(27 days)
The Power Linear Cutter Reusable Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
The device described here is a Power Linear Cutter Reusable Digital Loading Unit® with Reloads used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transactions and the creation of anastomoses. The Power Linear Cutter Reusable Digital Loading Unit® cuts and staples identically to the predicate device (K040720). The Power Linear Cutter Reusable Digital Loading Unit® has a rigid extension, allowing for more surgeon control of the Digital Loading Unit®. The remote control functions have been integrated into a hand piece at the end of the rigid shaft. These functions include an open, close and fire button. The integrated remote control buttons function identically to the SurgASSIST® Remote Control Unit buttons, which enable the surgeon to open, close and fire the predicate DLUs. The hand piece on the Power Linear Cutter Reusable Digital Loading Unit® has a proximal quick connect that connects to the distal end of the FlexShaft. The non-steerable FlexShaft serves as the conduit between the DLU and the Power Console.
The provided text is a 510(k) Pre-Market Notification for a device modification, not a study describing acceptance criteria and device performance. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical effectiveness studies with defined acceptance criteria for novel performance claims.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided document.
The document states:
- The device is a modification of a previously cleared predicate device (K040720).
- The modification involves a "rigid extension" and "integrated remote control functions" into a handpiece.
- The device "cuts and staples identically to the predicate device."
- "The Power Linear Cutter Reusable Digital Loading Units® have the same indications for use and the same functions as the previously cleared predicate Computer Mediated Linear Cutter Digital Loading Units® (K040720)."
This type of submission typically relies on non-clinical testing (e.g., bench testing, mechanical testing) to demonstrate the modified device performs as intended and is as safe and effective as the predicate, without needing to re-establish fundamental performance characteristics through detailed clinical studies with specific acceptance criteria as you might see for a novel device or a device making new performance claims.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.