(63 days)
Cutinova hydro is indicated for the management of surface, moderately to highly secreting wounds such as: Leg ulcers Stage I-IV pressure ulcers First and second degree burns
Cutinova hydro is a polyurethane dressing that is indicated for the management of moderately to highly exudating wounds. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic disocyanate and does not affect the indications for use.
The provided text is a 510(k) premarket notification for a medical device called Cutinova Hydro. It describes a modification to an already cleared wound dressing and aims to demonstrate substantial equivalence to the predicate device.
Regarding acceptance criteria and study information, the document unfortunately does not contain the detailed information you've requested for typical AI/ML device studies. This is because:
- It's a modification of a physical wound dressing, not an AI/ML device. The "device" in this context is a physical product (a polyurethane dressing), not a software algorithm. Therefore, the types of studies and acceptance criteria (e.g., sensitivity, specificity, F1 score) associated with AI/ML performance metrics are not applicable here.
- The regulatory submission is for substantial equivalence (510(k)). This type of submission focuses on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, rather than proving novel performance against specific clinical acceptance criteria in the way an innovative AI device would.
However, I can extract the relevant information presented in the provided text as it pertains to the safety and performance of this physical device:
Summary of Safety and Effectiveness for Cutinova® hydro - K984595
This submission is for a modification to an existing wound dressing, Cutinova hydro. The modification involves changing the material used for the urethane from an aromatic diisocyanate to an aliphatic diisocyanate and adding a small amount of an antioxidant (alpha-tocopherol) to improve thermal stability.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: No negative effects (in accordance with ISO 10993) | Biological tests in accordance with ISO 10993 showed no negative effects for the modified Cutinova hydro. |
| Performance Characteristics: Comparable to currently marketed product | Performance characteristics were comparable to the currently marketed product. |
| Thermal Stability: Improved (due to added alpha-tocopherol) | Alpha-tocopherol was added to improve the thermal stability of the product. |
| Indications for Use: No change from predicate device | The modification does not affect the indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document only states "Biological tests were done" and "Performance characteristics were also comparable."
- Data Provenance: Not specified. The study types (biological tests, performance characteristic comparisons) suggest laboratory-based testing rather than clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This is not an AI/ML device, and the evaluation relies on standardized biological and performance testing, not expert interpretation of outputs.
4. Adjudication Method for the Test Set
- Not applicable. (See #3)
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
- Not applicable. This is not an AI/ML device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used
- Ground Truth for Biocompatibility: Compliance with ISO 10993 standards and established toxicology/biocompatibility protocols.
- Ground Truth for Performance Characteristics: Comparative measurements against the established performance of the predicate device (the original Cutinova hydro) using standardized material testing methods.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device. There is no concept of a "training set" for the modification of a physical wound dressing; rather, it would be R&D and manufacturing process optimization.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
Conclusion from the document:
"Based on safety information in international data bases, biological testing and performance characteristics, it can be concluded that the modified Cutinova hydro is substantially equivalent to the current legally marketed Cutinova hydro."
Important Note on Indications for Use based on FDA Letter (March 19, 2007 - Correction Letter):
While the submission states the modification does not affect the indications for use, the FDA's corrected letter imposes specific labeling limitations:
- May not be labeled for use on third-degree burns.
- May not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
- May not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- May not be labeled as a treatment or a cure for any type of wound.
The 510(k) submission document itself (Page 4 & 5) lists the intended indications:
- Management of surface, moderately to highly exudating wounds such as:
- Leg ulcers
- Pressure ulcers (Stage I-IV, though the FDA approval slip on page 4 just says 'Pressure ulcers')
- Second-degree burns.
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