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This document summarizes the safety and effectiveness information for a disposable vaginal speculum submitted to the FDA in compliance with regulatory requirements.

How to fill out 510k summary for disposable

How to fill out 510(k) Summary for Disposable Vaginal Speculum

1. Review the FDA guidelines for 510(k) submissions.
2. Gather all necessary information about the Disposable Vaginal Speculum, including design, materials, and intended use.
3. Prepare a comparison table that outlines the similarities and differences between your device and predicate devices.
4. Conduct performance testing, if applicable, to demonstrate safety and efficacy.
5. Complete the 510(k) Summary by summarizing device descriptions, intended use, technological characteristics, and performance data.
6. Include any applicable labeling and instructions for use.
7. Submit the 510(k) Summary along with the appropriate fees to the FDA for review.

Who needs 510(k) Summary for Disposable Vaginal Speculum?

1. Manufacturers of Disposable Vaginal Speculums who intend to market their device in the United States.
2. Companies seeking to demonstrate that their device is substantially equivalent to a predicate device already cleared by the FDA.
3. Startups developing new types of Disposable Vaginal Speculums that need FDA clearance before commercialization.

People Also Ask about

How wide does a pediatric speculum open?

Pediatric or small. 75”, is typically used for patients who have not given birth or who have a smaller vaginal canal.

What type of examination is a speculum?

Speculum examination. The speculum is a metal or plastic instrument used to retract the vaginal walls to enable the clinician to examine the and . There are 2 main types of speculum: Graves (curved blades) and Pederson (straight blades).

What is the classification of a speculum?

Speculum, Vaginal, Nonmetal. Currently the device classification is Class II, under Product Code 85HIB, Regulation Number 884.4530, 21 CFR.

How to report a speculum exam?

To Complete the Examination Thank the patient and allow them to get dressed in private. Dispose of your gloves and wash your hands. Once the patient is dressed you can summarise the findings and suggest further investigations. Send any specimens with a request form.

Is a speculum a medical device?

A speculum (Latin for 'mirror'; pl. : specula or speculums) is a medical tool for investigating body orifices, with a form dependent on the orifice for which it is designed. In old texts, the speculum may also be referred to as a diopter or dioptra.

What is the speculum instrument called?

Bivalve speculum (Cusco's speculum) The two-bladed, or bivalve, speculum is the most common type of instrument gynecologists use to examine the and . The doctor inserts the speculum into the and opens up the blades, which exposes the inside of the and .

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What is 510(k) Summary for Disposable Vaginal Speculum?

The 510(k) Summary for Disposable Vaginal Speculum is a premarket submission made to the FDA to demonstrate that a medical device is safe and effective, and is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary for Disposable Vaginal Speculum?

Manufacturers of Disposable Vaginal Speculums that intend to market their device in the U.S. are required to file a 510(k) Summary with the FDA.

How to fill out 510(k) Summary for Disposable Vaginal Speculum?

To fill out the 510(k) Summary, manufacturers must provide information including device description, intended use, labeling, safety and effectiveness data, and comparison to a predicate device.

What is the purpose of 510(k) Summary for Disposable Vaginal Speculum?

The purpose of the 510(k) Summary is to demonstrate that the Disposable Vaginal Speculum is as safe and effective as a previously cleared device, allowing it to gain FDA clearance for marketing.

What information must be reported on 510(k) Summary for Disposable Vaginal Speculum?

The 510(k) Summary must report information including the device's name, indications for use, technology description, a comparison to predicate devices, and performance testing results.