(147 days)
BIOBRANE Dressings are indicated for:
- Covering clean partial thickness burn wounds
- Split thickness donor sites
BIOBRANE Glove is indicated for:
- Covering clean partial thickness burn wounds of the hand.
BIOBRANE Dressing and BIOBRANE Glove are wound dressings made from an ultrathin, semipermeable, perforated silicone membrane that is mechanically bonded to a flexible knitted tri-filament nylon fabric. Denatured porcine dermal collagen is bonded to the silicone-nylon membrane to provide a flexible and conformable dressing with adherence properties and a hydrophilic surface.
This document is a 510(k) K242146 premarket notification for the BIOBRANE Dressing and BIOBRANE Glove. It asserts substantial equivalence to the predicate device BIOBRANE II (K901369).
Here's an analysis of the provided information relating to acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide a table of acceptance criteria with specific performance metrics such as sensitivity, specificity, accuracy, or any quantitative measures for the device's diagnostic or predictive capabilities. This is likely because the device is a wound dressing, not a diagnostic AI/ML device.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and verification tests. The "acceptance criteria" can be inferred as successful completion of these tests and demonstration that the device's characteristics are similar to the predicate.
| Characteristic / Test | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate | Same |
| Indications for Use | Within scope of predicate's indications | More precise, but substantially equivalent |
| Principles of Operation | Same as predicate | Same |
| Materials and Structure | Same as predicate | Same (Silicone membrane, nylon, collagen) |
| Silicone Membrane Function | Same as predicate | Same |
| Nylon Function | Same as predicate | Same |
| Collagen Function | Same as predicate | Same |
| Principal Operator | Same as predicate | Same (Trained HCP only) |
| Environment of Use | Same as predicate | Same (Healthcare facility and home use) |
| Single-Use or Reusable | Same as predicate | Same (Single-Use) |
| Sterilization | Same as predicate | Same (Moist heat) |
| Sterility | Same as predicate | Same (Sterile, SAL 10-6) |
| Shelf Life | Same as predicate | Same (3 years) |
| Biocompatibility | Complies with ISO 10993 | Complies with ISO 10993 |
| Device Dimensions | Equivalent to predicate sizes | Equivalent to predicate sizes |
| Anatomical sites | Same as predicate | Same |
| Bench Performance Verification Tests | Meets design specifications | Completed and confirm specifications met |
| Product Characterization | Confirms product characteristics | Completed and confirm characteristics |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical data is relied upon in this submission to determine substantial equivalence."
Therefore:
- Sample size for the test set: Not applicable, as no clinical test set was used for substantial equivalence determination.
- Data provenance: Not applicable. The evaluation was based on non-clinical (bench) testing and comparison of technological characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as no clinical test set with a ground truth established by experts was used. The substantial equivalence was based on non-clinical data and direct comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or relied upon. This is a wound dressing, not an AI/ML diagnostic device where such studies are typical.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a wound dressing, not an algorithm or software-only device.
7. The Type of Ground Truth Used
Not applicable, as no clinical data or ground truth in the context of diagnostic performance was used. The "ground truth" for this submission is implicitly the established safety and efficacy profile of the legally marketed predicate device (BIOBRANE II, K901369) and the physical/chemical properties assessed through bench testing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device that requires a training set or ground truth for training.
N/A