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December 10 t, 2010 Special 510(k-) Summary 4D MV-Assessment 2.0 Owner's Name and Address Toltec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheimn Contact Person Inge Schmidt QM & RA
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How to fill out special 510k- summary
How to fill out special 510k- summary:
01
Enter the required information about the medical device being submitted for review.
02
Provide detailed descriptions of the device's intended use, components, and design.
03
Include a summary of the device's design verification and validation activities.
Who needs special 510k- summary:
01
Medical device manufacturers seeking to obtain clearance from the U.S. Food and Drug Administration (FDA) for a new medical device that is not substantially equivalent to a legally marketed device.
02
Manufacturers who have made modifications to an existing device that could significantly affect its safety or effectiveness.
03
Individuals involved in preparing the 510(k) submission, such as regulatory affairs professionals and product development teams.
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What is special 510k- summary?
A special 510(k) summary is a document that summarizes the intended use, technological characteristics, performance specifications, and labeling of a medical device, along with any clinical performance data.
Who is required to file special 510k- summary?
Manufacturers or sponsors of medical devices, who are submitting a special 510(k) application, are required to file a special 510(k) summary.
How to fill out special 510k- summary?
The special 510(k) summary should be filled out by providing the required information regarding the intended use, technological characteristics, performance specifications, labeling, and any clinical performance data of the medical device.
What is the purpose of special 510k- summary?
The purpose of the special 510(k) summary is to provide a summary of the information that supports the substantial equivalence of the proposed medical device to a legally marketed device.
What information must be reported on special 510k- summary?
The special 510(k) summary must report information such as the intended use of the medical device, technological characteristics, performance specifications, labeling, any clinical performance data, and any modifications to the device or its labeling compared to the predicate device.
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