Get the free 510(k) Summary - accessdata fda

This document summarizes the safety and effectiveness information submitted for the Sounmed SD-2000 Plus Portable Ultrasound Scanner in accordance with the 510(k) requirements of the FDA.

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Determine if your device is subject to 510(k) submission.
2. Identify a suitable predicate device that is already legally marketed.
3. Collect all necessary information about your device including design, materials, and intended use.
4. Conduct performance testing and, if applicable, clinical testing to demonstrate safety and effectiveness.
5. Prepare the 510(k) submission, including the 510(k) summary and additional supporting documentation.
6. Submit the 510(k) to the FDA along with the required fee.
7. Respond to any requests for additional information or clarification from the FDA.
8. Wait for FDA's review and decision regarding your 510(k) submission.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are not exempt from 510(k) requirements.
2. Companies looking to market new devices that are substantially equivalent to existing FDA-cleared devices.
3. Firms introducing modifications to existing devices that may significantly affect safety or effectiveness.

People Also Ask about

What are the three types of 510k?

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. Traditional, Special, and Abbreviated 510(k)s require the same user fee.

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

PMA submissions are intended for high-risk devices, whereas De Novo and 510(k) are suitable for lower-risk devices with suitable predicates. Choosing the right submission pathway depends on various factors, including your device's risk level, the availability of predicates, and the resources you have available.

What are the different types of 510k s?

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.

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 is the 510k pathway?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

What is the purpose of a 510 K to determine?

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.

How long does 501k approval take?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

What is the difference between 510k cleared and approved?

When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.

For pdfFiller’s FAQs

What is 510(k) Summary?

A 510(k) Summary is a document submitted to the FDA that provides detailed information about a medical device, demonstrating that it is at least as safe and effective as a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are seeking market approval and believe their device is not substantially different from a device already on the market are required to file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must include details such as device description, indications for use, technological characteristics, comparison to predicate devices, and results of any performance testing.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with sufficient information to determine whether the device is safe and effective, allowing for its clearance for marketing.

What information must be reported on 510(k) Summary?

Information that must be reported on the 510(k) Summary includes device name, description, intended use, predicate device information, technological characteristics, and performance data.