(383 days)
The TROJAN SUPRA® Lubricated Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
The TROJAN SUPRA® Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricated coating. The condom is a straight-walled, nontextured, nipple-end condom with a nominal length of 190 mm and an nominal flat-width of 58 mm.
The provided document describes the premarket notification (510(k) submission) for the TROJAN SUPRA® Lubricated Polyurethane Male Condom, outlining its characteristics, intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the studies performed, structured according to your request:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (TROJAN SUPRA® Lubricated Polyurethane Male Condom) | Study Title (if applicable) |
|---|---|---|
| Clinical Breakage Rate (compared to standard latex condom) | 1.1% (polyurethane condom) vs. 0.9% (control latex condom) | Clinical In-Use Slip/Break Study |
| Clinical Slippage Rate (compared to standard latex condom) | 2.0% (polyurethane condom) vs. 1.0% (control latex condom) | Clinical In-Use Slip/Break Study |
| Statistical Equivalence in Breakage & Slippage (vs. control latex condom) | Statistically no different from the control latex condom | Clinical In-Use Slip/Break Study |
| Tensile Strength, Force at Break, Elongation | Supported performance effectiveness | Physical Testing Data (ASTM D 6324-08) |
| Air Burst Volume & Pressure | Supported performance effectiveness | Physical Testing Data (ASTM D 6324-08) |
| Water Leakage (AQL) | Satisfied AQL = 0.25 | Physical Testing Data (ISO 4074) |
| Tear Resistance and Propagation | Supported performance effectiveness | Physical Testing Data (ASTM D 624-00) |
| Tensile Strength, Force at Break, Elongation at 37°C, 50% RH | Supported performance effectiveness | Physical Testing Data (simulating in-use conditions, ASTM D 6324-08) |
| Package Integrity | Satisfactory results | Package Integrity (ASTM D 6324-08) |
| Barrier Effectiveness (Viral Penetration) | Demonstrated barrier effectiveness to viral penetration | Viral Penetration Study |
| Shelf-life | Established at 60 months | Shelf-life (following 21 CFR 801.435 as a guide) |
| Lubricant Compatibility | Not compatible with any lubricant type (device labeled accordingly) | Lubricant Compatibility Study |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Toxicity, Implantation, Mutagenicity, Chromosomal Aberration) | No safety concerns / Conformed to safety standards | Biocompatibility Studies |
| Chemical Degradation | No safety concerns | Pre-Clinical Safety Studies |
2. Sample Size Used for the Test Set and the Data Provenance
-
Clinical In-Use Slip/Break Study:
- Sample Size: Over 290 couples.
- Data Provenance: Not explicitly stated, but typically such studies for US FDA submissions are conducted within regulated clinical environments, often in the US, though international sites are possible. The document does not specify the country of origin.
- Retrospective/Prospective: The phrasing "was conducted" implies a prospective study design.
-
Physical Testing Data (Tensile, Air Burst, Water Leakage, Tear, Package Integrity, Viral Penetration, Shelf-life):
- Sample Size: Three (3) lots of the 510(k)-subject condom, with an additional fourth lot tested for viral penetration at FDA's request.
- Data Provenance: Not explicitly stated, but typically conducted in manufacturing or testing facilities. The information states the device will be made in Japan, so some testing might originate from there.
- Retrospective/Prospective: These are typically laboratory tests performed prospectively on manufactured lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- For the Clinical In-Use Slip/Break Study: The "ground truth" (breakage and slippage events) would have been observed directly by the study participants (couples) and reported, likely verified by clinical staff/investigators. The document does not specify the number or qualifications of experts involved in establishing this ground truth, beyond the general oversight expected in a clinical study.
- For Physical and Barrier Properties: The "ground truth" is based on the objective measurements according to standardized test methods (ASTM, ISO). Experts would be the laboratory personnel performing these tests, qualified in analytical testing and materials science, but their specific number and qualifications are not detailed.
4. Adjudication Method for the Test Set
- Clinical In-Use Slip/Break Study: The document does not explicitly state an adjudication method (e.g., 2+1 or 3+1) for breakage and slippage events. These events are generally observed and recorded by the users themselves and then confirmed by study personnel.
- Physical and Laboratory Tests: Adjudication is not typically required for these objective, quantitative tests. Results are derived directly from 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
- Not Applicable. This device is a male condom, not an AI-powered diagnostic or screening tool that involves human readers interpreting cases. Therefore, an MRMC study or AI assistance effect size is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. As mentioned above, this device is a condom, not an algorithm. Standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Clinical In-Use Slip/Break Study: The ground truth for breakage and slippage was based on direct observation and reporting by the study participants (couples) as outcomes data (events of breakage or slippage during use).
- Physical and Barrier Properties Studies: The ground truth was based on objective laboratory measurements according to international standards (e.g., ASTM, ISO), representing the intrinsic physical properties and barrier effectiveness of the product.
- Biocompatibility and Safety Studies: Ground truth was based on established biological and chemical safety endpoints and adverse effect observations, in part outcomes data from in vitro and in vivo models.
8. The Sample Size for the Training Set
- Not Applicable. This device is a physical product, not a machine learning model. There is no concept of a "training set" in this context. The manufacturing process and quality control ensure consistency, but this is distinct from training an algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. No training set was used.
§ 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.