(180 days)
For storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Use for storage during chemical disinfection only. Do not use during heat disinfection.
Polaris Contact Lens Case is a product for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. This device is intended for use with a contact lens solution to store the contact lenses, This product is not to be used in heat disinfection. This device is manufactured in two variations: #101 and #201. The variants follow the same design principles and have the same intended use. The only differences are the dimensions and appearance between the two models. These variations do not affect the safety or effectiveness of the products' intended use. The primary materials which compose the applicant device are ST757M and PT231M; they are produced by Taiwan Polypropylene Co., Ltd. ST757M is a translucent raw material and PT231M is an opaque white raw material. The Polymer 27A55 is produced by Kraton Polymers UK Ltd. The volume of each of the two chambers in the applicant device #101 contact lens case is 4.5ml. The volume of each of the two chambers in the applicant device #201 contact lens case is 3ml. Contact lenses can be fully immersed into the chamber; both models can accommodate all lenses currently on the market.
This submission describes the Polaris Contact Lens Case (models #101 and #201), a device intended for the storage of soft (hydrophilic), rigid gas permeable, or hard contact lenses with chemical disinfectants. The acceptance criteria and the study that proves the device meets them are summarized below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-5:1999 (In vitro cytotoxicity - no cytotoxic effects) | The test article did not induce cytotoxic effects and did not inhibit cell proliferation after exposure for 24 to 48 hours in L929 colorectal carcinoma cells. |
| ISO 10993-10:2002 (Irritation and Delayed-Type Hypersensitivity - no delayed dermal contact sensitization) | There was no evidence of delayed dermal contact sensitization in guinea pigs after injection with 0.9% extracted Sodium Chloride. No deviation from protocol or adverse problems. | |
| ISO 10993-11:2006 (Systemic Toxicity - data for safety criteria for human exposure) | All data generated from this study will be used as safety criteria for human exposure (implies acceptable systemic toxicity profile based on the standard). | |
| Functional Equivalence | Able to fully immerse all contact lenses on the market | Models #101 (4.5 ml per chamber) and #201 (3ml per chamber) can fully immerse all contact lenses currently on the market (max 1.4 cm diameter x 0.35 cm height). |
| Leakage | Not explicitly stated, but implied as part of overall safety and effectiveness for a contact lens case | Leakage tests were performed on each variant. The result of testing supports the claim of substantial equivalence. |
| Intended Use | Same as predicate: Storage of soft, rigid gas permeable, or hard contact lenses with chemical disinfectants only, no heat disinfection. | Polaris Contact Lens Case has the same intended use. |
| Materials | Suitable for intended use and comparable to predicate. | Constructed from ST757M and PT231M (Taiwan Polypropylene Co., Ltd.) and Polymer 27A55 (Kraton Polymers UK Ltd.). Deemed comparable by the FDA as part of substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not specify a "test set" in the context of typical clinical or performance studies with separate training and testing data for an algorithm. Instead, the testing relates to biocompatibility and functional assessment.
- Biocompatibility Tests: The document details specific ISO standards used.
- ISO 10993-5:1999 (Cytotoxicity): Tested on L929 colorectal carcinoma cells. The sample size for the test article (the contact lens case materials) would be determined by the standard's methodology for preparing extracts from the device for cell culture exposure. The specific number of cell cultures or replicates is not stated.
- ISO 10993-10:2002 (Irritation and Delayed-Type Hypersensitivity): Tested on guinea pigs. The specific number of guinea pigs used for this test is not stated, but these studies typically involve a defined number of animals per group (e.g., 5-10 per group).
- ISO 10993-11:2006 (Systemic Toxicity): The specific animal model and sample size for systemic toxicity are not stated, but similar to hypersensitivity, these studies involve a defined number of animals.
- Functional Assessment (Volume and Lens Immersion): This was a qualitative assessment based on physical dimensions of the device and known dimensions of contact lenses. No "sample size" in the statistical sense is applicable here.
- Leakage Tests: Performed on "each variant" (#101 and #201). The specific number of units tested is not provided.
Data Provenance: The studies were conducted by or on behalf of Reliance Design & Manufacture Corp., located in Taiwan. The data is prospective for the specific tests performed on the Polaris Contact Lens Case.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is not an AI/ML device, and therefore, no experts were used to establish ground truth in the context of clinical interpretation or diagnosis. The "ground truth" for the performance criteria (biocompatibility, functional equivalence, leakage) is established by the international standards (ISO 10993 series) themselves and accepted scientific methodologies for assessing material safety and device function.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device involving human interpretation of results. The assessment of test results (e.g., cytotoxicity, allergic reactions in animals) is typically performed by trained laboratory personnel following established protocols and criteria defined by the ISO standards.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Established scientific methodologies and criteria defined by the ISO 10993 series of standards for biocompatibility (e.g., absence of cytotoxicity, irritation, sensitization).
- Physical measurements and known specifications for functional aspects (e.g., device chamber volume, typical contact lens dimensions).
- Predicate device's established safety and effectiveness: The primary pathway for approval is substantial equivalence to a legally marketed predicate device (Ningbo Kaida Rubber & Plastic Technology Co., Ltd. Contact Lens Case K071081). The fundamental "ground truth" for safety and effectiveness is that it performs comparably to a device already deemed safe and effective by the FDA.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. Since there is no training set, there is no ground truth established for one.
§ 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.”