(130 days)
The Remed Preventor Dotted Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Dotted condom is a dotted surfaced condom with no color additives, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.
Remed Pharma Male Dotted Condom is a dotted surfaced condom with no color additives.
The provided text is a 510(k) clearance letter from the FDA for a medical device: "Remed Pharma Male Dotted Rubber Latex Condom." This document primarily addresses regulatory aspects of the device's clearance based on substantial equivalence to a predicate device.
Crucially, the document DOES NOT contain information regarding acceptance criteria, study details (like sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment relevant to the performance of the condom as a medical device for its stated indications (contraception and STD prevention).
The letter states: "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the device was cleared because it was shown to be "substantially equivalent" to an already legally marketed device, not through a prospective clinical study proving its performance against new, specific acceptance criteria set for this particular device. The FDA essentially determined that because it's similar enough to an existing, safe, and effective device, it doesn't need to undergo new, extensive clinical trials defining performance metrics.
Therefore, I cannot fulfill the request for a table of acceptance criteria, study details, sample sizes, expert qualifications, or ground truth information based on the provided text. The document focuses on regulatory compliance and substantial equivalence, not a detailed performance study as would be required for novel devices or those undergoing a PMA pathway.
The only "acceptance criteria" mentioned indirectly pertains to labeling requirements for latex condoms (21 CFR 801.435) regarding expiration dating, which is a post-market requirement for all latex condoms, not a performance criterion for initial clearance based on a study presented in the 510(k).
§ 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.