(339 days)
Skin barrier for protection against the detrimental effects of moisture, urine, or feces.
NUVO™ is a liquid, alcohol-free, film-forming product.
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. |
§ 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.