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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 29, 2015

Novabay Pharmaceuticals, Inc. Foresight Regulatory Strategies, Inc. % Ms. Ellen M. Beucler Vice President 187 Ballardvale Street, Suite 180 Wilmington, Massachusetts 01887

Re: K143351

Trade/Device Name: Icase Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: March 30. 2015 Received: April 1, 2015

Dear Ms. Beucler:

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 yours,

Kesia Y. Alexander -A

for Malvina B. Eydelman, MD 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) K143351

Device Name iCase Contact Lens Case

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the text 'K143351' in a serif font. The text is underlined with a thin black line. The numbers are slightly larger than the letters.

Image /page/3/Picture/1 description: The image shows the logo for NovaBay Pharmaceuticals. The logo is in blue and features a stylized eye design as part of the "N" in NovaBay. Below the "Bay" portion of the logo, the word "PHARMA" is written in smaller, sans-serif font.

510(k) Summary

NOVABAY PHARMACEUTICALS, INC. iCase Contact Lens Case

1. Applicant Information

NovaBay Pharmaceuticals, Inc. 5980 Horton St., Suite 550 Emeryville, CA 94608

Contact Person:	Dr. Charles Francavilla
Telephone No.:	(510) 899 - 8831
Fax No.:	(510) 280 - 8379
E-mail:	cfrancavilla@novabaypharma.com
Date Prepared:	April 28, 2015

2. Device Information

Classification name:	Contact Lens Care Products
Device classification:	Class II
Regulation number:	21 CFR 886.5928 (Soft (hydrophilic) contact lens care products)
Product code:	LRX
Proprietary name:	NovaBay Pharmaceuticals, Inc. iCase Contact Lens Case

3. Predicate Devices

NovaBay Pharmaceuticals, Inc. claims substantial equivalence to PMA No. P820040, AOSept Lens Care System (Reclassified to Class II in 1997), Trade Name "Clear Care Contact Lens Care System", CIBA Vision.

4. Description of Device

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Image /page/4/Picture/0 description: The image shows the logo for NovaBay Pharma. The logo is in blue and features the word "NovaBay" in a stylized font. The "O" in NovaBay is designed to look like an eye. Below NovaBay is the word "PHARMA" in a smaller font.

K143351

5. Indications for Use

The NovaBay Pharmaceuticals, Inc. iCase contact lens case is indicated for the 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.

6. Performance Data

The key components of any hydrogen peroxide disinfection case includes: plastic vial, lens baskets, vented screw cap and catalytic platinum disk. The iCase Contact Lens Case and the predicate device incorporate all of these same components with identical functions.

The key electrical components of the iCase includes: power supply (battery), sensors, microcontroller and light emitting diodes. These components are unique to the iCase Contact Lens Case. The iCase Contact Lens Case with the integrated electrical components and software has undergone extensive evaluation and testing for IEC electrical safety testing. Risk Analysis, Device Hazard Analysis, Corrosion testing, Software validation and Cycling studies including peroxide degradation measurements.

Non-Clinical Data

The iCase Contact Lens Case was evaluated for Biocompatibility safety in accordance with the following standards. The iCase component testing included Cytotoxicity, Systemic Toxicity and Primary Ocular Irritation. The test results indicate the components are safe for the intended use.

· ISO Part 10993 Biological Evaluation of Medical Devices.

Electrical Safety Data

The iCase Contact Lens Case was evaluated for electrical safety in accordance with the following standards.

IEC 60601- 1 Medical Electrical Equipment Part 1: General Requirements for basic ● safety and essential performance.
IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General Requirements for safety ● - Collateral Standard: Usability - Application of Usability to Medical Devices.

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Image /page/5/Picture/0 description: The image shows the logo for NovaBay Pharma. The logo is in blue and features the word "NovaBay" in a stylized font. Below the word "NovaBay" is the word "PHARMA" in a smaller font. The logo is simple and professional, and it is likely used to represent the company's brand.

IEC 60601-1-11 Medical Electrical Equipment Part 1-11: General Requirements for . basic safety and essential performance, Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems use in the Home Healthcare Environment,
. IEC 62366 Medical Devices - Application of Usability Engineering to Medical Devices.

The iCase Contact Lens Case complies with the applicable sections of the referenced electrical standards. 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.

