(39 days)
The V.A.C.® GranuFoam® Silver Protection dressing is intended for use with the V.A.C.® family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in chronic, acute, traumatic, subacute, and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts and partial thickness burns.
The V.A.C.® GranuFoam® Silver Protection dressing is one of the V.A.C.® product line of dressings designed specifically for use with the V.A.C.® Family of negative pressure devices. The V.A.C.® GranuFoam® Silver Protection dressing is comprised of black, reticulated, polyurethane foam covered with a silver coating.
Acceptance Criteria and Study for V.A.C.® GranuFoam® Silver Protection Dressing
This device, the V.A.C.® GranuFoam® Silver Protection Dressing, received 510(k) clearance based on its substantial equivalence to a previously cleared predicate device, the V.A.C.® GranuFoam™ Silver Protection Dressing (K050260). The primary change in the current submission was labeling modifications, specifically the removal of a contraindication for use in magnetic resonance environments and the inclusion of labeling for conditions of safe use in such environments.
Therefore, the "acceptance criteria" and "study" are not based on the device's diagnostic performance or clinical effectiveness in the traditional sense, but rather on its safety and compatibility in a specific environment.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and compatibility in a magnetic resonance (MR) environment: The device must demonstrate safe operation and not pose undue risks to the patient or interfere with the MR imaging process when used within a magnetic resonance environment. (Implied requirement for label change) | Verification of safe use in MR environment: "Verification of the conditions for safe use of the V.A.C.® GranuFoam® Silver Protection dressing in a magnetic resonance environment is based on testing in accordance with international performance standards and peer-reviewed published literature." |
| Substantial Equivalence: The device must be shown to be as safe and effective as a legally marketed predicate device for its intended use. | Substantial Equivalence Achieved: The device is concluded to be "substantially equivalent to the V.A.C.® GranuFoam™ Silver Protection dressing (K050260)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a new clinical study. The evaluation focused on testing in accordance with international performance standards and review of peer-reviewed published literature regarding MR safety of similar materials/devices. The document does not specify a "test set" of patients or data in the typical sense of a clinical trial.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The evaluation relies on international performance standards (which are typically defined guidelines and test methods) and peer-reviewed published literature (which could be derived from various sources, but the origin is not specified here).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for MR compatibility is established through adherence to international performance standards and scientific evidence from peer-reviewed published literature, not through expert consensus on a test set of cases. These standards and literature would have been reviewed by individuals with expertise in regulatory affairs, engineering, and medical device safety (likely within the FDA and KCI).
4. Adjudication Method for the Test Set
Not applicable. There was no clinical "test set" requiring adjudication. The evaluation was based on demonstrating compliance with technical standards and scientific literature for MR compatibility.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this submission. This type of study is typically used to evaluate the diagnostic performance of software or imaging modalities with and without AI assistance. This device is a wound dressing, not a diagnostic tool requiring such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical wound dressing, not an algorithm, so a standalone performance evaluation in this context is not relevant.
7. The Type of Ground Truth Used
The "ground truth" here is the established scientific and regulatory understanding of magnetic resonance compatibility for medical devices. This is derived from:
- International performance standards: Standards specifically designed to test and assess device safety within MR environments (e.g., ASTM standards for MR safety).
- Peer-reviewed published literature: Existing scientific publications and research related to materials, device designs, and their interactions with MR fields.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for this device, as it is a physical wound dressing and not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.