because you don't know where your competitor obtained their materials and how they processed it to get to the final device. 

Note, if you using your own device as predicate for a modified device, you might be able to claim that if nothing changed, but be prepared to justify it in the biocomp section of the submission.

Good luck.  I suggest you look at competitive 510k summaries in your product code (FDA database)  for examples of how others position their SE statements.

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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
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Original Message:
Sent: 04-Jul-2023 11:10
From: Anonymous Member
Subject: Substantial Equivalence - Technological Characteristics

This message was posted by a user wishing to remain anonymous

For 510(k) substantial equivalence to predicate and specifically the technological characteristics from a material perspective, is it sufficient to demonstrate physical equivalence or is it necessary to also demonstrate material composition equivalence? <o:p></o:p>For example, if the new device is a tube that is implanted into a patient and but there is limited information available on the predicate 510(k) in relation to the material composition, is it sufficient to provide the dimensional characteristic comparison (length, OD, ID, tensile, etc.) to the predicate device or do you need to perform material testing (FTIR, etc), to determine the material content of the predicate in addition to biocompatibility, etc.? Is it acceptable to perform this type of reverse engineering for a 510(k) Substantial Equivalence?<o:p></o:p>

This message was posted by a user wishing to remain anonymous

Hi Anon,

In addition, you can always get a sample of the competitor's product and perform side-by-side testing. Would their brochure (public-facing) document contain any information? 

Original Message:
Sent: 04-Jul-2023 11:10
From: Anonymous Member
Subject: Substantial Equivalence - Technological Characteristics

This message was posted by a user wishing to remain anonymous

For 510(k) substantial equivalence to predicate and specifically the technological characteristics from a material perspective, is it sufficient to demonstrate physical equivalence or is it necessary to also demonstrate material composition equivalence? <o:p></o:p>For example, if the new device is a tube that is implanted into a patient and but there is limited information available on the predicate 510(k) in relation to the material composition, is it sufficient to provide the dimensional characteristic comparison (length, OD, ID, tensile, etc.) to the predicate device or do you need to perform material testing (FTIR, etc), to determine the material content of the predicate in addition to biocompatibility, etc.? Is it acceptable to perform this type of reverse engineering for a 510(k) Substantial Equivalence?<o:p></o:p>

Hi, you can provide high level data used in the predicate device summary to do the comparison. As product owner you will have access to your device material specs which can be submitted. FDA will have access to full file of the predicate, and they can determine if equivalent or they will ask you for specific data of your product to determine equivalence  Reverse engineering alone may not be sufficient to demonstrate substantial equivalence.

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Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
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Original Message:
Sent: 04-Jul-2023 11:10
From: Anonymous Member
Subject: Substantial Equivalence - Technological Characteristics

This message was posted by a user wishing to remain anonymous

For 510(k) substantial equivalence to predicate and specifically the technological characteristics from a material perspective, is it sufficient to demonstrate physical equivalence or is it necessary to also demonstrate material composition equivalence? <o:p></o:p>For example, if the new device is a tube that is implanted into a patient and but there is limited information available on the predicate 510(k) in relation to the material composition, is it sufficient to provide the dimensional characteristic comparison (length, OD, ID, tensile, etc.) to the predicate device or do you need to perform material testing (FTIR, etc), to determine the material content of the predicate in addition to biocompatibility, etc.? Is it acceptable to perform this type of reverse engineering for a 510(k) Substantial Equivalence?<o:p></o:p>