(90 days)
To lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Lubricating Jelly is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
This document is a 510(k) summary for a medical device (Lubricating Jelly, Low Viscosity). It describes the device, its intended use, and claims substantial equivalence to a predicate device.
However, this document does not contain any information about acceptance criteria or a study proving device performance against such criteria in the context of diagnostic accuracy, clinical outcomes, or AI algorithm performance. It's a regulatory filing for a low-risk medical device, where the primary demonstration of safety and effectiveness often relies on showing substantial equivalence to an already marketed device, rather than extensive performance studies with acceptance criteria as one would find for diagnostic algorithms.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) because it is not present in the provided text. The document's purpose is to outline the device's characteristics and its equivalence to a predicate device, not to detail the results of a performance study with specific metrics and acceptance criteria.
§ 880.6375 Patient lubricant.
(a)
Identification. A 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.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.