(29 days)
NovoSorb BTM is indicated for use in 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, lacerations, second-degree burns, and skin tears) and draining wounds.
The NovoSorb BTM device has been modified to expand the available thickness of the foam component from 2 mm to 2-6 mm. Sizes are limited to a maximum volume of 160 cm³. The device continues to be a porous, biodegradable, polyurethane foam, adhered to a fenestrated transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative moisture loss during integration of the foam. The sealing membrane is to be removed and discarded when appropriate, leaving only the foam layer to biodegrade in patients.
NovoSorb BTM is a terminally sterilized, single use device intended for deep partial and full thickness wounds. Each NovoSorb BTM is packed in a transparent polymer pouch, enclosed in an aluminized pouch. A product label is placed on the pouch. The aluminized pouch together with an instruction for use is individually packaged in a cardboard envelope and a product label is placed on the envelope.
It appears there might be a misunderstanding of the provided FDA 510(k) clearance letter. The document is for a medical device called "NovoSorb BTM," which is a wound dressing. This device is a physical medical device (a porous, biodegradable, polyurethane foam), not an AI/software-based medical device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance) is not applicable to this submission.
The 510(k) summary clearly states:
- "No clinical tests were performed; determination of substantial equivalence was not based on an evaluation of clinical performance data."
- "PolyNovo believes the modified NovoSorb BTM device is substantially equivalent to the legally marketed predicate devices NovoSorb BTM (K172140) and NovoSorb MTX (K242149), because no differences in technological characteristics exist between different foam thicknesses as there is no change to the foam density for different foam thicknesses."
The "acceptance criteria" for this device, as described in the non-clinical tests section, relate to physical and mechanical properties of the wound dressing, not diagnostic performance based on AI.
Below is a brief summary of how the device met its acceptance criteria, based only on the provided document, without attempting to fit it into an AI study framework:
Acceptance Criteria and Study for NovoSorb BTM (Physical Medical Device)
The NovoSorb BTM is a physical wound dressing device, not an AI or software-based diagnostic tool. Therefore, the acceptance criteria and supporting studies are based on the physical, mechanical, and biological properties of the material and its substantial equivalence to previously cleared predicate devices, rather than AI performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Substantial Equivalence Claim) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Physical Characteristics | Consistency in material properties (e.g., polyurethane composition, porosity, density, foam structure). | "modified to expand the available thickness of the foam component... Device continues to be a porous, biodegradable, polyurethane foam... properties of the foam component, including average pore size, porosity, and density, remain unchanged compared to both predicate devices." |
| "Sealing membrane adhered to the foam; constructed from the same synthetic biodegradable polyurethane material." | "Same as Predicate Device" | |
| Mechanical Strength | Ability to withstand typical handling and application, maintaining structural integrity (e.g., tensile strength, tear resistance). | "Verification performance testing demonstrates that the proposed NovoSorb BTM will consistently meet established functional and performance requirements. These requirements include physical characteristics, mechanical strength, and durability." |
| Durability | Resistance to degradation beyond intended bioabsorption timeframe, maintenance of integrity during use. | "Verification performance testing demonstrates that the proposed NovoSorb BTM will consistently meet established functional and performance requirements... include physical characteristics, mechanical strength, and durability." |
| Biocompatibility | Non-toxic and safe for contact with human tissue. | (Implied by substantial equivalence to predicate devices using same materials and manufacturing processes) |
| Sterility | Achievement and maintenance of desired sterility assurance level. | "sterilized using gamma radiation at a dose of 25–40 kGy, achieving a sterility assurance level (SAL) of 10⁻⁶". |
| Packaging & Shelf-life | Maintenance of sterility and device integrity throughout shelf-life. | "packed in a transparent polymer pouch, enclosed in an aluminized pouch... consistent with both predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The verification testing would involve a sufficient number of device samples to demonstrate consistency in manufacturing and material properties.
- Data Provenance: The data are from non-clinical bench testing. No geographical or temporal provenance is specified, as the tests are against material and mechanical standards for the device itself rather than patient data. The tests are prospective in the sense that they are performed on newly manufactured devices to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This concept is not applicable. "Ground truth" for this device relates to established engineering and material science standards for physical device properties (e.g., material composition confirmed by analytical chemistry, mechanical properties confirmed by engineering tests). It does not involve expert consensus on medical image interpretation or clinical outcomes.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are typically used in clinical studies or AI evaluations to resolve discrepancies among human readers or algorithm outputs. For physical device testing, the results are objective measurements against predefined specifications.
5. 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 relevant for diagnostic devices that involve human interpretation (often with AI assistance). The submission explicitly states: "No clinical tests were performed; determination of substantial equivalence was not based on an evaluation of clinical performance data."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not applicable. This device is not an algorithm or software. It is a physical wound dressing.
7. The Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on established engineering specifications, material science standards, and performance characteristics of the predicate devices. This includes:
- Chemical composition (e.g., polyurethane).
- Physical properties (e.g., density, porosity, pore size).
- Mechanical properties (e.g., strength, durability).
- Sterility assurance level (SAL).
- Packaging integrity.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI model, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no AI model or training set, the concept of establishing ground truth for it does not apply.
In summary, the FDA 510(k) for NovoSorb BTM is a clearance based on substantial equivalence to existing predicate devices, supported by non-clinical bench testing that confirms the modified device maintains the same physical, material, and performance characteristics. The detailed questions about AI study methodologies are not relevant to this specific device submission.
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