NUVO BARRIER FILM

K980117 · Biomedical Development Co. · KMF · Dec 18, 1998 · General Hospital

Device Facts

• Record ID: K980117
• Device Name: NUVO BARRIER FILM
• Applicant: Biomedical Development Co.
• Product Code: KMF · General Hospital
• Decision Date: Dec 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Skin barrier for protection against the detrimental effects of moisture, urine, or feces.

Device Story

NUVO™ is a liquid, alcohol-free, film-forming product used as a skin barrier. It is applied to the skin to provide protection against moisture, urine, or feces. The device functions as a liquid bandage, creating a protective barrier on the skin surface. It is intended for use by patients or clinicians to prevent skin irritation or damage caused by exposure to bodily fluids.

Clinical Evidence

No clinical data. Biocompatibility established via bench testing: acute dermal toxicity (rabbit), primary dermal irritation (rabbit), dermal sensitization (guinea pig), and in vitro cytotoxicity (USP XXIII).

Technological Characteristics

Liquid, alcohol-free, film-forming barrier product. Biocompatibility verified per USP XXIII standards.

Indications for Use

Indicated for use as a skin barrier to protect against the detrimental effects of moisture, urine, or feces.

Regulatory Classification

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.

Predicate Devices

• 3M™ No Sting Barrier Film (K955103)

Submission Summary (Full Text)

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DEC 1 8 1998

K980117

# 510 (k) SUMMARY

### l. ADMINISTRATIVE

Biomedical Development Corporation Submitter: 500 Sandau, Suite 200 San Antonio, Texas 78216 [phone]

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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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510(k) Number (if known):

K980117

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)