(258 days)
Durex Patronus CloseFit and Durex Patronus Regular condoms are used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Durex Patronus CloseFit and Durex Patronus Regular are natural rubber latex-based condoms indicated for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). Durex Patronus CloseFit and Durex Patronus Regular are made of a non-colored natural rubber latex with silicone lubricant and are taper shaft, teat ended smooth shaped condoms. Durex Patronus CloseFit and Durex Patronus Regular have a nominal length of 190 mm and 195 mm, width of 52.5 mm and 56 mm, and thickness of 52 microns and 54 microns, respectively. The condoms are available in regular and extra lubricant varieties with 400 mg and 480 mg silicone lubricant, respectively. The condoms are packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils are packaged in an outer consumer cardboard carton. The number of condoms in the carton may vary. Durex Patronus CloseFit and Durex Patronus Regular condoms are 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 Durex Patronus CloseFit and Durex Patronus Regular condoms. This document describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical performance testing. It is not an AI/ML medical device submission, therefore, much of the requested information regarding AI/ML study design characteristics (e.g., test set sample size, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth for training set) is not applicable.
However, I can extract the acceptance criteria and reported device performance for the physical performance testing and shelf-life as described in the document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| ISO 10993-5:2009/R 2014 Cytotoxicity | The subject device is non-cytotoxic. |
| ISO 10993-10:2010/R 2014 Sensitization | The subject device is non-sensitizing. |
| ISO 10993-10:2010/R 2014 Vaginal Irritation | The subject device is non-irritating. |
| ISO 10993-11:2017 Acute Systemic Toxicity | The subject device is not acutely, systemically toxic. |
| Physical Performance Testing | |
| ISO 4074:2015 Requirements and Test Methods | The device met all requirements. |
| ASTM D3492-16 Requirements | The device met all requirements. |
| Shelf Life | |
| Predefined acceptance criteria based on 21 CFR 801.435 | All samples met predefined acceptance criteria for a 5-year shelf life. |
Study Details:
- Sample size used for the test set and the data provenance: Not specified in the provided summary for performance testing. The document states "All samples" for the shelf-life testing, but a specific number is not given. Data provenance is not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is not an AI/ML product requiring expert ground truth for image interpretation or similar tasks.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device that requires MRMC studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
- The type of ground truth used: For biocompatibility, the ground truth is established through standardized biological tests. For physical performance, the ground truth is defined by the requirements outlined in international and national standards (ISO 4074:2015 and ASTM D3492-16). For shelf life, the ground truth is based on the device maintaining its performance over time as per 21 CFR 801.435.
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
- How the ground truth for the training set was established: Not applicable.
§ 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.