(127 days)
The PREVENA PLUS Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy. The PREVENA PLUS DUO Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment, and removing exudate via the application of negative pressure wound therapy.
The negative pressure technology for the subject device systems is the same as that for the predicate device systems. The PREVENA PLUS 125 Therapy Unit is a component of the PREVENA PLUS Incision Management System and the PREVENA PLUS DUO Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing to a dressing placed over the incision site. The occlusive drape over the dressing provides a negative pressure environment and protects the incision from external contamination. The application of negative pressure draws the incision edges together, and removes fluid from the incision site into a canister fitted into the therapy unit.
The provided text is a 510(k) Summary for the PREVENA PLUS Incision Management System and PREVENA PLUS DUO Incision Management System. It details an FDA submission for substantial equivalence.
Based on the provided information, there are no acceptance criteria or studies proving device performance in the context of AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, AUC, human reader improvement with AI assistance).
This document describes a medical device related to negative pressure wound therapy and its equivalence to predicate devices, not an AI/ML powered device. The "Performance Data" section specifically states:
- "Bench testing demonstrated that the PREVENA PLUS 125 Therapy Unit is able to deliver continuous negative pressure at 125 mmHg within specifications under worst case conditions of air leak rate and fluid input during a 7 day test. Alarms for blockage, leakage and full canister were tested with both the PREVENA PLUS and the PREVENA PLUS DUO Systems and met specifications."
- "Electrical safety and electromechanical emissions testing confirm that the subject therapy unit meets the following standards: ANSI/AAMI ES60601-1:2005/(R)2012 ... IEC 60601-1-2 ... IEC 60601-6 ... IEC 60601-1-8 ... IEC 60601-1-11."
- "The new lithium battery has been verified to meet IEC 62133 Edition 2.0 2012-12."
- "No clinical tests were necessary. No usability testing was required, as there has been no change to the user interface or to the Instructions for Use."
This indicates performance criteria related to mechanical function, electrical safety, and alarm systems of a physical medical device, not analytical or clinical performance of an AI model.
Therefore, I cannot provide the requested information regarding AI/ML performance criteria and studies.
§ 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.