LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT by REDDY MEDTECH HEALTH PRODUCTS LTD.

If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.

Device Description

Not Found

AI/ML Overview

The provided documents are a 510(k) clearance letter and an "Indications For Use" statement for a Latex Condom with Spermicidal Lubricant. These documents confirm the device has been cleared by the FDA as substantially equivalent to previously marketed devices. However, they do not contain any information regarding specific acceptance criteria, performance studies, or technical data that would describe how the device meets such criteria.

Therefore, for each of your requested points, I must state that the information is not available in the provided text.

Here's a breakdown based on your request:

A table of acceptance criteria and the reported device performance
- Not Available: The provided documents do not specify any acceptance criteria (e.g., burst pressure, freedom from holes, shelf life, or spermicide effectiveness) or report specific performance metrics against such criteria.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Available: The documents do not describe any specific test sets, sample sizes, or data provenance for performance evaluation.
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 Available: This type of information is typically related to diagnostic devices where expert interpretation establishes ground truth (e.g., pathology, radiology). For a condom, "ground truth" would relate to its physical properties and effectiveness, which are measured through standardized tests, not expert consensus in the same way. The documents do not describe any expert involvement in establishing ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Available: Similar to point 3, adjudication methods are relevant for subjective interpretations, often in diagnostic studies. For a physical barrier device like a condom, performance is assessed objectively via standardized tests, not through adjudication of expert opinions. The documents do not mention any adjudication method.
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: MRMC studies are used for evaluating diagnostic imaging devices, often involving AI assistance for human readers. This device is a condom, not an AI-assisted diagnostic imaging tool. Therefore, an MRMC study is not relevant or described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This question pertains to AI algorithms. The device is a latex condom with spermicidal lubricant, not an algorithm, so a standalone algorithm performance study is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available / Not Applicable in the way typically asked for diagnostic devices: For a condom, ground truth would fundamentally be established through standardized physical and chemical testing (e.g., burst strength, freedom from holes, spermicide efficacy testing). The documents do not detail the specific types of ground truth used for performance assessment.
The sample size for the training set
- Not Applicable / Not Available: This question is relevant to machine learning/AI models, which do not apply to this device. Also, the documents do not describe any "training set" for physical product testing.
How the ground truth for the training set was established
- Not Applicable / Not Available: Similar to point 8, this question is for AI/machine learning models and does not apply to this device.

In summary, the provided FDA 510(k) clearance documentation for this condom confirms its regulatory status but does not delve into the detailed performance study data, acceptance criteria, or methodology that would be expected for a comprehensive technical report. Such information would typically be found in the manufacturer's internal test reports or the complete 510(k) submission, which is not provided here.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized human figure with three curved lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH" which is arranged vertically.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ravi Reddy Reddy Medtech Health Products, Ltd. 9 Webster Court Plainsboro, NJ 08536

Re: K974324

Latex Condoms, with Spermicidal Lubricant Dated: November 7, 1997 Received: November 18, 1997 Regulatory Class: II 21 CFR 884.5310/Procode: 85 LTZ & HIS

FEB - 9 1998

Dear Mr. Reddy:

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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 requirement, as set forth in the Quality System Regulation (OS) 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (30) 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/dsmamain.html".

Sincerely yours,

h. William Griffin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of --

510(k) NUMBER (IF KNOWN): K 97432

DEVICE NAME:

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 (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Robert D. Rathbun/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

K974324 510(k) Number

Regulation Number and Section

§ 884.5310 Condom with spermicidal lubricant.

(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).