← Product Code FRO · K131542 # NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC (K131542) _Novabay Pharmaceuticals, Inc. · FRO · Jul 24, 2013 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K131542 ## Device Facts - **Applicant:** Novabay Pharmaceuticals, Inc. - **Product Code:** FRO - **Decision Date:** Jul 24, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use NeutroPhase® Skin and Wound Cleanser OTC is intended for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin. ## Device Story NeutroPhase® Skin and Wound Cleanser OTC is a liquid wound cleanser/dressing containing 0.01% hypochlorous acid (HOCl) in saline. Device functions as antimicrobial agent to inhibit microorganism growth in solution. Provided in glass bottle with pump attachment for topical spray application. Used in clinical or home settings for management of minor skin wounds/irritations. Cleanser applied directly to affected area; antimicrobial properties assist in wound management. Device is identical to previously cleared Rx version; manufactured using same processes. ## Clinical Evidence Bench testing only. Antimicrobial effectiveness demonstrated per USP <51> against P. aeruginosa, E. coli, S. aureus, C. albicans, and A. niger. Biocompatibility testing performed per ISO 10993 confirms safety and non-toxicity. Stability testing supports 24-month shelf life. ## Technological Characteristics Liquid solution containing 0.01% hypochlorous acid in saline. Packaging includes glass bottle and pump spray attachment. Antimicrobial mechanism via HOCl. Biocompatibility per ISO 10993. No software or electronic components. ## Predicate Devices - NeutroPhase® Skin and Wound Cleanser ([K113820](/device/K113820.md)) - Oculus Puracyn™ Skin and Wound Cleanser with Preservatives ([K090206](/device/K090206.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 550
Emeryville, 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, NovaBay
Pharmaceuticals, Inc.
K090206, Oculus Puracyn™ Skin and Wound Cleanser with
Preservatives, Oculus Innovative Sciences, Inc. | | Indications for Use
Statement: | NeutroPhase® Skin and Wound Cleanser OTC is intended for the
management of skin abrasions, lacerations, minor irritations, cuts,
and intact skin. | | Device Description:
Design and
Summary of
Technological
Characteristics | 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. | | Testing: | The antimicrobial activity in solution of the product is documented
by extensive testing performed both by NovaBay and certified test
laboratories to the criteria specified in USP <51> Antimicrobial
Effectiveness Test; effectiveness against the following organisms
has 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 the
NeutroPhase® Skin and Wound Cleanser OTC. | | Submitter:
NovaBay Pharmaceuticals, Inc. | NeutroPhase® Skin and Wound Cleanser OTC
Traditional 510(k) | | | The biocompatibility testing required for this category of body
contact device, according to ISO 10993, has been performed with
results establishing the NeutroPhase® product is safe,
biocompatible and non-toxic for the use intended. | | Comparison to the
Predicate Devices: | The NeutroPhase® Skin and Wound Cleanser OTC has the same
intended use as the predicate Puracyn™ cleanser and a similar
intended use as the NeutroPhase® Rx Only product. | | | The NeutroPhase® Skin and Wound Cleanser OTC has the same
ingredients as the NeutroPhase® predicate and is similar to the
Puracyn™ predicate in that both contain hypochlorous acid as a
preservative in solution. | | | The new NeutroPhase® cleanser is manufactured by the same
contract manufacturer and under the same processes as the
predicate NeutroPhase® cleanser. | | Conclusion regarding
Substantial
Equivalence: | Based on the above and the documentation in the 510(k) the
NeutroPhase® Skin and Wound Cleanser OTC is substantially
equivalent to both predicate devices. | | Verifications
regarding this 510(k)
Summary: | The summary includes only information that is also covered in the
body of the 510(k). The summary does not contain any puffery or
unsubstantiated labeling claims. The summary does not contain
any raw data, i.e., contains only summary data. The summary
does not contain any trade secret or confidential commercial
information. The summary does not contain any patient
identification information. | . {1}------------------------------------------------ K131542 page 2/2 {2}------------------------------------------------ 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 {3}------------------------------------------------ #### 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 {4}------------------------------------------------ 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) X (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 Page 1 of 1 --- **Source:** [https://fda.innolitics.com/device/K131542](https://fda.innolitics.com/device/K131542) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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