(88 days)
The TROJAN® CRYSTAL CLEAR Liquid is principally designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. The TROJAN® CRYSTAL CLEAR Liquid may be used with condoms. The TROJAN CRYSTAL CLEAR Liquid patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
The TROJAN® CRYSTAL CLEAR Liquid personal lubricant is a water-soluble, greaseless, unscented, clear, colorless liquid, 2.1 oz of which is packaged in a clear plastic bottle.
The provided text is a 510(k) Summary for a personal lubricant (TROJAN® CRYSTAL CLEAR Liquid). This type of regulatory submission in the medical device field typically focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information required to answer your questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Here's why the requested information is not present based on the provided text:
- Acceptance Criteria & Device Performance: For a personal lubricant, the primary "performance" relates to its physical and chemical properties (e.g., pH, viscosity, osmolality) and biocompatibility, as well as its ability to provide lubrication. The document states "There are no exceptional technological characteristics associated with TROJAN® CRYSTAL CLEAR Liquid." and compares its formulation to "conventional water-soluble lubricant bases" and predicate devices. It does not provide a table of performance metrics or acceptance criteria for these characteristics.
- Study That Proves Device Meets Acceptance Criteria: The submission is a 510(k) for substantial equivalence. This means the manufacturer is arguing their new device is as safe and effective as a legally marketed predicate device (H·R® Lubricating Jelly and TROJAN® FOR WOMEN Personal Lubricant). It does not typically involve a clinical study designed to demonstrate performance against specific, pre-defined acceptance criteria.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These are all elements typically found in clinical studies, particularly for diagnostic devices or those requiring complex performance evaluation. A lubricant does not necessitate such studies for a 510(k) submission. The "study" here is essentially a comparison of the new lubricant's formulation and intended use to existing, legally marketed lubricants, demonstrating similarity rather than novel performance.
§ 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.