(225 days)
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, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
NeutroPhase Skin and Wound Cleanser is a clear, liquid solution cleanser and wound dressing that helps maintain a moist wound environment by removing dirt, debris and foreign material by the action of the skin and wound cleanser moving across the wound bed. The product is composed of HOCl 0.01% in saline. The antimicrobial agent inhibits the growth of microorganisms in solution.
The provided text describes modifications to an existing device, NeutroPhase Skin and Wound Cleanser, and outlines the performance data submitted for its 510(k) clearance. However, it does not contain information typically found in a study demonstrating how a device meets acceptance criteria, especially for AI/ML devices. The device described is a medical cleanser, not an AI-powered diagnostic or therapeutic tool.
Therefore, many of the requested categories in your prompt are not applicable to the provided document. I will describe what is present and explicitly state what information is missing based on the context of the device.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (a wound cleanser) and the information provided, the "acceptance criteria" appear to be related to its antimicrobial activity and material compatibility, rather than a diagnostic performance metric.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Antimicrobial activity in solution (criteria specified in USP <51>). | "Antimicrobial activity in solution is documented by extensive testing performed by NovaBay together with additional testing by a certified test laboratory to criteria specified in USP <51>." |
| Materials compatibility of the spray attachment. | "The provision of a spray attachment to the bottle has been tested for verification of materials compatibility." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified in terms of number of samples/tests, but it mentions "extensive testing" and "additional testing by a certified test laboratory."
- Data provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by NovaBay and a "certified test laboratory," implying internal and external validation.
- Retrospective or Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a cleanser, not a diagnostic tool requiring expert interpretation or ground truth establishment in the traditional sense of medical imaging or clinical decision support. The testing involves chemical and microbiological standards (USP <51>) and material science.
4. Adjudication method for the test set
Not applicable. There is no mention of human adjudication for the performance tests, as these appear to be laboratory-based chemical and microbiological evaluations and material compatibility tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device, and no MRMC study was conducted or is relevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
The "ground truth" for the performance claims appears to be:
- USP <51> criteria: Standardized microbiological tests for antimicrobial effectiveness.
- Material Science Standards: Implicitly, for the compatibility of the spray attachment.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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510(k) Summary Prepared December 16, 2011 Revised June 26, 2012
NovaBay Pharmaceuticals, Inc. Sponsor: 5980 Horton Street Suite 550 Emeryville, CA 94608 Behzad Khosrovi M.A. Ph.D. Contact Person: 510 899 8800 Telephone: Fax: 510 740 3986 Submission Date: December 16, 2011 NeutroPhase Skin and Wound Cleanser® Device Name: Wound Cleansing Solution Common Name: Classification: Regulatory Class: Unclassified
Classification Name: Review Code: Classification Panel:
Dressing, Wound, Drug FRO, Unclassified General and Plastic Surgery
A. Legally Marketed Predicate Devices
The modified device is substantially equivalent to NeutroPhase (K081009), also manufactured by NovaBav Pharmaceuticals, Inc., Vashe Wound Therapy+ Solution manufactured by PuriCore (K100918), Oculus Puracyn Antimicrobial Skin and Wound Cleanser manufactured by Oculus Innovative Sciences (K090206) and Anasept Antimicrobial Wound Cleanser (K073547), manufactured by Anacapa Technologies, Inc.
B. Device Description:
NeutroPhase Skin and Wound Cleanser is a clear, liquid solution cleanser and wound dressing that helps maintain a moist wound environment by removing dirt, debris and foreign material by the action of the skin and wound cleanser moving across the wound bed. The product is composed of HOCl 0.01% in saline. The antimicrobial agent inhibits the growth of microorganisms in solution.
C. Intended Use
NeutroPhase Skin and Wound Cleanser is intended for use under the supervision of healthcare professionals for cleansing and removal of foreign material including micro-
8 2012 AUG
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organisms 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, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
D. Substantial Equivalence
The NeutroPhase Skin and Wound Cleanser is shown to be substantially equivalent to the predicate devices in intended use, product material composition and in method of delivery.
E. Performance Data
The modifications to the device required the following performance data: The antimicrobial activity in solution is documented by extensive testing performed by NovaBay together with additional testing by a certified test laboratory to criteria specified in USP <51>. The provision of a spray attachment to the bottle has been tested for verification of materials compatibility.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
AUG 8 2012
NovaBay Pharmceuticals, Incorporated % Sheila W. Pickering Consulting Ms. Sheila W. Pickering 2081 Longden Circle Los Altos, California 94024
Re: K113820
Trade/Device Name: NeutroPhase® Skin and Wound Cleanser Regulation Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO Dated: July 20, 2012 Received: July 25, 2012
Dear Ms. Pickering:
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
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Page 2 - Ms. Sheila W. Pickering
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number K113820 :
Device Name: ,NeutroPhase® Skin and Wound Cleanser
Indications for Use:
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. this 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113820
N/A