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510(k) Data Aggregation
(156 days)
iCase Contact Lens Case
For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered, saline, 3% hydrogen peroxide contact lens solution. Not to be used with multi-purpose (chemical) disinfection, heat disinfection or saline solutions.
The iCase is a personal contact lens case used with one step hydrogen peroxide (H2O2) lens disinfecting/cleaning solutions. The iCase monitors the initial rate of neutralization of hydrogen peroxide (H2O2) and indicates the status of the disinfection cycle using the LED display in the cap. The iCase LED display and monitoring system are disabled after 65 cycles of use to promote routine lens case replacement.
This document is a 510(k) summary for the NovaBay Pharmaceuticals, Inc. iCase Contact Lens Case. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.
Based on the provided text, the device is an iCase Contact Lens Case. The "acceptance criteria" discussed are primarily related to safety, functionality, and meeting regulatory standards for medical devices, rather than a quantifiable performance metric for an AI or imaging device.
Here's an attempt to extract and format the requested information, acknowledging that many fields will be "Not Applicable" (N/A) due to the nature of this submission (a medical device accessory designed for safety and usability, not an AI or diagnostic tool):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Components used must be safe for intended use. Evaluated according to ISO Part 10993 Biological Evaluation of Medical Devices, including Cytotoxicity, Systemic Toxicity, and Primary Ocular Irritation. | "The test results indicate the components are safe for the intended use." |
| Electrical Safety | Compliance with applicable sections of: IEC 60601-1 (General Requirements for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-1-6 (Usability - Application of Usability to Medical Devices), IEC 60601-1-11 (Home Healthcare Environment), IEC 62366 (Application of Usability Engineering to Medical Devices). Note regarding red/yellow indicator lights: they do not indicate Warning/Caution as listed in 60601-1 Section 7.8.1. | "The iCase Contact Lens Case complies with the applicable sections of the referenced electrical standards." and "The iCase red/yellow indicator lights vary from the standard, as they do not indicate Warning/Caution as listed 60601-1 Section 7.8.1." (This indicates an acknowledgement of a deviation from standard color coding but implies it was assessed and deemed acceptable in context). |
| Software Validation | Compliance with FDA guidance: "General Principles of Software Validation: Final Guidance for Industry and FDA Staff, January 2002" and "Guidance for Premarket Submissions for Software Contained in Medical Devices, May 2005." | "The iCase software has been evaluated... and complies with the applicable sections of the referenced software validation guidance." |
| Functional Equivalence | Similar design, materials, and intended function to a predicate device for 3% hydrogen peroxide disinfection. Must successfully monitor the initial rate of neutralization of hydrogen peroxide and indicate disinfection cycle status using an LED display, with disablement after 65 cycles. | "The iCase is a personal contact lens case used with one step hydrogen peroxide (H2O2) lens disinfecting/cleaning solutions. The iCase monitors the initial rate of neutralization of hydrogen peroxide (H2O2) and indicates the status of the disinfection cycle using the LED display in the cap. The iCase LED display and monitoring system are disabled after 65 cycles of use to promote routine lens case replacement." Extensive evaluation and testing for Risk Analysis, Device Hazard Analysis, Corrosion testing, Software validation and Cycling studies including peroxide degradation measurements are listed as performed. The conclusion states it is "as safe, as effective and performs as well as the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not explicitly stated in terms of number of devices tested for each criterion. The evaluation appears to be based on engineering tests, risk analyses, and compliance with standards rather than a statistical "test set" of consumer usage or adverse events.
- Data Provenance: The studies mentioned (Biocompatibility, Electrical Safety, Software Validation, Cycling studies, Peroxide Degradation measurements, Risk Analysis, Device Hazard Analysis, Corrosion testing) were conducted by NovaBay Pharmaceuticals, Inc. (the applicant). The country of origin of the data is not specified beyond being generated by the applicant for FDA submission. It is retrospective data collected to support the premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: N/A. This device is not an AI/diagnostic tool requiring expert-established ground truth for performance evaluation in a clinical sense. The "ground truth" here is adherence to engineering standards, safety requirements, and functional specifications established through recognized testing methods.
- Qualifications of Experts: N/A for the same reason. The expertise lies within the engineering, regulatory, and quality teams involved in designing, testing, and submitting the device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: N/A. Not applicable to engineering and regulatory compliance testing.
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
- MRMC Study: No. This is a contact lens case, not an imaging or diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: N/A. While the iCase has integrated electrical components and software to monitor peroxide neutralization and indicate cycle status, it's a functional device, not an "algorithm" in the sense of an AI model being evaluated for standalone performance. Its performance is intrinsically linked to the chemical process it monitors and its physical design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For this device, the "ground truth" is defined by:
- Regulatory Standards: ISO biocompatibility standards, IEC electrical safety standards, FDA software validation guidance.
- Engineering Specifications: Successful monitoring of H2O2 neutralization, accurate cycle indication via LED, proper device disablement after 65 cycles, material compatibility.
- Predicate Device Equivalence: The performance of the legally marketed predicate device (Clear Care Contact Lens Case) forms a benchmark for "safe and effective."
8. The sample size for the training set
- Sample Size (Training Set): N/A. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): N/A. Not applicable.
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