(250 days)
Prescription: LUOFUCON® Extra Silver Alginate Dressing (Rx only) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.
OTC: LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) is first aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) is a sterile, single-use dressing composed of calcium alginate and silver antibacterial agent, which absorbs wound exudate and release silver ions in the presence of wound fluid in the dressing. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The alginate material contains silver which inhibits bacterial growth within the dressing. Based on in vitro laboratory testing, the silver has been shown to protect the dressing against both Gram positive and Gram negative bacteria, such as Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Methicillin-resistant Staphylococcus aureus (MRSA), and Vancomycin-resistant Enterococcus (VRE). And the silver protects the dressing from a broad spectrum of bacteria up to seven days. All dressings are sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.
This document describes the premarket notification for the LUOFUCON® Extra Silver Alginate Dressing (Rx Only) and LUOFUCON® Antibacterial Alginate Wound Dressing (OTC). The acceptance criteria and supporting studies are presented below.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Free Swell Absorption Capacity | Not explicitly stated; implied to be comparable to predicate device. | Performance comparable to the predicate device. |
| Loss on Drying | Not explicitly stated; implied to be comparable to predicate device. | Performance comparable to the predicate device. |
| pH Value | Not explicitly stated; implied to be comparable to predicate device. | Performance comparable to the predicate device. |
| Silver content | Not explicitly stated; implied to be controlled and effective for indicated antibacterial properties. | Contained silver which inhibits bacterial growth within the dressing. Shown to protect against Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Methicillin-resistant Staphylococcus aureus (MRSA), and Vancomycin-resistant Enterococcus (VRE). |
| Antibacterial Activity | The subject device achieves antibacterial duration for seven days. | Passed (Achieved antibacterial duration for seven days). In vitro laboratory testing demonstrated protection against both Gram positive and Gram negative bacteria, including MRSA and VRE, for up to seven days. |
| Biocompatibility (Surface device; contacting breached or compromised skin for prolonged duration) | No new safety concerns raised as per ISO 10993-1:2009. Must be safe for intended use. Must pass tests for Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Implantation, and Material-mediated pyrogenicity. | No new safety concerns were raised. Device demonstrated to be safe for its intended use, having been evaluated for: Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Implantation, Material-mediated pyrogenicity. The porcine wound healing study showed silver did not cause cytotoxicity or delay normal wound healing. |
| Sterilization | Validated following ISO 11137-2:2013 for radiation sterilization. | All dressings were sterilized by radiation using conditions validated following ISO 11137-2:2013. |
2. Sample Size and Data Provenance for Test Set (Performance Tests)
The document primarily describes in vitro and animal studies, not human clinical trials with a "test set" in the typical sense for AI/software devices.
- Antibacterial Activity Test: The sample size for the AATCC 100-2012 testing is not specified. The data provenance is from in vitro laboratory testing performed by the manufacturer, Huizhou Foryou Medical Devices Co., Ltd., likely in China (country of origin for the submitter). This would be considered retrospective data in the context of the submission.
- Biocompatibility Tests: The sample sizes for the various ISO 10993-1:2009 biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Implantation, Material-mediated pyrogenicity) are not specified in this summary. These are laboratory tests.
- Porcine Wound Healing Study: The sample size for the porcine wound healing study is not specified. This is an animal model study.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
Not applicable. The reported studies are laboratory performance tests and an animal study, not studies involving human experts establishing ground truth for diagnostic or AI performance.
4. Adjudication Method (Test Set)
Not applicable. This is not a study requiring adjudication of human interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes the performance of a wound dressing, not an AI or diagnostic device that would involve human readers or MRMC studies.
6. Standalone Performance
Yes, the performance tests (Free Swell Absorption Capacity, Loss on Drying, pH Value, Silver content, Antibacterial Activity, and Biocompatibility tests, including the porcine wound healing study) represent the standalone performance of the device itself. These tests assess the inherent physical, chemical, and biological properties of the wound dressing without human-in-the-loop intervention for diagnostic or interpretative purposes.
7. Type of Ground Truth Used
The ground truth for the performance tests is based on:
- Quantitative measurements against established standards and methodologies (e.g., AATCC 100-2012 for antibacterial activity, ISO 10993-1:2009 for biocompatibility).
- Direct observation and assessment in the porcine wound healing study (e.g., absence of cytotoxicity, normal wound healing).
- Laboratory analysis for material properties (e.g., silver content, pH).
8. Sample Size for Training Set
Not applicable. This is a medical device (wound dressing), not an AI or machine learning algorithm that requires a "training set."
9. How Ground Truth for Training Set was Established
Not applicable, as there is no training set for this device type.
N/A