(140 days)
Prescription Use: Neuwater (Hydrocyn aqua) is intended for moistening acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritation of the skin.
Over-the-Counter: Neuwater (Hydrocyn aqua) is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the NEUWATERTM (HydrocynTM aqua) Wound Cleanser. This type of document declares substantial equivalence to a predicate device, which means it asserts that the new device is as safe and effective as a legally marketed device.
However, the provided text does not contain any information about the acceptance criteria, device performance study, sample sizes, expert qualifications, or ground truth details that would typically be found in a performance study report for an AI/ML powered medical device.
This document is for a "Wound Cleanser," which is a relatively simple medical device (likely a liquid solution) and not an AI/ML diagnostic or prognostic tool. Therefore, the detailed performance metrics, ground truth establishment, and expert adjudication methods commonly associated with AI/ML device approval are not applicable here and are not present in this regulatory filing.
To answer your request, if this were an AI/ML device, the relevant information would typically be found in sections discussing performance data, clinical trials, or validation studies, which are absent in this specific 510(k) clearance letter for a wound cleanser.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2015
Vigilenz Medical Devices % Mr. Glen Feye Accurate Consultants Incorporated 3234 Ibis Street San Diego, California 92103
Re: K142775
Trade/Device Name: NEUWATERTM (HydrocynTM aqua) Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: December 12, 2014 Received: December 18, 2014
Dear Mr. Feye:
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
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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142775
Device Name NEUWATER (Hydrocyn aqua) Wound Cleanser
Indications for Use (Describe)
Prescription Use: Neuwater (Hydrocyn aqua) is intended for moistening acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritation of the skin.
Over-the-Counter: Neuwater (Hydrocyn aqua) is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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