Help with Surgical Class I + 510(k) exemption

marmotte

Diapason Consulting
Dear all,

I have a fair bit of experience with class II and SW/active devices, not surgical "passive" stuff).
Working for a client (no other products, no listing/registration yet, early stages of dev) who is developing a new surgical device. It is aimed primarily at a specific plastic procedure but could have other use.

The device is a handheld dissector, not powered, disposable/single use, standalone (i.e. not to be used with laparoscopy).

In my book it is class I under product code GDI and reg 878.4800, “Manual surgical instrument for general use” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=878.4800

I'm not sure what to make though of the exemption rule :

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 § 878.9. CFR - Code of Federal Regulations Title 21

These limitations describe:

The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic[...]
Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:


(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology;


I am a bit confused by this process / rule

Are there any guidance doc available to explain / illustrate what are "existing or reasonably foreseeable" characteristics? The examples they give "laser versus blade" are so stereotypical that they are not helpful. Same with the doctor/lay difference like Is a 510K required for a Home Use Class I Exempt Medical Device?

In our case, the differences are more subtle. I don't believe I could find an existing device in this product code specifically intended for the exact same procedure - but at the same time all the devices in this sort of products are always aimed a specific procedure / different parts of the body. When you look at a surgical tools catalogue you'd have hundreds of sorts of dissectors with geometries adapted to different areas and types of surgeries etc - yet I cannot find any such 510(k)s so obviously the "current practice" is to take this rule liberally.

Still if I understand this rule well:
A/ if the device has existing or reasonably foreseeable characteristics of commercially distributed device of this same type (name / product code), then it can be marketed without a 510(k).
B/ if not, then a 510(k) is required.

But if B/ is required - then what predicate can be used for the 510(k)? The trigger for needing a 510(k) then is not having a predicate in a first place. Is this some sort of easter egg / catch 22?

I hope my question makes sense.

THX for your help
 
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