(53 days)
The BioDerm BTF Wound Dressing is a sterile thin film dressing intended for over-the-counter use and prescription use. The BioDerm BTF consists of a transparent, polyurethane film backed with a hypoallergenic pressure sensitive adhesive. The BTF is permeable to moisture vapor and oxygen and intended to maintain a moist wound healing environment. A moist wound environment allows atolytic debridement.
OTC Indications for Use:
- Abrasions, lacerations, minor/superficial cuts;
- Minor scalds, minor burns;
- Minor irritations to the skin
Under the Care of a Health Care Professional:
- Leg ulcers, pressure ulcers (stages I and II);
- Surgical wounds (post operative wounds, donor sites);
- 1st and 2nd degree burns;
- Cover and protect catheter sites and wounds;
- Securement of medical appliances;
- Catheter securing device;
- Dermal lesions:
- Non-exuding to minimally exuding wounds
The BioDerm BTF Thin Film Wound Dressing is a sterile thin film dressing which consists of a polyurethane film backed with a hypoallergenic pressure sensitive adhesive. The BTF is a transparent dressing which is permeable to moisture vapor and oxygen and intended to provide a moist wound healing environment to facilitate the normal wound healing process. The BTF Thin Film Wound Dressing provides a barrier to bacteri and external contaminates.
This submission describes a 510(k) premarket notification for the BioDerm BTF Thin Film Wound Dressing, seeking substantial equivalence to already marketed devices. The study provided focuses on biocompatibility testing rather than device performance benchmarks related to its primary function (wound healing).
Here's an analysis of the provided information:
Acceptance Criteria and Device Performance
The core of this submission is demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and biocompatibility. There are no explicit performance acceptance criteria in terms of wound healing rates or infection reduction that the device is quantitatively measured against. Instead, the acceptance is based on meeting safety standards (biocompatibility) and having similar characteristics and intended use to legally marketed predicate devices.
Table 1: Biocompatibility Testing and Results
| Test | Acceptance Criteria (Implicit: Pass all tests) | Reported Device Performance |
|---|---|---|
| Primary Dermal Irritation | No significant irritation (based on ISO 10993-1) | Passed |
| Sensitization | No significant sensitization (based on ISO 10993-1) | Passed |
| Cytotoxicity | No significant cytotoxic effect (based on ISO 10993-1) | Passed |
| Repeated Insult Patch Test | No significant irritation or sensitization after repeated exposure | Passed |
Note: The document explicitly states: "Based upon the results of biocompatability tests, the device is safe and effective for its intended purpose." This is the key "acceptance criteria" met in the provided study.
Study Details for Biocompatibility Testing
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Sample Size used for the test set and the data provenance:
- The document does not specify the sample size used for each biocompatibility test (e.g., number of animals or human subjects/volunteers).
- Data Provenance: Not explicitly stated, but these types of tests are typically conducted in a laboratory setting, often by contract research organizations specializing in medical device biocompatibility. The country of origin is not mentioned. The nature of these tests is prospective, as they are performed specifically for device evaluation before market entry.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For biocompatibility tests, "ground truth" is established by the standardized protocols (e.g., ISO 10993-1) and performed by trained laboratory personnel. Typically, experts in toxicology or pathology review the results against the criteria. The document does not specify the number or qualifications of these particular experts, but their expertise would be implicit in the adherence to ISO standards.
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Adjudication method for the test set:
- Not applicable in the traditional sense for biocompatibility testing. The "adjudication" is the assessment of the test results against the pass/fail criteria outlined in the ISO standards, performed by the testing laboratory and reviewed by the submitter.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is more common for imaging devices or diagnostic aids where human interpretation is a critical component.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this device is a physical wound dressing and does not involve an algorithm or AI.
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The type of ground truth used:
- The "ground truth" for the biocompatibility study is defined by the established scientific and regulatory standards (ISO 10993-1) for assessing biological responses to medical devices. These standards dictate what constitutes an acceptable biological reaction (e.g., no irritation, no sensitization).
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The sample size for the training set:
- Not applicable. Biocompatibility testing does not involve a training set as would be used in machine learning or AI development.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of evaluation.
Additional Notes from the Submission:
- Substantial Equivalence: The primary strategy of this 510(k)_ is to demonstrate substantial equivalence to existing predicate devices (Smith & Nephew OpSite, 3M Tegaderm, Hollister Simplicare, J&J Bioclusive MVP, Innovative Technologies Transparent Thin Film). This is done through a comparative table highlighting similar materials, visibility, packaging, adhesive, moisture vapor permeability, sterilization, intended use, and bacterial barrier characteristics.
- No Clinical Efficacy Study: There is no mention of a human clinical trial to demonstrate wound healing efficacy, infection reduction, or other performance characteristics of the dressing itself. The biocompatibility tests address safety. For 510(k) submissions, clinical data are often not required if substantial equivalence can be demonstrated through technological characteristics and non-clinical performance (like biocompatibility).
- Limitations on Labeling: The FDA's response letter (pages 3-4) imposes specific limitations on what the device can be labeled for, such as not for third-degree burns, not having an accelerating effect on wound healing, not being a long-term dressing or artificial skin, and not being a "treatment or cure." These limitations reflect the scope of the substantial equivalence determination and the data provided.
N/A