(406 days)
The Genadyne DUO Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
· The Genadyne DUO NPWT System, in the absence of instillation is 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. • Instillation therapy is indicated for patients who would benefit from vacuum assisted drainery of topical wound treatment solutions and suspensions over the wound bed.
The Genadyne DUO Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
The Genadyne DUO NPWT is a Negative Pressure Wound Therapy unit with instillation option. The DUO NPWT features an interface touch panel which provides user selectable therapy modes (continuous mode and variable mode) and multi pressure options from 40 m m H g to 200 mmHg). The DUO NPWT is packaged in a box that includes a universal charger, power cable, a user manual and a user carry bag. The dressing kits includes the transparent film dressings, the Genadyne foam dressing and the Genadyne Port. The DUO NPWT is designed to be used with a canister collection system. The canister will have 3 sizes available (600cc, 800cc and 1100cc). All the dressings and canisters are single use disposable items. To help ensure safe and effective use, the DUO NPWT are to be used only with the Genadyne supplied dressings and canisters. There is an instillation option on the device for instillation therapy for the patient that requires it. The installation option provides a controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The instill mode consists of NPWT combined with the automatic, controlled delivery and removal of wound treatment solutions to and from the wound bed. It offers a more conducive dressing environment for wound bed management with adjustable target pressure, vacuum time, instill volume, and soaking time. With the adjustable target pressure, negative pressure in mmHg is applied to the wound.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (Genadyne DUO NPWT), but it does not include details about acceptance criteria, specific study results proving device performance against those criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies.
The document primarily focuses on:
- Device Description and Indications for Use: What the device is and what it's used for.
- Substantial Equivalence: How the device is similar to a legally marketed predicate device.
- Regulatory Compliance: Information about general controls, quality system regulations, UDI, and adverse event reporting.
- Non-clinical Testing: Mentions that bench tests were performed per ISO10079-1 to show the device functions appropriately, including "Pressure precision test, absorption test, alert capacity test, instill therapy test." It also mentions software documentation and a "Moderate" level of concern for software.
It does not provide the quantitative results or the methodology of these tests in detail, nor does it define acceptance criteria for these tests or relate them to clinical performance metrics. The information needed for a detailed description of acceptance criteria and the study proving performance (as outlined in your request) is simply not present in the provided text.
§ 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.