Clarity on requirements for a 510k exempt Class I device - Suture removal kit

I'm wondering if anyone can provide some clarity on requirements for a 510k exempt Class I device - a suture removal kit.

I need to know if the following are required for a device of this class:
- Shelf Life testing
- Sterility
- Certificate of Analysis
- Biocompatibility Testing

Thank you,
Hi Chris -

Thank you for your reply - very helpful.

I'm wondering if you can also provide clarification about EO sterilized devices in a sterile pouch. My understanding from the sterilizer is that EO is valid for two years. Even if the device would otherwise have a shelf life of ten years, the EO shortens it to two.

Would it be permitted to resterilize by EO at the two-year mark to extend the shelf life of the product?

Thank you,

I would like to ask you if the 510k exempt Class I device is also for custom made medical devices, in this case, I mean custom-made insole (insole which is putting into the shoe). I was looking for the code and for the standard insole, it should be:

Sec. 880.6280 Medical insole.
(a) Identification. A medical insole is a device intended for medical purposes that is placed inside a shoe to relieve the symptoms of athlete's foot infection by absorbing moisture.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 880.9.

Is this code applied also for custom-made insoles?

Thank you


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