(165 days)
Not Found
No
The device description and intended use focus on the mechanical action of a wound cleansing solution. There are no mentions of AI, ML, image processing, or any data-driven algorithms.
No
The device is a wound cleansing solution for irrigating and cleansing dermal wounds, which is a supportive rather than a direct therapeutic function.
No
The device description states it is a wound cleansing solution for irrigating and cleansing dermal wounds, operating through mechanical action to remove foreign objects. It does not mention any diagnostic capabilities.
No
The device description clearly states it is a "wound cleansing solution," which is a physical substance (liquid) and not software. The mechanism of action is described as "mechanical action of fluid moving across the wound," further indicating a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound cleansing solution for irrigating and cleaning dermal wounds and lesions. This is a topical application for treating the wound itself, not for analyzing a sample taken from the body to diagnose a condition or monitor a physiological state.
- Device Description: The description reinforces the intended use, stating it's a wound cleansing solution with a mechanical action for removing foreign objects.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on such analysis.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (on the body) for wound care.
N/A
Intended Use / Indications for 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.
Product codes
KMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dermal wounds, 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
ge 1/2
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 Pharmaceuticals
5980 Horton Street
Suite 550
Emeryville, California 94608 |
|-----------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Behzad Khosrovi Ph.D.
Telephone: (510) 899 8852
Fax: (510) 740 3986
e-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 Wound | ||
| Care | Oculus Innovative | |
| Sciences, Inc | K060113 | |
| Dermacyn Wound | ||
| Irrigation | Oculus Innovative | |
| Sciences, Inc.. | K042729 |
Description of Device:
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.
1
page 2/2
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.
2
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.
3
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
4
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:
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.
(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)