(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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2016
Optics Laboratory, Inc. % Mr. Paul Kramsky President Rockin' Regulatory, Inc. 21831 Tumbleweed Circle Lake Forest, CA 92630
Re: K161622
Trade/Device Name: LensGiene™ Sterile Saline Solution Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Regulatory Class: Class II Product Code: MRC, LPN Dated: June 10, 2016 Received: June 13, 2016
Dear Mr. Kramsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Kesia Alexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161622
Device Name LensGiene(TM) Sterile Saline Solution
Indications for Use (Describe)
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 cav to rinse contact lenses.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for the LensGiene™ Sterile Saline Solution
"Submission Sponsor:
Optics Laboratory, Inc. 9480 Telstar Ave Ste 3 El Monte, CA 91731-2988 Telephone: 626-350-1926 Fax: 626-350-1906 FDA Establishment Registration #: 3001918419
Submission Correspondent:
Rockin' Regulatory, Inc. 21831 Tumbleweed Circle Lake Forest, CA 92630 Telephone: 949-636-1464 Contact: Paul Kramsky, President Email: pkramsky@cox.net
Date Prepared:
June 10, 2016
Device Name:
| Trade/Proprietary Name: | LensGiene™ Sterile Saline Solution |
|---|---|
| Classification Name: | Contact Lens Care Products |
| Product Code: | MRC and LPN |
| Regulation Number: | 21 CFR 886.5918 (Rigid Gas Permeable Contact Lens Care Products) |
| 21 CFR 886.5928 (Soft (hydrophilic) Contact Lens Care Products) | |
| Device Classification: | II |
| Review Panel: | Ophthalmic |
Predicate Devices:
The LensGiene™ Sterile Saline Solution is substantially equivalent to the Menicon Co., Ltd. Saline Rinse Solution (K151768) and the Optics Laboratory, Inc. EyeCept™ Sterile Saline Solution (K110221).
Device Description:
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
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Optics Laboratory, Inc. LensGiene™ Sterile Saline Solution Traditional 510(k) Premarket Notification
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.
Indications for Use:
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.
Performance Data:
Non-Clinical Data
Non-clinical tests were unnecessary for this application because this testing was previously submitted for this solution under cleared 510(k) K110221.
Clinical Data
Clinical studies were unnecessary for this application because this solution was previously cleared for rinsing soft (hydrophilic) contact lenses under K110221.
Conclusion
Based upon the composition of the saline solution and previous test data submitted in K110221, the LensGiene™ Sterile Saline Solution is as safe, as effective and performs as well as the predicate devices. A comparison of the LensGiene™ Sterile Saline Solution and the predicate devices is presented in Table 1.
Substantial Equivalence:
The claim of substantial equivalence to the previously cleared Menicon Co., Ltd. Saline Rinse Solution (K151768) and the Optics Laboratory, Inc. EyeCept™ Sterile Saline Solution (K110221) is supported by the following Comparison of Characteristics in Table 1. The LensGiene™ Sterile Saline Solution and the predicates are similar in composition and intended use. Therefore, the LensGiene™ Sterile Saline Solution is substantially equivalent to the predicate devices.
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| Table 1 Comparison of Characteristics | |||
|---|---|---|---|
| LensGiene™ Sterile Saline Solution | Menicon Saline Rinse Solution | EyeCept™ Sterile Saline Solution | |
| Device Name | Contact Lens Care Product | SAME | SAME |
| Trade Name | LensGiene™ Sterile Saline Solution | Menicon Saline Rinse Solution | EyeCept™ Sterile Saline Solution |
| Document Number | K151768 | K110221 | |
| Classification | Ophthalmic | SAME | SAME |
| Product Code | MRC and LPN | SAME | LPN |
| Regulation Number | 21 CFR 886.591821 CFR 886.5928 | SAME | 21 CFR 886.5928 |
| Class | II | II | II |
| Intended Use | For use following proper lensdisinfection as recommendedby the eye care practitioner.The LensGiene™ SterileSaline Solution is for rinsingsoft (hydrophilic), rigid gaspermeable and hard contactlenses prior to lens insertion.This solution may also be usedas an insertion solution forlarge diameter (scleral) contactlenses, as a rinse for contactlens cases, and may be used asneeded throughout the day torinse contact lenses. | SAME | For rinsing softcontact lenses aftercleaning and forwetting soft contactlenses afterdisinfection beforeuse. |
| 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 twistoff cap | SAME | SAME |
| Biocompatibility | Evaluated in accordance withFDA Guidance for Contact LensCare Products | SAME | SAME |
§ 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.”