(271 days)
LiquiShield™ Liquid Bandage is intended for over the counter (OTC) use to cover minor cuts and scrapes and minor irritations of the skin and help protect them from infection.
LiquiShield™ Liquid Bandage biocompatible cyanoacrylate-based, drying, liquid barrier film for the protection the skin. It is applied as a liquid and dries, within approximately 45 seconds, adhering to the contours of the skin to form a transparent, flexible film. LiquiShield™ Liquid Bandage wears off naturally as the skin regenerates. The applicator and contents are supplied sterile, and the device is, therefore, suitable for aseptic techniques.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the LiquiShield™ Liquid Bandage:
Acceptance Criteria and Study Information for LiquiShield™ Liquid Bandage
This device is not an AI/ML powered device, therefore some sections are not applicable (N/A) as they relate specifically to AI device evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device and meeting intended use requirements through various testing.
| Aspect of Performance | Acceptance Criteria (Inferred from Substantial Equivalence and Intended Use) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Confirmation that the product is safe for its intended use (in accordance with BSENISO 10993-1). | "LiquiShield™ Liquid Bandage has been subjected to the appropriate biocompatibility testing in accordance with BSENISO 10993-1, the results of which confirm that the product is safe for its intended use." |
| Mechanical & Performance Equivalence | Equivalence to the predicate device (LIQUIDERM™ Liquid Adhesive Bandage) in properties such as application, drying, barrier formation, haemostatic, quick drying, keeps out dirt and germs, waterproof, and flexibility. | "LiquiShield™ Liquid Bandage has also been subjected to mechanical and performance testing to demonstrate equivalence to the predicate device, with clinical evaluations conducted to demonstrate that LiquiShield™ Liquid Bandage meets its intended use requirements. Substantial equivalence is also based on intended use, application, product performance, haemostatic, quick drying, keeps out dirt and germs, waterproof and flexibility properties." The device "is applied as a liquid and dries, within approximately 45 seconds, adhering to the contours of the skin to form a transparent, flexible film." and "wears off naturally as the skin regenerates." |
| Intended Use Requirements | Ability to cover minor cuts and scrapes, minor irritations of the skin, and help protect them from infection. | "Clinical evaluations conducted to demonstrate that LiquiShield™ Liquid Bandage meets its intended use requirements." |
| Sterility | Supplied sterile and suitable for aseptic techniques. | "The applicator and contents are supplied sterile, and the device is, therefore, suitable for aseptic techniques." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The document mentions "appropriate biocompatibility testing" and "mechanical and performance testing" along with "clinical evaluations," but does not detail the sample sizes for these tests.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. This type of device evaluation (for a liquid bandage) typically does not involve expert adjudication in the same way an AI diagnostic device would.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is typically relevant for diagnostic devices involving interpretation by multiple readers, often with AI assistance. It is not applicable to a liquid bandage.
- Effect Size of AI improvement: N/A, as no AI was involved.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No. This is also not applicable as the device is a physical product (liquid bandage), not a standalone algorithm.
7. Type of Ground Truth Used
The ground truth for this device's evaluation appears to be based on:
- Established Biocompatibility Standards: BSENISO 10993-1.
- Direct Measurement/Observation of Physical Properties: Such as drying time, film formation, adherence, waterproof nature, flexibility, and ability to keep out dirt and germs.
- Clinical Observation: To demonstrate that the product "meets its intended use requirements" for covering minor cuts/scrapes and protecting from infection.
- Comparison to Predicate Device: The predicate device serves as the benchmark for "substantial equivalence" across various performance aspects.
8. Sample Size for the Training Set
- Sample Size for Training Set: N/A. This concept is relevant for AI/ML models that require training data. The LiquiShield™ Liquid Bandage is a conventional medical device and does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: N/A, as there is no training set for this conventional device.
§ 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.