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510(k) Data Aggregation
(447 days)
The BTM Wound Dressing is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears) and draining wounds. The device is intended for one-time use.
The BTM Wound dressing is a biodegradable dermal covering that is comprised of three layers: Biodegradable Layer: 1. Foam A wound-facing, 2mm thick, white, open cell degradable foam with a high degree of porosity (>90%) designed to subsequently biodegrade. The foam is a biocompatible, biodegradable polyurethane material. Removable Layer: 2. Adhesive (bonding) layer A polyurethane bonding layer which bonds the Foam and Sealing Membrane together. 3. Sealing Membrane A transparent polyurethane membrane designed to physiologically close the wound and limit evaporative water loss. The sealing membrane is designed to remain attached to the dermal foam, if required, for at least 30 days in vivo. The BTM Wound dressing is supplied in various sizes, ranging from 10cm x 10cm, up to 20cm x 40cm. The dressings are single use, terminally sterilized devices, individually packed in a polymer pouch within an aluminized envelope.
The provided text describes a 510(k) summary for the BTM Wound Dressing (K142879), which seeks to demonstrate substantial equivalence to predicate devices rather than fulfilling specific acceptance criteria in the manner of a new device approval or AI/software device. Therefore, much of the requested information regarding acceptance criteria, specific device performance metrics, sample sizes for test sets, expert involvement, and ground truth establishment, which are typical for AI/software device evaluations, is not directly stated in this document.
However, I can extract and infer information relevant to the study of the BTM Wound Dressing as it relates to establishing substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the BTM Wound Dressing's performance against a quantifiable benchmark. Instead, it relies on demonstrating substantial equivalence to predicate devices in terms of indications for use, design, materials, mechanical properties, and non-clinical/clinical performance. The "performance" reported is related to biocompatibility and clinical safety.
| Aspect of Equivalence | Predicate Device Information (Benchmarking) | BTM Wound Dressing Reported Performance | Assessment |
|---|---|---|---|
| Indications for Use | Suprathel Wound and Burn Dressing (K090160), Bilayer Matrix Wound Dressing (K021792) | Matches the Integra predicate device's indications precisely. | Substantially Equivalent |
| Design/Materials | Integra: collagen foam with silicone sealing membrane. Suprathel: polyester-carbonate synthetic foam (no sealing membrane). | Synthetic foam (biocompatible, biodegradable polyurethane) with a polyurethane sealing membrane. | Contains a skin-facing layer designed to biodegrade, similar to predicates. |
| Porosity | Integra predicate device (value not explicitly stated but implied as comparable). | Average porosity: 188um | Substantially Equivalent |
| Mechanical Properties | Suprathel predicate device. | Improved tensile strength and elongation at break compared to Suprathel. Superior cyclic testing robustness compared to Suprathel. | Equivalent/Improved (not a direct "acceptance criterion" but a comparison point) |
| Thickness | Suprathel: 160 um. Integra: 2 mm. | Average thickness: approximately 2mm | Substantially Equivalent to Integra, different from Suprathel. |
| Sterilization & Use | Both predicate devices are radiation sterilized and for single use. | Radiation sterilized, single use only. | Substantially Equivalent |
| Biocompatibility | (Implied safe for predicate devices) | Non-cytotoxic, non-irritating, non-sensitizing. Supported by in vitro chemical analyses, degradation, pH studies, and toxicological risk analysis. | Supports safety. |
| Adverse Events (Graft Failure) | Moazzam et al., 2003: 15% | 1 out of 14 patients (approximately 7%) | Similar frequency to reported literature for similar studies. |
| Adverse Events (Hematoma) | Lutz et al., 1999: 6.3% | 1 out of 14 patients (approximately 7%) | Similar frequency to reported literature for similar studies. |
| Adverse Events (Elevated LFTs) | Control cohort undergoing similar procedures requiring long duration anesthesia. | Reported in some patients, similar frequency to control cohort of patients undergoing similar procedures. | Unlikely related to BTM, likely side effect of long-duration anesthesia. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study): 14 patients
- Data Provenance: Clinical studies were conducted. The location (country of origin) is not explicitly stated, but the company is based in Australia. The studies appear to be prospective clinical studies, as they involve "patients requiring free flap surgery" and "patients undergoing BTM application at donor harvest sites," indicating active treatment and observation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided. For a medical device like a wound dressing, the "ground truth" for clinical outcomes (e.g., graft failure, hematoma, LFTs) would typically be established by the treating physicians and clinical investigators involved in the study. Their qualifications are not detailed.
4. Adjudication Method for the Test Set
- This information is not provided. Clinical studies generally involve independent review or consensus among clinicians, but a specific adjudication method (like 2+1 or 3+1) is not mentioned. The adverse events were "deemed 'possibly related' to the BTM by the investigators," suggesting internal assessment among the study investigators.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation, which is not applicable to a physical wound dressing device. This device is not an AI or software device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical wound dressing, not an algorithm or AI.
7. The Type of Ground Truth Used
- For the clinical studies, the "ground truth" was based on clinical observation and patient outcomes data as assessed by the investigators, including reports of adverse events like graft failure, hematoma, and laboratory test results (LFTs). Comparison was made against published literature and control cohorts for similar procedures.
8. The Sample Size for the Training Set
- This concept is not applicable as this is a physical medical device (wound dressing), not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- This concept is not applicable as this is a physical medical device.
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