NeutroPhase® Skin and Wound Cleanser OTC is a clear, liquid solution cleanser and wound dressing that was previously cleared by FDA for Rx Use only. The device for OTC use is exactly the same as the Rx product. It is composed of hypochlorous acid (HOCI) 0.01% in saline. As a known antimicrobial, it inhibits growth of microorganisms in solution. The cleanser is provided in a glass bottle; a pump attachment for use in spraying the cleanser on wounds is also provided.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for NeutroPhase® Skin and Wound Cleanser OTC:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes performance testing related to antimicrobial activity and biocompatibility, but does not explicitly state numerical acceptance criteria in a structured manner. Instead, it states that the product is "documented by extensive testing" and that "results establishing the NeutroPhase® product is safe, biocompatible and non-toxic for the use intended."

However, based on the information provided, we can infer some "acceptance criteria" through the testing performed.

Acceptance Criteria (Inferred)	Reported Device Performance
Antimicrobial Effectiveness:
Meet criteria specified in USP <51> Antimicrobial Effectiveness Test against:	Documented effectiveness against:
- Pseudomonas aeruginosa	- Pseudomonas aeruginosa
- Escherichia coli	- Escherichia coli
- Staphylococcus aureus	- Staphylococcus aureus
- Candida albicans (fungi)	- Candida albicans
- Aspergillus niger (fungi)	- Aspergillus niger
Stability:
Support a specified shelf life	Shelf life of 24 months supported
Biocompatibility:
Meet requirements of ISO 10993 for body contact device (safe, biocompatible, non-toxic for intended use)	Results establish product is safe, biocompatible, and non-toxic for the use intended.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the antimicrobial effectiveness, stability, or biocompatibility testing.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided. It mentions "testing performed both by NovaBay and certified test laboratories," suggesting a combination of internal and external testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable in the context of this device. The testing described (antimicrobial, stability, biocompatibility) are laboratory-based tests with objective endpoints, not human interpretation requiring expert adjudication for ground truth.

4. Adjudication Method for the Test Set

This is not applicable for the type of laboratory testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is not an imaging or diagnostic device that relies on human interpretation.

6. Standalone Performance Study

The described testing (antimicrobial activity, stability, biocompatibility) can be considered standalone (algorithm only without human-in-the-loop performance) in the sense that the device's inherent properties are being tested directly in a laboratory setting, independent of human interaction beyond the conduct of the test.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on:

Antimicrobial Effectiveness: Adherence to the criteria specified in USP <51> Antimicrobial Effectiveness Test. This is a recognized standard method to determine the efficacy of antimicrobial preservatives in pharmaceutical products. The presence or absence of growth of specific microorganisms after exposure to the product serves as the ground truth.
Stability: Laboratory measurements over time to confirm the product maintains its specified characteristics (e.g., concentration of active ingredients, physical properties) for the claimed shelf life.
Biocompatibility: Results from ISO 10993 standard tests, which evaluate the biological response of medical devices to contact with the body. These tests have defined endpoints and criteria for safety, biocompatibility, and non-toxicity.

8. Sample Size for the Training Set

This information is not applicable. The NeutroPhase® Skin and Wound Cleanser OTC is a chemical formulation, not an algorithm or AI model that requires a "training set." The testing described verifies the product's inherent properties.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this type of device.

Summary

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K 131542 Page 1/2

Submitter: NovaBay Pharmaceuticals, Inc. NeutroPhase® Skin and Wound Cleanser OTC Traditional 510(k)

