(348 days)
Genadyne Hybrid Foam Dressings when used in conjunction with the XLR8+, UNO30 and UNO Plus NPWT System is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
The Genadyne Hybrid foam dressings are designed to be used with the Genadyne XLR8+ NPWT (K143726), UNO30 (K190028) and UNO Plus (K210107). The dressing has a layer of silicone that will be placed as a contact layer to the patients wound. All the dressings are single use disposable items. To help ensure safe and effective use, the Genadyne Hybrid foam dressings are to be used only with the Genadyne supplied devices. The decision to use clean versus sterile/aseptic technique for wound cleaning is dependent upon wound pathophysiology, physician/clinician preference, and institutional protocol.
This document is an FDA 510(k) clearance letter for a medical device called "Genadyne Hybrid Foam Dressings." It does not contain any information about an AI/ML device or a study proving its performance against acceptance criteria.
The information provided describes a dressing used in Negative Pressure Wound Therapy (NPWT) and compares it to a predicate device. The review focuses on the device's technological characteristics and intended use, asserting substantial equivalence based on bench testing of the dressings' function with existing NPWT systems.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance for an AI/ML device, as the provided text doesn't concern such a 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.