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JUL 08 2014K14 1151Section 5ATraditional 510KSubmitter Information:Submitter:WEBCOMIC 1499 Help Drive11UdCOMP0 I499 Help Drive51IO(k) SUMEIARYHarleysville. PA 19438 Contact: Date Prepared:(215) 2569191

How to fill out traditional 510k

How to fill out traditional 510k

1. Prepare the necessary documents and information required to fill out the traditional 510k form.
2. Start by providing the device identification information, including the name, model number, and intended use.
3. Include the device's substantial equivalence statement, demonstrating how it is similar to another legally marketed device.
4. Describe the device's technological characteristics and identify any electrical, mechanical, or performance specifications.
5. Provide detailed information on the device's components and materials used in its manufacturing.
6. Include labeling information, such as the device's indications for use, warnings, and contraindications.
7. Describe any specific performance testing conducted on the device and provide the results.
8. Complete the biocompatibility section, outlining any potential risks associated with the device's contact with the human body.
9. Submit any clinical data and studies conducted to validate the device's safety and effectiveness.
10. Include any previous history of FDA submissions related to the device.
11. Ensure all information provided is accurate and up-to-date before finalizing the form.
12. Submit the completed traditional 510k form to the FDA for review.

Who needs traditional 510k?

1. Manufacturers of Class II medical devices that are not subject to an exemption, modification, or special controls under the FDA regulations require a traditional 510k submission.

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What is traditional 510k?

Traditional 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device).

Who is required to file traditional 510k?

Manufacturers of medical devices that are not exempt from the 510(k) requirements are required to file a traditional 510(k).

How to fill out traditional 510k?

To fill out a traditional 510(k), manufacturers must provide detailed information about the device, predicate device, testing data, labeling, and any relevant clinical studies.

What is the purpose of traditional 510k?

The purpose of traditional 510(k) is to demonstrate that a medical device is as safe and effective as a legally marketed device, known as the predicate device.

What information must be reported on traditional 510k?

Information reported on traditional 510(k) includes device description, intended use, substantial equivalence to predicate device, testing data, labeling, and any information that demonstrates the device's safety and effectiveness.

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