(286 days)
Prescription: LUOFUCON® PHMB Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including postoperative wounds, trauma wounds, leg ulcers, diabetic ulcers, graft and donor sites.
OTC: LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is indicated for first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
LUOFUCON® PHMB Alginate Dressing /LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is a sterile, single-use dressing consisting of calcium alginate fiber impregnated with polyhexamethylene biguanide, and the maximum polyhexamethylene biquanide content is 0.8% w/w. LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing can absorb wound exudate. As wound exudate is absorbed, the alginate forms a gel, which provide a moist wound healing environment, and allows intact removal. Based on in vitro performance data, LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing has broad spectrum antibacterial effects, and the polyhexamethylene biguanide prevents colonization and proliferation of bacteria within the dressing for up to seven days.
The provided document is an FDA 510(k) Premarket Notification for a wound dressing, not a device that relies on complex algorithms or AI. Therefore, the questions related to AI acceptance criteria, ground truth establishment, expert consensus, MRMC studies, and training/test set sample sizes are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of material, indications for use, and performance testing typically associated with wound dressings, such as absorbency, pH, sterility, and antibacterial effectiveness. There is no mention of a "device" in the context of an AI/ML-driven diagnostic or analytical tool.
Here's a breakdown of the relevant information provided, and where the requested AI-related information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparison table between the subject device (LUOFUCON® PHMB Alginate Dressing) and two predicate devices (COPA AMD antimicrobial wound dressing K082296 and LUOFUCON® Extra Silver Alginate Dressing K172554). This table essentially outlines the "acceptance criteria" through comparison to legally marketed devices and reports the subject device's performance against these comparative standards.
| Item | Subject Device (K201016) | Primary Predicate Device (K082296) | Secondary Predicate Device (K172554) |
|---|---|---|---|
| Product Code | FRO | FRO | FRO |
| Class | Unclassified | Unclassified | Unclassified |
| Indications for Use | (See full description in the document) | (See full description in the document) | (See full description in the document) |
| Mechanism | Alginate for absorbing liquid, PHMB for reducing bacteria colonization in dressing. | Polyurethane foam for absorbing liquid, PHMB for reducing bacteria colonization in dressing. | Alginate for absorbing liquid, silver for reducing bacteria colonization in dressing. |
| Material | Alginate 99.2% w/w, PHMB 0.80% w/w | Polyurethane foam 99.5% w/w, PHMB 0.50% w/w | Alginate 99.2%, Silver 0.80% w/w |
| Antibacterial agent | PHMB | PHMB | Silver |
| Dressing Use-life | Up to Seven days | Up to Seven days | Up to Seven days |
| Shelf-life | Two years | / | Two years |
| Package information | Aluminum foil or paper aluminum plastic pouch, box and Carton | Paper-plastic bag, box and Carton | Aluminum foil pouch, box and Carton |
| Single Use | Yes | Yes | Yes |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Size | Prescription: Max. 200mm×200mm, OTC: Max. 200mm×200mm | Prescription: Max. 20.3cm×20.3cm | Prescription: Max. 200mm×200mm, OTC: Max. 200mm×100mm |
| Weight per unit area | 120 g/m² - 240 g/m² | N/A | 120 g/m² - 240 g/m² |
| Free swell absorption capacity | ≥12g/100cm² | N/A | ≥12g/100cm² |
| pH value | 4.0-5.0 | N/A | 4.0-7.0 |
| PHMB content | 0.40-0.80% w/w | 0.50% w/w | N/A |
| Antibacterial effectiveness | 4 Log Reduction for six organisms up to 7 days (MRSA/VRE/ Streptococcus pyogenes/Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia) | 4 Log Reduction for six organisms up to 7 days (MRSA/VRE/ Streptococcus pyogenes/Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia) | 4 Log Reduction for six organisms up to 7 days (MRSA/VRE/ Streptococcus pyogenes/Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia) |
The acceptance criteria for this non-AI medical device are primarily established by demonstrating substantial equivalence to existing legally marketed predicate devices in terms of:
- Intended Use: The indications for use are highly similar to the predicate devices.
- Design and Materials: The core components (alginate/PHMB) and their functions are comparable.
- Performance: Various physical and biological tests show comparable performance characteristics. Specifically, the antibacterial effectiveness demonstrating a "4 Log Reduction for six organisms up to 7 days" is a key performance metric that aligns across all compared devices.
2. Sample size used for the test set and the data provenance:
This is a wound dressing, not a data-driven AI device. Therefore, the concept of a "test set" in the context of machine learning does not apply. The performance testing refers to laboratory studies on the physical and chemical properties of the dressing and its biological effectiveness (antibacterial activity). The document does not specify sample sizes for these tests, only that they were conducted "on subject devices."
The provenance of data would be from laboratory testing conducted by the manufacturer, Huizhou Foryou Medical Devices Co., Ltd., based in Huizhou, Guangdong, China. This would be considered prospective lab testing for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. "Ground truth" in the context of expert consensus on data is irrelevant for a physical wound dressing. The "truth" here is determined by validated laboratory test methods (e.g., BS EN 13726-1, USP , USP , ISO 11737-2, Modified AATCC TM100, ISO 10993-1).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there is no "test set" requiring adjudication by human experts in this context.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this wound dressing, the "ground truth" for its performance is established through:
- Standardized performance tests: Adherence to international standards (e.g., ISO, USP, BS EN, AATCC) for physical properties (e.g., absorbency, pH, weight) and sterility.
- Microbiological assays: In vitro studies demonstrating antibacterial effectiveness (4 Log Reduction) against specified organisms.
- Biocompatibility testing: In vitro and in vivo (porcine wound healing study) tests to assess biological safety, following ISO 10993-1 guidelines.
8. The sample size for the training set:
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI device.
N/A