(170 days)
Sterile Saline Solution is indicated for rinsing and wetting of soft (hydrophilic) contact lenses.
Sterile Saline Solution is a sterile, preservative free, buffered, isotonic, clear, colourless aqueous solution containing Sodium Chloride, Sodium Borate, Boric Acid and Nitrogen as Propellant. The solution is packaged in lacquered aluminum spray containers with caps. Each container is sealed with a tamper evident hologram seal at the junction of the container and the cap.
Acceptance Criteria and Study Details for Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution
This document describes the acceptance criteria and related study details for the Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution, based on the provided 510(K) premarket submission.
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new performance criteria. Therefore, the "acceptance criteria" are primarily framed around demonstrating equivalence in key characteristics and safety.
| Feature/Characteristic | Predicate Device (Blairex Sterile Saline Solution - P850045) Specification/Performance (Implicit Acceptance Criteria) | Cachet Sterile Saline Solution Reported Performance |
|---|---|---|
| Intended Use | For rinsing and wetting of soft (hydrophilic) contact lenses | For rinsing and wetting of soft (hydrophilic) contact lenses |
| Formulation | Sodium Chloride, Sodium borate, Boric Acid, Purified Water | Sodium Chloride, Sodium borate, Boric Acid, Purified Water |
| Propellant | Nitrogen | Nitrogen |
| Preservative | No | No |
| Sterility Claim | Sterile | Sterile |
| Toxicity | Non-toxic, comparable to marketed solutions | No evidence of toxicity demonstrated in cytotoxicity and eye irritation studies |
| Bacteriostasis | Bacteria (Staph. aureus, E. coli, P. aeruginosa, C. albicans, A. niger) no significant growth | Bacteria (Staph. aureus, E. coli, P. aeruginosa, C. albicans, A. niger) no significant growth and survive over designated period (supports 30-day discard statement) |
Note: The acceptance criteria are implicitly met by demonstrating that the Cachet Sterile Saline Solution is substantially equivalent to the predicate device in all critical aspects and adheres to relevant guidance documents.
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated as numerical sample sizes for individual tests. The studies are described as "a series of studies" and "a bacteriostasis study."
- Data Provenance: Not explicitly stated in terms of country of origin for the specific test data. The submitter is Cachet Pharmaceuticals Pvt. Ltd. from India. The studies were conducted in accordance with FDA guidance documents. The studies appear to be prospective in nature, as they were conducted to support the premarket submission.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The studies were conducted in accordance with "Micro Appendix C of the Premarket Notification 510 (K) Guidance Document for Contact Lens Care Products" and "FDA's May 1, 1997 Guidance for Industry, Premarket Notification 510 (K) Guidance Document for Contact Lens Care products," implying that relevant scientific and regulatory expertise was involved in designing and interpreting these tests, but specific expert qualifications are not detailed.
4. Adjudication Method
Not applicable. This submission is for a medical device (saline solution) and not an AI or diagnostic device that would typically involve expert adjudication of results. The "adjudication" is implicitly done through laboratory testing and comparison to established standards and predicate device characteristics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study comparing human reader performance with and without AI assistance, but rather a submission for a sterile saline solution.
6. Standalone Performance Study
Yes, a standalone performance was done in the sense that the device's performance was evaluated independently through a series of tests (toxicity, bacteriostasis) to demonstrate its safety and functionality compared to regulatory requirements and the predicate device. These tests evaluated the algorithm (the saline solution's formulation and properties) without human interpretation as a primary output.
7. Type of Ground Truth Used
- Toxicity: The ground truth for toxicity was established through in vitro (cytotoxicity) and in vivo (eye irritation) studies, where the outcome (e.g., cell viability, irritation levels) was measured and compared against established safety benchmarks and the predicate device's expected non-toxic profile.
- Bacteriostasis: The ground truth for bacteriostasis was established by controlled laboratory experiments where the survival and growth of specific microorganisms (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger) in the saline solution were directly measured and compared against acceptance criteria outlined in the relevant guidance document (Micro Appendix C).
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such a device would be the extensive research and development that led to its formulation, which is not quantified in terms of a "training set" sample size in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. The ground truth for the device's properties (formulation, sterility, safety) is established through standard laboratory testing and adherence to regulatory guidance as detailed in section 7.
§ 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.”