The iCase Contact Lens Case utilizes data acquisition software to monitor the status of the peroxide neutralization process. The iCase software has been evaluated in accordance with FDA guidance, General Principles of Software Validation: Final Guidance for Industry and FDA Staff, January 2002 and the FDA Guidance for Premarket Submissions for Software Contained in Medical Devices, May 2005. The iCase Contact Lens Case complies with the applicable sections of the referenced software validation guidance.

Clinical Data

Clinical studies involving contact lens wear were unnecessary for this application. Lens care hydrogen peroxide solutions used with this iCase Contact Lens Case are already cleared for use as cleaning, rinsing, disinfection and storage solutions for contact lenses.

Conclusion

Based upon the test data presented, the NovaBay Pharmaceuticals, Inc. iCase Contact Lens Case is as safe, as effective and performs as well as the predicate device. A comparison of the new device and the predicate device is presented in Table 1.

7. Substantial Equivalence

The claim of substantial equivalence to the approved PMA No. P820040, AOSept Lens Care System (Reclassified to Class II in 1997), Trade Name "Clear Care Contact Lens Care System, is supported by the Comparison of Characteristics in Table 1. The predicate device was approved under the FDA product code LPN (accessories, soft lens products) and included a lens care solution and lens case. The iCase 510(k) application includes only a lens case and is identified by the FDA product code LRX (case, contact lens).

The iCase Contact Lens Case and the Clear Care contact lens case are similar in design and volume. Both lens cases are manufactured from similar materials that have been proven to be safe for use. Both lens cases can be used for one step hydrogen peroxide disinfection treatments. The new components used in the iCase Contact Lens Case have been evaluated for electrical safety and validated for their intended functions and do not pose any new risks for safety and effectiveness. Therefore, NovaBay Pharmaceuticals, Inc. iCase Contact Lens Case is substantially equivalent to the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for NovaBay Pharma. The logo is in blue and features the word "NovaBay" in a stylized font. Below the word "NovaBay" is the word "PHARMA" in a smaller font. There is a registered trademark symbol to the right of the word "Bay".

Table 1 Comparison of Characteristics
	NovaBay Pharmaceuticals, Inc. iCase	Clear Care CIBA VISION
Device Name	Contact Lens Case	Contact Lens Case
Trade Name	iCase Contact Lens Case	Clear Care Contact Lens Case
Document Number	510(k) K143351	PMA No. P820040
Classification	Ophthalmic	Ophthalmic
Product Code	LRX	LPN
Regulation Number	21 CFR 886.5928	21 CFR 886.5928
Class	II	II
Intended Use	For use during 3% hydrogen peroxidecleaning, disinfection and storage ofsoft (hydrophilic) and rigid gaspermeable contact lenses.	For use during 3% hydrogen peroxidecleaning, disinfection and storage ofsoft (hydrophilic) and rigid gaspermeable contact lenses.
Disinfection Type	3% Hydrogen Peroxide catalyzedby platinum coated disk	3% Hydrogen Peroxide catalyzedby platinum coated disk
Disinfection Cycle	Minimum of 6 hours	Minimum of 6 hours
Vial Design	Barrel style vented lens case withplastic screw top. Lens baskets and aneutralizing platinum disk aresuspended from the cap	Barrel style vented lens case withplastic screw top. Lens baskets and aneutralizing platinum disk aresuspended from the cap
Power Supply	3 V coin style battery hermeticallysealed in the vial cap supplies powerto internal clock and sensors	None
Cycle Indicator Lights	The screw cap contains three coloredLED lights that indicate the status ofthe neutralization cycle	None
Cycle Timer	An internal timer monitors the lengthof the 6 hour neutralization cycle	Patients use an external timer tomonitor the 6 hour neutralizationcycle
Materials	Plastic resin vial, lens baskets andscrew cap with a platinum coatedneutralizing disk	Plastic resin vial, lens baskets andscrew cap with a platinum coatedneutralizing disk
Biocompatibility	Components used in this lens casehave been evaluated in accordancewith Part 10993 of the ISO standardfor Biological Evaluation. Test resultsindicate the test article meets theISO standards	Components used in this lens casehave been evaluated in accordancewith FDA Guidance for lens casematerials.

Regulation Number and Section

§ 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.”