(67 days)
The storage and disinfection of soft, rigid gas permeable or hard contact lenses. For use during chemical disinfection only. Not to be used with heat.
The Eye Care and Cure Contact Lens Case consists of a lens case base with adjoining dual walls for the containment of fluid and separate integral hinged self-sealing caps. The Eye Care and Cure Contact Lens Case is polyethylene and consists of a two adjoining wells, with hinged self-sealing caps, in which contact lenses are immersed in fluid. The two adjoining wells of the Eye Care and Cure Contact Lens Case each have a capacity of 1.0ml. The inner height of the well measures 8mm. The Eye Care and Cure Contact Lens Case is made of Dow Chemical Company Low Density Polyethylene, Dow Product #9931. No colorant will be added.
The provided text is a 510(k) summary for a contact lens case, focusing on demonstrating substantial equivalence to predicate devices, rather than a study proving performance against acceptance criteria in the context of a new efficacy claim or a complex diagnostic algorithm.
Therefore, many of the requested categories are not applicable to this document. The submission aims to show that the new device is fundamentally similar to existing, legally marketed devices, and thus does not require extensive new studies or data to establish safety and effectiveness.
Here's an assessment based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence: | Same intended use: storage during chemical disinfection of soft, rigid gas permeable, or hard contact lenses. Not for heat disinfection. |
| Design/Material Equivalence: | Similar product design: two adjoining wells with integral hinged caps. Same material: Dow Chemical Company Low Density Polyethylene, Dow Product #9931. |
| Effectiveness Equivalence: | Same performance effectiveness: two adjoining wells with sufficient capacity for full lens immersion. |
| Safety Equivalence: | Same material as predicate device (Dow Chemical Company Low Density Polyethylene, Dow Product #9931), which has established safety in predicate. |
| Labeling & Packaging Equivalence: | Similar: Refers to product as contact lens case; instructs cleaning as recommended by eye care professional (Predicate refers to disinfecting solution). |
Study Information (Based on provided text, most are Not Applicable for this type of submission):
This 510(k) submission establishes substantial equivalence to predicate devices, therefore, a traditional "study that proves the device meets the acceptance criteria" in the sense of a clinical trial or performance study for a novel algorithm is not present. The demonstration of equivalence relies on comparing the applicant's device to already approved predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission did not involve a formal "test set" for performance evaluation in the typical sense of a diagnostic or therapeutic device. Substantial equivalence is established through comparison of specifications and existing data from predicate devices. The safety data referenced for the predicate (K042578) with biocompatibility tests (In Vitro Cyto-Toxicity, Delayed-Type Hypersensitivity, Eye Irritation, Systemic Toxicity) would have had their own sample sizes, but these are not for the applicant device and are not detailed in this summary.
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)
- Not Applicable. Ground truth establishment by experts for a test set is not relevant for this 510(k) submission, which focuses on material composition, design, and intended use equivalence to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used in studies involving expert review of data, which is not the nature of this submission.
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 device is a contact lens case, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical contact lens case, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Based on Equivalence: The "ground truth" here is the established safety and effectiveness of the identified predicate devices, particularly the i-Promotions Contact Lens Case (K042578). The applicant device's material is the same, and its design and function are deemed equivalent to these already approved devices. For the predicate device's safety, the ground truth would have been established by standard biocompatibility testing (cytotoxicity, hypersensitivity, irritation, systemic toxicity).
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this device.
§ 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.”