Get the free 510(k) Summary - Infiniti Vision System (Evergreen 11) - accessdata fda

This document provides a summary of the 510(k) premarket notification for the Infiniti Vision System, detailing its intended uses, device descriptions, and compliance with safety standards.

How to fill out 510k summary - infiniti

How to fill out 510(k) Summary - Infiniti Vision System (Evergreen 11)

1. Identify the intended use of the Infiniti Vision System (Evergreen 11).
2. Gather the necessary information regarding the device description, including design, materials, and components.
3. Compile performance data, including clinical and non-clinical tests to demonstrate safety and effectiveness.
4. Compare the Infiniti Vision System to a legally marketed predicate device to establish substantial equivalence.
5. Prepare a summary of the device's performance testing results and a general discussion of the device's compliance with relevant standards.
6. Include labeling information that will accompany the device, such as instructions for use and indications for use.
7. Ensure all documentation is organized and formatted according to FDA guidelines.
8. Submit the completed 510(k) Summary to the FDA for review, ensuring all required elements are included.

Who needs 510(k) Summary - Infiniti Vision System (Evergreen 11)?

1. Manufacturers of the Infiniti Vision System (Evergreen 11) seeking market clearance in the U.S.
2. Distributors or suppliers of the device who need to demonstrate regulatory compliance.
3. Healthcare providers or institutions planning to use or implement the system and require clarity on its regulatory status.
4. Regulatory affairs professionals involved in guiding the device through the FDA submission process.

People Also Ask about

How to view 510 k submissions?

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 is a 510k device?

Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.

What is the difference between 510k and FDA approval?

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 FDA 510k pathway?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

What is the 510k clearance process?

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.

What is the 510k pathway?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

For pdfFiller’s FAQs

What is 510(k) Summary - Infiniti Vision System (Evergreen 11)?

The 510(k) Summary is a document submitted to the FDA by manufacturers to demonstrate that their medical device, such as the Infiniti Vision System (Evergreen 11), is substantially equivalent to a device already on the market.

Who is required to file 510(k) Summary - Infiniti Vision System (Evergreen 11)?

Manufacturers of medical devices that are not exempt from premarket notification requirements must file a 510(k) Summary for products like the Infiniti Vision System (Evergreen 11) before they can be marketed.

How to fill out 510(k) Summary - Infiniti Vision System (Evergreen 11)?

To fill out the 510(k) Summary, manufacturers must complete the relevant sections of the FDA Form 3514, providing information on device identification, intended use, technological characteristics, and evidence of substantial equivalence.

What is the purpose of 510(k) Summary - Infiniti Vision System (Evergreen 11)?

The purpose of the 510(k) Summary is to provide the FDA with enough information to determine whether the Infiniti Vision System (Evergreen 11) is safe and effective for the intended use and if it is substantially equivalent to a predicate device.

What information must be reported on 510(k) Summary - Infiniti Vision System (Evergreen 11)?

The 510(k) Summary must include the manufacturer's name and address, device name, intended use, description of the device, predicate device details, performance testing results, and a comparison of the technological characteristics to the predicate device.