(295 days)
The 3M™ V.A.C. Veraflo Cleanse Choice™ 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.
· 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, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
· 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. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.
The 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit with and without instillation 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 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.
· 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.
· 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. It provides hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.
The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehised wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
Both dressing kits are intended to be used with the 3M™ V.A.C.® Ulta Therapy Unit and its associated canisters and cassette for the delivery of 3M™ Veraflo™ Therapy that provides Negative Pressure Wound Therapy coupled with controlled delivery and drainage of topical wound treatment solutions and suspensions over the wound bed. The dressing kits provide sterile disposable components needed for delivery of 3MTM VerafloTM Therapy.
Each kit contains a wound dressing with 10 mm diameter holes specifically designed for use with 3M™ Veraflo™ Therapy (either the 3M™ V.A.C. Veraflo™ Cleanse Choice™ or the 3MTM Veraflo™ Cleanse Choice Complete™ Dressing), an occlusive drape covering the dressing (either the 3MTM V.A.C. Advanced Drape or the V.A.C. Dermatac™ Drape), a tubing set for connecting the dressing to the negative pressure and instillation pumps (either the 3M™ V.A.C. VeraT.R.A.C.TM Pad or the 3M™ VeraT.R.A.C. Duo™ Tube Set, depending on dressing size) and a wound measuring ruler.
The subject dressings differ only in the number of dressing pieces provided in the kit, in the drape materials of construction and in the method of sterilization:
- . The 3M™ V.A.C. Veraflo™ Cleanse Choice™ Dressing Kit is gray in color, has three dressing layers (one with holes, one thin cover layer and one thick cover layer without holes), has a drape constructed of a polyurethane film with acrylic adhesive and is sterilized by irradiation.
- The 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit is blue in color, has only one ● dressing piece (which consists of a combination of the layer with holes and the thin cover layer without holes in the 3M™ V.A.C. Veraflo™ Cleanse Choice™ Dressing), has a drape constructed of a polyurethane film with acrylic adhesive and a perforated silicone layer, and is sterilized by ethylene oxide (ETO).
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit and 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit.
It's important to note that this document is an FDA 510(k) summary for a medical device (dressing kit), not an AI/ML powered device. Therefore, many of the typical questions for AI/ML device studies regarding ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to this type of submission. The performance described here relates to the physical and functional characteristics of dressings in wound care, not algorithmic performance.
Acceptance Criteria and Device Performance (Not applicable for AI/ML specific criteria)
The document primarily focuses on demonstrating substantial equivalence to predicate devices for a dressing kit. The "acceptance criteria" here are implied by the claim of substantial equivalence and are met through comparative analysis and leveraging existing clinical data for the predicate device, rather than new, large-scale clinical trials with pre-defined statistical endpoints for novel performance metrics.
Implicit Acceptance Criteria (Met by comparison and leveraging existing data):
- Functional Equivalence: The subject dressings perform the intended functions (negative pressure wound therapy, instillation, hydromechanical removal of infectious materials, non-viable tissue, and wound debris) comparably to the predicate devices.
- Material Equivalence/Safety: The materials of construction, physical properties, and sterilization methods are either identical or demonstrably safe and effective.
- Shelf-Life: The device maintains its stability and performance over the proposed shelf-life.
- Biocompatibility & Sterility: Meets all relevant FDA biocompatibility requirements and is sterile at a SAL of 10^-6.
