(601 days)
"CUTICOVER™ SKIN is a skin barrier for protection against the detrimental effects of moisture, urine, or feces."
CUTICOVER™ SKIN is a barrier film of identical formulation to the predicate NUVO Barrier Film device.
The provided text is a 510(k) summary for the CUTICOVER™ SKIN Barrier Device (K042955). This document primarily establishes substantial equivalence to a predicate device (NUVO Barrier Film, K980117) and does not contain detailed information about a comprehensive study with specific acceptance criteria and performance metrics as typically expected for novel devices or those requiring clinical studies. The basis for clearance is that the device is identical in formulation, design, composition, indications, and packaging to a previously cleared device.
Therefore, many of the requested categories will be marked as "Not applicable" or "Not provided" because the nature of this submission does not involve a de novo study to prove device performance against acceptance criteria in the way a clinical trial or algorithm validation study would.
Here is the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: The formulation is safe for its intended use as a skin barrier. (Implied by substantial equivalence to a marketed device) | "The formulation is identical to that currently used in the marketed device, NUVO Barrier Film." (Section 10.5) This implies that the device is considered safe due to the predicate's established safety profile, not through independent performance metrics. |
| Effectiveness/Intended Use: The device performs as a skin barrier for protection against detrimental effects of moisture, urine, or feces. (Implied by substantial equivalence to a marketed device with the same intended use) | "CUTICOVER™ SKIN is a barrier film of identical formulation to the predicate NUVO Barrier Film device." (Section 10.3) |
| "INDICATIONS: "CUTICOVER™ SKIN is a skin barrier for protection against the detrimental effects of moisture, urine, or feces." (Section 10.4) This indicates that the device is expected to perform effectively because it is identical to the predicate device which is already marketed for this indication. No specific performance metrics like durability, barrier efficacy, or duration of protection are reported here for the CUTICOVER™ SKIN device itself. | |
| Basis of Substantial Equivalence: Design, composition, indications, and packaging are equivalent to currently marketed similar devices. | "The design, composition, indications and packaging are equivalent to similar devices currently marketed." (Section 10.6) |
Details of the Study (or lack thereof)
This 510(k) summary primarily relies on demonstrating substantial equivalence to a predicate device, rather than providing data from a new study designed to meet specific performance acceptance criteria for the CUTICOVER™ SKIN device itself. Therefore, many of the following points are not applicable as no such detailed study is presented in the provided text.
- Sample size used for the test set and the data provenance: Not applicable. No test set data is presented for CUTICOVER™ SKIN. The submission relies on the established safety and effectiveness of the predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a skin barrier, not an AI-assisted diagnostic tool, so an MRMC study is irrelevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a new study for this device. The "ground truth" for clearance is the established performance and safety of the predicate device.
- The sample size for the training set: Not applicable. No training set is mentioned as this is not an algorithm or a device requiring a training phase in this context.
- How the ground truth for the 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.