(89 days)
CURAD® Spray Bandage is indicated for providing a covering over minor cuts and scrapes that are clean and dry.
The product is packaged in a pressurized can. The can is held about 5 inches from affected area, and a light coat is sprayed onto the skin. CURAD® Spray Bandage typically dries in 2-3 minutes. Once dried, additional coats can be applied, if needed.
CURAD® Spray Bandage will typically adhere for several days before losing its adhesive strength. To remove it before it has lost its adhesive strength, the user can apply isopropyl alcohol to the bandage to dissolve it.
CURAD® Spray Bandage is composed of the following ingredients:
poly(methylacrylate-isobutene-monoisopropylmaleate), ethyl acetate, npentane, carbon dioxide, menthol
Here's an analysis of the provided text regarding the CURAD® Spray Bandage's acceptance criteria and studies, organized as requested:
Acceptance Criteria and Study for CURAD® Spray Bandage
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Claimed | Reported Device Performance |
|---|---|
| Flexible | Flexible |
| Transparent | Transparent |
| Water-tight | Water-tight |
| Allows passage of water vapor | Allows passage of water vapor |
| Seals out germs | Seals out germs |
| Biocompatible | Biocompatibility assessment performed with satisfactory results |
| Adheres for several days | Typically adheres for several days |
| Dries in 2-3 minutes | Typically dries in 2-3 minutes |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for the test set for any of the performance claims. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The document states that "A summary of testing to support each of these claims has been established and verified," implying that tests were conducted, but the details are omitted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The provided 510(k) summary does not mention the use of experts to establish ground truth for the test set. The performance claims appear to be based on physical/material property testing rather than expert-derived diagnoses or assessments.
4. Adjudication Method for the Test Set
Since the ground truth appears to be based on objective physical/material property testing rather than expert consensus on subjective assessments, an adjudication method for a test set is not applicable and not mentioned in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided document. The device in question is a liquid bandage, and the performance claims relate to its physical properties, not diagnostic accuracy where human readers would typically be involved.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to this device. The CURAD® Spray Bandage is a physical product, not a software algorithm that performs diagnostic or analytical tasks. Therefore, a "standalone algorithm performance" study was not conducted.
7. Type of Ground Truth Used
The ground truth used for the performance claims appears to be based on objective physical and material property measurements/testing. Examples include evaluating flexibility, transparency, water-tightness, water vapor permeability, germ sealing capability, drying time, adhesion duration, and biocompatibility.
8. Sample Size for the Training Set
There is no mention of a "training set" in the context of this device. A training set is typically associated with machine learning algorithms, which are not relevant to the CURAD® Spray Bandage.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for this device, the question of how its ground truth was established is 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.