- Clinical Efficacy (Leveraged): The device, in conjunction with the therapy unit, effectively promotes wound healing, granulation tissue formation, and removal of undesirable wound materials, as demonstrated by prior clinical data for the predicate device.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Criterion (Implied) | Reported Device Performance (Summary from document) |
|---|---|---|
| Functional Equivalence | The subject dressings ("Cleanse Choice Complete" and "Cleanse Choice") demonstrate equivalent performance in delivering Negative Pressure Wound Therapy (NPWT) and Instillation Therapy, including hydromechanical removal of infectious materials, non-viable tissue, and wound debris, compared to their respective predicates. | Bench tests and evaluations (comparison of materials, physical properties, finite element modeling of strain profiles, foam changes under negative pressure) were conducted. These tests "indicate that the two dressings are functionally equivalent" and that literature-reported clinical data for one dressing is "also applicable" to the other. |
| Material & Design Equivalence | Materials of construction, dressing dimensions/geometry, and system components (when used with the V.A.C. Ulta Therapy Unit) are substantially equivalent or justified. | 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing Kit: "Same as predicate" for patient-contacting materials, NPWT system design, operating principles. Differences noted in drape (one has perforated silicone layer) but deemed non-significant for equivalence. 3M™ Veraflo™ Cleanse Choice Complete™ Dressing Kit: "Same as predicate" for patient-contacting materials, NPWT system design, operating principles. Differences in color and 1-piece vs 3-piece design, but otherwise equivalent. |
| Sterilization | The devices are sterile and the sterilization method is validated. | No change in design impacting sterilization; data from predicates leveraged. Sterilized by irradiation (Cleanse Choice) or ethylene oxide (Cleanse Choice Complete). Must be sterile at a SAL of 10^-6 (general requirement, met by leveraging predicate data). |
| Biocompatibility | The patient-contacting materials are biocompatible. | No change in design impacting biocompatibility; data from predicates leveraged. All relevant FDA biocompatibility requirements met (general requirement, met by leveraging predicate data). |
| Shelf-Life | The device maintains performance over its stated shelf-life. | Stability testing conducted on production equivalent samples accelerated aged to proposed shelf life (Two years). "Stability indicating parameters for delivery of hydromechanical removal... were within specification." |
| Clinical Efficacy (Hydromechanical Removal) | The device, when used as part of the 3M™ Veraflo™ Therapy system, provides hydromechanical removal of infectious materials, non-viable tissue, and wound debris, and promotes granulation tissue formation, reducing the need for surgical debridements. | A literature search identified 21 reference publications (177 patients) supporting hydromechanical removal and promotion of granulation tissue with the 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing. The "functional equivalence" testing extends these findings to the "Cleanse Choice Complete" dressing. The report states: "This body of evidence supports that the adjunctive use of 3M™ V.A.C. Veraflo™ Therapy... can provide hydromechanical removal... and promote granulation tissue development." |
Study Details (As applicable to a medical device, not an AI/ML device):
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Sample sizes used for the test set and the data provenance:
- Test Set (for Functional Equivalence/Bench Testing): Not explicitly stated numbers of devices tested. The "test set" here refers to samples subjected to bench tests (material comparisons, physical properties, finite element modeling, foam changes under negative pressure). The document states "production equivalent samples accelerated aged to the proposed shelf life" for shelf-life testing.
- Clinical Data Provenance: The clinical data leveraged is from "literature-reported clinical data" from "21 retrieved reference publications" including "177 patients." This implies retrospective data from various clinical settings and possibly multiple countries, given it's a literature search. It is "real-world clinical evidence."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the typical AI/ML sense. For this medical device, "ground truth" for the bench tests would be established by validated measurement techniques and engineering specifications. For the clinical data, the "truth" is based on the reported clinical outcomes in the published literature (e.g., reduction in non-viable tissue, granulation tissue formation), which were assessed by the authors of those papers (presumably clinicians). The 510(k) relies on the validity of these published clinical observations.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the typical AI/ML sense. There was no human expert adjudication of model outputs or image interpretations. The "adjudication" for the bench tests would be through standard laboratory procedures and data analysis. For the clinical literature, the FDA reviews the cited publications for their relevance and applicability.
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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-powered device. No MRMC study was performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-powered device/algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing: Engineering specifications, validated measurement results, and comparative physical/mechanical properties.
- Clinical "Ground Truth": For the clinical claims, the "ground truth" is based on the reported clinical outcomes data from the cited literature, specifically "evidence of reduction in non-viable wound tissue" and "impact on granulation tissue formation." Indirect endpoints included "decrease in the need for surgical debridement or visible evidence of reduction of nonviable tissue in photographs."
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.
§ 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.