(387 days)
The Durex Condom with Benzocaine is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
The Durex Condom with Benzocaine is a natural rubber latex-based condom used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). This is a textured condom with a silicone-based lubricant. Durex Condom with Benzocaine has a nominal length of 195 mm and width of 56 mm with a thickness of 65 um. The Durex Condom with Benzocaine is packaged with 480 mg of silicone lubricant. In addition, the Benzocaine male genital desensitizer paste on the condom helps in temporarily prolonging the time until ejaculation. This condom is a surface device that comes into contact with skin and mucosal membranes. Durex Condom with Benzocaine is packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils come packaged in an outer consumer cardboard carton. The Durex Condom with Benzocaine is intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
The provided document is a 510(k) summary for the Durex Condom with Benzocaine, which is a medical device. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving effectiveness in the same way a clinical trial for a drug or a novel medical device would.
Therefore, the study described here is about confirming that the condom meets specific performance standards and is biocompatible, rather than conducting a comparative effectiveness study with human readers or standalone algorithm performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Physical Performance: | |
| ASTM D3492-16 (Standard Specification for Rubber Contraceptives) | Met all requirements of ASTM D3492-16 |
| ISO 4074:2015 (Natural rubber latex male condoms – Requirements and test methods) | Met all requirements of ISO 4074:2015 |
| Air Burst Pressure: > 1.0 kPa (per ISO 4074:2015/ASTM D3492-16) | > 1.0 kPa |
| Air Burst Volume: $\geq 18.0$ L (per ISO 4074:2015/ASTM D3492-16) | $\geq 18.0$ L |
| Nominal Width: 56 ± 2 mm | 56 ± 2 mm |
| Nominal Length: 195 ± 10 mm | 195 ± 10 mm |
| Nominal Thickness: 0.065 ± 0.01 mm | 0.065 ± 0.01 mm |
| Lubricant Quantity: 480 ± 50 mg | 480 ± 50 mg |
| Benzocaine Quantity: $140 \pm 20$ mg (5% Benzocaine) | $140 \pm 20$ mg (5% Benzocaine) |
| Biocompatibility: | |
| Cytotoxicity (ISO 10993-5:2009/R 2014) | Device is non-cytotoxic (implied by meeting general biocompatibility conclusion) |
| Sensitization (ISO 10993-10:2010/R 2014) | Device is non-sensitizing |
| Vaginal Irritation (ISO 10993-10:2010/R 2014) | Device is non-irritating |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Device is not acutely, systemically toxic |
| Shelf Life: | |
| Accelerated stability evaluations (per 21 CFR 801.435) | All samples met predefined acceptance criteria for a 5-year shelf life |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes (number of condoms) used for each specific test (e.g., air burst, dimensions, biocompatibility assays). It generally states "All samples met predefined acceptance criteria" for shelf-life testing and that the device "was tested and met all the requirements" of the specified standards.
Data provenance is not detailed in terms of country of origin or whether it was retrospective/prospective. These are standard performance tests for condom manufacturing and regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This type of information is not relevant to the evaluation of a condom's physical and biological performance tests. The "ground truth" here is defined by the established international and national standards (ASTM D3492-16, ISO 4074:2015, ISO 10993 series). The tests are objective and measurable, not based on expert interpretation of complex data like medical images.
4. Adjudication Method for the Test Set
Not applicable. The performance criteria are objective measurements against defined physical and biological specifications in recognized standards. There is no subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This device is a condom, and the studies described are performance and safety (biocompatibility) tests against industry standards, not studies involving human readers or comparative effectiveness in a clinical diagnostic sense. The concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an AI-powered diagnostic or interpretive device.
7. The Type of Ground Truth Used
The "ground truth" is established by:
- International and National Standards: Specifically, ISO 4074:2015 and ASTM D3492-16 for physical performance, and the ISO 10993 series for biocompatibility.
- Defined Specifications: The specific nominal dimensions, lubricant quantities, and benzocaine quantities (e.g., 56 ± 2 mm nominal width, 480 ± 50 mg lubricant).
- Regulatory Guidance: FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and 21 CFR 801.435 for shelf life.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set." The tests are empirical and based on physical and chemical properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in this context.
§ 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.