(293 days)
The Luofucon Silver Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds. Some typical wounds are:
- · Ulcers (venous, arterial, diabetic)
- Pressure Sores
- · Donor Sites
- · Surgical Incisions
- · Surgical Excisions
- · Burns (1st and 2nd degree)
Luofucon Silver Foam Dressing is a sterile, single-use dressing composed of polyurethane and silver particles, which absorbs wound exudate and releases silver ions in the presence of wound fluid. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The polyurethane material consists of metallic silver that provides effective protection of the dressing material (not wound) against bacterial contamination. The silver is a preservative that protects the dressing material (not wound) from a broad spectrum of bacteria over three days, based on in vitro laboratory testing.
All dressings are sterilized and sold directly to users after sterilization by EtO using conditions validated following ISO 11135-1: 2007.
The silver foam dressing in this submission consists of four variants:
The basic model, dressing without backing, is a sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth, elastic and breathable Polyurethane foam encapsulated with silver particles as an antimicrobial barrier. The product line is available in different sizes.
A second variant, non adhesive PU backing variant, has a two-layered structure: a thick layer of soft, smooth elastic and breathable Polyurethane foam encapsulated with silver particles, and a thin layer (0.025±0.005 mm thick) of non porous breathable Polyurethane film (backing film) laminated on the outer side (non-wound contacting side) of the thick layer. The thin backing has the same area as the thick soft Polyurethane layer and is for cosmetic purpose. The product line is available in different sizes.
A third adhesive variant, bordered PU adhesive backing variant, has a three-layered structure. A thin Polyurethane film layer (0.04±0.005 mm thick), served as backing, is laminated to the top of the thick layer of soft, breathable, and silver encapsulated Polyurethane foam. Then on top of second layer is a large thin film of Poly(ethylene terephthalate) (PET) (0.04±0.005 mm thick) with pressure-sensitive adhesive to secure the dressing on patient skin surface. The backing polyurethane layer and PET layer are waterproof and semi permeable, and are used to secure the foam onto patient skin. The product line is available in different sizes.
A fourth adhesive variant, bordered non-woven adhesive backing variant, is similar to the third variant and also has a three layered structure. A thin Polyurethane film layer (0.04±0.005 mm thick), served as backing, is laminated to the top of the thick layer of soft, breathable, and silver encapsulated Polyurethane foam. Then on top of second layer is a large thin film of non-woven material (0.28±0.02 mm thick) with pressure-sensitive adhesive to secure the dressing on patient skin surface. The non woven material is made from viscose rayon fiber and poly(ethylene terephthalate) fiber. The backing polyurethane layer and non woven layer are waterproof and semi permeable, and are used to secure the foam onto patient skin. The product line is available in different sizes.
The dressing has white appearance and is available in the form of pad and in different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size and backing.
This document is a 510(k) premarket notification for the "Luofucon Silver Foam Dressing." It describes the device, its intended use, and provides a comparison to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of acceptance criteria and the reported device performance
| Description | Acceptance Criteria (Our Device) | Reported Device Performance (Our Device) | Predicate Device (K110062) Performance |
|---|---|---|---|
| Biocompatibility | |||
| Cytotoxicity | No Toxic Effect (ISO 10993-5) | No Toxic Effect | Biocompatible (implicit) |
| Skin Irritation and Sensitization | No Effect (ISO 10993-10) | No Effect | Biocompatible |
| Systematic Toxicity | No Effect (ISO 10993-11) | No Effect | Biocompatible (implicit) |
| Antimicrobial Performance | |||
| Antibacterial Activity | Broad spectrum protection | Broad spectrum protection | Broad spectrum protection |
| Antibacterial Duration | At least 3 days (based on predicate) | 3 days (4 log reduction in 6 bacteria) | 5-7 days |
| Physical/Chemical Properties | |||
| Silver Concentration on the device | 3 ± 1 µg/cm³ silver particles | 3 ± 1 µg/cm³ silver particles | (Implicitly higher than subject device) |
| Sterilization | Validated following ISO 11135-1: 2007 | Validated following ISO 11135-1: 2007 | Sterile |
Note: The document explicitly states acceptance criteria for biocompatibility (conformance to specific ISO standards) and antibacterial activity (broad spectrum protection). For antibacterial duration, the acceptance criterion appears to be "at least 3 days" to show equivalence with the predicate for a "use case" of three days, even though the predicate performs for 5-7 days. The silver concentration is a specification, implying it was an acceptance criterion for manufacturing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- For biocompatibility testing, details on the number of samples (e.g., number of test specimens, animal subjects) are not explicitly stated in this summary. It mentions compliance with ISO standards, which would typically specify sample sizes for these tests.
- For antibacterial activity, "a total of six (three Gram positive and three Gram negative) bacteria" were evaluated. This refers to the types of bacteria, not the number of physical dressing samples tested with each bacterium. The number of dressing samples per bacterial strain is not specified.
- Data Provenance: The studies were conducted for Huizhou Foryou Medical Devices Co., Ltd., which is located in Huizhou, Guangdong Province, China. The testing itself is indicated as "in vitro laboratory testing." The provenance of the actual lab where the tests were performed is not explicitly stated beyond the manufacturer's location. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document describes a medical device (wound dressing) and its performance in in vitro and biocompatibility testing. It does not involve a "test set" in the context of diagnostic or AI-driven devices that require expert-established ground truth on patient data (e.g., imaging reports). Therefore, this question is not applicable to the type of information provided. The "truth" for these tests (e.g., presence of toxicity, bacterial reduction) is determined by quantitative laboratory assays and adherence to international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this summary pertains to a medical device's in vitro and biocompatibility performance, not a diagnostic algorithm requiring human adjudication of 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
Not applicable. This is not an AI-driven diagnostic device; it's a wound dressing. Therefore, MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims in this submission is established through:
- Quantitative Laboratory Assays: For antibacterial activity (4 log reduction).
- Standardized Biocompatibility Protocols: Conformance to ISO 10993 series for cytotoxicity, skin irritation/sensitization, and systematic toxicity. These standards define the methods and criteria for evaluating biological responses to the device materials.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
N/A