(302 days)
Not Found
Not Found
No
The provided text describes a wound and skin wash product and does not mention any AI or ML components, image processing, or data analysis related to AI/ML.
Yes
The device is intended for the mechanical cleansing/irrigation of wounds and skin, which is a therapeutic function in the management and treatment of injuries.
No
Explanation: The device, "Hypo Clenz Wound & Skin Wash," is described as being for "mechanical cleansing (irrigation)" and "management of wounds." This indicates a therapeutic or cleansing function, not a diagnostic one. There is no mention of identifying, measuring, or analyzing medical conditions.
No
The device description is not found, but the intended use clearly describes a "Wound & Skin Wash," which is a physical substance (liquid) 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 clearly states that the device is for the mechanical cleansing (irrigation) of wounds and skin. This is a physical action performed on the body's surface.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not involve testing bodily samples.
- Device Description: While the device description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
Therefore, the function of this device is external cleansing and not diagnostic testing of bodily samples.
N/A
Intended Use / Indications for Use
OTC - Hypo Clenz Wound & Skin Wash is intended for OTC use for the mechanical cleansing (for irrigations) to help remove foreign material from minor cuts, minor burns, minor lacerations, minor skin abrasions, minor skin irritations and intact skin.
Professional - Hypo Clenz Antimicrobial Wound & Skin Wash is intended by be used by health care professionals in the managements of wounds such as Stage I-IV pressure ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, grafted and donor sites to remove foreign materials including microorganisms.
Product codes
FRO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OTC use: Over-The-Counter Use
Professional use: health care professionals
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)
Not Found
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.
Not Found
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
Not Found
N/A
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or other bird with its wings outstretched, rendered in a simple, graphic style.
the submit and the submit of the submit of the subsequence of
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Nevoa Life Sciences, LLC % Piper Medical Products S. David Piper, PE 4807 El Camino Avenue, Suite C Carmichael, California 95608
FEB -- 2 2011
Re: K100948
Trade/Device Name: Hypo Clenz Antimicrobial Wound & Skin Wash Regulatory Class: Classified Product Code: FRO Dated: January 11, 2011 Received: January 19, 2011
Dear S. David Piper:
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
and the contraction of the consisted on the consisted on the comments of the comments of the comments of
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1
Page 2 - Ms. Mary Lou Mooney
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 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 Patt 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOfficcs/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/ReportalProblem/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,
For
Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K100948
Device Name: Hypo Clenz Antimicrobial Wound & Skin Wash
Indications For Use:
OTC - Hypo Clenz Wound & Skin Wash is intended for OTC use for the mechanical OTC - Hypo Cleilz Would be Skill Wash is intential from material from minor cuts, cleansing (firigations, minor skin abrasions, minor skin irritations and intact skin.
minor burns, minor lacerations, minor skin abrasions, minor skin irritations and intact
Professional - Hypo Clenz Antimicrobial Wound & Skin Wash is intended by be used by Professional - Trypo Ciciz Amilinorooian Trouismical irrigation debridement to nealth care protessionals in the managements of wounds such as Stage I-V
remove foreign materials including microorganisms, of wounds such as accept be femove foreign matchals morading more organisms, will be second degree burns, grafted and donor sites.
AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use __ X
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daird Krams /m MyM Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100948