(316 days)
Sterile Saline Solution is indicated for rinsing & 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 and Boric Acid. The solution is packaged in plastic sterile single use twist open pods, reusable bottles with dropper tips and caps. Each bottle is closed with tamper resistant cap with a breakable ring, which must be broken in order to open the bottle.
This document describes the premarket submission for Cachet Pharmaceuticals Pvt. Ltd.'s Sterile Saline Solution.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are primarily focused on demonstrating substantial equivalence to existing legally marketed predicate devices and meeting specific safety and performance standards for contact lens care products.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Must be for rinsing and wetting of soft (hydrophilic) contact lenses. | "Sterile Saline Solution is indicated for rinsing & wetting of soft (hydrophilic) contact lenses." This matches the predicate devices' broader indications for use (rinsing, wetting, cleaning, disinfecting, storing). The FDA clearance letter confirms the indication for use: "Sterile Saline Solution is indicated for rinsing and wetting of soft (hydrophilic) contact lenses." |
| Formulation | Must be comparable to predicate devices in its essential components. | "Sodium chloride, Sodium borate, Boric acid." This is compared favorably to the predicate devices which also contain Sodium chloride and Boric acid, with one also containing Sodium borate. |
| Preservation | Must be preservative-free (or equivalent to predicate's preservative status). | "No" (preservative). This matches all predicate devices. |
| Sterility | Must be sterile. | "Sterile." This matches all predicate devices. |
| Toxicity | Non-toxic / no evidence of toxicity. | "A series of cytotoxicity and eye irritation studies of the Sterile Solution were undertaken. In these studies, there was no evidence of toxicity." |
| Bacteriostasis | Must demonstrate no significant growth/survival of specified bacteria over the designed discard period for reclosable containers. | "A bacteriostasis study was conducted... The results show that Staphylococcus aureous, Escherichia coli, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger have no significant growth and survive over the designed period. The data support the desire discard statement on label up to 30 days." |
| Compliance with Guidance | Must meet guidelines set forth in FDA's May 1, 1997 Guidance for Industry, Premarket Notification 510 (K) Guidance Document for Contact Lens Care products. | "Sterile Saline Solution meets the guideline set forth in FDA's May 1, 1997 Guidance for Industry, Premarket Notification 510 (K) Guidance Document for Contact Lens Care products." The bacteriostasis study was explicitly conducted "in accordance with Micro Appendix C" of this document. |
| Substantial Equivalence | Overall device must be substantially equivalent to legally marketed predicate device(s). | The submission concludes: "The data provide in this 510 (K) submission concludes that Sterile Saline Solution is substantially equivalent to currently cleared Purilens Saline Solution -K002319, Lens Plus Rewetting Drops -K042562, Unisol- P790011 cleared for marketing under 510 (K) for rinsing and wetting of soft (hydrophilic) contact lenses." The FDA's letter (K093367) confirms this determination. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample sizes used for the cytotoxicity, eye irritation, or bacteriostasis studies.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the submitter is based in India, it is possible the studies were conducted there. The studies are described in a way that suggests they were prospectively conducted for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable or not provided for this device. The Sterile Saline Solution is a chemical solution, not an imaging or diagnostic AI device that requires expert ground truth establishment for a test set. The "ground truth" for this device relates to established scientific and regulatory standards for sterility, non-toxicity, and inhibition of microbial growth, as determined by laboratory testing and specified protocols rather than expert consensus on interpretations of complex data like medical images.
4. Adjudication Method for the Test Set
This is not applicable or not provided. As explained above, the assessment criteria are based on objective laboratory tests against pre-defined thresholds, not on subjective interpretations requiring adjudication.
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
This is not applicable. The device is a sterile saline solution, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical product (saline solution), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance relies on:
- Laboratory-based scientific testing: This includes cytotoxicity studies, eye irritation studies, and bacteriostasis studies conducted according to established protocols (e.g., Micro Appendix C of FDA Guidance).
- Regulatory standards and guidance: Compliance with the FDA's "Guidance for Industry, Premarket Notification 510 (K) Guidance Document for Contact Lens Care products."
- Chemical and physical properties: Assessed through the formulation details (components, preservative status, sterility claim).
8. The Sample Size for the Training Set
This is not applicable. As a physical product, there is no "training set" in the context of machine learning or AI algorithms. The development of the solution would involve formulation studies and pilot testing, but these are not considered "training sets" in the AI sense.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as point 8. The "ground truth" for the development of the saline solution would have been established through a combination of pharmaceutical formulation science, existing knowledge of safe and effective ingredients for ophthalmic use, and preliminary laboratory testing to optimize the solution's properties.
§ 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.”