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APR 1 020138. 510(K) Summary 807.921The following Special 51 0(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92. Manufacturer Information Name & Address Submitted by:
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01
To fill out a special 510k summary APR, follow these steps:
02
Start by identifying the specific device and intended use.
03
Provide a brief description of the device, including its design, features, and components.
04
Include information about the device indications for use and any specific patient population it targets.
05
Detail any modifications or changes made to the device, including design changes, materials, or software updates.
06
Describe any performance testing conducted to demonstrate the safety and effectiveness of the device.
07
Discuss the results of the testing and provide supporting data or documentation.
08
Include information about any clinical studies or investigations conducted on the device.
09
Provide a summary of the device's labeling, including instructions for use, warnings, and precautions.
10
Include any adverse event reports, recalls, or complaints related to the device.
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Finally, ensure that the summary APR is accurate, clear, and concise, and meets all regulatory requirements.

Who needs special 510k summary apr?

01
Special 510k summary APR is required for medical device manufacturers who are seeking to make modifications or changes to an existing device that may affect its safety or effectiveness.
02
These modifications or changes can include design changes, materials, software updates, or changes in indications for use.
03
The special 510k summary APR is necessary to demonstrate that these modifications or changes maintain the device's safety and effectiveness and comply with regulatory requirements.
04
It is also required for devices that have been previously cleared or approved through the 510k process and are being used as a reference for a new device.
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Special 510k summary apr is a summary document that provides a concise explanation of the data and information submitted in support of a special 510(k) submission.
Manufacturers who are submitting a special 510(k) application are required to include a special 510k summary apr with their submission.
The special 510k summary apr should be filled out by providing a summary of the data and information that supports the special 510(k) submission in a clear and concise manner.
The purpose of special 510k summary apr is to provide a quick and informative overview of the data and information submitted in a special 510(k) application.
The special 510k summary apr should include a summary of the purpose of the submission, a brief description of the device, a summary of the performance data, and any other relevant information.
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