(42 days)
Not Found
No
The description focuses on the mechanical action of a wound cleansing solution and does not mention any AI/ML terms or capabilities.
Yes
The device is intended for cleaning and debriding acute and chronic dermal lesions, including various types of ulcers and burns, which are therapeutic actions aimed at promoting wound healing.
No
The device is described as a wound cleansing solution for irrigating and cleansing dermal wounds, aiding in the removal of foreign objects. Its intended use is for moistening and cleaning wounds and lesions, not for diagnosing a condition or disease.
No
The device description clearly states it is a "wound cleansing solution" offered in "various bottle sizes," indicating it is a physical product (liquid and container) and not solely software.
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 moistening, cleaning, and debriding dermal wounds and skin irritations. This is a topical application for external use on the body.
- Device Description: The description reinforces that it's a wound cleansing solution with a mechanical action for removing foreign objects.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples taken from the body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease. IVDs are used in vitro (outside the body) to analyze these samples.
Therefore, this device falls under the category of a wound care product, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is intended 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, 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. The device is offered in various bottle sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (dermal wounds)
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 under the company's Design Control Process has confirmed the device's conformance with specifications. The specifications do not include any significant differences from those of the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NeutroPhase (K071056)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
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Page 1 of
510(k) Summarv Prepared March 28, 2008
MAY 20 2008
| Submitted by: | NovaBay Pharmaceuticals, Inc.
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 Wound Cleanser | |
| Common Name: | Liquid bandage/wound cleanser | |
| Classification: | KMF 880.5090 Class I | |
| Predicate Devices: | The modified NeutroPhase is substantially equivalent to
NeutroPhase (K071056) | |
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. The device is offered in various bottle sizes.
Intended Use:
The device is intended 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, abrasions and minor irritations of the skin.
Comparison with Predicate Devices:
The modified device represents a minor change to the prodicate specification. The submission device and the predicate device have the same intended use and substantially equivalent technological specifications.
Performance:
The NeutroPhase verification testing under the company's Design Control Process has confirmed the device's conformance with specifications. The specifications do not include any significant differences from those of the predicate.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is black and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Novabay Pharmaceuticals, Inc. % Ms. Sheila W. Pickering, Ph.D. Regulatory Affairs Consultant 5980 Horton Street, Suite 550 Emeryville, California 94608
MAY 20 2008
Re: K081009
Trade/Device Name: Modified NeutroPhase Wound Cleanser Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: April 4, 2008 Received: April 8, 2008
Dear Dr. 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.
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.
2
Page 2 - Ms. Sheila W. Pickering, Ph.D.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Millerson
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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Page 1 of 1
510(k) Number (if known):
Kosloq
Device Name: Modified NeutroPhase Wound Cleanser
Indications For Use:
The device is intended 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, abrasions and minor irritations of the skin.
Prescription Use X OR Over-The-Counter Use (Per 21CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence Of CDRH, Office Of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K081009
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