(66 days)
For storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection. Use for storage during chemical disinfection only. Do not use during heat disinfection.
The Contact Lens Case is a lens case product to be used by the contact lens wearer or practitioner for storing soft (hydrophilic), hard and rigid gas permeable contact lenses during chemical disinfection. The Case is to be designed during chemical disinfection only. No designed for heat disinfecting system.
The Contact Lens Case includes A-1 and B-1 two models. Both have adopted the same structure design, consisting of two parts: holder and cover. The holder is based with adjoining dual wells for the containment of fluid, and two covers are designed for screwing. At the same time, the bottom of each well is marked with L (left) and R (right) letters, and the covers are also labeled with L (left) and R (right) letters.
The Contact Lens Case is simple with a well volume of 4.2mL ±0.15. This volume capacity can provide sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately over the lenses for cleaning.
The provided document describes a 510(k) premarket notification for a Contact Lens Case, Model: A-1, B-1. The primary focus of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing novel safety and effectiveness through extensive clinical trials for a new medical device. Therefore, the information regarding acceptance criteria and studies will be different from what might be found for a device requiring more comprehensive performance validation (e.g., AI algorithms or complex medical devices).
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely based on demonstrating equivalence in product design, material biocompatibility, and functional performance (leakage) to existing, approved predicate devices.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Requirement | Reported Device Performance |
|---|---|---|
| I. Biocompatibility | Must comply with ISO 10993-1, specifically tests for: | All tests were passed (see details below). |
| Cytotoxicity | ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity | Passed |
| Skin Sensitization | ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization | Passed |
| Ocular Irritation | ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Ocular Irritation | Passed |
| Systemic Toxicity | ISO 10993-11:2006/(R)2010, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity | Passed |
| II. Leakage Testing | No leakage when filled to 2/3 with liquid, turned upside down for 15 minutes, repeated 3 times. | None of the tested contact lens cases showed any leakage and all passed the leakage tests successfully. (120 combinations of different tops and bottoms were tested). |
| III. Effectiveness (Volume) | The capacity must be sufficient for the contact lens to be fully immersed under use conditions. (Predicate devices had volumes of 4.2mL ± 0.15 and 4.8mL, and "over 3.0mL"). Subject device has a well volume of 4.2mL ± 0.15. | The capacity is sufficient for contact lens to be fully immersed under use conditions. (Stated in the comparison table and device description, implicitly meeting the criterion by matching/exceeding predicate volume). |
| IV. Material Equivalence | The subject device materials should be similar to or have demonstrated equivalent safety profile to predicate devices. (A-1: Polypropylene (holder), High-density Polyethylene (HDPE) (cover); B-1: Acrylonitrile-Butadiene-Styrene copolymer (ABS)) | A-1 Model is made of similar materials as Predicate Device 1 (Polypropylene holder, Polyethylene lid). B-1 Model is made of the same material as Predicate Device 2 (Acrylonitrile-Butadiene-Styrene copolymer (ABS)). Relevant biocompatibility tests were conducted and met all requirements, demonstrating comparability. |
| V. Design & Intended Use | Similar design (holder with two wells, screw covers, L/R markings) and identical intended use (storage of soft, hard, RGP contact lenses during chemical disinfection, not heat disinfection) to predicate devices. | The subject device has the same classification, intended use, and similar product design as the predicate devices. Minor differences in material and appearance were addressed by safety testing. The subject device has "the same performance effectiveness as the predicate devices." (Stated in comparison tables). |
Study Details
Given the nature of a 510(k) for a contact lens case, the "study" is primarily a set of non-clinical tests to demonstrate safety and performance equivalence.
1. Sample size used for the test set and the data provenance:
- Biocompatibility Testing: The specific sample sizes for each individual biocompatibility test (cytotoxicity, sensitization, ocular irritation, systemic toxicity) are not explicitly stated in the provided text. These tests are typically performed on extracts from a representative number of device components or material samples under controlled laboratory conditions, not on a "test set" in the sense of clinical cases.
- Leakage Testing:
- Sample Size: 120 combinations of different tops and bottoms.
- Data Provenance: Not explicitly stated but implied to be conducted by the manufacturer or a contracted testing lab as part of the device's validation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable or not provided for this type of device and submission. "Ground truth" established by experts is typically relevant for diagnostic devices or AI algorithms where human interpretation is being evaluated or augmented. For a contact lens case, the "ground truth" for performance is defined by adherence to physical and biological testing standards.
3. Adjudication method for the test set:
- This information is not applicable or not provided. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations of data, usually in diagnostic imaging or clinical trials. For a non-clinical device like a contact lens case, the test results are usually measured objectively against predefined pass/fail criteria.
4. 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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers. The contact lens case is a physical medical device, not an AI diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device does not involve an algorithm.
6. The type of ground truth used:
- The "ground truth" for this device's performance is established by objective measurements against recognized international standards and specifications:
- Biocompatibility: Adherence to ISO 10993 standards for cytotoxicity, sensitization, ocular irritation, and systemic toxicity.
- Leakage: Absence of visible liquid escape under specified test conditions.
- Volume/Effectiveness: Physical measurement of fluid capacity compared to the functional requirement (sufficient immersion) and predicate devices.
7. The sample size for the training set:
- Not applicable / Not provided. This device is not an AI algorithm that requires a "training set." The testing performed (biocompatibility, leakage) is for validation against established standards.
8. How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no "training set" for an AI algorithm, this question is irrelevant to this device 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.”