(207 days)
Rx: Under the supervision of a healthcare professional, the Stay Fresh Hydrocolloid dressing is intended for use as a primary dressing for exuding wounds that acts as a barrier to bacterial penetration, for use on first and second degree burns, surgical wounds, pressure ulcers, dermal ulcers, as well as minor cuts, abrasions, lacerations.
OTC: The Stay Fresh Hydrocolloid dressing acts as a barrier to bacterial penetration and is indicated for first aid to cover minor cuts, minor abrasions, and minor lacerations.
Sarasota Medical Products hydrocolloid dressing adhesive formulations are composed of naturally occurring substances that turn into a gel when they come into contact with wound fluid. Superabsorbent particles are embedded in an inert polymer matrix that provides the desired level of cohesiveness required to prevent leaving any residue in the wound. The outer most layer of the dressing is covered by a polyurethane film that reinforces the dressing's barrier properties and helps to reduce friction on clothing, bedding, and opposing extremities. When placed over a wound, these dressings create a moist environment. This environment has been shown to help to facilitate the removal of debris and protect the wound against bacteria and other external contaminants.
The Stay Fresh Hydrocolloid includes sequestered hydrogen peroxide (0.2 to 0.35% by weight). The sequestered hydrogen peroxide is an effective and safe antibacterial agent that protects the dressing. The role of antibacterial agents in wound dressings is: 1) to reduce the incidence of bacterial colonization within the dressing and 2) to provide a potential barrier to bacterial entry into the wound. The Stay Fresh Hydrocolloid is effective in controlling growth of bacteria commonly found to populate dressings. The outer thermoplastic layer is effective at providing a physical barrier to bacterial entry into the wound.
The Stay Fresh Hydrocolloid dressing will be supplied sterile. Sterilization will be achieved by gamma radiation at 25 Kgy in accordance with ISO 11137 and ISO 14385.
The provided text describes a 510(k) premarket notification for a medical device called "Stay Fresh Hydrocolloid." It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results similar to a clinical trial efficacy endpoint. Instead, the "Performance Testing" section lists various tests conducted to establish safety and efficacy, implying that meeting the standards for these tests serves as the acceptance criteria. The results are generally described as supporting the safety and efficacy of the device.
Implicit Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (Agar Diffusion Direct Contact Method) | Tests performed to assess biocompatibility. |
| Irritation (Primary Skin Irritation) | Tests performed to assess biocompatibility. |
| Sensitization (Buehler Test) | Tests performed to assess biocompatibility. |
| Wound Healing: | |
| Porcine wound healing model (Full and partial thickness wounds) | Evaluated for 14 and 6 days respectively, including comparison to predicate and reference devices. Implies favorable/comparable outcome. |
| Physical Characteristics: | |
| Physical inspection (dispersion, lamination, weight, thickness) | Confirmed. |
| Tack (probe tack, 90° peel, rolling ball) | Confirmed. |
| Absorbance (@ 4 hr and @ 24 hr) | Confirmed. |
| Hydrogen peroxide concentration (permanganate titration) | Confirmed (0.2 to 0.35% by weight). |
| Final product packaging and inspection | Confirmed. |
| Antibacterial Efficacy: | |
| Efficacy testing (QMT 03-2013 - modified ASTM E2180-01) | Effective in controlling growth of bacteria commonly found to populate dressings. |
| Minimum Effective Concentration (MEC) determination | Confirmed. |
| Bacterial Barrier Testing (Barrier Test Protocol) | Effective at providing a physical barrier to bacterial entry into the wound. |
| Sterility: | |
| Sterilization by gamma radiation at 25 Kgy (ISO 11137 & ISO 14385) | Supplied sterile. |
The document states, "Non-clinical testing demonstrates substantially equivalent safety and efficacy as compared to the predicate device." This is the overarching "reported device performance."
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each test within the "Performance Testing" section. For the Porcine wound healing model, it mentions "Full and partial thickness wounds," but not the number of animals or wounds.
- Data Provenance: The studies are non-clinical (laboratory and animal studies). The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying adherence to U.S. regulatory standards for such tests. All studies appear to be prospective in nature as they were conducted specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is not an AI/CADe device where human expert review establishes ground truth for image interpretation. The ground truth for performance tests (e.g., bacterial growth, wound healing, physical properties) is established by the methodologies of the tests themselves (e.g., lab measurements, histological analysis in animal models).
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Adjudication method for the test set:
- Not applicable. There is no human interpretation involved that would require an adjudication method like 2+1 or 3+1.
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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:
- No. This is not an AI/CADe device, and no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an AI/CADe device, so the concept of "standalone performance" in that context does not apply. The performance tests conducted are inherently "standalone" in the sense that they evaluate the physical, chemical, and biological properties of the dressing itself.
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The type of ground truth used:
- Laboratory Measurements: For physical properties (tack, absorbance, thickness, hydrogen peroxide concentration, etc.), the ground truth is established by standard laboratory measurement techniques.
- Microbiological Standards: For antibacterial efficacy, the ground truth is based on established microbiological assay standards (e.g., modified ASTM E2180-01) and observed bacterial growth/inhibition.
- Histopathology/Clinical Observation in Animal Models: For wound healing, the ground truth would be established through histological examination and macroscopic observation of wound closure/healing in the porcine model.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set. The development of the hydrocolloid formulation and design would be based on general scientific principles and material properties, not statistical learning from a "training set."
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How the ground truth for the training set was established:
- Not applicable, as no training set is relevant for this type of device and submission.
N/A