(329 days)
The RENASYS™ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids, wound exudate and infectious materials. Appropriate wound types include:
- Chronic
- · Acute
- · Traumatic
- Sub-acute and dehisced wounds
- · Ulcers (such as pressure or diabetic)
- · Partial-thickness burns
- · Flaps
- Grafts
The RENASYS™ EDGE pump is compatible with the following accessory dressing kits:
- RENASYS™ Foam Dressing Kits
- · RENASYS™ Foam Dressing Kit XL
- · RENASYS™ Gauze Dressing Kits
- · RENASYSTM Abdominal Dressing Kit
- · RENASYS™ Y Connector Kit
- · RENASYSTM White Foam Wound Dressing
When used with the RENASYS™ AB Abdominal Kit with Soft Port, the RENASYS EDGE™ pump is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The use of RENASYS™ AB Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
The RENASYS™ EDGE device is a software controlled suction device consisting of an electric motor driven, diaphragm, vacuum pump. The device is designed to provide Negative Pressure Wound Therapy at a range of pressure settings between 25-200mmHg to a closed environment over one or two wounds. The device removes exudate from the wound site(s) to a disposable container, which may promote wound healing via removal of fluids, including irrigation of body fluids, wound exudates and infectious materials.
RENASYS™ EDGE can be operated by either a mains power supply or internal battery. The RENASYS™ EDGE device is compatible with Smith & Nephew RENASYS™ Dressing Kits.
The provided text is a 510(k) summary for the RENASYS™ EDGE device. This document focuses on demonstrating substantial equivalence to a previously cleared device, not an AI/ML powered device, and thus does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 of the prompt, which are typically associated with performance studies for AI/ML medical devices.
The submission is specifically for adding "RENASYS™ White Foam dressing kits" as compatible accessories to the existing RENASYS™ EDGE negative pressure wound therapy system. It explicitly states: "No clinical data was provided to support the demonstration of substantial equivalence."
Instead, the document details non-clinical tests performed to demonstrate that the overall system performance of the RENASYS™ EDGE device is not impacted by the use of the new dressing. These tests are:
- Simulated wound model tests: To ensure satisfactory performance, including fluid management and Negative Pressure Wound Therapy (NPWT) delivery.
- EMC Testing: In accordance with IEC 60601-1-2 and RTCA DO-160G.
- Cybersecurity testing: In accordance with FDA guidance "Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff".
- Software design and testing: In accordance with the framework set out in IEC 62304:2006.
- Low air pressure environment testing: EMC testing (RTCA DO-160G) and NPWT wound model testing were carried out to support the new environment for use (aircraft).
Therefore, I cannot provide a response for the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this information is not present in the provided document.
§ 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.