(54 days)
Bausch + Lomb Sensitive Eyes Plus Salinon is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.
Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, isotonic, buffered solution that contains boric acid, sodium borate, potassium chloride, sodium chloride, preserved with polyaminopropyl biguanide (0.00003%) and edetate disodium (0.025%). The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.
This document describes the premarket notification (510(k)) for the Bausch + Lomb Sensitive Eyes Plus Saline Solution, which is a sterile, preserved solution for rinsing contact lenses. The study mainly focuses on demonstrating substantial equivalence to predicate devices and expanding its indications for use to include gas permeable contact lenses.
Here's an analysis of the provided text in the context of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance metrics for a diagnostic device. Instead, it refers to standards and general requirements for contact lens care products. The "acceptance criteria" are implied by adherence to these standards and the demonstration of safety and effectiveness.
Here's a summary of the performance claims based on the described studies:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Microbiology: Antimicrobial Preservative Efficacy for Discard Dating | |
| (Meets requirements of ISO 14730, Annex C Procedure II for a 90-day discard date) | Sensitive Eyes Plus Saline Solution meets the requirements of ISO 14730, Annex C Procedure II for the designation of a 90-day discard date. The test articles were evaluated initially and again following simulated use for the proposed discard date of 90 days, demonstrating efficacy. |
| Microbiology: Regimen Evaluation (Modified Regimen) | |
| (Meets FDA performance criteria for regimen evaluation as described in the May 1, 1997 Guidance for Industry, Pre-market Notification (510(k)) Guidance Document for Contact Lens Care Products when used in a 10-second rub, 5-second rinse regimen, and ISO Standard 14729: 2001/Amd. 1:2010 (E)) | A modified regimen procedure (rinse with Sensitive Eyes Plus Saline Solution in place of tap water) for Boston Conditioning Solution and Boston Advance Conditioning Solution demonstrated that the modified regimen with Sensitive Eyes Plus Saline Solution meets FDA performance criteria (1997 Guidance) and ISO Standard 14729:2001/Amd. 1:2010 (E) when used in a 10-second rub, 5-second rinse (per lens side) regimen. |
| Biocompatibility | |
| (No new testing required as per previous clearance for use and no new indications that necessitated new testing) | Biocompatibility tests were deemed unnecessary for this application because the Sensitive Eyes Plus Saline Solution was previously cleared for use, and the expansion of the indication (to include gas permeable lenses) did not trigger the need for new testing. This implies that the product's biocompatibility was already established and met previous criteria. |
| Lens Compatibility | |
| (Meets ISO 11981 for rigid gas permeable contact lenses) | Results of lens compatibility studies per ISO 11981 demonstrate Bausch + Lomb Sensitive Eyes Plus Saline Solution is compatible with rigid gas permeable contact lenses. |
| Clinical Data / Overall Safety and Efficacy | |
| (Established safety and efficacy, substantial equivalence to predicate) | Clinical studies were deemed unnecessary for this application as the Sensitive Eyes Plus Saline Solution has been commercially available for over 25 years with "well demonstrated safety and efficacy." The cumulative results of laboratory testing sponsored by Bausch + Lomb demonstrate substantial equivalence in safety, effectiveness, and performance when used with gas permeable contact lenses to the current product indicated for soft contact lenses. |
2. Sample size used for the test set and the data provenance
- The document does not specify the sample sizes used for the microbiology, biocompatibility, or lens compatibility test sets.
- Data provenance: The studies were performed by or sponsored by Bausch + Lomb. The specific country of origin for the data is not mentioned but appears to be part of a submission to the U.S. FDA, indicating the data would be accepted under U.S. regulatory standards. These are preclinical (laboratory) studies, not typically categorized as retrospective or prospective in the same way clinical trials are.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The studies are primarily laboratory-based (microbiology, lens compatibility) and a declaration of no new biocompatibility testing needed due to prior clearance. Expert consensus for "ground truth" as typically understood in diagnostic device evaluations is not applicable here.
4. Adjudication method for the test set
- This information is not provided and is not applicable for the type of laboratory and preclinical studies presented. Adjudication methods are typically used in clinical studies involving human observers or subjective assessments.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is a saline solution and not an AI-powered diagnostic device. Therefore, a study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical product (saline solution), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the microbiology studies, the "ground truth" would be defined by the established laboratory methods and criteria in ISO 14730 and the FDA Guidance document. This involves direct measurement of antimicrobial efficacy against specified microorganisms.
- For lens compatibility, the "ground truth" is defined by the objective standards and methods outlined in ISO 11981, which assess physical characteristics of lenses after exposure to the solution.
- For biocompatibility, the "ground truth" was established by previous testing and regulatory clearance of the device/components, meaning it met established safety standards.
- The absence of clinical studies for this submission means no direct "outcomes data" or "pathology" was generated for new approval, relying instead on historical data and preclinical testing.
8. The sample size for the training set
- This is not applicable as this submission is for a medical device (saline solution), not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established
- This is not applicable for the same reason as point 8.
§ 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.”