(1169 days)
Condoms, when properly used, are an effective way to prevent pregnancy, although no contraceptive can guarantee 100 % effectiveness. They will also reduce the risk of spreading sexually transmitted diseases such as AIDS, syphilis, etc.
The device in this 510(K) summary is a spermicidal lubricated condom. The condom will be sold under various trade names including Eros, Iris, Amoret, Galant, Gemini, Brillant, Casanova and Galla.
This document, K931220, describes a spermicidal lubricated condom and its specifications. It predates the widespread use of AI in medical device evaluation and therefore does not contain information related to AI/ML device performance or evaluation. The concepts of "acceptance criteria for an AI device," "test sets," "ground truth experts," "MRMC studies," or "standalone AI performance" are not applicable to the information provided.
Therefore, I cannot fulfill the request as it pertains to an AI/ML device. The provided text describes a traditional medical device (condom) and its compliance with established physical and manufacturing standards.
§ 884.5310 Condom with spermicidal lubricant.
(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).