The provided document is a 510(k) summary for the NUVO™ Barrier Film, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on comparing the new device to an existing one, rather than conducting extensive clinical studies to establish original performance criteria and statistically prove that the device meets those criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's why and what the document does provide:

Acceptance Criteria and Reported Device Performance: This document states the device "performs as least as well as other liquid bandage devices, such as the 3M™ No Sting Barrier Film." It does not define specific performance metrics or acceptance criteria for properties like skin protection efficacy, durability, or user comfort. Instead, it relies on comparison to a predicate device.
Study That Proves the Device Meets Acceptance Criteria: The "study" mentioned is a set of biocompatibility tests:
- acute dermal toxicity test (rabbit)
- primary dermal irritation test (rabbit)
- dermal sensitization test (guinea pig)
- in vitro cytotoxicity test (USP XXIII)
  These tests establish the biocompatibility of the film, not its primary intended use performance (protection against moisture, urine, or feces) in a clinical setting with human subjects.
Sample Size for Test Set and Data Provenance: Not applicable for a comparative performance study on human subjects in this 510(k) submission. The biocompatibility tests used animal models (rabbits, guinea pigs) for toxicity, irritation, and sensitization, and an in vitro test for cytotoxicity. The specific number of animals or in vitro replicates is not provided.
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. The ground truth for biocompatibility tests is based on established scientific protocols and observations of biological responses, not expert consensus on clinical images or outcomes.
Adjudication Method: Not applicable.
Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: Not conducted or mentioned. This type of study is typically for diagnostic devices where human interpretation is involved.
Standalone (algorithm-only) Performance: Not applicable. This device is a barrier film, not a software algorithm.
Type of Ground Truth Used: For the biocompatibility claims, the ground truth is derived from the established biological responses observed in the animal and in vitro tests according to standardized protocols.
Sample Size for Training Set: Not applicable. This is not a machine learning device.
How Ground Truth for Training Set Was Established: Not applicable.

Summary Table of Information from the Provided Document:

Criterion/Information	Details from Document
1. Acceptance Criteria & Reported Device Performance	Acceptance Criteria: Implicitly, "performs at least as well as other liquid bandage devices, such as the 3M™ No Sting Barrier Film" (K955103). Reported Device Performance: Biocompatibility established via acute dermal toxicity (rabbit), primary dermal irritation (rabbit), dermal sensitization (guinea pig), and in vitro cytotoxicity (USP XXIII) tests.
2. Sample Size (Test Set) & Data Provenance	Not applicable for human-subject performance. Biocompatibility tests used rabbits and guinea pigs; specific numbers not provided. Data provenance is laboratory testing.
3. Number & Qualifications of Experts (Ground Truth - Test)	Not applicable for this type of submission/device.
4. Adjudication Method (Test Set)	Not applicable.
5. MRMC Comparative Effectiveness Study & Effect Size	No MRMC study was conducted or mentioned.
6. Standalone Performance (Algorithm Only)	Not applicable (device is a film, not an algorithm).
7. Type of Ground Truth Used	Biocompatibility: Biological responses in animal models and in vitro tests (e.g., absence of toxicity, irritation, sensitization).
8. Sample Size for Training Set	Not applicable (not a machine learning device).
9. How Ground Truth for Training Set Was Established	Not applicable.

Summary

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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 (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.

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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.

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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 (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

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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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Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.