(59 days)
The LensGiene™ Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The LensGiene™ Sterile Saline Solution is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
The LensGiene™ Sterile Saline Solution is a sterile, preservative-free, aqueous solution of sodium chloride, boric acid, and sodium borate provided in single does, carry-on size 10 ml bottles. The sterile saline solution has a pH 7.2-7.8 and a tonicity of 290-320 mOsm/kg. It rinses loose debris and cleaning solution off soft (hydrophilic), rigid gas permeable (RGP) and hard contact lenses prior to insertion. The rinsing solution removes debris and bacteria following proper disinfection as recommended by the eye care practitioner. The sterile saline solution can be used to rinse contact lens cases, rinse lenses as needed throughout the day and to fill the concave posterior surface of scleral lenses prior to insertion to provide a more natural environment than currently approved multipurpose solutions which contain preservatives and osmolarity agents that are not designed to be held against the cornea for extended periods of time.
The LensGiene™ Sterile Saline Solution is a clear solution and should not be used if cloudy or discolored. The individual 10 ml bottle should be discarded after opening and use and should not be used after its labeled expiry date.
This document describes the 510(k) summary for the LensGiene™ Sterile Saline Solution. It is a submission for a medical device and, as such, there are no acceptance criteria or studies to prove the device meets acceptance criteria in the way you've outlined for an AI/algorithm-based device.
The document states that non-clinical and clinical data were unnecessary because the solution was previously submitted and cleared under 510(k) K110221. This means the current submission is relying on prior approvals and established equivalence to predicate devices, rather than new performance studies with specific acceptance criteria.
Therefore, for the information you've requested, the answer is that these criteria and studies were not conducted for this 510(k) submission. However, I can still extract details that relate to the device's characteristics and the basis for its clearance, if reinterpreted for this context:
1. A table of acceptance criteria and the reported device performance:
Since this is a submission for a sterile saline solution and not an AI or algorithm, there aren't "acceptance criteria" in the traditional sense of performance metrics for an algorithm. Instead, the "performance" is based on its composition and how it compares to predicate devices. The closest equivalent is the comparison table to predicate devices.
| Characteristic | LensGiene™ Sterile Saline Solution | Menicon Saline Rinse Solution (Predicate) | EyeCept™ Sterile Saline Solution (Predicate) |
|---|---|---|---|
| Device Name | Contact Lens Care Product | SAME | SAME |
| Trade Name | LensGiene™ Sterile Saline Solution | Menicon Saline Rinse Solution | EyeCept™ Sterile Saline Solution |
| Document Number | N/A (this submission) | K151768 | K110221 |
| Classification | Ophthalmic | SAME | SAME |
| Product Code | MRC and LPN | SAME | LPN |
| Regulation Number | 21 CFR 886.5918, 21 CFR 886.5928 | SAME | 21 CFR 886.5928 |
| Class | II | II | II |
| Intended Use | For use following proper lens disinfection as recommended by the eye care practitioner. For rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. May also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses. | SAME | For rinsing soft contact lenses after cleaning and for wetting soft contact lenses after disinfection before use. |
| Volume | 10 ml | 5 ml | 10 ml |
| Preservative Free | Yes | SAME | SAME |
| Container Usage | Single use | SAME | SAME |
| Sterility | Sterile | SAME | SAME |
| Materials | Plastic resin container with twist off cap | SAME | SAME |
| Biocompatibility | Evaluated in accordance with FDA Guidance for Contact Lens Care Products | SAME | SAME |
2. Sample size used for the test set and the data provenance: Not applicable. No new test set was used for this 510(k) submission as the device's performance relies on previously cleared data and substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment was performed for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new adjudication was performed.
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: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this submission. The "ground truth" for saline solutions generally pertains to sterility, biocompatibility, and chemical composition, which would have been established during the studies for the predicate devices (K110221 specifically).
8. The sample size for the training set: Not applicable. No training set for an algorithm was used.
9. How the ground truth for the training set was established: Not applicable. No training set was used.
Summary of the basis for clearance for this specific submission (K161622):
The LensGiene™ Sterile Saline Solution received 510(k) clearance based on its substantial equivalence to two predicate devices:
- Menicon Co., Ltd. Saline Rinse Solution (K151768)
- Optics Laboratory, Inc. EyeCept™ Sterile Saline Solution (K110221)
The key justification was that the LensGiene™ solution has a similar composition (sterile, preservative-free aqueous solution of sodium chloride, boric acid, and sodium borate with specific pH and tonicity) and intended use as the predicate devices. The submission explicitly states: "Non-clinical tests were unnecessary for this application because this testing was previously submitted for this solution under cleared 510(k) K110221." and "Clinical studies were unnecessary for this application because this solution was previously cleared for rinsing soft (hydrophilic) contact lenses under K110221." This means that the original safety and effectiveness data for a very similar product (EyeCept™ Sterile Saline Solution, K110221) was leveraged for this new submission.
§ 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.”