AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 by AMNISURE INTERNATIONAL, LLC

The Amnisure® ROM (rupture of fetal membrane) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of ammiotic fluid in vaginal secretion of pregnant women. Amnisure® detects PAMG-1 protein marker of the amnictic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of ROM when patients report signs, symptoms or complaints suggestive of ROM.

Device Description

AI/ML Overview

The request asks to extract information about the acceptance criteria and study details for the Amnisure® ROM (rupture of fetal membrane) test. However, the provided document is a 510(k) clearance letter from the FDA, which confirms the substantial equivalence of the device but does not contain the detailed study results, acceptance criteria, or performance data that would typically be found in a clinical study report or a more comprehensive submission summary.

The letter explicitly states that it is a substantial equivalence determination and does not imply that the FDA has made a determination that the device complies with other requirements of the Act or other federal statutes and regulations. The details of the performance study are not included in this document.

Therefore,Based on the provided document, the following information cannot be extracted:

A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. Such details would typically be in the 510(k) submission itself or a summary thereof, not the clearance letter.
Sample sized used for the test set and the data provenance: Not available in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
Adjudication method for the test set: Not available in this document.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available in this document. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for image interpretation or similar.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is an immunochromatographic test, not an algorithm.
The type of ground truth used: Not available in this document.
The sample size for the training set: Not applicable as this is not an AI/algorithm-based device in the sense of requiring a "training set" for machine learning.
How the ground truth for the training set was established: Not applicable for the same reason as above.

The document only describes the device, its indication for use, and its classification and clearance by the FDA based on substantial equivalence to a predicate device. It does not contain the specific performance study details requested.

Summary

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AmniSure® International, LLC c/o Mr. Michael Friedman Director of Regulatory Affairs 30 JFK Street, 4th Floor Cambridge, MA 02138

JAN - 9 2009

Re: K081767

Trade/Device Name: Amnisure® ROM (rupture of fetal membrane) test Regulation Number: 21 CFR 862.1550 Regulation Name: Urinary pH test system Regulatory Class: Class I, meets limitations of exemptions 862.9 (a) Product Code: NOM Dated: December 22, 2008 Received: December 29, 2008

Dear Mr. Friedman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. Yourse us comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally marketed predicate device results in a classification for your device and thus, bereat to your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Officer of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please othe the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolly free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K081767

Device Name: Amnisure® ROM (rupture of fetal membrane) test

Indications For Use:

Prescription Use_______________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

Carol Benson

Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081767

Regulation Number and Section

§ 862.1550 Urinary pH (nonquantitative) test system.

(a)
Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.