The Remed Preventor Ribbed Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Ribbed condom is a ribbed surfaced condom with no color additives, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.

Device Description

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the "Remed Pharma Male Ribbed Rubber Latex Condom." This type of document declares a device substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

Crucially, this document is not a study report or clinical trial summary. Therefore, it does not contain the detailed information needed to answer many of the questions about acceptance criteria, study design, sample size, ground truth, or expert qualifications. The FDA clearance is based on the claim of substantial equivalence to a predicate device, meaning it's assumed to perform similarly to what's already on the market, rather than requiring a detailed new performance study as would be the case for a novel device or a Premarket Approval (PMA) application.

However, I can extract what is explicitly stated or can be reasonably inferred from the document:

1. A table of acceptance criteria and the reported device performance:

The document does not provide a table of acceptance criteria or specific reported device performance data in the format typically found in a study report. It acknowledges the device as a "Male Ribbed Rubber Latex Condom" and states its intended uses for "contraception and to help prevent the transmission of sexually transmitted diseases."

The only performance-related requirement mentioned is regarding expiration dating:

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with 21 CFR 801.435 for expiration dating.	Not explicitly reported in this letter, but compliance is required.
Supported by test data developed under 801.435(d).	Not explicitly reported in this letter, but data must be maintained by the manufacturer.
Shelf life not more than five years.	Not explicitly reported; if real-time data fails to confirm estimated shelf life, relabeling is required.
For spermicidal condoms, shelf life of spermicide compared to condom shelf life and labeled accordingly.	Not applicable, as this device's indication does not mention spermicide.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided. This document is a regulatory clearance letter, not a study report. The FDA's 510(k) process for substantial equivalence typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new large-scale clinical trials or specific sample sizes for "test sets" in the manner of an AI/ML device study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not provided. The concept of "ground truth" established by experts for a test set (as in an AI/ML context) is not relevant to this 510(k) clearance for a condom.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not provided.

5. 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 applicable/Not provided. This is relevant for AI/ML device evaluations, not for a condom.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable/Not provided in the context of typical clinical study ground truth. For a condom, "ground truth" regarding its effectiveness would typically relate to physical properties, barrier integrity, and contraceptive/disease prevention efficacy established through standardized testing methods, not expert consensus on image interpretation or pathology. The letter mentions that expiration dates must be "supported by test data," implying physical integrity and efficacy over time, but details of these tests are not provided.

8. The sample size for the training set:

Not applicable/Not provided. This is an AI/ML concept.

9. How the ground truth for the training set was established:

Not applicable/Not provided. This is an AI/ML concept.

In summary, the provided document is a regulatory approval, not a scientific study report. It confirms that the device is "substantially equivalent" to existing devices but does not detail the specific performance studies, sample sizes, or ground truth methodologies that would be pertinent to a comprehensive evaluation of an AI-powered medical device. The only "acceptance criteria" discussed relate to regulatory compliance, particularly regarding labeling and expiration dating based on pre-existing regulations.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2000

Remed Pharma c/o E. J. Smith Consultant Smith Associates P.O. Box 4341 Crofton, MD 21114 Re: K993408 Remed Pharma Male Ribbed Rubber Latex Condom Dated: December 20, 1999 Received: December 21, 1999 Regulatory Class: II 21 CFR §884.5300/Procode: 85 HIS

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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

Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR 884.5300 and 884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the expiration dates. Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in 801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.

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Page 2 - Mr. E. J. Smith

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597,or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

for

CAPT Daniel G. Schultz, M.D. Acting Director Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATION FOR USE STATEMENT

k-193408 510(K) Number (if known):

Device Name: Remed Pharma Male Ribbed Condom

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use ✓

David U. Seymour

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993408

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.