(90 days)
The proposed change to the lubricant consists of expanding the indications for use to specifically include the facilitation of breast self-examination.
Clear, water-soluble lubricating gel
This 510(k) summary (K961222) describes the EVRON GEL, a lubricating gel intended to facilitate breast self-examination. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The document focuses on demonstrating substantial equivalence to pre-amendment devices and other legally marketed lubricants, primarily by emphasizing its long history of safe use and the common mechanism of lubrication. Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets such criteria because this information is not present in the provided text.
Here’s why the requested information cannot be extracted:
- No quantifiable acceptance criteria are stated. The document asserts the device's effectiveness based on its lubricating properties and its similarity to soapy water for reducing friction. There are no numerical targets or thresholds provided for lubrication, friction reduction, or other performance metrics.
- No specific study or clinical trial is described. The document relies on the device's long history of commercial distribution (over 25 years) and the lack of reported safety concerns as evidence for its safety. For effectiveness, it uses logical reasoning about lubrication being similar to soapy water. This is not a study with the elements requested (sample size, ground truth, expert opinions, etc.).
Therefore, for all the requested points (1-9), the answer is "Not applicable" or "Information not provided in the document." The submission focuses on demonstrating substantial equivalence through established use and a common mechanism, rather than presenting a performance study against specific 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.