(90 days)
The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
This document describes the 510(k) notification for a Male Latex Condom and does not contain information about an AI/ML powered device. Therefore, it is impossible to extract the requested information regarding acceptance criteria and studies related to AI/ML device performance.
The document provides details about:
- The manufacturer and contact information
- Device description (male latex condom, natural latex, straight-walled, reservoir tip, specific dimensions, lubricated with silicone, cornstarch as dressing material)
- Intended use (contraception and prophylaxis against STDs, including HIV)
- Technological characteristics (conformance with ASTM Latex Condom Standard D3492 and ISO 4074)
- Predicate device (Thai Nippon Condom; K982380)
- FDA's substantial equivalence determination for marketing the device
- Labeling requirements for latex condoms, specifically regarding expiration dating (21 CFR 801.435)
Since the request is specifically about acceptance criteria and studies for an "AI device," and this submission is for a physical medical device (a condom), the requested information cannot be provided from the given text.
Therefore, I cannot fulfill the request as the provided document does not pertain to an AI/ML 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.