(63 days)
Cutinova foam is indicated for the management of surface, moderately to highly secreting wounds surrounded by sensitive skin, such as: Stage I-IV pressure ulcers Leg ulcers Diabetic ulcers First and second degree burns
Cutinova foam may be used under the direction of a health care professional for the management of moderately to highly exudating wounds surrounded by sensitive skin, such as: Pressure ulcers Leg ulcers Diabetic ulcers Second degree burns
Cutinova foam is a polyurethane dressing that is indicated for the management of moderately to highly exudating wounds surrounded by sensitive skin. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic diisocyanate and does not affect the indications for use.
The provided text describes a 510(k) submission for a modification to an existing wound dressing, Cutinova foam. The submission focuses on demonstrating substantial equivalence to the predicate device, not on proving new efficacy or performance standards through extensive clinical studies. Therefore, many of the requested categories for a typical medical device study are not applicable or explicitly mentioned in this document.
Here's an analysis based on the provided text:
Acceptance Criteria and Study for Cutinova foam - K984599
| Category | Description of Acceptance Criteria (if stated) | Reported Device Performance / Study Findings |
|---|---|---|
| Substantial Equivalence | The modified device must be substantially equivalent to the legally marketed predicate device (Cutinova foam cleared in 1992, K922681) in terms of safety and effectiveness, and must not affect the indications for use. | The modified Cutinova foam demonstrated "no negative effects" in biological tests conducted in accordance with ISO 10993. "Performance characteristics were also comparable to the currently marketed product." |
| Material Change Impact | The change from an aromatic diisocyanate to an aliphatic diisocyanate for urethane material should not negatively impact safety or performance, and should not affect indications for use. | Biological tests (ISO 10993) showed "no negative effects" for the modified foam. Performance characteristics were "comparable" to the predicate. Addition of a "very small amount of α Tocopherol" was to improve thermal stability. |
| Biocompatibility | The device should not cause adverse biological reactions. | Biological tests were done in accordance with ISO 10993 and showed "no negative effects." |
| Performance Characteristics | Performance characteristics should be equivalent to the predicate device. | Performance characteristics were "comparable" to the currently marketed product. |
| Thermal Stability | (Implicit) The device should maintain its stability. | A very small amount of α Tocopherol was added to improve the thermal stability of the product. |
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in the context of human subjects or clinical data for performance comparison. The biological tests were conducted in accordance with ISO 10993, which are standardized laboratory tests. No information is provided regarding the specific number of samples or data provenance for these biological or performance characteristics tests beyond the standard ex vivo or in vitro nature implied by ISO 10993. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The study described is not a diagnostic or clinical study requiring expert ground truth in the traditional sense. The "ground truth" for the substantial equivalence claim relies on standardized biological testing and comparative performance evaluations against a predicate device. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set with adjudicated outcomes is described. -
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:
Not applicable. This is not an AI/imaging device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/imaging device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth used for demonstrating substantial equivalence was based on:- Biological testing results: Conformance to ISO 10993 standards for biocompatibility.
- Comparative performance characteristics: Evaluation against the predicate device's established performance.
- Safety information from international databases: Used as supporting evidence.
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The sample size for the training set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training data" for the device's design would effectively be the knowledge and experience used to develop the predicate device and the understanding of material science. -
How the ground truth for the training set was established:
Not applicable. As there's no training set mentioned for an AI/machine learning device, this question is not relevant to the provided text.
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