(90 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 TACTYLON® condom is made from styrene-ethylene-butylenestyrene thermoplastic elastomer block copolymer but has physical properties (e.g., strength, elasticity, and tactility) and general form that are substantially equivalent to a NRL condom.
Here's an analysis of the provided text to extract information about acceptance criteria and supporting studies for the LUBRICATED BAGGY CONDOM:
Note: The provided document is a 510(k) summary for a condom, which focuses on demonstrating substantial equivalence to a predicate device rather than setting a new performance standard. Therefore, the "acceptance criteria" discussed here are mainly related to demonstrating equivalence and safety/efficacy, not necessarily numerical performance targets in the way one might expect for a diagnostic or AI device. Many of the requested fields (like MRMC studies, expert qualifications, etc.) are not applicable to this type of medical device submission.
Acceptance Criteria and Supporting Study for LUBRICATED BAGGY CONDOM
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Requirement | Reported Device Performance |
|---|---|---|
| Material Toxicity | Conformity to FDA Class VI materials for nontoxicity; absence of primary skin irritation, vaginal mucosal irritation, irritation/toxicity in surgical mucosal implantation, delayed dermal sensitization, mutagenic changes, and cytotoxicity. | TACTYLON® block copolymer meets FDA Class VI requirements. Studies on non-lubricated (K911431) and lubricated (K953583) condoms showed: |
- No primary skin irritation or vaginal mucosal irritation in rabbits.
- No irritation/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) for real-time aged and oven-conditioned samples. |
| Material Allergenicity | Absence of natural rubber latex protein allergens or sensitizing chemicals; non-irritating and non-sensitizing in human subjects, including latex-sensitive individuals. | The synthetic TACTYLON® condom contains neither NRL protein allergens nor sensitizing chemicals. - Modified Draize test (200 human subjects): nonirritating and nonsensitizing in all subjects.
- Use tests and skin prick tests (20 latex-sensitive individuals): no adverse reactions. |
| Barrier Efficacy to Viral Surrogates | Substantial equivalence to NRL products in preventing passage of viral surrogates (e.g., φ X174) to simulate HIV. | In vitro challenge with viral surrogate (φ X174) demonstrated barrier properties "substantially equivalent to NRL" and "as impermeable to a viral surrogate as NRL in nonclinical studies." |
| Clinical Breakage & Slippage Rates | Clinical breakage and slippage rates of the lubricated Baggy TACTYLON® condoms should be similar to predicate TACTYLON® condoms (Standard TACTYLON® K953583 and High Elongation K971590). | Clinical trials showed that "clinical breakage of the Baggy TACTYLON® condoms were similar to the Standard TACTYLON® condom cleared by 510(k) K953583 and the High Elongation condom cleared by 510(k) K971590." |
| Resistance to Environmental Factors | Resistance to conditions such as ultraviolet radiation, ozone, oxygen, heat, and humidity, that can accelerate aging and adversely affect barrier properties, demonstrating advantage over NRL in terms of shelf-life. | The copolymer's chemical structure (no unsaturated bond) makes it "resistant to conditions such as ultraviolet radiation, ozone, oxygen, heat and humidity" and confers "a distinct advantage over NRL in terms of potential shelf-life." This is intrinsic material property, not a measured performance criterion in this document. |
| Physical Properties & General Form | Physical properties (e.g., strength, elasticity, and tactility) and general form substantially equivalent to a NRL condom. | The TACTYLON® condom "has physical properties (e.g., strength, elasticity, and tactility) and general form that are substantially equivalent to a NRL condom." (Stated as a characteristic, implied to be verified but specifics not detailed). |
2. Sample Size Used for the Test Set and Data Provenance
- Toxicity/Irritation (Rabbit Models): Not explicitly stated, but implies multiple animals for vaginal irritation, surgical mucosal implantation, and primary skin irritation. Data provenance: Pre-clinical animal models.
- Delayed Dermal Sensitization (Guinea Pig Model): Not explicitly stated, but implies multiple animals. Data provenance: Pre-clinical animal model.
- Mutagenicity (Salmonella typhimurium): Not explicitly stated. Data provenance: In-vitro lab tests.
- Cytotoxicity (USP elution method): Not explicitly stated. Data provenance: In-vitro lab tests.
- Draize Test (Human Subjects): 200 human subjects. Data provenance: Clinical trial.
- Latex-Sensitive Individuals Test: 20 latex-sensitive individuals. Data provenance: Clinical trial.
- Viral Surrogate Challenge (φ X174): Not explicitly stated, but in-vitro lab tests. Data provenance: In-vitro lab tests.
- Clinical Breakage & Slippage Trial (Lubricated Condoms): Not explicitly stated, but referred to as a "large clinical trial" (implied to be significant enough to compare rates to predicate devices). The reference Contraceptive Research and Development Program Final Report, April 18, 1997 suggests this was a prospective clinical study. Data provenance: Clinical trial.
Overall, the studies encompass both pre-clinical (in-vitro and animal) and clinical (human) data. The clinical data appears to be prospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device (condom). Ground truth for condom performance primarily relies on objective measurements in lab tests (e.g., material properties, viral penetration) and observed clinical outcomes (breakage/slippage rates, irritation/sensitization in human subjects). There isn't a "ground truth" established by experts in the context of interpretation, like there would be for an AI diagnostic device.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies where expert (often subjective) interpretation is involved. For condom performance, the outcomes are generally objective (e.g., presence/absence of irritation, breakage occurrence, material measurements).
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
This information is not applicable. This is a medical device for contraception and STD prevention, not an AI-assisted diagnostic tool. No MRMC studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Toxicity/Irritation/Sensitization: Direct observation of physiological responses in animal models and human subjects (e.g., absence of lesions, allergic reactions). For in-vitro tests, adherence to established laboratory protocols and measurement thresholds (e.g., USP requirements for cytotoxicity).
- Barrier Efficacy: Objective measurement of viral surrogate penetration in an in-vitro setup.
- Clinical Breakage & Slippage: Observed events during clinical use (direct outcome data).
- Material Properties: Objective measurements of physical characteristics (strength, elasticity) against predetermined specifications (implied, not fully detailed but stated as "substantially equivalent").
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/machine learning device that requires a "training set." The development of the TACTYLON® material and condom design would involve iterative testing and refinement, but not in the context of machine learning training data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" in the machine learning sense. The material development and device design would be based on engineering principles, materials science, and previous pre-clinical and clinical data on similar devices or materials, guided by regulatory requirements for safety and performance (e.g., ISO standards for condoms, FDA guidance).
§ 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.