(66 days)
The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Not Found
The provided text is a 510(k) clearance letter from the FDA for a male natural rubber latex condom. It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. While it mentions regulatory compliance and substantial equivalence to a predicate device, it does not describe performance metrics or study designs typically associated with AI/ML device evaluations.
Therefore, I cannot fulfill your request for the specific details outlined as they are not present in this document.
However, I can extract the information that is available:
Device Name: Male Natural Rubber Latex Condom
Indications For Use: Contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Regulatory Class: II
Product Code: 85 HIS
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom
The document primarily focuses on:
- Confirming the device's substantial equivalence to a legally marketed predicate device.
- Outlining general controls provisions and potential additional controls for Class II devices.
- Emphasizing compliance with labeling regulations, specifically regarding expiration dating for latex condoms (21 CFR §801.435).
To answer your questions, I would need a different type of document, such as a clinical study report or a 510(k) submission detailing the performance evaluation of an AI-powered 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.