(463 days)
The Kendall NPWT Incision Management Dressing Kit, when used with a Cardinal Health NPWT CATALYST, ALLY or ALLY TO GO Devices, 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 Cardinal Health NPWT CATALYST, ALLY TO GO System is intended for use in acute, extended and home care settings.
The Kendall Negative Pressure Wound Therapy Incision Management Dressing Kit is a wound dressing kit to be used with cleared Cardinal Health Negative Pressure Wound Therapy (NPWT) CATALYST, ALLY, and ALLY to GO systems (K171499).
The disposable single-use sterile Kendall NPWT Incision Management Dressing Kit consists of five dressing configurations, tubing, and drape strips. The dressing covers the closed surgical site and forms a seal over the sutured or stapled surgical site. The proximal end of the tubing is attached to the dressing while the distal end of the tubing attaches to an exudate canister. The powered suction pump delivers negative pressure to the dressing to aid in the removal of exudate from the wound into the exudate canister. The drape strips are used to patch any air leaks if necessary.
Here's an analysis of the provided text, focusing on acceptance criteria, study details, and how the device meets those criteria:
Device: Kendall NPWT Incision Management Dressing Kit
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (Prevena Plus Incision Management System) through various non-clinical tests. The reported device performance is presented as successfully meeting the objectives of these tests, implying they are comparable to or within acceptable limits for the predicate.
| Acceptance Criteria (Implied by Testing Objectives) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 for limited contact exposure (>24 hrs to |
§ 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.