← Product Code [KMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF) · K980117 # NUVO BARRIER FILM (K980117) _Biomedical Development Co. · KMF · Dec 18, 1998 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K980117 ## Device Facts - **Applicant:** Biomedical Development Co. - **Product Code:** [KMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF.md) - **Decision Date:** Dec 18, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5090 - **Device Class:** Class 1 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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](/device/K955103.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ DEC 1 8 1998 K980117 # 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a handwritten sequence of numbers and letters, appearing as k9841117. Below this sequence, the text "Page 1 of 1" is present, indicating that this is the first and only page of a document. The handwriting is bold and dark, contrasting with the white background. 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 Image /page/3/Picture/10 description: The image shows the words "Prescription Use" on the first line and "(Per 21 CFR 801.109)" on the second line. There is a signature to the right of the text. The text is in a simple, sans-serif font. OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K980117](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMF/K980117) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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