(159 days)
For Latex Sensitive Condom Users: This is a TACTYLON® condom. This is not a latex condom. You may use this TACTYLON ® condom if you or your partner are allergic to latex. You should know: - . The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS (HIV infection), are not known for this condom. A study is being done. - . There are laboratory tests on this TACTYLON® material. These tests show that organisms even as small as sperm and viruses like HIV cannot pass through it. Latex condoms for men, if used correctly with every act of vaginal intercourse are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection).
The synthetic TACTYLON® condom contains neither NRL protein allergens nor sensitizing chemicals. The TACTYLON® condom is made from styrene-ethylene-butylene-styrene thermoplastic elastomer block copolymer but has physical properties (e.g., strength, elasticity, and tactility) and dimensions that are substantially equivalent to a NRL condom.
Here's a breakdown of the acceptance criteria and study information for the LUBRICATED HIGH ELONGATION CONDOM, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The device's acceptance criteria are based on demonstrating substantial equivalence to Natural Rubber Latex (NRL) condoms, particularly concerning barrier properties, clinical breakage/slippage rates, and safety (non-allergenicity, non-toxicity, non-irritating).
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Material Safety (Non-Toxicity) | Meets FDA Class VI requirements for materials. | TACTYLON® block copolymer meets FDA Class VI requirements. Plastisizer is USP recognized as safe for human consumption. No primary skin irritation or vaginal mucosal irritation in rabbits. No irritation or toxicity in 3-day, 7-day, or 90-day surgical mucosal implantation in rabbits. No delayed dermal sensitization in guinea pigs. No mutagenic changes in Salmonella typhimurium. No positive indicators in cytotoxicity tests (USP elution method, real-time aged 14 months, oven-aged at 70°C for 7 days). Lubricated condom tested for systemic toxicity (Saline & Cottonseed Oil) and vaginal irritation (saline extract) in rabbits, meeting USP requirements. | Extensively tested for various aspects of toxicity and irritation using animal models and in vitro methods. |
| Material Safety (Non-Allergenicity/Non-Sensitization) | No adverse reactions in latex-sensitive individuals or general population. | In a modified Draize test (200 human subjects), TACTYLON® was non-irritating and non-sensitizing in all subjects. In 20 latex-sensitive individuals (use tests and skin prick tests), TACTYLON® caused no adverse reactions. | Directly addresses concerns for latex-sensitive individuals. |
| Barrier Efficacy | Substantially equivalent to NRL condoms in preventing passage of viral surrogates. | In vitro challenge with viral surrogate (φ X174) to simulate HIV (AIDS) showed barrier properties substantially equivalent to NRL. | Tested against a viral surrogate, the primary concern for barrier efficacy. |
| Clinical Performance (Breakage & Slippage Rates) | Clinical breakage and slippage rates similar to predicate NRL condoms. | Clinical breakage rates of High Elongation TACTYLON® condoms were similar to the Standard TACTYLON® condom (which was previously cleared and presumed to be equivalent to NRL). | Clinical trial directly addresses real-world performance for breakage and slippage. |
| Chemical Stability/Aging | Resistance to conditions that accelerate aging (UV, ozone, oxygen, heat, humidity). | Copolymer has no unsaturated bond, providing resistance to UV radiation, ozone, oxygen, heat, and humidity, which can accelerate aging and adversely affect barrier properties. | An advantage over NRL in terms of potential shelf-life. |
Study Information
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Sample size used for the test set and the data provenance:
- Modified Draize Test: 200 human subjects.
- Latex-Sensitive Individuals Test: 20 latex-sensitive individuals.
- Clinical Trial for Breakage/Slippage: The document does not specify the exact number of subjects for the lubricated condom trial, but states it was a "large clinical trial" and references a previous study (Trussell J, Warner DL, Hatcher RA: Condom performance during vaginal intercourse: comparison of Trojan-enz and TACTYLON condoms. Contraception 1992;45:11-19) for the non-lubricated version.
- Data Provenance: Not explicitly stated, but clinical trials are typically prospective. References to published papers (e.g., in Contact Dermatitis and Contraception) suggest scientific rigor. Given the FDA submission context, it's implied these studies were conducted to support the device's market clearance. No specific country of origin is mentioned beyond the company's US address.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical studies. For the modified Draize test and latex-sensitive individual tests, the assessment of "non-irritating," "non-sensitizing," and "no adverse reactions" would have been performed by clinical professionals (e.g., dermatologists, allergists, nurses) following standardized protocols. For the clinical performance trial (breakage/slippage), data collection would likely involve patient self-reporting and/or clinical observation, potentially overseen by clinicians. The cited publications would have peer review by experts in the field.
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Adjudication method for the test set:
- Not explicitly described. For the Draize and latex-sensitive tests, a single blinded assessment or consensus among clinical observers might have been used, but no specific method like "2+1" or "3+1" is mentioned. For the clinical performance, outcomes like breakage and slippage are generally observable events, and adjudication often involves clear definitions and reporting protocols.
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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:
- No. This is a medical device (condom) and not an AI/imaging diagnostic tool. Therefore, a MRMC study for AI assistance is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm.
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The type of ground truth used:
- Material Safety (Toxicity/Irritation): In vitro assays, animal model histopathology and clinical observation (rabbit, guinea pig), and direct human clinical observation for skin reaction/sensitization.
- Material Safety (Allergenicity/Sensitization): Clinical observation and specific skin tests (e.g., skin prick tests, patch tests) on human subjects.
- Barrier Efficacy: In vitro viral surrogate challenge; this uses a controlled laboratory standard to simulate real-world conditions.
- Clinical Performance (Breakage/Slippage): Real-world clinical use data, likely involving user self-reporting and/or clinical observation during vaginal intercourse.
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The sample size for the training set:
- This is not applicable as the device is a physical product, not a machine learning model requiring a "training set." The development process would involve iterative material science and engineering, with testing at various stages, but not in the sense of a machine learning training set.
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How the ground truth for the training set was established:
- Not applicable for the same reason as point 7. The "ground truth" for the material's properties and performance would have been established through a combination of established engineering standards, material science testing (e.g., tensile strength, elasticity), chemical analysis, and preliminary biological/clinical tests to refine the formulation and design.
§ 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.