(67 days)
The TROJAN® MINT TINGLE™ Latex Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).
The TROJAN® MINT TINGLE™ Brand Latex Condom is a male condom consisting of a sheath of natural rubber latex with a colored pigment and a flavored water-based lubricant. The condom is a straight-walled, nipple-end condom with a nominal length of 180 mm and an approximate width of 52 mm.
This document is a 510(k) summary for a TROJAN® MINT TINGLE™ Brand Latex Condom, seeking clearance from the FDA. It does not include acceptance criteria or the study details you've requested. The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through new studies in the same way a PMA (Premarket Approval) might require.
Therefore, I cannot provide the information you asked for based on the provided text, as it is not present in this 510(k) summary. I can only confirm that this document pertains to a condom and its intended uses for contraception and STD prevention, and that it was deemed substantially equivalent to a predicate device.
To give you the information you're looking for, the document would need to include details about:
- Specific performance tests conducted (e.g., burst strength, leak test, freedom from holes, dimensions).
- Quantitative acceptance criteria for these tests (e.g., "99.9% freedom from holes").
- The actual results from testing the TROJAN® MINT TINGLE™ condom against these criteria.
- Sample sizes used for these performance tests.
- Ground truth establishment, expert qualifications, adjudication methods, and details about MRMC or standalone studies are generally not relevant for 510(k) submissions of devices like condoms, as they typically don't involve algorithms or image analysis. Their performance is assessed through physical and mechanical property testing and adherence to standards like ASTM D-3492-97.
§ 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.