(302 days)
The subject polyurethane condom has the same intended use as the predicate latex condoms. The condom is used for contraceptive and for prophylactic purposes (hclping to prevent transmission of venereal disease). If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted discases, including chlamydia, genital warts, genital warts, gonorrhea, hepatitis B, and syphilis. No contraceptive can guarantee 100% effectiveness. Any use of the condom for other than vaginal intercourse can increase the potential of damage to the condom. For maximum benefits, it is important to follow the instructions for use that accompany the product. Failure to do so may result in the loss of the benefits of a condom. During intimate contact, lesions and various body fluids can transmit sexually transmitted diseases (STDs); therefore, a new condom should be applied each and every time before any such contact occurs. The condom with spermicidal lubricant combines the use of a condom with a spermicidal lubricant. The spermicide, nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if erection is lost before withdrawal and some semen spills outside the condom. However, the extent of decreased risk has not been established. A condom with spermicidal lubricant should not be used as a substitute for the combined use of a vaginal spermicide and a condom.
A condom is a sheath which completely covers the penis with a closely fitting membrane in the case of the subject medical device is made The polyurethanc utilized for the TROJAN® Polyurethane of a polyurethane matcrial. Condom is an aliphatic polyurethane. Unlike an aromatic polyurethane, the aliphatic polyurethane utilized for the TROJAN® Condom does not have the inherent danger of forming methylene dianiline (MDA), a known carcinogen, which can be leached from some aromatic polyurethane materials. The condom provides a physical barrier between the penis and vagina thus. when properly used. reducing the risk of exchange of semen, other body fluids, or microorganisms during sexual intercourse. The subject condom is approximately 59 mm in width and approximately 180 mm in length, with a reservoir tip at the closed end and an integral ring (rim) at the open end. The subject condom is one of two versions intended to be marketed - this version with spermicidal lubricant (nonoxynol-9, 8%) and the other with a silicone lubricant. In consumer use studies with heterosexual couples, the subject device was found to have equivalent performance to that of the predicate device with regard to the parameters of breakage and slippage.
The provided text describes a 510(k) summary for the TROJAN® Polyurethane Condom with Spermicidal Lubricant. This document is a premarket notification demonstrating that the device is at least as safe and effective as a legally marketed predicate device. It does not contain information about an AI/ML powered medical device, therefore, the requested information cannot be extracted from the provided text.
Here's why and what information related to device performance can be extracted:
The document focuses on:
- Device Description and Intended Use: Explaining what the condom is made of (polyurethane), its dimensions, and its purpose (contraception and STI prevention).
- Comparison to Predicate Device: Highlighting the polyurethane material as a key difference from latex condoms and discussing its benefits (no latex allergy risk, stronger, more resistant to deterioration).
- Performance Equivalence: Stating that in consumer use studies, the polyurethane condom had "equivalent performance to that of the predicate device with regard to the parameters of breakage and slippage."
However, the document does NOT include information about:
- AI/ML algorithms
- Acceptance criteria for AI performance metrics (like sensitivity, specificity, AUC)
- Sample sizes for test sets in the context of AI evaluation
- Ground truth establishment by experts for AI
- MRMC studies for AI or any human reader improvement with AI
- Standalone AI performance
- Training set details for AI
The study mentioned ("consumer use studies with heterosexual couples") is a clinical performance study comparing a new medical device to an existing one, not a study evaluating an AI/ML algorithm.
Therefore, I cannot populate the requested table and sections related to AI/ML device evaluation.
