510k Submission all Products to be Lisited?

[mpfizer]

we manufacture orthopaedic implants viz screws , plates and nails in various diameters , size and types e.g. in screws we have say cortical , cancellous , malleolar etc in diameter from 1.5 mm to 7mmm and length from 5mm to 110mm do we need to list each and every product size wise ?


Please help

Thanks

michelle

 

[MIREGMGR]

"Listing" is a different action from "510(k) inclusion". I assume you mean the latter.

FDA nominally discourages inclusion of multiple devices in a single 510(k), primarily because different devices may have different issues and FDA doesn't want a confused examination process in which some of the content of a 510(k) applies to only part of its scope.

FDA however normally does accept 510(k)s written to encompass a family of essentially similar devices, with essentially equal intended uses and risks, differing only in geometry. Sometimes that can be extended to multiple pieces of hardware that are used together to accomplish a single clinical action, if they're sufficiently closely related in intended use and risk. Your 510(k) will need to explain why such a combination/family filing approach fully communicates how your devices are safe and effective.

 

[Ronen E]

Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089731.htm

 

[yana prus]

Michelle,

For implantable devices, usually the 510(k) submission is for the system, which includes the implant, class II device and the accessories, which might be class I or II depends on the classification, and depends on it are subject on the 510(k) submission or otherwise exempt from 510(k) submission. In your product description, including the 510(k) summary, all the parts of the system should be mentioned, while the completed list of sizes, diameters etc. should be only provided for the devices subject to the 510(k) clearance.
Moreover, as you can see in the recent FDA guidance - Refuse to Accept Policy for 510(k)shttp://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM315014.pdf
para. 13 states: If device is intended to be marketed with multiple components, accessories, and/or as part of a system,
Select “N/A” if the device is not intended to be marketed with multiple components, accessories, and/or as part of a system.
a. Submission includes a list of all components and accessories to be marketed with the subject device.
b. Submission includes a description (as detailed in item 11.a. and b. and 12 above) of each component or accessory.
Select “N/A” if the component(s)/accessory(ies) has been previously cleared, or is exempt, and the proposed
indications for use are consistent with the cleared indications
As for the representative drawing for the components:
Submission contains representative engineering drawing(s), schematics,illustrations and/or figures of the device that are clear, legible, labeled, and include dimensions.
In lieu of drawings, schematics, etc. of each device to be marketed, ”representative” drawings, etc. may be provided, where
“representative” is intended to mean that the drawings, etc. provided capture the differences in design, size, and other important
characteristics of the various models, sizes, or versions of the device(s) to be marketed.
Select “N/A” if the submitter provided a rationale for why the submission does not contain engineering drawings, schematics, etc. (e.g., device is a reagent and figures are not pertinent to describe the device).
As you can see, if the full list of the components is not provided, this might lead to the refuse to accept 510(k) decision, so I would say that it is rather critical to provide as full list of the components subject to 510(k) clearance as possible.

Good Luck,

Yana

 

[MIREGMGR]

I read the original post to refer to hardware devices that are marketed as such, and not as clinical-procedure-specific systems.

If that was wrong, then Yana's information is on point.

 

[Lynn.Fu]

in your 510k report, it is necessary to narrate the specificaitons of the subjected device and their accessories

 

[nutty12]

Hi!
where does this information have to be included?
Just in the CDRH PREMARKET REVIEW SUBMISSION COVER SHEET?

For example, if the common name of a device is "syringe kit" and the models are "small syringe kit", "large syringe kit" and "medium syringe kit" depending on the size of the syringe, how do we have to specify and where exactly in the 510K submission?

Thanks in advance,

 

[yana prus]

Hi,

This information should be included in the 510(k) Summary section, in the Executive summary chapter brief information regarding "syringe kit" and the models.

In addition, detailed description of "syringe kit" and the models should be included in the device description section of 510(k).

Hope that helps.

Yana