(196 days)
Bausch & Lomb ReNu® Effervescent Enzymatic Contact Lens Cleaner is indicated for use with either heat or chemical lens care systems in the weekly cleaning of soft contact lenses.
Bausch & Lomb ReNu® Effervescent Enzymatic Contact Lens Cleaner is supplied in a tablet format packaged in a foil strip. The tablets contain a proteolytic enzyme, Subtilisin, Polyethylene Glycol 3350 as a binding agent and salts for effervescence and tonicity. The tablet may be dissolved in either preserved or sterile un-preserved saline solution or Bausch & Lomb ReNu® MultiPurpose Solution.
The ReNu Effervescent Enzymatic Contact Lens Cleaner did not undergo a clinical study to establish acceptance criteria and prove its performance in that context. The manufacturer, Bausch & Lomb, determined that a clinical study was not required based on the FDA's guidance document "Premarket Notification 510(k) Guidance Document for Contact Lens Care Products" (May 1, 1997). This decision was based on the device having the same qualitative formulation, manufacturing process, and similar quality standards as its predicate device, the Bausch & Lomb Sensitive Eyes® Enzymatic Cleaner. Therefore, the device's safety and effectiveness were established through substantial equivalence to the predicate device, rather than new clinical outcome measures.
Here's a breakdown of the information provided, tailored to your request, but acknowledging the absence of a clinical study for direct performance metrics:
Acceptance Criteria and Device Performance
Since no clinical study with predefined acceptance criteria for clinical outcomes was performed, the "acceptance criteria" here refer to the demonstration of substantial equivalence to a predicate device through non-clinical studies. The "reported device performance" is the determination that it is substantially equivalent.
| Acceptance Criterion (Demonstrated through Non-Clinical Studies) | Reported Device Performance (Conclusion) |
|---|---|
| Physical Properties | Substantially equivalent to predicate device |
| Chemical Properties | Substantially equivalent to predicate device |
| Cleaning Efficacy | Substantially equivalent to predicate device |
| Toxicology | Substantially equivalent to predicate device |
| Microbiological Studies | Substantially equivalent to predicate device |
2. Sample Size and Data Provenance
- Sample Size (Test Set): Not applicable, as a clinical study with a test set of human subjects was not performed. The non-clinical studies would have involved laboratory samples for testing physical, chemical, cleaning efficacy, toxicological, and microbiological properties. The sizes of these experimental samples are not specified in the provided text.
- Data Provenance: Not applicable for a clinical test set. The non-clinical studies were performed by Bausch & Lomb, but the specific location or retrospective/prospective nature of the non-clinical data collection is not detailed.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable, as the ground truth for clinical performance was not established through expert consensus on a test set.
- Qualifications of Experts: N/A.
4. Adjudication Method
- Adjudication Method: Not applicable, as no human-reviewed test set requiring adjudication was used to establish clinical ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. The submission explicitly states that a clinical study was not required.
- Effect Size: Not applicable.
6. Standalone Performance Study
- Standalone Performance Study: No, a standalone algorithm-only performance study was not performed, as this is a contact lens cleaning device, not a diagnostic algorithm. The non-clinical studies assessed the device's inherent properties and performance in controlled laboratory settings for cleaning efficacy, toxicology, and microbiology, but this is distinct from "standalone performance" in the AI/algorithm context.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the safety and effectiveness of the device as presented in the 510(k) submission was substantial equivalence to a legally marketed predicate device. This was established through a series of non-clinical studies (physical, chemical, cleaning efficacy, toxicology, and microbiological studies) demonstrating that the new device shares the "same qualitative formulation" and is manufactured with the "same process and similar quality standards" as the predicate.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This device is not an AI/ML algorithm and therefore does not have a "training set" in that sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment (Training Set): Not applicable. There is no training set for this device.
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”