(268 days)
Durex Polyisoprene Condom is used for contraception and for prophylactic purposes (to help regnancy and the transmission of sexually transmitted infections, STIs).
Not Found
The provided document is an FDA 510(k) clearance letter for the Durex Polyisoprene Condom. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance in a clinical or AI context.
The letter focuses on regulatory approval, including:
- Device Name: Durex Polyisoprene Condom
- Regulation Number: 21 CFR 884.5300 (Condom)
- Regulatory Class: II
- Product Code: MOL
- Indications for Use: Contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections, STIs).
- Type of Use: Over-The-Counter Use
The content discusses regulatory compliance, quality systems, labeling, adverse event reporting, and unique device identification. It does not include information about clinical trials, performance metrics, ground truth establishment, sample sizes for training or testing, or expert reviews as would be relevant for an AI/ML device or a device with specific performance criteria beyond general manufacturing standards.
Therefore, I cannot provide the requested information based on the given text.
§ 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.