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Attachment 4 510(k) Summary: JA N 10 2014 This summary is provided as part of this Pre-market Notification in compliance with 21 CRF, Section 807.92. Submitters name: BK Medical Address: Mileparken

How to fill out attachment 4 510k summary

How to fill out Attachment 4 510k summary:

1. Start by providing the necessary information in the header section of the form. This includes the company name, address, and contact details.
2. Move on to the "Device Information" section. Fill in the details about the device for which the 510k submission is being made. Include the device's name, classification, intended use, and relevant regulatory information.
3. In the "Indications for Use" section, describe the specific medical conditions or purposes for which the device is intended to be used. Be clear and concise in explaining the device's intended use and target patient population.
4. Next, provide a detailed summary of the device's technological characteristics in the "Technological Characteristics" section. Describe the device's design, materials used, components, and any specific features that differentiate it from other similar devices.
5. Explain the device's performance and how it meets the safety and effectiveness criteria in the "Performance Data" section. Provide data and supporting evidence to demonstrate that the device performs as intended and is safe for its intended use.
6. Include any previous regulatory information or clearance in the "Previous Submissions or Clearance" section. If the device has gone through any previous regulatory processes or has obtained clearances, provide the relevant details and include copies of any approval letters or documentation.
7. The "Conclusion" section should summarize the key points made throughout the attachment. Briefly highlight the device's intended use, technological characteristics, performance data, and any previous regulatory history.

Who needs Attachment 4 510k summary?

1. Medical device manufacturers who are planning to submit a 510k application for their device to the US Food and Drug Administration (FDA) would need to include Attachment 4 510k summary as part of their submission.
2. Regulatory affairs professionals and consultants who assist medical device companies in preparing and submitting 510k applications would also need to be familiar with Attachment 4 510k summary to ensure accurate and complete submissions.
3. FDA reviewers and officials responsible for evaluating 510k submissions rely on Attachment 4 510k summary to gain a comprehensive understanding of the device's characteristics, intended use, and performance data. Therefore, it is important for them to be knowledgeable about the requirements and formatting of Attachment 4.

For pdfFiller’s FAQs

What is attachment 4 510k summary?

Attachment 4 510k summary is a concise summary of the contents of a 510k submission.

Who is required to file attachment 4 510k summary?

The manufacturer is required to file attachment 4 510k summary.

How to fill out attachment 4 510k summary?

Attachment 4 510k summary should be filled out with a summary of the key information in the 510k submission.

What is the purpose of attachment 4 510k summary?

The purpose of attachment 4 510k summary is to provide a quick overview of the contents of the 510k submission.

What information must be reported on attachment 4 510k summary?

The key information such as device description, indications for use, and device specifications must be reported on attachment 4 510k summary.

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