NAW Alution for prescription use is intended for use under the supervision of healthcare professionals for cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, leg ulcers, diabetic foot ulcers, postsurgical wounds, first and second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor burns, superficial abrasions and minor irritations of the skin.

NAWAlution for over-the-counter use is intended for cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

Device Description

The subject device of this submission is NAWAlution Skin and Wound Cleanser for prescription and OTC use. NAWAlution is a clear, colorless liquid intended for the management of wounds. The solution is applied by spraying it directly onto the affected area and/or the dressing. As a result of mechanical action of the solution moving across the wound bed foreign objects, foreign debris and exudate, including, dirt, debris, and microorganisms, are removed from the wound. Moistening and cleansing a wound, such as by using NAWAlution, allows for the natural healing process to take place. NAWAlution for prescription use is supplied in an 8 fluid oz. (237 mL) or 16 fluid oz. (473 mL) spray bottle with a plunger-activated pump applicator. NAWAlution for over-the-counter is supplied in a 50 mL (1.8 fluid oz.) spray bottle with a plunger-activated pump applicator. The solution contains cocamidopropylbetaine, hydrochloric acid, PHMB, zinc/iron, and purified water.

AI/ML Overview

The provided document is a 510(k) premarket notification for the NAWAlution Skin and Wound Cleanser, which has been determined to be substantially equivalent to legally marketed predicate devices. It describes the device's intended use and compares its features to several predicate devices. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document states that "The safety and effectiveness of NAWAlution is supported by biocompatibility testing, functional performance testing, and shelf-life testing conducted with the proposed device." However, no details about the acceptance criteria for these tests, the specific results that met them, or the methodologies are provided.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving their fulfillment. The document focuses on demonstrating substantial equivalence to predicate devices based on identical intended use and similar technological characteristics, rather than presenting a performance study against predefined acceptance criteria.

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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

October 31, 2014

NAWA Heilmittel GmbH % Ms. Allyson B. Mullen Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, North West Washington, District of Columbia 20005

Re: K141660

Trade/Device Name: NAWAlution Regulatory Class: Unclassified Product Code: FRO Dated: October 6, 2014 Received: October 6, 2014

Dear Ms. Mullen:

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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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/Resourcesfor You/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 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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) To be determined

Device Name NAWAlution

Indications for Use (Describe)

NAWAlution for over-the-counter use is intended for cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

Type of Use (Select one or both, as applicable)

2 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 A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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III.

NAWAlution

Submitter Name:	NAWA Heilmittel GmbH
Submitter Address:	Ostendstrasse 10090482 NuernbergGermany
Contact Person:	Thomas Riesinger
Phone Number:	011-49-911-5444126
Fax Number:	011-49-911-5444111
Date Prepared:	June 20, 2014
Device Trade Name:	NAWAlution Skin and Wound Cleanser
Device Common Name:	Dressing, Wound, Drug
Product Code:	FRO
Classification:	Unclassified
Predicate Devices:	NeutroPhase Skin and Wound Cleanser, NovaBayPharmaceuticals, Inc., K113820, Product Code FRO,Unclassified
Predicate Devices:	NeutroPhase Skin and Wound Cleanser OTC, NovaBayPharmaceuticals, Inc., K131542, Product Code FRO,Unclassified
Predicate Devices:	Prontosan Wound Irrigation Solution, B. Braun Medical,Inc., K072876, Product Code FRO, Unclassified
Predicate Devices:	Prontosan Wound Irrigation Solution, B. Braun Medical,Inc., K110744, Product Code FRO, Unclassified
Predicate Devices:	BioDerm Wound Spray, BioDerm Sciences, Inc., K042084Product Code FRO, Unclassified.
Device Description:	The subject device of this submission is NAWAlution Skinand Wound Cleanser for prescription and OTC use.

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NAWAlution is a clear, colorless liquid intended for the management of wounds. The solution is applied by spraying it directly onto the affected area and/or the dressing. As a result of mechanical action of the solution moving across the wound bed foreign objects, foreign debris and exudate, including, dirt, debris, and microorganisms, are removed from the wound. Moistening and cleansing a wound, such as by using NAWAlution, allows for the natural healing process to take place. NAWAlution for prescription use is supplied in an 8 fluid oz. (237 mL) or 16 fluid oz. (473 mL) spray bottle with a plunger-activated pump applicator. NAWAlution for over-the-counter is supplied in a 50 mL (1.8 fluid oz.) spray bottle with a plunger-activated pump applicator. The solution contains cocamidopropylbetaine, hydrochloric acid, PHMB, zinc/iron, and purified water. NAWAlution for prescription use is intended for use under Intended Use: the supervision of healthcare professionals for cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, venous ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. NAWAlution for over-the-counter use is intended for cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns. Substantial Equivalence: The proposed device and the predicate devices have the identical intended use and similar indications for use and technological characteristics, as shown in Table I.1, below. The safety and effectiveness of NAWAlution is supported by biocompatibility testing, functional performance testing, and shelf-life testing conducted with the proposed device.