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Page 827
TROJAN® Polyurethane Condom with Spermicidal Lubricant
510(k) #K955672 - Additional Information
October 30, 1995
510(k) SUMMARY
| Submitted by: | Carter-Wallace, Inc.Carter Products DivisionP.O. Box 1001Cranbury, NJ 08512(609) 655-6000 |
|---|---|
| Contact Person: | Stephen C. Kolakowsky |
| Date Prepared: | October 30, 1995 |
| Name of Device: | TROJAN® Polyurethane Condomwith Spermicidal Lubricant |
| Classification Name: | Condom with Spermicidal Lubricant |
| Predicate Device: | TROJAN® Latex Condoms |
Description of the Device: A condom is a sheath which completely covers the penis with a closely fitting membrane in the case of the subject medical device is made The polyurethanc utilized for the TROJAN® Polyurethane of a polyurethane matcrial. Condom is an aliphatic polyurethane. Unlike an aromatic polyurethane, the aliphatic polyurethane utilized for the TROJAN® Condom does not have the inherent danger of forming methylene dianiline (MDA), a known carcinogen, which can be leached from some aromatic polyurethane materials. The condom provides a physical barrier between the penis and vagina thus. when properly used. reducing the risk of exchange of semen, other body fluids, or microorganisms during sexual intercourse. The subject condom is approximately 59 mm in width and approximately 180 mm in length, with a reservoir tip at the closed end and an integral ring (rim) at the open end. The subject condom is one of two versions intended to be marketed - this version with spermicidal lubricant (nonoxynol-9, 8%) and the other with a silicone lubricant. In consumer use studies with heterosexual couples, the subject device was found to have equivalent performance to that of the predicate device with regard to the parameters of breakage and slippage.
Intended Use of the Device: The subject polyurethane condom has the same intended use as the predicate latex condoms. The condom is used for contraceptive and for prophylactic purposes (hclping to prevent transmission of venereal disease). If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted discases, including chlamydia, genital warts, genital warts, gonorrhea, hepatitis B, and syphilis. No contraceptive can guarantee 100% effectiveness. Any use of the condom for other than vaginal intercourse can increase the potential of damage to the condom. For
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510(k) SUMMARY (cont'd)
maximum benefits, it is important to follow the instructions for use that accompany the product. Failure to do so may result in the loss of the benefits of a condom. During intimate contact, lesions and various body fluids can transmit sexually transmitted diseases (STDs); therefore, a new condom should be applied each and every time before any such contact occurs. The condom with spermicidal lubricant combines the use of a condom with a spermicidal lubricant. The spermicide, nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if erection is lost before withdrawal and some semen spills outside the condom. However, the extent of decreased risk has not been established. A condom with spermicidal lubricant should not be used as a substitute for the combined use of a vaginal spermicide and a condom.
- Technological Characteristics: The subject device differs from the predicate device in its material composition, i.e., the subject device is composed of polyurcthane and the predicate device is composed of natural rubber latex. The subject device, therefore, docs not have the inherent potential for latex protein sensitization or latex protein allergic reaction as does a latex condom. Also due to the inherent nature of the polyurethane material as compared to natural rubber latex, the subject condom is stronger (has a higher tensile strength and break force), has a lower ultimate elongation, and is more resistant to deterioration by oil and oilhased materials, UV light, and oxidation. The barrier properties of the subject polyurethane condom were compared to those of a latex condom in a viral permeability study. The results of this study demonstrate that the subject polyurcthane condom has equivalent barrier properties to that of a typical latex condom for preventing the transmission of small viral particles across the condom membrane. Toxicological suudies performed provided no indication for toxicological concern. In consumer use studies with heterosexual couples, the subject polyurethane condom was found to have equivalent performance to that of a typical latex condom with regard to the parameters of breakage and slippage. Thus, although the subject polyurethane condom has different technological characteristics, i.e., a different material composition, than that of the predicate latex condoms, the difference does not raise different questions of safety and efficacy. The subject polyurethane condom is, therefore, substantially equivalent in terms of safety and effectiveness. in helping to prevent prognancy and in helping to reduce the risk of transmission of FIN infection (AIDS) and other sexually transmitted diseases (STDs), to the predicate latex condoms currently marketed.
Ussolye
George H. Ohyc Corporate Vice President Compliance and Regulatory
§ 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.