Hello Shiven,
After email that you sent me these are my thoughts:
I would recommend to evaluate your case by using the flowchart included in the guidance "Deciding when to submit a 510(k) for a change to an existing device (K97-1)".
Answering the questions in the flowchart might help you decide whether to 1) submit a Special or Traditional 510(k); or 2) document the decision-making.
The guidance also indicates that if the consideration of all changes results in a decision to document the decision-making, it is necessary to provide the application of the model and all the records of validation of changes to the device.
Nazanin Shalchian-Gregoretti, M.D., M.S. -------------------------------------------
Nazanin Shalchian Gregoretti MD
Lexington MA
United States
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Original Message:
Sent: 10-30-2014 12:28
From: Nazanin Shalchian Gregoretti
Subject: IEC 60601: Essential Performance and 510(K)
Hello Shiven,
According to your description the modification does not affect the intended use of the device or alter the fundamental scientific technology of the device. As already suggested by Dr. Lim, I also think a Special 510(k) submission might be applicable. The summary information that results from the design control process can serve as the basis for clearing the application along with the required elements of a 510(K) found in 21 CFR 807.87.
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 manufacturer is allowed 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.
In summary, to optimize that a Special 510(k) will be accepted and cleared, you should ensure that the particular change does not affect the intended use of the device or alter the fundamental scientific technology of the device.
Nazanin Shalchian-Gregoretti, M.D., M.S.
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Nazanin Shalchian Gregoretti MD
Lexington MA
United States
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Original Message:
Sent: 10-28-2014 13:23
From: Shiven Gandhi
Subject: IEC 60601: Essential Performance and 510(K)
Hello,
I am working on a FDA submission strategy on deciding 'When to file a 510(K)' for a Class 2 medical device which is a modification to our existing device (predicate).
While comparing to the predicate device (which was a Class 2 510(K) device), our subject (modified) device has same intended use and same technological characteristics as predicate device however we have some new software features in the subject (modified) device which as per IEC 60601 are Essential performance for the device. For the new features we have evaluated through our risk management and have design mitigation are in place. These new features do not raise any new/different questions of safety and effectiveness. The design validations also do not raise any new issues of S&E. Hence going through the SE guidance of July 2014 (which supersedes K-86), the two devices are SE.
The FDA K97-1 guidance on "When to file a 510(K) for a change to an existing device" does not mention anything about filing a new 510(K) when the modified device has new features which are essential performance for the device.
Any suggestions if we are required to file a 510(K) if the subject (modified) device has new features which qualify as 'Essential Performance' under IEC 60601?
Thank you
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Shiven Gandhi
Regulatory Affairs Specialist
Karl Storz
El Segundo CA
United States
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