(281 days)
LT Antibacterial Alginate with Silver Dressing is used for management acute and chronic wounds, partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, surgical wounds, traumatic wounds, first and second-degree burns.
LT Antibacterial Alginate with Silver Dressing is intended for external use only.
LT Antibacterial Alginate with Silver Dressing is an advanced wound care dressing composed of calcium alginate and silver salt (3.5%). The dressing forms a gel when absorbs wound fluid to provide a moist environment and allows intact removal. When in contact with wound fluid, silver ions within the dressing inhibit bacterial growth in the dressing. LT Antibacterial Alginate with Silver Dressing is available in pad and ribbon configurations and various sizes. The pad is used to cover and protect the wound bed and the ribbon is used to pack the wound with cavity.
LT Antibacterial Alginate with Silver Dressing can be cut and layered for various wound shapes and types.
This document describes the FDA 510(k) clearance for the LT Antibacterial Alginate with Silver Dressing. Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) process for this device relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than explicit acceptance criteria and performance against those criteria in a typical clinical trial sense. The performance is assessed through non-clinical (bench and animal) testing and similarity to the predicate device.
| Parameter | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Subject Device) |
|---|---|---|
| Biocompatibility | Biocompatible (per ISO standards) | Passed Cytotoxicity, Irritation, Sensitization, Implantation, Acute toxicity, Sub-acute toxicity, Pyrogenicity tests. |
| Antibacterial Activity | 4-log reduction (as per AATCC 100) | Demonstrated 4-log antibacterial activity against gram-negative, gram-positive, and yeast for up to 7 days. |
| Moisture Exudate Capacity | Comparable to predicate | MEC results reported (actual value not specified, but implied to be acceptable for substantial equivalence). |
| Silver Content & Elution | Specified ranges/comparable to predicate | Silver content: 35 mg/g or 42mg/100cm2; Elution results reported (implied acceptable). |
| Absorption | Comparable to predicate | Absorption results reported (implied acceptable). |
| Moisture Vapor Transmission Rate (MVTR) | Comparable to predicate | MVTR results reported (implied acceptable). |
| Tensile Strength | Comparable to predicate | Tensile strength results reported (implied acceptable). |
| Stability | Stable over shelf life | Stability study performed (implied acceptable). |
| Sterilization | Sterility Assurance Level (SAL) of 10-6 | Gamma Irradiation, SAL of 10-6. |
| Wound Healing | Evidence of promoting wound healing (animal model) | Porcine wound healing study performed (implied acceptable for substantial equivalence). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Non-Clinical Tests: Not specified in the document for individual tests (e.g., number of samples for AATCC 100, number of animals for the porcine study). The various configurations of the dressing (different sizes) would likely have been tested.
- Data Provenance: Not explicitly stated, but based on the manufacturer's location (Zhejiang, China) and common industry practices, it's highly likely the non-clinical testing was conducted in laboratories, possibly in China or by contract research organizations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the document. For non-clinical studies (bench and animal), specific "experts" establishing ground truth in the sense of clinical adjudication are typically not involved. Results are measured objectively according to standard protocols (e.g., ISO, AATCC).
4. Adjudication Method for the Test Set
- None as described in a clinical context. Non-clinical tests follow established protocols and measurement techniques for objective results.
5. 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
- No MRMC study was done. This device is a wound dressing, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a wound dressing, not a software algorithm.
7. The Type of Ground Truth Used
- Objective Test Results and Animal Models:
- Bench Testing: Ground truth is established by standardized laboratory methods and measurements (e.g., bacterial count reduction for antibacterial activity, physical properties like tensile strength, chemical assays for silver content).
- Biocompatibility Testing: Ground truth is determined by standardized biological response assessments according to ISO 10993 series.
- Animal Testing: Ground truth is established by observational and histological assessments in a controlled animal model (porcine wound healing study).
8. The Sample Size for the Training Set
- Not applicable. This device is a physical wound dressing; it does not involve machine learning or a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for a machine learning model, there is no ground truth established for it.
N/A