(180 days)
The V.A.C. PLUS is a powered suction pump that is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound* healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.
*The V.A.C. PLUS is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.
This notification for The V.A.C. Plus device is for labeling changes only, as have evolved over time. There have been no significant modifications or design changes to the presently cleared and marketed V.A.C. Plus device, 510(k) No. K945062.
The labeling changes have not been fully itemized, but include changes in the listing of specific wound types addressed.
The provided document K992448 describes a 510(k) premarket notification for the V.A.C. PLUS device. However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is present:
- Device Type: The V.A.C. PLUS is described as a "Powered Suction Pump" intended for wound healing and removal of infectious material/fluids from wounds.
- Nature of Submission: This 510(k) notification is specifically for "labeling changes only" for an already cleared device (K945062). The document explicitly states: "There have been no significant modifications or design changes to the presently cleared and marketed V.A.C. Plus device, 510(k) No. K945062."
- Clinical Studies: The document mentions "Clinical studies are provided to support these claims" (referring to the listed wound types like acute, chronic, traumatic, subacute, dehisced, diabetic, and pressure ulcers). However, it does not provide details about these clinical studies. It only makes a general statement that such studies exist to support the indications for use.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This document does not specify any performance-based acceptance criteria or report performance data.
- Sample sized used for the test set and the data provenance: No details about a test set or its sample size are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on ground truth establishment for a test set is present.
- Adjudication method: Not applicable as no test set details are given.
- MRMC comparative effectiveness study: This type of study is not mentioned.
- Standalone performance study: No details about a standalone algorithm performance study are given. The device is a physical pump, not an AI algorithm.
- Type of ground truth used: Not specified, as no study details are provided.
- Sample size for the training set: Not specified, as no study details are provided.
- How the ground truth for the training set was established: Not specified, as no study details are provided.
The document's purpose is to seek clearance for updated labeling based on previously established equivalence and existing clinical evidence, not to present a new clinical study to establish acceptance criteria for a modified device.
§ 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.