(159 days)
Antimicrobial 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,
- · lacerations,
- · superficial and partial thickness burns,
- · dermatologic disorders,
- · other wounds inflicted by trauma and,
- · as a secondary dressing or cover dressing for packed wounds.
Antimicrobial Silicone PHMB Foam Wound 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 dressing has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment.
Based on in vitro performance data, the Antimicrobial Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria, yeast and mold within the dressing for up to 7 days. Antimicrobial Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing.
The perforated wound contact layer contains a gentle silicone adhesive that provides secure, nonirritating adhesion and supports non-traumatic 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 (64cm) to 64 in2 (400cm).
The provided text describes a 510(k) submission for a medical device called "Antimicrobial Silicone PHMB Foam Wound Dressing." The submission aims to demonstrate substantial equivalence to a predicate device, "Silicone PHMB Foam Wound Dressing (K190819)." The key difference is the addition of an antimicrobial claim for the subject device.
Here's an analysis of the acceptance criteria and supporting study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the typical numerical performance thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, the "acceptance" is focused on demonstrating substantial equivalence to an existing predicate device, particularly concerning the newly added antimicrobial claim.
Acceptance Criteria (Implicit from the 510(k) submission):
- Antimicrobial Efficacy: The modified device must demonstrate efficacy against gram-positive bacteria, gram-negative bacteria, yeast, and mold within the dressing.
- Identical Design, Materials, and Manufacturing Process: The subject device must be identical to the predicate device in these aspects, except for modifications related to the antimicrobial claim.
- Substantially Equivalent Intended Use and Performance Characteristics: The device's overall intended use and other performance (biocompatibility, absorption, MVTR, waterproofness, peel resistance, bacterial barrier, distribution) must be consistent with the predicate device.
- No New Questions of Safety or Effectiveness: The modifications should not introduce new safety or effectiveness concerns.
Reported Device Performance (from "Performance Testing Summary" and "Comparison of Technological Characteristics"):
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Antimicrobial Efficacy (Key criterion for the new claim): Demonstrate efficacy against gram-positive bacteria, gram-negative bacteria, yeast, and mold within the dressing. | "Based on in vitro performance data, the Antimicrobial Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria, yeast and mold within the dressing for up to 7 days." |
| "Antimicrobial Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing." | |
| "Microbial efficacy performance data submitted in support of this 510(k) includes in-vitro testing against a mold challenge organism. Testing was performed on real time aged predicate device in accordance with the well-established modified AATCC TM 100 method previously used for the predicate device." | |
| Identical Design, Materials, and Manufacturing Process: The subject device must be identical to the predicate device in these aspects, except for modifications related to the antimicrobial claim. | |
| Substantially Equivalent Intended Use and Performance Characteristics: The device's overall intended use and other performance (biocompatibility, absorption, MVTR, waterproofness, peel resistance, bacterial barrier, distribution) must be consistent with the predicate device. | |
| No New Questions of Safety or Effectiveness: The modifications should not introduce new safety or effectiveness concerns. | "Antimicrobial Silicone PHMB Foam Wound Dressing has substantially equivalent intended use and performance characteristics, identical design, materials and manufacture process to the predicate device Silicone PHMB Foam Wound Dressing (K190819)." |
| "The subject device, Antimicrobial Silicone PHMB Foam Wound Dressing, is manufactured with the exact same materials and processes as the predicate." | |
| All performance data (Biocompatibility, Absorption, MVTR, Waterproofness, Peel Resistance, Bacterial Barrier, Distribution) was leveraged from the predicate device (K190819) and deemed applicable to the subject device. | |
| "The modified device... is identical to the predicate... with regard to technology, materials, manufacture process, intended use, and target population. The only difference... is that the subject device has an antimicrobial claim, this minor modification does not raise any new questions of safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions in-vitro testing for antimicrobial efficacy. It does not provide a specific "sample size" in terms of number of patient cases or imaging data. Instead, it refers to testing against "mold challenge organism," "gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms."
- Sample Size: Not applicable in the context of patient cases or images for this type of in-vitro study. The "sample" would be the wound dressing material itself and the microbiological cultures. Specific numbers of microbial samples or dressing replicates are not provided.
- Data Provenance: In-vitro testing. No country of origin is specified for the testing itself, but the manufacturer is based in the UK. The study is prospective in the sense that the testing was conducted specifically for this submission, although it followed a "well-established modified AATCC TM 100 method previously used for the predicate device."
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 is not applicable to the type of study presented. The ground truth for antimicrobial efficacy is established through standardized objective in-vitro microbiological testing methods (modified AATCC TM 100) using known challenge organisms, not through expert consensus or interpretation of patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable to the type of study presented. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from human expert interpretations, typically in diagnostic imaging or clinical trials. Here, the ground truth is determined by the results of the specific in-vitro microbiological assay.
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
This is not applicable. The 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
This is not applicable. The device is a physical wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the antimicrobial efficacy claim, the ground truth is established through objective microbiological culture results using a modified AATCC TM 100 method. This method quantifies the reduction or prevention of microbial growth on the dressing.
For the other performance characteristics (Biocompatibility, Absorption, MVTR, Waterproofness, Peel Resistance, Bacterial Barrier, Distribution), the ground truth was established by various standardized test methods (e.g., ISO 10993-1, USP 41-NF36, BS EN 13726 series, ASTM D6282-11, ASTM D4169).
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not a machine learning or AI device. The testing conducted is for verification of physicochemical and antimicrobial properties.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set mentioned or implied for this device.
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