(217 days)
The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is used as part of an integrated wound management system that provides 3M™ Veraflo™ Therapy, which consists of negative pressure wound therapy (3M™ V.A.C.® Therapy) with an instillation option.
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3M™ V.A.C.® Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion. and by removing exudate and infectious material.
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The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit with and without is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
The Veraflo™ Cleanse Choice Complete Dressing Kit is intended to be used with the separately provided V.A.C.® Ulta Therapy Unit and its associated canisters and cassette for the delivery of Veraflo Therapy that provides V.A.C.® Therapy Negative Pressure Wound Therapy with an instillation option. The system kit provides sterile disposable components needed for delivery of Veraflo Therapy. The kit contains the wound dressing (Veraflo Cleanse Choice Complete Dressing), drape (V.A.C. Dermatac Drape), tubing set (3M™ V.A.C. VeraT.R.A.C.™ Pad or 3M™ V.A.C. VeraT.R.A.C. Duo™ Tube Set) and a wound measuring ruler. The kit components are intended to simplify wound dressing applications by replacing the multiple grey foam dressing pieces in the predicate kit with a single blue foam piece and to provide the V.A.C. Dermatac Drape in the same package with the dressing. Because V.A.C. Dermatac Drape can only be sterilized by ethylene oxide, the kit must also be sterilized by this method.
The provided text describes the 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit, which is a component of a powered suction pump system for wound therapy. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and does not involve an AI/ML algorithm or a study comparing AI performance against human readers. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in the typical sense for an AI/ML device (e.g., AUC > X, sensitivity > Y). Instead, it focuses on verifying that the modified device performs as expected and meets existing predicate design requirements.
| Acceptance Criteria (General Design Requirements) | Reported Device Performance |
|---|---|
| Biocompatibility | Biological safety evaluation performed and compliance verified. |
| System Performance (maintaining negative pressure, removing fluid) | System performance test performed; able to maintain negative pressure and remove fluid from the wound site over the three-day use life under worst-case/clinically relevant simulated conditions. |
| Usability | Usability assessment concluded no negative impact on use-safety and no supplemental usability validation required. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device (medical device, not AI/ML). The "tests" performed were physical and biological evaluations of the dressing kit, not a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for the device's function (e.g., maintaining negative pressure) would be established through engineering and biological testing standards, not expert consensus on data interpretation.
4. Adjudication method for the test set
Not applicable.
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 device is a dressing kit for wound therapy, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by:
- Compliance with biological safety standards (ISO 10993-1).
- Demonstration of physical functionality (maintaining negative pressure, fluid removal) under simulated use conditions.
- Usability assessment against existing predicate device's usability profile.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.