(148 days)
The ActiV.A.C., InfoV.A.C., V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings.
When used on open wounds, they are 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. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
When used on closed surgical incisions, they are also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Negative pressure wound therapy system for application to surgically closed incisions.
Here's an analysis of the provided text regarding the acceptance criteria and study for the K120033 device:
Based on the provided K120033 510(k) Summary, the submission is focused on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study with explicit acceptance criteria.
The 510(k) Summary for K120033 states that the "V.A.C. Therapy Systems are substantially equivalent to the Prevena Incision Management System (K100821) in terms of safety, function and indications for use." The primary purpose of this submission is to expand the existing indications for use of the V.A.C. Therapy Systems to include closed surgical incisions, which is an indication already cleared for the predicate device, Prevena Incision Management System.
Therefore, the "acceptance criteria" discussed are centered around demonstrating equivalence to the predicate device's performance for this specific extended indication, rather than quantitative performance metrics for the device itself.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an equivalence submission, the "acceptance criteria" are implied by the demonstration of equivalence to the predicate device for the extended indication. There are no explicit quantitative performance metrics or acceptance criteria stated for the device's performance that are typically seen in a de novo study.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Delivery of negative pressure to indicated wound type (closed incisions) | "The subject device was found to be equivalent to the predicate device in delivery of negative pressure to the indicated wound type." |
| Safety, function, and indications for use (for closed incisions) | "Equivalency testing... demonstrated that the systems are equivalent under all test conditions. The ActiV.A.C., InfoV.A.C., V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are substantially equivalent to the Prevena Incision Management System (K100821) in terms of safety, function and indications for use." |
2. Sample Size Used for the Test Set and Data Provenance
The submission explicitly states:
- "Non-clinical tests were not necessary to demonstrate substantial equivalence."
- "Clinical tests were not necessary to demonstrate substantial equivalence."
This indicates that no test set (clinical or non-clinical) with a sample size was used or reported in this 510(k) submission to directly evaluate the device's performance against specific acceptance criteria. The equivalence was established based on existing knowledge of the device's functionality and the predicate's cleared indications. Therefore, there is no information on data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no test set (clinical or non-clinical) was used, no experts were utilized to establish ground truth for a test set within this submission.
4. Adjudication Method for the Test Set
As no test set was used, there was no adjudication method employed or reported in this submission.
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
This device is not an AI-powered diagnostic or assistive tool. It is a negative pressure wound therapy system. Therefore, no MRMC comparative effectiveness study was done and the concept of human readers improving with AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical medical device (negative pressure wound therapy system), not an algorithm or AI. Therefore, a standalone performance study in this context is not applicable. The "performance data" section states that non-clinical and clinical tests were not necessary to demonstrate substantial equivalence.
7. The Type of Ground Truth Used
Given that no clinical or non-clinical tests were conducted for this specific submission to demonstrate performance, no "ground truth" was established or used in the context of validating a device's performance against a reference standard. The claim is based on the equivalence of the subject device's known functionalities to the predicate device's cleared indications.
8. The Sample Size for the Training Set
This submission is not for an AI model or a device that requires a training set. Therefore, there is no training set or associated sample size.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this information is 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.