(56 days)
Not Found
No
The device description and performance studies focus on the chemical composition and antimicrobial properties of the cleanser, with no mention of AI or ML.
No
The device is a cleanser intended for managing skin abrasions, lacerations, minor irritations, cuts, and intact skin, and is not designed to treat a specific disease or condition.
No
Explanation: The device is described as a "cleanser and wound dressing." Its intended use is for "management of skin abrasions, lacerations, minor irritations, cuts, and intact skin," and it functions as an antimicrobial to inhibit the growth of microorganisms. These functions are therapeutic or preventative, not diagnostic.
No
The device is a liquid solution cleanser and wound dressing provided in a glass bottle with a pump attachment, clearly indicating it is a physical product and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin. This involves direct application to the body surface for cleaning and wound dressing.
- Device Description: The device is a liquid cleanser and wound dressing applied externally.
- Lack of In Vitro Testing: The description of performance studies focuses on antimicrobial effectiveness in solution and biocompatibility, which are relevant for a topical wound care product, not for diagnosing conditions in vitro (outside the body).
- No Mention of Diagnostic Purpose: There is no indication that this device is used to test samples (like blood, urine, or tissue) to diagnose a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
NeutroPhase® Skin and Wound Cleanser OTC is intended for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
NeutroPhase® Skin and Wound Cleanser OTC is a clear, liquid solution cleanser and wound dressing that was previously cleared by FDA for Rx Use only. The device for OTC use is exactly the same as the Rx product. It is composed of hypochlorous acid (HOCI) 0.01% in saline. As a known antimicrobial, it inhibits growth of microorganisms in solution.
The cleanser is provided in a glass bottle; a pump attachment for use in spraying the cleanser on wounds is also provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The antimicrobial activity in solution of the product is documented by extensive testing performed both by NovaBay and certified test laboratories to the criteria specified in USP Antimicrobial Effectiveness Test; effectiveness against the following organisms has been shown in this testing: bacteria: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus; and fungi: Candida albicans, Aspergillus niger.
Stability testing supports a shelf life of 24 months for the NeutroPhase® Skin and Wound Cleanser OTC.
The biocompatibility testing required for this category of body contact device, according to ISO 10993, has been performed with results establishing the NeutroPhase® product is safe, biocompatible and non-toxic for the use intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
K 131542 Page 1/2
Submitter: NovaBay Pharmaceuticals, Inc. NeutroPhase® Skin and Wound Cleanser OTC Traditional 510(k)
510(k) Summary
NeutroPhase® Skin and Wound Cleanser OTC
| Submitter Name: | NovaBay Pharmaceuticals, Inc. |
|---|---|
| Submitter Address: | 5980 Horton Street, Suite 550 |
| Emeryville, CA 94608 | |
| Contact Person: | Keith Bley, Ph.D. |
| Senior Vice President of Product Development | |
| Phone Number: | 650.861.0388 |
| Fax Number: | 510.225.0371 |
| Date Prepared: | May 23, 2013 |
| Device Name: | NeutroPhase® Skin and Wound Cleanser OTC |
| Common Name | Wound Cleanser |
| Classification Name: | Dressing, Wound, Drug |
| Classification #: | Unclassified (Pre-amendment) |
| Product Code: | FRO |
| Classification Panel: | General and Plastic Surgery |
| Predicate Devices: | K113820, NeutroPhase® Skin and Wound Cleanser, NovaBay |
| Pharmaceuticals, Inc. | |
| K090206, Oculus Puracyn™ Skin and Wound Cleanser with | |
| Preservatives, Oculus Innovative Sciences, Inc. | |
| Indications for Use | |
| Statement: | NeutroPhase® Skin and Wound Cleanser OTC is intended for the |
| management of skin abrasions, lacerations, minor irritations, cuts, | |
| and intact skin. | |
| Device Description: | |
| Design and | |
| Summary of | |
| Technological | |
| Characteristics | NeutroPhase® Skin and Wound Cleanser OTC is a clear, liquid |
| solution cleanser and wound dressing that was previously cleared | |
| by FDA for Rx Use only. The device for OTC use is exactly the | |
| same as the Rx product. It is composed of hypochlorous acid | |
| (HOCI) 0.01% in saline. As a known antimicrobial, it inhibits | |
| growth of microorganisms in solution. | |
| The cleanser is provided in a glass bottle; a pump attachment for | |
| use in spraying the cleanser on wounds is also provided. | |
| Testing: | The antimicrobial activity in solution of the product is documented |
| by extensive testing performed both by NovaBay and certified test | |
| laboratories to the criteria specified in USP Antimicrobial | |
| Effectiveness Test; effectiveness against the following organisms | |
| has been shown in this testing: bacteria: Pseudomonas aeruginosa, | |
| Escherichia coli, Staphylococcus aureus; and fungi: Candida albicans, | |
| Aspergillus niger. | |
| Stability testing supports a shelf life of 24 months for the | |
| NeutroPhase® Skin and Wound Cleanser OTC. | |
| Submitter: | |
| NovaBay Pharmaceuticals, Inc. | NeutroPhase® Skin and Wound Cleanser OTC |
| Traditional 510(k) | |
| The biocompatibility testing required for this category of body | |
| contact device, according to ISO 10993, has been performed with | |
| results establishing the NeutroPhase® product is safe, | |
| biocompatible and non-toxic for the use intended. | |
| Comparison to the | |
| Predicate Devices: | The NeutroPhase® Skin and Wound Cleanser OTC has the same |
| intended use as the predicate Puracyn™ cleanser and a similar | |
| intended use as the NeutroPhase® Rx Only product. | |
| The NeutroPhase® Skin and Wound Cleanser OTC has the same | |
| ingredients as the NeutroPhase® predicate and is similar to the | |
| Puracyn™ predicate in that both contain hypochlorous acid as a | |
| preservative in solution. | |
| The new NeutroPhase® cleanser is manufactured by the same | |
| contract manufacturer and under the same processes as the | |
| predicate NeutroPhase® cleanser. | |
| Conclusion regarding | |
| Substantial | |
| Equivalence: | Based on the above and the documentation in the 510(k) the |
| NeutroPhase® Skin and Wound Cleanser OTC is substantially | |
| equivalent to both predicate devices. | |
| Verifications | |
| regarding this 510(k) | |
| Summary: | The summary includes only information that is also covered in the |
| body of the 510(k). The summary does not contain any puffery or | |
| unsubstantiated labeling claims. The summary does not contain | |
| any raw data, i.e., contains only summary data. The summary | |
| does not contain any trade secret or confidential commercial | |
| information. The summary does not contain any patient | |
| identification information. |
.
1
K131542 page 2/2
2
Image /page/2/Picture/0 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NovaBay Pharmaceuticals, Incorporated % Trisler Consulting Ms. Patsy J. Trisler, JD, RAC Regulatory Consultant 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815
July 24, 2013
Re: K131542
Trade/Device Name: NeutroPhase® Skin and Wound Cleanser OTC Regulatory Class: Unclassified Product Code: FRO Dated: May 23, 2013 Received: May 31, 2013
Dear Ms. Trisler:
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
3
Page 2 - Ms. Patsy J. Trisler, JD, RAC
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name:
NeutroPhase® Skin and Wound Cleanser OTC
Indications for Use:
NeutroPhase® Skin and Wound Cleanser OTC is intended for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use __ (21 CFR 801 Subpart C)
X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause - S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131542
Section 4.0
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