The device is intended for moistening absorbent wound dressings and irrigating and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening, debriding and irrigating 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, abrasions and minor irritations of the skin.

Device Description

NeutroPhase™ is a wound cleansing solution for irrigating and cleansing of dermal wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device called NeutroPhase™ Wound Cleanser. This type of submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria as typically seen for AI/ML-driven devices.

Therefore, many of the requested data points (such as acceptance criteria tables, sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable or not provided within this document. The device in question is a wound cleansing solution, not an AI-powered diagnostic or predictive tool.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable / Not Provided: The document states, "The NeutroPhase™ verification testing has confirmed the device's conformance with specifications. The functional specifications do not include any significant differences from those of the predicates." However, it does not specify what those "specifications" or "acceptance criteria" were, nor does it provide a table with quantitative performance metrics against such criteria. The focus is on substantial equivalence to existing devices rather than meeting new, pre-defined quantitative performance targets.

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

Not Applicable / Not Provided: This device is a wound cleanser, not a data-driven diagnostic tool. Therefore, there is no "test set" in the context of AI/ML performance evaluation. The "verification testing" mentioned would likely refer to chemical, physical, and sterility testing of the solution, not performance on a dataset of patient samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable / Not Provided: See point 2.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided: See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not Applicable / Not Provided: The device is a wound cleanser, not an AI tool designed to assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable / Not Provided: The device is a wound cleanser, not an algorithm.

7. The Type of Ground Truth Used

Not Applicable / Not Provided: There is no "ground truth" in the context of AI model training or evaluation for this type of device. The "verification testing" likely relies on established laboratory methodologies for product quality and safety.

8. The Sample Size for the Training Set

Not Applicable / Not Provided: This device is a wound cleanser, not an AI model.

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

Not Applicable / Not Provided: See point 8.

Summary of the Study (Based on Provided Text):

The "study" described in the document is a 510(k) premarket notification to establish substantial equivalence of the NeutroPhase™ Wound Cleanser to two predicate devices: Dermacyn Wound Care (K060113) and Dermacyn Wound Irrigation (K042729).

Objective: To demonstrate that NeutroPhase™ is as safe and effective as the predicate devices.
Methodology: The submission highlights that the "intended use and technological specifications" of NeutroPhase™ are "substantially equivalent" to those of the predicate devices. It states that "NeutroPhase™ verification testing has confirmed the device's conformance with specifications." This implies internal testing was conducted, but the details of this testing (specific parameters, methods, and results) are not elaborated in the provided summary.
Conclusion: The FDA reviewed the submission and determined that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. The basis for this determination is the shared intended use and lack of significant differences in functional specifications from the predicates.

Summary

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K071056

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NovaBay Pharmaceuticals, Inc Response to Request for Additional Information

SEP 2 8 2007

Revision to 510(k) summary - pages 028-029

510(k) Summary Prepared April 11, 2007 (Revised September 19, 2007)

Submitted by:	NovaBay Pharmaceuticals5980 Horton StreetSuite 550Emeryville, California 94608
Contact Person:	Behzad Khosrovi Ph.D.Telephone: (510) 899 8852Fax: (510) 740 3986e-mail: bkhosrovi@novabaypharma.com
Product Name:	NeutroPhase™
Common Name:	Liquid bandage/wound cleanser
Classification:	KMF 880.5090 Class II

Predicate Devices:

Device Name	Manufacturer	K Number
Dermacyn WoundCare	Oculus InnovativeSciences, Inc	K060113
Dermacyn WoundIrrigation	Oculus InnovativeSciences, Inc..	K042729

Description of Device:

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K071056

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NovaBay Pharmaceuticals, Inc Response to Request for Additional Information

Intended Use:

The device is intended for moistening absorbent wound dressings and irrigating and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin, It is also intended for moistening, debriding and irrigating 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, abrasions and minor irritations of the skin.

Comparison with Predicate Devices:

The submission device and the predicate devices have substantially equivalent intended use and technological specifications.

Performance:

The NeutroPhase™ verification testing has confirmed the device's conformance with specifications. The functional specifications do not include any significant differences from those of the predicates.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2007

NovaBay Pharmaceuticals, Inc. % Behzad Khosrovi Ph.D. Vice President of Research and Development 5980 Horton Street. Ste. 550 Emeryville, California 94608

Re: K071056

Trade/Device Name: NeutroPhase "Wound Cleanser Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: September 18, 2007 Received: September 20, 2007

Dear Mr. Khosrovi:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Khosrovi

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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NovaBay Pharmaceuticals, Inc Response to Request for Additional Information

Revision to FDA Indications for use form- pages 012

510(k) Number (if known):

Device Name: NeutroPhase™ Wound Cleanser

Indications For Use:

(Division Sign Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use X (Per 21CFR 801)

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

Concurrence Of CDRH, Office Of Device Evaluation (ODE)

Regulation Number and Section

N/A