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This document provides a summary of the safety and effectiveness of the Bipolar Forceps, a medical device intended for use in open and laparoscopic surgeries for grasping, coagulating, and transecting

How to fill out 120 510k summary of

How to fill out 12.0 510(k) Summary of Safety and Effectiveness

1. Gather product information including intended use and indications for use.
2. Identify the predicate device(s) that your product is comparable to.
3. Collect safety and effectiveness data such as clinical studies or literature.
4. Provide a description of the device, including materials and mechanisms.
5. Document any potential risks associated with the device and how they are mitigated.
6. Prepare summary tables for performance testing results against the predicate.
7. Draft the summary sections adhering to FDA formatting guidelines.
8. Review and revise the summary for clarity and completeness.
9. Compile all sections into a cohesive 510(k) submission package.
10. Submit the 510(k) to the FDA and await feedback.

Who needs 12.0 510(k) Summary of Safety and Effectiveness?

1. Manufacturers of medical devices that are seeking FDA clearance for marketing.
2. Developers looking to demonstrate their device's safety and effectiveness based on existing predicates.
3. Companies needing to comply with regulatory requirements for new or modified medical devices.

People Also Ask about

What is the FDA 510k summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

What is 501k approval?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

What is the 510k summary?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is the 510k clearance process?

The 510k clearance process is the most common pre-market pathway used by medical device companies to legally sell products in the US, as data from the FDA shows that: 35% of medical devices are in Class I, the lowest risk class, as they present minimal potential for harm to the end user.

What is the 501k process?

It's important to note that clearance under the 510(k) pathway does not indicate that the FDA has approved the device but rather that the FDA has determined the device is equivalent to a similar device already on the market.

What is 510k summary report?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

What does FDA granted 510 K clearance mean?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

For pdfFiller’s FAQs

What is 12.0 510(k) Summary of Safety and Effectiveness?

The 12.0 510(k) Summary of Safety and Effectiveness is a document submitted to the FDA that outlines the safety and effectiveness of a medical device. It provides information on the device's design, materials, intended use, and clinical data to demonstrate that it is as safe and effective as a legally marketed device.

Who is required to file 12.0 510(k) Summary of Safety and Effectiveness?

Manufacturers of medical devices who wish to market a device that is similar to an already marketed device are required to file a 510(k) Summary of Safety and Effectiveness. This includes companies looking to introduce new devices or modifications to existing devices.

How to fill out 12.0 510(k) Summary of Safety and Effectiveness?

To fill out the 12.0 510(k) Summary, manufacturers need to provide detailed information including device description, intended use, labeling, proposed indications for use, comparison to predicate devices, and any safety and effectiveness data obtained through testing and clinical trials.

What is the purpose of 12.0 510(k) Summary of Safety and Effectiveness?

The purpose of the 12.0 510(k) Summary is to demonstrate to the FDA that a new device is safe and effective for its intended purpose based on substantial equivalence to a predicate device. It allows for a streamlined process for market entry of devices that do not require premarket approval.

What information must be reported on 12.0 510(k) Summary of Safety and Effectiveness?

The information that must be reported includes the device name, model, regulatory information, description, intended use, labeling, any clinical data, and comparisons with predicate devices, including details on safety and performance testing.