(115 days)
Silicone PHMB Foam Wound Dressings are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma, and as a secondary dressing for packed wounds.
The subject device, Silicone PHMB Foam Dressing, is a polyurethane foam trilaminate dressing impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment.
Based on in vitro performance data, the Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria within the dressing for up to 7 days. Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against the following bacteria (MRSA, Streptococcus pyogenes, VRE, Escherichia coli, Klebsiella pneumoniae, Serratia marcescens) and yeast (Candida albicans) challenge organisms within the dressing.
The perforated wound contact layer contains a gentle silicone adhesive that provides secure, non-irritating adhesion and supports nontraumatic removal during dressing changes.
The device is presented in a border (adhesive) version. The dressing is supplied sterile in a range of sizes between 10.24 in2 to 64 in2.
The provided text describes a 510(k) submission for a medical device, the "Silicone PHMB Foam Wound Dressing." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical outcome studies with specific acceptance criteria as might be seen for novel devices or high-risk applications.
Therefore, the information typically requested in your prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, effect sizes, adjudication methods, type of ground truth for training) is not applicable in the context of this 510(k) submission for a wound dressing.
Instead, the submission focuses on performance testing (in-vitro and animal testing) and biological evaluation to demonstrate safety and functional equivalence to the predicate device.
Here's what can be extracted from the document regarding the device's performance and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for a wound dressing, "acceptance criteria" are generally framed as demonstrating equivalence to a predicate device in terms of design, materials, indications for use, and performance characteristics. The specific metrics for "device performance" are primarily related to its physical and antimicrobial properties rather than diagnostic accuracy metrics.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Silicone PHMB Foam Wound Dressing) |
|---|---|
| Intended Use (Wound dressing containing PHMB for wound management) | Equivalent to Predicate Device: Wound dressing containing PHMB designed for the management of wounds. |
| Indications for Use (Specific wound types) | Equivalent to Predicate Device: Indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma, and as a secondary dressing or cover dressing for packed wounds. |
| Single Use | Yes, Equivalent to Predicate Device. |
| Materials (Polyurethane backing layer, PHMB foam layer) | Equivalent to Predicate Device: Polyurethane backing layer, Polyurethane foam layer containing Polyhexamethylene Biguanide (PHMB). (Note: Comparison also notes a change in wound contact layer adhesive from acrylic to silicone, but concludes no new questions of safety/effectiveness). |
| Construction (Wound contact layer with adhesive) | Comparable to Predicate Device: Clear polyurethane wound contact layer with silicone adhesive. (Predicate had acrylic adhesive, but deemed not to raise new questions of safety or effectiveness). |
| Exudate Management (High absorbency, high total fluid handling) | Equivalent to Predicate Device: A high absorbency capacity for wound exudates and high total fluid handling. |
| Moist Environment Maintenance | Equivalent to Predicate Device: Maintains a moist wound healing environment. |
| Wound Protection (Barrier to bacterial penetration) | Equivalent to Predicate Device: Provides a barrier to bacterial penetration through the dressing. In-vitro performance shows it provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria within the dressing for up to 7 days. |
| Sterility (Provided as sterile) | Yes, Ethylene Oxide (Predicate was Gamma irradiation). Comparison deemed not to raise new questions of safety or effectiveness. |
| Effectiveness against bacteria/yeast within dressing (in-vitro) | Demonstrated effectiveness against: Methicillin-Resistant S. aureus (MRSA), Streptococcus pyogenes, Vancomycin-Resistant E. faecalis (VRE), Escherichia coli, Klebsiella pneumonia, Serratia marcescens, and Candida albicans. |
| Biocompatibility (ISO 10993-1 compliance for prolonged contact) | Meets the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices) and is safe. |
| Physical Performance (e.g., peel adhesion) | Performance testing included total fluid handling and peel adhesion. (Specific numerical results not provided in this summary, but indicated as having been submitted and reviewed). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of "test set" for human performance, as this is a device for physical wound management. The performance data relied on in-vitro and animal testing. Specific numbers of samples or animals are not provided in this summary document.
- Data Provenance: Not explicitly stated but the applicant is based in the UK (Advanced Medical Solutions Ltd, Winsford, Cheshire, CW7 3RT GB). The studies conducted would typically comply with international standards (e.g., ISO for biological evaluation). The document does not specify if the studies were retrospective or prospective, but in-vitro and animal studies are typically prospective experimental designs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a diagnostic device requiring expert interpretation for ground truth. Ground truth for in-vitro antimicrobial effectiveness would be based on laboratory microbiological assays, and for physical properties, on engineering and material science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No human interpretation or adjudication process is described for this device's performance evaluation.
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/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithmic device. The "standalone" performance refers to the intrinsic properties of the wound dressing (e.g., absorbency, antimicrobial activity).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Antimicrobial Efficacy: Ground truth established via
- In-vitro microbiological assays: (e.g., confirming inhibition of bacterial/yeast growth on/in the dressing).
- For Biocompatibility: Ground truth established via
- Compliance with International Standard ISO 10993-1: Biological evaluation based on established protocols and endpoints (e.g., cytotoxicity, sensitization, irritation) in animal models or in-vitro tests.
- For Physical Performance: Ground truth established via
- Standardized physical testing methods: (e.g., for absorbency, fluid handling, peel adhesion), often against industry benchmarks or the predicate device's measured properties.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning/AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML algorithm.
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