(28 days)
The DUREX Latex Condom with Male Genital Desensitizer Lubricant is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases. The male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation.
DUREX Latex Condom with Male Genital Lubricant is made of a natural rubber latex sheath with lubricant Desensitizer containing Benzocaine, an over-the-counter drug recognized as safe and effective by US FDA under 21 CFR 5300 for condom and 21 CFR Part 348 for external analgesic drug products for over-the-counter human use. The condom is a straightwalled, nipple-end condom with the nominal length of 180 mm and width of 52 mm as required by ASTM D-3492-97.
The provided text is a 510(k) Pre-market Notification for a latex condom, and as such, it does not contain the detailed information typically associated with clinical studies for device performance or AI/ML model evaluations. The document focuses on demonstrating substantial equivalence to a predicate device, which primarily relies on technological characteristics, safety, and intended use, rather than a rigorous performance study with acceptance criteria in the manner requested.
Therefore, many of the requested categories cannot be populated from the provided text.
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to compliance with ASTM D-3492-97 for "Rubber Contraceptives (Male Condoms)" as the primary standard for the device's technical specifications. While the exact acceptance criteria from this ASTM standard are not explicitly listed in the document, meeting this standard would imply passing its specified tests for dimensions, burst volume/pressure, and freedom from holes. The document states that both the proposed and predicate devices "are of the similar design meeting ASTM Standard (D3492) specification."
| Acceptance Criteria (Implied by ASTM D-3492-97 compliance) | Reported Device Performance (Implied by substantial equivalence and ASTM compliance) |
|---|---|
| Nominal length of 180 mm | Meets nominal length of 180 mm |
| Nominal width of 52 mm | Meets nominal width of 52 mm |
| Burst volume/pressure (specific values not stated) | Meets ASTM D-3492-97 requirements |
| Freedom from holes (specific values not stated) | Meets ASTM D-3492-97 requirements |
| Benzocaine concentration for desensitizer (effective and safe) | Benzocaine recognized as safe and effective by US FDA under 21 CFR 5300 and 21 CFR Part 348 |
| Shelf life for latex condom and lubricant | Must comply with 21 CFR 801.435, with expiration date supported by test data (data not included in 510(k), but required to be maintained) |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the 510(k) summary. The document focuses on substantial equivalence based on design and material rather than a specific clinical performance test set. Data provenance is not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable and not provided. This is a device submission for a condom, not an AI/ML diagnostic device requiring expert ground truth for image or diagnostic interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
This information is not applicable and not provided. This is not an AI-assisted device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This is not an algorithm-based device.
7. The Type of Ground Truth Used:
For the physical characteristics of the condom, the "ground truth" would be established by physical measurements and standardized tests as outlined in ASTM D-3492-97. For the desensitizer lubricant, the ground truth for safety and effectiveness is based on the FDA's existing recognition of Benzocaine as safe and effective under 21 CFR 5300 and 21 CFR Part 348.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This is not an AI/ML device relying on a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided.
Summary of what is present in the document regarding "proof of meeting acceptance criteria":
The primary "proof" relies on the device meeting the ASTM D-3492-97 standard for male condoms and the fact that Benzocaine is a recognized over-the-counter drug for desensitizing purposes by the FDA. The submission states that the proposed device, with "variation merely in the lubricant application," is technologically similar to the predicate device and meets the same ASTM standard. The FDA's letter of clearance indicates that the agency determined the device is "substantially equivalent" to legally marketed predicate devices, implying that it meets the necessary safety and effectiveness requirements, including those indirectly referenced by the ASTM standard and Benzocaine's existing regulatory status. The FDA also specifically mentions the requirement to comply with 21 CFR 801.435 for expiration dating, supported by test data, which must be maintained by the manufacturer.
§ 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.