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This document outlines the 510(k) premarket notification for Toshiba America Medical Systems, Inc.'s Aplio XG SSA-790A Ultrasound System. It includes device specifications, intended use, safety considerations,

How to fill out 510k premarket notification

How to fill out 510(k) Premarket Notification

1. Determine if your device is eligible for 510(k) submission.
2. Identify a suitable predicate device that is already on the market.
3. Collect data on your device's performance, safety, and efficacy.
4. Prepare the 510(k) submission package, including a cover letter, table of contents, labeling, design specifications, and any necessary testing results.
5. Complete the appropriate FDA forms, including the 510(k) form.
6. Pay the required user fee for the 510(k) submission.
7. Submit the 510(k) to the FDA and monitor for any requests for additional information.

Who needs 510(k) Premarket Notification?

1. Manufacturers of medical devices that are new or modifications of existing devices.
2. Companies seeking to market devices that are not substantially different from already marketed devices.
3. Entities looking to demonstrate that their device is safe and effective for its intended use.

People Also Ask about

What is a 510 K premarket notification?

Information from the Design Controls process is crucial. The FDA usually takes 30-90 days to process 510(k) submissions—however, the entire premarket notification process can take much longer. If accepted, the submission is listed in the database. Generally, Class II medical devices require a 510k submission.

What is the difference between premarket notification and 510k?

510(k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products.

When to submit a 510 K premarket notification?

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the 21 CFR 807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.” This significant effect could be positive or

What is an exemption from the 510K premarket notification requirements?

The premarket notification 510(k) process requires a medical device manufacturer to 'notify' FDA 90 days before they propose to begin marketing a new or certain modified device. This notification submission allows FDA to determine whether a device is substantially equivalent to one or more predicate devices.

What is the pre market notification process?

The premarket notification 510(k) process requires a medical device manufacturer to 'notify' FDA 90 days before they propose to begin marketing a new or certain modified device. This notification submission allows FDA to determine whether a device is substantially equivalent to one or more predicate devices.

How long does it take for the 510 K determination in the case of traditional premarket notification?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

What is a section 510k premarket notification of intent?

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).

For pdfFiller’s FAQs

What is 510(k) Premarket Notification?

The 510(k) Premarket Notification is a submission made to the FDA to demonstrate that a medical device is safe and effective for its intended use, and is substantially equivalent to a device already on the market.

Who is required to file 510(k) Premarket Notification?

Manufacturers of medical devices that are not exempt from premarket notification and intend to market a device that is substantially equivalent to a predicate device must file a 510(k) Premarket Notification.

How to fill out 510(k) Premarket Notification?

To fill out a 510(k), manufacturers must complete the FDA Form 3514 and provide detailed information about the device, its intended use, comparisons with predicate devices, device specifications, and supporting data to demonstrate safety and effectiveness.

What is the purpose of 510(k) Premarket Notification?

The purpose of the 510(k) Premarket Notification is to ensure that medical devices are safe and effective for their intended use by requiring manufacturers to demonstrate that their devices are substantially equivalent to an already legally marketed device.

What information must be reported on 510(k) Premarket Notification?

The information that must be reported includes the device description, intended use, labeling, performance testing data, substantial equivalence claims, and details about the manufacturing process and quality system.