(90 days)
The TheyFit male condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The TheyFit Male Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is flat with a cylindrical shape. TheyFit condoms are available in 34 sizes, of different length/width combinations. TheyFit Condoms are provided pre-lubricated with a silicone-based lubricant. TheyFit condoms are not provided with spermicide. The user must use a fitting kit (FitKit) to select the appropriate size TheyFit Condom.
The provided text describes the 510(k) summary for the TheyFit Male Condom, detailing its performance data and substantial equivalence to a predicate device. Here's an analysis to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated (leveraged predicate data) | Device identical to predicate in material composition and manufacturing; predicate device's biocompatibility testing leveraged. |
| Airburst | Met ASTM D3492-14 and ISO 4074:2014 | Acceptance criteria met. |
| Water Leak | Met ASTM D3492-14 and ISO 4074:2014 | Acceptance criteria met. |
| Dimensional Analysis | Met ASTM D3492-14 and ISO 4074:2014 | Acceptance criteria met. |
| Clinical Performance (Total Clinical Failure Rate) |
§ 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.