(57 days)
The Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
The Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a silicone-based lubricant containing low levels of sensory ingredients applied directly to the condom to create a perception of warming, cooling, and/or tingling. The condom is a bulbous shaped condom with 11 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant meets the specifications of ASTM D3492-16. The condom has a nominal length of 185 mm and a nominal flat-width of 54 mm, measured 30 mm from the open end. The bulbous portion at the closed end of the condom has a flat-width of 65 mm.
The provided document is a 510(k) summary for a medical device, specifically a natural rubber latex condom. The document describes the device, its intended use, comparison to a predicate device, and performance testing.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
Important Note: The device described is a medical device (condom) and the performance testing focuses on biocompatibility, physical strength (airburst), and shelf-life, which are typical for such devices. This is not a software/AI-based device, therefore, many of the questions related to AI performance, human reader studies, ground truth for AI, etc., are not applicable to this document. The answers will reflect this.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Cytotoxicity (ISO 10993-5) | "The results of testing demonstrate that the subject device is biocompatible." (Specific values/pass/fail stated as 'biocompatible' rather than numerical) |
| - Rabbit Vaginal Irritation (ISO 10993-10) | "The results of testing demonstrate that the subject device is biocompatible." |
| - Rabbit Penile Irritation (ISO 10993-10) | "The results of testing demonstrate that the subject device is biocompatible." |
| - Primary Rabbit Skin Irritation (ISO 10993-10) | "The results of testing demonstrate that the subject device is biocompatible." |
| - Guinea Pig Maximization Sensitization (ISO 10993-10) | "The results of testing demonstrate that the subject device is biocompatible." |
| - Acute Systemic Toxicity (ISO 10993-11) | "The results of testing demonstrate that the subject device is biocompatible." |
| Physical Testing (Airburst): | |
| - Meet airburst specifications of ASTM D3492-16 Standard Specifications for Rubber Contraceptives (Male Condoms) | "Three (3) lots of Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant were tested at baseline and met airburst specifications of ASTM D3492-16 Standard Specifications for Rubber Contraceptives (Male Condoms)." (Specific quantitative airburst values or thresholds are not provided in this summary, but the report explicitly states the criteria were met). |
| Shelf Life/Stability: | |
| - Establish expiration date based on physical testing data following 21 CFR §801.435 as a guide | "Based on the evaluation of the results of the physical testing data, the expiration date has been initially set at 36 months and will be then verified through real-time stability through five (5) years in compliance with FDA expiration labeling requirements in 21 CFR §801.435." |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility: The specific number of animals (rabbits, guinea pigs) used for the tests is not detailed in this summary, but standard ISO 10993 protocols would involve a defined minimum number of animals. The data provenance would be laboratory testing conducted for C&D Co.
- Physical Testing (Airburst): "Three (3) lots" of condoms were tested. The exact number of condoms per lot is not specified, but implied to be sufficient for ASTM testing. Data provenance is laboratory testing.
- Shelf Life: Testing was ongoing to support 36-month initial dating, with real-time stability through five years. The sample size for this ongoing testing is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable as the device is a physical medical device (condom), not an AI/software device requiring expert interpretation for ground truth. The "ground truth" for this device lies in objective physical and biological test results (e.g., cell viability for cytotoxicity, physical airburst pressure, etc.) against established ASTM and ISO standards.
4. Adjudication Method for the Test Set
This question is not applicable as the tests performed are objective, laboratory-based physical and biological assays with defined pass/fail criteria according to international standards (ISO, ASTM). There is no "adjudication" between multiple human reviewers of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
This question is not applicable. MRMC studies are relevant for imaging or diagnostic devices where human readers interpret outputs, often with and without AI assistance, to assess changes in diagnostic accuracy. This is a physical condom, not an AI diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable. The device is a physical condom, not an algorithm. Therefore, no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
The ground truth used for this device's testing is based on:
- International Standards: Specific criteria defined in ISO 10993 series for biocompatibility and ASTM D3492-16 for physical condom properties (like airburst).
- Laboratory Measurements: Objective measurements derived from these standardized tests, which are interpreted directly against the standard's specifications (e.g., a certain pressure must be withstood, a certain level of cell viability or irritation score must not be exceeded).
8. The Sample Size for the Training Set
This question is not applicable. This is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of device.
§ 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.