(413 days)
Prescription Use:
LUOFUCON® Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, diabetic foot ulcers, superficial second- degree burns, donor sites, surgical wounds, lacerations and abrasions.
OTC Use:
LUOFUCON® Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
LUOFUCON® Aq+ Foam Dressing/LUOFUCON® Ag+ Antibacterial Foam Dressing is a sterile, single-use wound dressing. The device has a single or multi-layer structure and its foam layer is containing 0.40mg/cm² maximum content of ionic silver. According to the different composition of product structure, the device provides three models: Easy, Backing and Adhesive.
- (a) The first model, Easy, consist of a single exudate absorption layer (Polyurethane foam containing silver compound).
- (b) The second model, Backing, consist of a backing layer (Polyurethane film); an exudate absorption layer (Polyurethane foam containing silver compound).
- (c) The third model, Adhesive, consist of a self-adhesive layer (Adhesive tape); an exudate absorption layer (Polyurethane foam containing silver compound); a release liner covers on the adhesive tape.
Depending on its exudate absorption layer, the device can absorb wound exudates and maintain a moist wound healing environment. As wound exudates are absorbed, the silver ions released from the polyurethane foam to assist in inhabiting bacterial growth within the dressing for up to 7days, as demonstrated in vitro. The polyurethane film of dressing is waterproof and breathable which can provide a microbial barrier to prevent the microbial penetrating through it.
This is a 510(k) premarket notification for a medical device called LUOFUCON® Ag+ Foam Dressing and LUOFUCON® Ag+ Antibacterial Foam Dressing. It is important to understand that a 510(k) submission seeks to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to set new performance criteria or conduct studies proving superiority. Therefore, the information provided focuses on showing that the new device is as safe and effective as existing ones.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of explicit acceptance criteria with numerical targets alongside reported device performance in the way one might expect for a diagnostic AI device. Instead, the performance data provided are primarily bench performance tests and biocompatibility tests, which largely demonstrate the physical and biological characteristics of the wound dressing and confirm it meets established standards for such devices. The "acceptance criteria" are implied by the standards chosen (e.g., BS EN 13726-1 for water absorbency, ISO 10993 for biocompatibility).
Here's a breakdown based on the provided text:
| Acceptance Criteria Category (Implied by Test) | Reported Device Performance (Summary) | Relevant Standard/Method |
|---|---|---|
| Physical/Chemical Bench Tests | ||
| Appearance | Not specified beyond "conformant" | Not specified |
| Size | Not specified beyond "conformant" | Not specified |
| Water absorbency | Performed | BS EN 13726-1 |
| pH Value | Performed | USP pH |
| Silver content | 0.40mg/cm² maximum content of ionic silver (in foam layer) | Not specified, but a specific value is mentioned |
| MVTR (Moisture Vapor Transmission Rate) | Performed | BS EN 13726-2 |
| Waterproofness | Performed | BS EN 13726-3 |
| Microbial barrier | Performed (polyurethane film provides microbial barrier) | Not specified |
| EO and ECH residuals | Performed | ISO 10993-7 |
| Antibacterial effectiveness | Demonstrated effectiveness for up to 7 days in vitro | Modified AATCC TM100 |
| Sterility | Performed (SAL: 10-6 via EtO) | ISO 11737-2 |
| Biocompatibility Tests | ||
| Cytotoxicity | No new safety concerns; Demonstrated safe for intended use | ISO 10993-5:2009 |
| Intracutaneous Reactivity | No new safety concerns; Demonstrated safe for intended use | ISO 10993-10:2010 |
| Sensitization | No new safety concerns; Demonstrated safe for intended use | ISO 10993-10:2010 |
| Acute Systemic toxicity | No new safety concerns; Demonstrated safe for intended use | ISO 10993-11:2017 |
| Material-mediated pyrogenicity | No new safety concerns; Demonstrated safe for intended use | USP |
| Sub chronic toxicity | No new safety concerns; Demonstrated safe for intended use | ISO 10993-11:2017 |
| Implantation | No new safety concerns; Demonstrated safe for intended use | ISO 10993-6:2016 |
| Animal Study | ||
| Wound Healing | Did not affect normal wound healing | Porcine Wound Healing Study |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device (wound dressing), not an AI/software device. Therefore, the concepts of "test set" and "data provenance" (e.g., country of origin, retrospective/prospective) are not directly applicable in the same way they would be for an AI algorithm.
- The "test set" for the bench performance tests would be samples of the LUOFUCON® Ag+ Foam Dressing itself. The number of samples tested for each bench test is not specified, but it would typically follow the requirements of the respective ISO/EN standards.
- The "test set" for the animal study was a cohort of pigs. The number of animals used is not specified.
- There's no mention of human clinical data or patient data "test sets" for evaluation in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device is a wound dressing, not an AI diagnostic system requiring expert interpretation for ground truth establishment. The performance is assessed against established physical, chemical, and biological standards.
4. Adjudication Method for the Test Set
Not applicable for a physical medical device like a wound dressing. Adjudication methods like "2+1" or "3+1" are typical for establishing ground truth in image interpretation studies for AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable as this is not an algorithm or AI device.
7. The Type of Ground Truth Used
- Bench Performance Tests: The "ground truth" is defined by specific quantitative and qualitative criteria outlined in international and national standards (e.g., BS EN, USP, ISO). These are objective measurements.
- Biocompatibility Tests: The "ground truth" is based on the absence of adverse biological reactions as defined by ISO 10993 standards.
- Animal Study: The "ground truth" for wound healing was based on observations and measurements within a porcine model, comparing the effect of the device to control or normal healing processes. The precise metrics are not detailed but generally involve macroscopic and microscopic evaluation of wound closure, inflammation, and tissue regeneration.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The manufacturing process of the wound dressing is well-established, and its characteristics are determined by its materials and design, not by learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
N/A