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Feature Being Compared	PROPOSED DEVICE	PREDICATE DEVICE	PREDICATE DEVICE	PREDICATE DEVICE
	NAWAlution Skin and	NeutroPhase Skin and	Prontosan Wound	BioDerm Wound Spray
	Wound Cleanser	Wound Cleanser	Irrigation Solution
Indications for Use (Rx)	NAWAlution is intended foruse under the supervision ofhealthcare professionals forcleansing, moistening,debriding, and removal offoreign material includingmicroorganisms and debrisfrom wounds, including acuteand chronic dermal lesions,such as Stage I-IV pressureulcers, venous ulcers, legulcers, diabetic foot ulcers,post-surgical wounds, firstand second degree burns,grafted and donor sites. It isalso intended for moisteningabsorbent wound dressingsand cleaning minor cuts,minor burns, superficialabrasions and minorirritations of the skin.	K113820: NeutroPhase Skinand Wound Cleanser isintended for use under thesupervision of healthcareprofessionals for cleansingand removal of foreignmaterial includingmicroorganisms and debrisfrom wounds and formoistening absorbent wounddressings and cleaning minorcuts, minor burns, superficialabrasions and minorirritations of the skin. It isalso intended for moisteningand debriding acute andchronic dermal lesions, suchas Stage I-IV pressure ulcers,stasis ulcers, leg ulcers,diabetic foot ulcers, post-surgical wounds, first andsecond degree burns, graftedand donor sites.	K072876: Prontosan WoundIrrigation Solution is intendedfor prescription use isintended for cleaning woundsand for moistening andlubricating absorbent wounddressings for ulcers, burns,post-surgical wounds andabrasions.	K042084: BioDerm SciencesWound Spray is intended tocleanse, rinse and externallymanage dermal lesions suchas lacerations, post-operative(surgical) wounds, partial andfull-thickness wounds, burnsand ulcers (diabetic, venousstasis, pressure). It may alsobeused in conjunction with adressing that absorbs fluids(i.e. gauze, gel, alginate,foam,hydrocolloid).
Feature Being Compared	PROPOSED DEVICE	PREDICATE DEVICE	PREDICATE DEVICE	PREDICATE DEVICE
	NAWAlution Skin and	NeutroPhase Skin and	Prontosan Wound	BioDerm Wound Spray
	Wound Cleanser	Wound Cleanser	Irrigation Solution
Indications for Use (OTC)	NAWAlution Skin and	K131542: NeutroPhase Skin	K110744: Prontosan Wound	K042084: BioDern Sciences
	Wound Cleanser for over-	and Wound Cleanser OTC is	Irrigation Solution for over-	Wound Spray is intended to
	the-counter use is intended	intended for the management	the-counter use, is intended	clean, rinse and externally
	for cleansing wounds and	of skin abrasions, lacerations,	for cleansing wounds and	manage skin
	moistening absorbent wound	minor irritations, cuts, and	moistening absorbent wound	wounds such as minor
	dressings for the management	intact skin.	dressings for the management	lacerations, minor cuts, minor
	of minor cuts, abrasions,		of minor cuts, abrasions,	burns and abrasions.
	lacerations and minor burns.		lacerations and minor burns.
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Biocompatible
Appearance	Clear, colorless solution	Colorless	Clear, colorless	Clear, colorless solution
Application method	Spray bottle (50 mL (1.8fluid oz.) - OTC);Spray bottle (8 fluid oz. (237mL) or 16 fluid oz. (473 mL)– Rx)	Spray bottle (40 mL)	Tube applicator (40 mL);Squeeze bottle (350 mL)	Spray bottle (100 mL)
Characteristics	Aqueous	Aqueous	Aqueous	Aqueous
Density(at 20°C)	0.9 - 1 g/ml	~ 1.0 g/ml	~ 1.0 g/ml	0.990 - 1.000 g/ml
Materials	Purified water,Cocamidopropylbetaine, ZincChloride, PHMB,Hydrochloric acid, TraceElement	Purified water, SodiumChloride, SodiumHypochlorite	Purified water, PHMB,UndecylenamidopropylBetaine	Purified water, Zinc Chloride,Sulfuric Acid, TraceElements
Buffer	Not buffered	Not buffered	Not buffered	Not buffered
Feature Being Compared	PROPOSED DEVICENAWAlution Skin andWound Cleanser	PREDICATE DEVICENeutroPhase Skin andWound Cleanser	PREDICATE DEVICEProntosan WoundIrrigation Solution	PREDICATE DEVICEBioDerm Wound Spray
Sterility	Non-sterile	Non-sterile	Sterile	Non-sterile

Table III.1. Proposed and Predicate Device Comparison Matrix

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Regulation Number and Section

N/A