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This document provides a summary of safety and effectiveness for the SonoSite MaxxTM Series Ultrasound System as part of the Premarket Notification required by the FDA, including device descriptions,

How to fill out 510k summary of safety

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

1. Identify the device that requires a 510(K) submission.
2. Gather all relevant data and documentation regarding the device's safety and effectiveness.
3. Prepare a detailed description of the device, including its intended use and technological characteristics.
4. Conduct a comparison with a legally marketed device (predicate device) to demonstrate substantial equivalence.
5. Include results from any clinical studies or tests that support the device’s safety and effectiveness.
6. Draft the summary in a clear and organized manner, addressing all required elements as per FDA guidelines.
7. Review the summary for completeness and accuracy before submission.
8. Submit the 510(K) summary to the FDA along with the required fee and any additional necessary documentation.

Who needs 510(K) Summary of Safety and Effectiveness?

1. Manufacturers of medical devices intending to market in the United States.
2. Companies introducing a new device that is similar to an existing, legally marketed device (predicate).
3. Developers looking to demonstrate that their device is safe and effective for the intended use.

People Also Ask about

What is the difference between 510k and FDA approval?

The purpose of a 510(k) submission is to prove that your device is safe and effective by comparing it to a similar, legally marketed device—what the FDA calls a “predicate device.” If your 510(k) submission is approved, your product has earned FDA clearance, and you can legally market it.

How long does it take to get a 510 K approval?

The FDA has 90 days to review a traditional 510(k), but the timeline can vary from three to eight months depending on additional information requests and other factors.

What are class 1, class 2, and class 3 devices?

Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)

What are the three types of 510k?

If so, then the 510(k) pathway is not appropriate, and instead, a De Novo or PMA is needed. There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices.

What is the difference between 510k and de novo 510k?

De Novo submissions establish a new classification for devices without predicates and offer a streamlined pathway for low—to moderate-risk devices. 510(k) submissions rely on the substantial equivalence to a predicate device and are the most common route for device approval.

What is the 5 10k approval process?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

What are the different types of 510k?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

For pdfFiller’s FAQs

What is 510(K) Summary of Safety and Effectiveness?

The 510(K) Summary of Safety and Effectiveness is a document submitted to the FDA by medical device manufacturers that provides evidence that a device is safe and effective for its intended use. It is required for certain devices before they can be marketed.

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

Manufacturers of medical devices that are classified as Class II or Class III and intend to sell their devices in the U.S. market are required to file a 510(K) Summary. This also includes companies wanting to demonstrate that their device is substantially equivalent to an already legally marketed device.

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

To fill out a 510(K) Summary, manufacturers must provide comprehensive information including device description, intended use, identifying information, summary of technological characteristics, performance data, and comparisons to predicate devices, among other details. Submission must be aligned with FDA guidelines.

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

The purpose of the 510(K) Summary is to ensure that any medical device being marketed is safe and effective for its intended use, and to demonstrate that it is substantially equivalent to other devices already approved by the FDA.

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

The information that must be reported includes the manufacturer's details, device identification, intended use, description of the device, comparisons to predicate devices, summary of safety and effectiveness data, and any clinical or non-clinical data that supports the claims of safety and effectiveness.