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

S

SutureOut

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,
Rishi
 
S

SutureOut

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,
Rishi
 

Lukas_Peter

Registered
Dears,

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

lukas
 

QANowatzke

Registered
Hello Experts,
I have a question about 820 requirements for a 510(k) Exempt Class I product (FFT code). Are all the parts of 820 still required, except Design Controls? UDI will also be required correct?
Also, does anyone know where I can find out if this device is required to be provided sterile?
Thank you!
 

chris1price

Trusted Information Resource
Hi, the requirement for sterility is not a direct regulatory issue. It should come from your risk analysis or failing that from market / clinical / surgical requirements.
 

Ronen E

Problem Solver
Moderator
Are all the parts of 820 still required, except Design Controls?
820.1:
[...] If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged. [...]



UDI will also be required correct?
801.20:
(a) In general. (1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter.

(2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter.

(b) Exceptions. Exceptions to the general rule of paragraph (a) of this section are provided by §§801.30, 801.45, and 801.128(f)(2), and §801.55 provides a means to request an exception or alternative not provided by those provisions.
 
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