NAWALUTION SKIN AND WOUND CLEANSER

• K Number: K141660
• Device Name: NAWALUTION SKIN AND WOUND CLEANSER
• Manufacturer: NAWA HEILMITTEL GMBH
• Date Cleared: 2014-10-31 ( 133 days)
• Product Code: FRO
• Regulation Number: N/A

Intended Use

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.

Predicate Devices

K113820, K131542, K072876, K110744, K042084

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly describe a liquid wound cleanser that works through mechanical action. There is no mention of any computational or analytical capabilities, let alone AI/ML.

Therapeutic

Yes

The device is intended for cleansing, moistening, debriding, and removal of foreign material from wounds, including various types of dermal lesions and burns, to allow for natural healing. These actions indicate a therapeutic purpose.

Diagnostic

No

The device is a wound cleanser intended for cleansing, moistening, debriding, and removal of foreign material from wounds, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "clear, colorless liquid" and is supplied in a "spray bottle with a plunger-activated pump applicator," indicating it is a physical product, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly describes the device as a wound cleanser and moistener applied directly to the skin and wounds. This is a topical application for managing external wounds.
• Device Description: The description reinforces this by stating it's a liquid sprayed onto the affected area and/or dressing for mechanical removal of debris and microorganisms.
• Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of biological specimens outside the body.

The device is a topical wound care product, not an in vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

NAWAlution 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.

Product codes

FRO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

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. Minor cuts, abrasions, lacerations and minor burns.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Healthcare professionals for prescription use. Over-the-counter use.

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

The safety and effectiveness of NAWAlution is supported by biocompatibility testing, functional performance testing, and shelf-life testing conducted with the proposed device.

Key Metrics

Not Found

Predicate Device(s)

K113820, K131542, K072876, K110744, K042084

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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 100
90482 Nuernberg
Germany
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, NovaBay
Pharmaceuticals, Inc., K113820, Product Code FRO,
Unclassified
Predicate Devices:	NeutroPhase Skin and Wound Cleanser OTC, NovaBay
Pharmaceuticals, 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., K042084
Product Code FRO, Unclassified.
Device Description:	The subject device of this submission is NAWAlution Skin
and 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 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, 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.	K113820: NeutroPhase Skin
and Wound Cleanser is
intended for use under the
supervision of healthcare
professionals for cleansing
and removal of foreign
material including
microorganisms and debris
from wounds and for
moistening absorbent wound
dressings and cleaning minor
cuts, minor burns, superficial
abrasions and minor
irritations of the skin. It is
also intended for moistening
and debriding acute and
chronic dermal lesions, such
as Stage I-IV pressure ulcers,
stasis ulcers, leg ulcers,
diabetic foot ulcers, post-
surgical wounds, first and
second degree burns, grafted
and donor sites.	K072876: Prontosan Wound
Irrigation Solution is intended
for prescription use is
intended for cleaning wounds
and for moistening and
lubricating absorbent wound
dressings for ulcers, burns,
post-surgical wounds and
abrasions.	K042084: BioDerm Sciences
Wound Spray is intended to
cleanse, rinse and externally
manage dermal lesions such
as lacerations, post-operative
(surgical) wounds, partial and
full-thickness wounds, burns
and ulcers (diabetic, venous
stasis, pressure). It may also
be
used in conjunction with a
dressing 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 (1.8
fluid oz.) - OTC);
Spray bottle (8 fluid oz. (237
mL) 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, Zinc
Chloride, PHMB,
Hydrochloric acid, Trace
Element	Purified water, Sodium
Chloride, Sodium
Hypochlorite	Purified water, PHMB,
Undecylenamidopropyl
Betaine	Purified water, Zinc Chloride,
Sulfuric Acid, Trace
Elements
Buffer	Not buffered	Not buffered	Not buffered	Not buffered
Feature Being Compared	PROPOSED DEVICE
NAWAlution Skin and
Wound Cleanser	PREDICATE DEVICE
NeutroPhase Skin and
Wound Cleanser	PREDICATE DEVICE
Prontosan Wound
Irrigation Solution	PREDICATE DEVICE
BioDerm Wound Spray
Sterility	Non-sterile	Non-sterile	Sterile	Non-sterile

Table III.1. Proposed and Predicate Device Comparison Matrix

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