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K Number
K121510
Device Name
IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER
Manufacturer
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
Date Cleared
2012-07-25

(65 days)

Product Code
GDW
Regulation Number
878.4750
Type
Traditional
Panel
SU
Reference & Predicate Devices
K102325,K111825
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The iDrive ™ Ultra powered handle and En do GIA ™ adapter, when used with En do GIA ™ single use reloads have applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection rof liver substance, hepatic vasculature, and biliary structures and for transection and resection of pancreas.

The iDrive ™ Ultra powered handle and Endo GIA TM adapter, when used with Endo GIA TM curved tip single use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.

The iDrive ™ Ultra powered handle and En do GIA TM adapter, when used with the Endo GIA TM Radial Reload with Tri-Staple ™ Technology, has applications in open or minimally invasive raneral abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Device Description

Surgical stapler with a powered handle, delivering implantable titanium staples.

AI/ML Overview

The provided submission describes a surgical stapler, the iDrive™ Ultra powered handle and Endo GIA™ adapter, and does not relate to an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not applicable and cannot be extracted from this document.

The document focuses on the safety and effectiveness of a physical medical device, not a software algorithm. The "Performance Data" section lists various in-vitro and in-vivo tests for the stapler's mechanical and biological properties, as well as adherence to electrical safety standards. This is typical for a traditional 510(k) submission for a non-AI device.

§ 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.