(213 days)
To cover intact skin or minor cuts, scrapes, burns, and irritations of the skin, to help keep them clean and dry and help protect them from infection
This product is a liguid polymer in a spray format. The solution is topically applied to the affected area and the carrier solvent evaporates allowing polymerization of the remaining constituents to form a non-toxic, hydrophobic, elastomeric polymer coating that provides a barner against moisture but that is permeable to oxygen. The intended use is as a liquid bandage, as this coating is biocompatible and forms a tough yet pliable seal, preventing it from cracking and peeling as the skin heals.
Here's a breakdown of the acceptance criteria and the study that proves the Chesson Labs Liquid Bandage device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter / Acceptance Criteria | Reported Device Performance |
|---|---|
| Microbial Barrier (per modified ASTM F1608) | The film formed an effective barrier to all organisms tested (five species of bacteria). |
| Biocompatibility (per ISO-10993) | The product was shown to be biocompatible based on twelve different types of tests for cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, mutagenicity, and implantation. |
| Bench Testing (Bulk formulation & packaged product) | All product lots met specifications for: molecular weight, purity, residual components, water content, setting/drying time, viscosity, percent solids, color and particulates, heat of polymerization, moisture vapor transmission rate, tensile strength of dried film, and distribution/ship tests of packaged product. Performance characteristics are similar to those of the predicate devices. |
| Functional Characteristics (compared to predicate devices) | The Chesson Labs product is described as having "many of the same functional characteristics, such as water-tightness, water vapor permeability, oxygen permeability, flexibility, and barrier film duration." |
| Safety and Effectiveness (compared to predicate devices) | Biocompatibility and design verification testing "demonstrated that the Chesson Labs Liquid Bandage has the same performance, safety and technical characteristics and therefore raises no new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set for each specific experiment. However, it mentions:
- Microbial Barrier: Tested with "five species of bacteria." The sample size for the material itself isn't specified, but it implies tests against these five species.
- Biocompatibility: "Twelve different types of tests were run." No specific sample sizes (e.g., number of animals, cell cultures) are provided.
- Bench Testing: "All product lots met specifications." No specific number of lots or samples per lot is given.
The data provenance is retrospective, as this is a 510(k) submission describing tests already conducted to demonstrate substantial equivalence to existing predicate devices. The country of origin of the data is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The studies described are primarily laboratory-based performance and safety tests (microbial barrier, biocompatibility, bench testing) and do not involve human evaluation of device efficacy that would require expert-established ground truth in the way a diagnostic imaging study would. The acceptance criteria are based on measurable physical and biological properties.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies are not clinical trials or diagnostic studies requiring expert adjudication of results. The "ground truth" for the performance tests (e.g., whether a microbial barrier was effective, whether a material was biocompatible, or whether a property met a specification) would be determined by the results of the specific test methods and their defined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and the device's impact on their performance is being assessed. The Chesson Labs device is a liquid bandage, and its effectiveness is determined through physical and biological property testing, not through human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:
A standalone performance study was done, in the sense that the device's performance was evaluated inherently without human-in-the-loop interaction for its primary function. The biocompatibility, microbial barrier, and bench tests are all evaluations of the device's inherent properties and performance when applied appropriately, without requiring a human to interpret an output or act on a recommendation from the device itself.
7. Type of Ground Truth Used:
The ground truth used for these studies is based on:
- Standardized Test Methods: For microbial barrier, it's defined by the modified ASTM F1608. For biocompatibility, it's defined by ISO-10993 guidelines.
- In vitro and In vivo Laboratory Results: Direct measurements and observations from the conducted tests.
- Pre-defined Specifications: For bench testing, the ground truth is whether the measured values for molecular weight, viscosity, etc., fall within the established specifications.
- Comparison to Predicate Devices: The overall "ground truth" for substantial equivalence relies on demonstrating that the new device's performance, safety, and technical characteristics are comparable to legally marketed predicate devices.
8. Sample Size for the Training Set:
This information is not applicable/not provided. The Chesson Labs liquid bandage is a physical medical device, not an AI/ML algorithm that requires a "training set" of data in the computational sense. The "development" process would involve formulation, characterization, and iterative testing, but not a distinct "training set" similar to what's used for AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" in the context of this 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.