510(k) Summary

NeutroPhase® Skin and Wound Cleanser OTC

Submitter Name:	NovaBay Pharmaceuticals, Inc.
Submitter Address:	5980 Horton Street, Suite 550Emeryville, CA 94608
Contact Person:	Keith Bley, Ph.D.Senior Vice President of Product Development
Phone Number:	650.861.0388
Fax Number:	510.225.0371
Date Prepared:	May 23, 2013
Device Name:	NeutroPhase® Skin and Wound Cleanser OTC
Common Name	Wound Cleanser
Classification Name:	Dressing, Wound, Drug
Classification #:	Unclassified (Pre-amendment)
Product Code:	FRO
Classification Panel:	General and Plastic Surgery
Predicate Devices:	K113820, NeutroPhase® Skin and Wound Cleanser, NovaBayPharmaceuticals, Inc.K090206, Oculus Puracyn™ Skin and Wound Cleanser withPreservatives, Oculus Innovative Sciences, Inc.
Indications for UseStatement:	NeutroPhase® Skin and Wound Cleanser OTC is intended for themanagement of skin abrasions, lacerations, minor irritations, cuts,and intact skin.
Device Description:Design andSummary ofTechnologicalCharacteristics	NeutroPhase® Skin and Wound Cleanser OTC is a clear, liquidsolution cleanser and wound dressing that was previously clearedby FDA for Rx Use only. The device for OTC use is exactly thesame as the Rx product. It is composed of hypochlorous acid(HOCI) 0.01% in saline. As a known antimicrobial, it inhibitsgrowth of microorganisms in solution.The cleanser is provided in a glass bottle; a pump attachment foruse in spraying the cleanser on wounds is also provided.
Testing:	The antimicrobial activity in solution of the product is documentedby extensive testing performed both by NovaBay and certified testlaboratories to the criteria specified in USP <51> AntimicrobialEffectiveness Test; effectiveness against the following organismshas been shown in this testing: bacteria: Pseudomonas aeruginosa,Escherichia coli, Staphylococcus aureus; and fungi: Candida albicans,Aspergillus niger.Stability testing supports a shelf life of 24 months for theNeutroPhase® Skin and Wound Cleanser OTC.
Submitter:NovaBay Pharmaceuticals, Inc.	NeutroPhase® Skin and Wound Cleanser OTCTraditional 510(k)
	The biocompatibility testing required for this category of bodycontact device, according to ISO 10993, has been performed withresults establishing the NeutroPhase® product is safe,biocompatible and non-toxic for the use intended.
Comparison to thePredicate Devices:	The NeutroPhase® Skin and Wound Cleanser OTC has the sameintended use as the predicate Puracyn™ cleanser and a similarintended use as the NeutroPhase® Rx Only product.
	The NeutroPhase® Skin and Wound Cleanser OTC has the sameingredients as the NeutroPhase® predicate and is similar to thePuracyn™ predicate in that both contain hypochlorous acid as apreservative in solution.
	The new NeutroPhase® cleanser is manufactured by the samecontract manufacturer and under the same processes as thepredicate NeutroPhase® cleanser.
Conclusion regardingSubstantialEquivalence:	Based on the above and the documentation in the 510(k) theNeutroPhase® Skin and Wound Cleanser OTC is substantiallyequivalent to both predicate devices.
Verificationsregarding this 510(k)Summary:	The summary includes only information that is also covered in thebody of the 510(k). The summary does not contain any puffery orunsubstantiated labeling claims. The summary does not containany raw data, i.e., contains only summary data. The summarydoes not contain any trade secret or confidential commercialinformation. The summary does not contain any patientidentification information.

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K131542 page 2/2

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Image /page/2/Picture/0 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

NovaBay Pharmaceuticals, Incorporated % Trisler Consulting Ms. Patsy J. Trisler, JD, RAC Regulatory Consultant 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815

July 24, 2013

Re: K131542

Trade/Device Name: NeutroPhase® Skin and Wound Cleanser OTC Regulatory Class: Unclassified Product Code: FRO Dated: May 23, 2013 Received: May 31, 2013

Dear Ms. Trisler:

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. 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

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Page 2 - Ms. Patsy J. Trisler, JD, RAC

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K131542

Device Name:

NeutroPhase® Skin and Wound Cleanser OTC

Indications for Use:

NeutroPhase® Skin and Wound Cleanser OTC is intended for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use __ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause - S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131542

Section 4.0

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Regulation Number and Section

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