Do we need to submit Special 510K for a Blood Glucose System?

P

paullarn

#1
Hi,

We have a 510K for blood glucose system. We are modifying Glucose meter by relocating meter's buttons and changing enclosure.

Do we need to submit a special 510K?

Regards,


Paul Larn
 
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Ajit Basrur

Staff member
Admin
#2
Re: Do we need to submit for Special 510K?

Hello Paul,

Yes .... but have a look here and see if you meet all requirements - http://www.fda.gov/MedicalDevices/D...sions/PremarketNotification510k/ucm134573.htm


Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls.

The "Special 510(k): Device Modification" utilizes the design control requirement of the Quality System Regulation (21 CFR 820) and may be submitted for a modification to a device that has been cleared under the 510(k) process. The Special 510(k) allows the manufacturer to declare conformance to design controls without providing the data. While the basic content requirements of the 510(k) (21 CFR 807.87) remain the same, this type of submission should also reference the cleared 510(k) number and contain a "Declaration of Conformity" with design control requirements. Manufacturers of Class I devices requiring 510(k) may elect to comply with the design control provision of the QS regulation and submit Special 510(k)s.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Hi,

We have a 510K for blood glucose system. We are modifying Glucose meter by relocating meter's buttons and changing enclosure.

Do we need to submit a special 510K?

Regards,


Paul Larn
Could be, but not necessarily. Check yourself against FDA's guidance:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm

For a brief moment we had an updated guidance, but thanks to politics it was withdrawn until further notice.

Given that you intend to modify the meter's exterior, I strongly recommend that you take a good look at this letter (if you don't already know it by heart):

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm227935.htm

All the best,
Ronen.
 
P

paullarn

#4
Hi Ronen,

Thanks for prompt reply. Can you believe it we had no issues preparing documents for 510K but unable to figure out what they mean by following:

A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on
the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities
required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should
include:
i) A statement signed by the individual responsible, that, as required by the risk
analysis, all verification and validation activities were performed by the designated
individual(s) and the results demonstrated that the predetermined acceptance criteria
were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in
conformance with design control procedure requirements as specified in 21 CFR
820.30 and the records are available for review.

IS FDA looking for "I agree" statements here or are they looking for detailed analysis.

Any example template or example documents will be really appreciated.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
E.g. ISO 14971:2007. Submit the risk analysis results, i.e. the list of identified risks, their estimates and evaluations.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
Submit your detailed verification and/or validation plan(s), aimed at any mitigated risks.
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.
"I agree" statements (in your terms) would do for this item.
 
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