(156 days)
PMA No. P820040
Not Found
No
The description focuses on monitoring the rate of neutralization and indicating status via an LED display, which are standard sensor and display functions, not indicative of AI/ML. There is no mention of AI, ML, or related concepts like image processing or training/test sets.
No
The device is a contact lens case used for disinfection, not directly for treating a disease or condition. Its function is to facilitate the cleaning of lenses.
No
The device is a contact lens case designed for disinfection with hydrogen peroxide solutions. While it monitors the neutralization rate and indicates the disinfection status, its primary function is not to diagnose medical conditions or diseases in a patient. It is designed to facilitate a care process for the lenses, not the user's health.
No
The device description explicitly mentions "integrated electrical components and software" and describes a physical case with an LED display and monitoring system, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the storage of contact lenses during disinfection with a specific type of solution. It monitors the disinfection process, but it does not analyze a biological sample from the human body to provide diagnostic information about a disease or condition.
- Device Description: The device monitors the neutralization of hydrogen peroxide and indicates the status of the disinfection cycle. This is related to the efficacy of the cleaning process for the contact lens, not a diagnostic test on a patient.
- Lack of Biological Sample Analysis: IVDs are designed to analyze biological samples (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological sample from a patient.
The device is a contact lens accessory that aids in the proper disinfection of contact lenses. While it has electronic components and software to monitor the process, its function is related to the care of the medical device (the contact lens) rather than providing diagnostic information about a patient.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The iCase Contact Lens Case was evaluated for electrical safety in accordance with the following standards: IEC 60601- 1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, and IEC 62366. The iCase Contact Lens Case complies with the applicable sections of the referenced electrical standards.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PMA No. P820040
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
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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)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| 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
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.
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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.
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 peroxide | |
| cleaning, disinfection and storage of | ||
| soft (hydrophilic) and rigid gas | ||
| permeable contact lenses. | For use during 3% hydrogen peroxide | |
| cleaning, disinfection and storage of | ||
| soft (hydrophilic) and rigid gas | ||
| permeable contact lenses. | ||
| Disinfection Type | 3% Hydrogen Peroxide catalyzed | |
| by platinum coated disk | 3% Hydrogen Peroxide catalyzed | |
| by platinum coated disk | ||
| Disinfection Cycle | Minimum of 6 hours | Minimum of 6 hours |
| Vial Design | Barrel style vented lens case with | |
| plastic screw top. Lens baskets and a | ||
| neutralizing platinum disk are | ||
| suspended from the cap | Barrel style vented lens case with | |
| plastic screw top. Lens baskets and a | ||
| neutralizing platinum disk are | ||
| suspended from the cap | ||
| Power Supply | 3 V coin style battery hermetically | |
| sealed in the vial cap supplies power | ||
| to internal clock and sensors | None | |
| Cycle Indicator Lights | The screw cap contains three colored | |
| LED lights that indicate the status of | ||
| the neutralization cycle | None | |
| Cycle Timer | An internal timer monitors the length | |
| of the 6 hour neutralization cycle | Patients use an external timer to | |
| monitor the 6 hour neutralization | ||
| cycle | ||
| Materials | Plastic resin vial, lens baskets and | |
| screw cap with a platinum coated | ||
| neutralizing disk | Plastic resin vial, lens baskets and | |
| screw cap with a platinum coated | ||
| neutralizing disk | ||
| Biocompatibility | Components used in this lens case | |
| have been evaluated in accordance | ||
| with Part 10993 of the ISO standard | ||
| for Biological Evaluation. Test results | ||
| indicate the test article meets the | ||
| ISO standards | Components used in this lens case | |
| have been evaluated in accordance | ||
| with FDA Guidance for lens case | ||
| materials. |