(339 days)
No
The summary describes a liquid barrier film and its biocompatibility testing, with no mention of AI or ML.
No.
Explanation: The device is described as a skin barrier for protection against moisture, urine, or feces, which is a prophylactic or protective function, not a therapeutic one that treats a disease or condition. The performance studies focus on biocompatibility and safety, not on treating a specific ailment.
No
This device is described as a skin barrier for protection, not for diagnosing conditions. Its performance studies focus on biocompatibility and effectiveness as a barrier, not on diagnostic accuracy.
No
The device description clearly states it is a "liquid, alcohol-free, film-forming product," indicating it is a physical substance applied to the skin, 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 "Skin barrier for protection against the detrimental effects of moisture, urine, or feces." This describes a topical application for physical protection of the skin.
- Device Description: The description is of a "liquid, alcohol-free, film-forming product." This aligns with a topical barrier product.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in a laboratory setting for diagnostic purposes.
The device is clearly intended for external, topical application to the skin for protective purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Skin barrier for protection against the detrimental effects of moisture, urine, or feces.
Product codes
KMF
Device Description
NUVO™ is a liquid, alcohol-free, film-forming product.
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
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 biocompatibility of the NUVO™ Barrier Film has been established in an acute dermal toxicity test (rabbit), a primary dermal irritation test (rabbit), a dermal sensitization test (quinea pig), and an in vitro cytotoxicity test (USP XXIII). Accordingly, Biomedical Development Corporation has concluded that the NUVO™ Barrier Film is safe and effective for its intended use, and performs as least as well as other liquid bandage devices, such as the 3M™ No Sting Barrier Film.
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
§ 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.
0
DEC 1 8 1998
510 (k) SUMMARY
l. ADMINISTRATIVE
Biomedical Development Corporation Submitter: 500 Sandau, Suite 200 San Antonio, Texas 78216 (210) 308-0636
Contact Person: Ms. Phyllis B. Siegel
Date of Preparation: January 12, 1998
- DEVICE NAME 11.
Proprietary Name: NUVO™ Common Name: Barrier Film Classification Name: Liquid Bandage
PREDICATE DEVICE =
3M™No Sting Barrier Film, 3M Health Carc
IV. DEVICE DESCRIPTION
NUVO™ is a liquid, alcohol-free, film-forming product.
INTENDED USE V.
Skin barrier for protection against the detrimental effects of moisture, urine, or feces.
VI. COMPARISON TO PREDICATE DEVICE
NUVO™ Barrier Film is similar in composition, function and design, and has the same intended use as leqally marketed liquid bandages, such as the 3M™ No Sting Barrier Film (K955103, 3M Health Care). The biocompatibility of the NUVO™ Barrier Film has been established in an acute dermal toxicity test (rabbit), a primary dermal irritation test (rabbit), a dermal sensitization test (quinea pig), and an in vitro cytotoxicity test (USP XXIII). Accordingly, Biomedical Development Corporation has concluded that the NUVO™ Barrier Film is safe and effective for its intended use, and performs as least as well as other liquid bandage devices, such as the 3M™ No Sting Barrier Film.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
DEC 1 8 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard A. Hamer Consultant To Biomedical Development Corporation Richard Hamer Associates, Inc. 6401 Meadows West Drive Fort Worth, Texas 76132
K980117 Re: Trade Name: NUVO™ Barrier Film Regulatory Class: I Product Code: KMF Dated: November 30, 1998 Received: December 1, 1998
Dear Mr. Hamer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 -- Mr. Richard A. Hamer
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Acosta
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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510(k) Number (if known):
NUVO™ Barrier Film Device Name:
Indications for Use:
Skin barrier for protection against the detrimental effects of moisture, urine, or feces.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
focale
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
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OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)