HYPO CLENZ WOUND WASH MODEL 100 PPM

K100948 · Nevoa Life Sciences, LLC · FRO · Feb 2, 2011 · SU

Device Facts

• Record ID: K100948
• Device Name: HYPO CLENZ WOUND WASH MODEL 100 PPM
• Applicant: Nevoa Life Sciences, LLC
• Product Code: FRO · SU
• Decision Date: Feb 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

OTC - Hypo Clenz Wound & Skin Wash is intended for OTC use for the mechanical cleansing (irrigations, minor cuts, minor burns, minor lacerations, minor skin abrasions, minor skin irritations and intact skin. Professional - Hypo Clenz Antimicrobial Wound & Skin Wash is intended to be used by health care professionals in the management of wounds such as Stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites to remove foreign materials including microorganisms.

Device Story

Hypo Clenz Antimicrobial Wound & Skin Wash is a topical solution used for mechanical cleansing, irrigation, and debridement of wounds. It is intended for both OTC use by patients for minor skin injuries and professional use by healthcare providers for complex wounds, including pressure, stasis, and diabetic ulcers, as well as surgical sites and burns. The solution functions by physically removing foreign materials and microorganisms from the wound bed. It is applied directly to the affected area. The device aids in wound management by facilitating a clean environment, which supports the healing process. No complex electronic or software components are involved.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the intended use and technological characteristics consistent with legally marketed predicate devices.

Technological Characteristics

Antimicrobial wound and skin wash solution. The device is a liquid formulation intended for topical application. It functions via mechanical irrigation and debridement. No electronic, software, or complex mechanical components are present.

Indications for Use

Indicated for OTC use for mechanical cleansing of minor cuts, burns, lacerations, skin abrasions, irritations, and intact skin. Indicated for professional use for irrigation and debridement of Stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, and grafted/donor sites to remove foreign materials and microorganisms.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Nevoa Life Sciences, LLC % Piper Medical Products S. David Piper, PE 4807 El Camino Avenue, Suite C Carmichael, California 95608

FEB -- 2 2011

Re: K100948

Trade/Device Name: Hypo Clenz Antimicrobial Wound & Skin Wash Regulatory Class: Classified Product Code: FRO Dated: January 11, 2011 Received: January 19, 2011

Dear S. David Piper:

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

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Page 2 - Ms. Mary Lou Mooney

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 Patt 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOfficcs/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
For

Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known): K100948

Device Name: Hypo Clenz Antimicrobial Wound & Skin Wash

Indications For Use:

OTC - Hypo Clenz Wound & Skin Wash is intended for OTC use for the mechanical OTC - Hypo Cleilz Would be Skill Wash is intential from material from minor cuts, cleansing (firigations, minor skin abrasions, minor skin irritations and intact skin.
minor burns, minor lacerations, minor skin abrasions, minor skin irritations and intact

Professional - Hypo Clenz Antimicrobial Wound & Skin Wash is intended by be used by Professional - Trypo Ciciz Amilinorooian Trouismical irrigation debridement to nealth care protessionals in the managements of wounds such as Stage I-V
remove foreign materials including microorganisms, of wounds such as accept be femove foreign matchals morading more organisms, will be second degree burns, grafted and donor sites.

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use __ X

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Daird Krams /m MyM Page 1 of 1

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100948