(86 days)
Use blink™ CL Lubricant Eye Drops to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses; to help relieve dryness, irritation and discomfort that may be associated with lens wear; and to cushion lenses by placing a drop on the lens prior to application on the eye.
blink™ CL Lubricant Eye Drops is a sterile, isotonic, buffered solution containing a lubricant, a preservative, buffers, tonicity agents, and purified water. The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Nonclinical Studies | ||
| Lens Compatibility | Compatible with both soft (hydrophilic) and RGP contact lenses to be considered substantially equivalent to the control. | The product is compatible with soft (hydrophilic) and RGP contact lenses and substantially equivalent to the control. |
| Solution Compatibility | Compatible with leading contact lens care products on the market. | The product is compatible with leading contact lens care products. |
| Preservative Uptake and Release | Very little, if any, uptake of the preservative into or onto soft or RGP lenses, with any absorbed amounts quickly released, indicating compatibility and acceptability for use. | There is very little, if any, uptake of the preservative in or onto soft or RGP lenses. Any amounts taken up are quickly released. The product is compatible and acceptable for use with soft (hydrophilic) and RGP contact lenses. |
| Contact Lens Wetting Angle | Substantially equivalent in wetting properties to predicate lubricating and rewetting products. | blink™ CL Lubricant Eye Drops is substantially equivalent in wetting properties to the predicate devices. |
| Microbiological Studies (Preservative Efficacy) | Meets acceptance criteria for Preservative Effectiveness Testing as outlined in ISO 14730:2000(E), "Ophthalmic optics – Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date." | The product meets the acceptance criteria for Preservative Effectiveness Testing as outlined in ISO 14730:2000(E). |
| Microbiological Studies (Sterility) | Meets USP Sterility test requirements. | The product meets USP Sterility test requirements. |
| Stability | Remains stable for the labeled shelf-life based on accelerated testing. | Accelerated testing predicts that the product will remain stable for the labeled shelf-life. |
| Toxicology | Non-cytotoxic, non-irritating, and well-tolerated. | blink™ CL Lubricant Eye Drops is non-cytotoxic, non-irritating and well-tolerated. |
| Clinical Studies | ||
| Safety and Acceptability | Safe, acceptable, and substantially equivalent to the control. | The investigational formulation is safe, acceptable, and substantially equivalent to the control. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated for each non-clinical test. The clinical study was a "multi-center" and "parallel-group" evaluation, but specific patient numbers are not provided.
- Data Provenance: The document does not specify the country of origin for the data. The clinical study was conducted by AMO (Advanced Medical Optics). No information is provided on whether it was retrospective or prospective, though a "multi-center, double-masked, randomized, parallel-group, one-month evaluation" suggests a prospective design.
3. Number of Experts and Qualifications
- No information provided regarding the number or qualifications of experts used to establish ground truth for the test set in either non-clinical or clinical studies. The clinical study was "double-masked," implying that both participants and evaluators were unaware of treatment assignments, but it does not specify who established the clinical endpoints or evaluated outcomes for ground truth.
4. Adjudication Method
- No information provided on adjudication methods for establishing ground truth in either non-clinical or clinical studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The studies described are primarily aimed at demonstrating the equivalence of the device to predicate devices, not at evaluating the improvement of human readers with or without AI assistance. The device is a lubricant eye drop, not an AI-powered diagnostic or assistive tool.
6. Standalone (Algorithm Only) Performance
- Not applicable. The device is a lubricant eye drop and does not involve an algorithm or AI component.
7. Type of Ground Truth Used
- Nonclinical Studies: Ground truth was established through in-vitro laboratory testing and adherence to recognized standards (e.g., ISO 14730:2000(E) for preservative efficacy, USP Sterility test requirements). The comparison was often against "control" or "predicate" devices, meaning the performance of an established, similar product served as the reference.
- Clinical Studies: Ground truth for safety and acceptability would have been based on clinical evaluations and observations, likely including patient reported outcomes and objective clinical assessments, compared against a "control" in a "double-masked" study.
8. Sample Size for the Training Set
- Not applicable. This device is a pharmaceutical product (lubricant eye drops), not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of 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.”