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MAR 2 22012 510(k) Summary K113657 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R.

How to fill out this summary of 510k

How to fill out this summary of 510k?

1. Start by gathering all the necessary information regarding the medical device for which the 510k summary is being filled out. This includes details on the device's intended use, design, specifications, and any changes made since the previous submission.
2. Begin the summary by providing a concise description of the medical device. Include its intended use, indications for use, and a summary of its technological characteristics. This section should clearly define the device and its purpose.
3. Identify any similar devices that are currently marketed and provide a comparison with the device being submitted. Highlight the similarities and differences, emphasizing how the new device meets the same safety and efficacy standards.
4. Include a detailed summary of any scientific and technical information available regarding the device. This may include data from clinical studies, bench tests, or other relevant studies. Provide a thorough analysis of this information, presenting it in a clear and understandable manner.
5. Describe any potential risks or hazards associated with the device and detail the mitigations put in place to minimize these risks. This includes any labeling or instructions for use that are necessary for safe and effective use of the device.
6. Outline any performance characteristics or parameters of the device that are important for its safe and effective use. This may include details on its reliability, durability, or any specific design features that contribute to its functionality.
7. Provide a summary of any non-clinical testing performed on the device, such as biocompatibility studies, electrical safety tests, or mechanical testing. Include the results and explain how they support the device's safety and performance.
8. If applicable, include information on the device's compatibility with other devices or systems. Highlight any necessary precautions or considerations when using the device in conjunction with other medical equipment.
9. Finally, conclude the summary by reiterating the key points and summarizing why the device meets the requirements for clearance or approval. Emphasize its safety, effectiveness, and any unique advantages it may offer over similar devices in the market.

Who needs this summary of 510k?

1. Manufacturers or developers of medical devices seeking clearance or approval from regulatory agencies, such as the U.S. Food and Drug Administration (FDA).
2. Regulatory affairs professionals or consultants responsible for compiling and submitting the 510k application on behalf of the manufacturer.
3. Quality assurance and compliance teams within the medical device industry who ensure adherence to regulatory requirements.
4. Healthcare professionals, researchers, and other stakeholders who need to assess the safety and effectiveness of medical devices before using or recommending them in clinical practice.

For pdfFiller’s FAQs

What is this summary of 510k?

The summary of 510k is a concise overview of the submission made to the FDA for a medical device clearance.

Who is required to file this summary of 510k?

Manufacturers of medical devices seeking FDA clearance through the 510k process are required to file this summary.

How to fill out this summary of 510k?

The summary of 510k can be filled out by providing a brief description of the device, its intended use, and the basis for substantial equivalence to a predicate device.

What is the purpose of this summary of 510k?

The purpose of the summary of 510k is to provide a high-level overview of the information submitted in the full 510k application.

What information must be reported on this summary of 510k?

The summary of 510k must include information on the device, its intended use, the predicate device used for comparison, and any differences or modifications.

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