The iDrive™ Ultra powered handle and Endo GIA™ adapter, when used with Endo 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 of liver substance, hepatic vasculature, and biliary structures and for transection and reseation of pancreas.

The iDrive™ Ultra powered handle and Endo GIA™ adapter, when used with Endo GIA™ 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 Endo GIA™ adapter, when used with the Endo GIA™ Radial Reload with Tri-Staple™ Technology, has applications in open or minimally invasive general 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

This 510(k) introduces an accessory to the iDrive™ Ultra powered handle and Endo GIA™ adapter system (K121510), the iDrive™ Ultra reusable manual adapter tool. The iDrive™ Ultra reusable manual adapter tool is a reusable, handheld device that can be used to operate an Endo GIA™ adapter manually. It can be used to complete a firing, retract the knife and open the jaws, and to articulate an Endo GIA™ reload. The "manual tool" is not intended to initiate a reload firing. It is intended to provide the user with a manual method of operating the reload.

In addition. this premarket notification reports non-significant changes made to the iDrive™ Ultra powered handle and Endo GIA™ adapter (K121510) since their clearance in July 2012. At the time of their implementation, these changes did not necessitate a 510(k) notification. These changes are described in this 510(k) according to the FDA Draft Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k)".

AI/ML Overview

The provided text describes a 510(k) premarket notification for a surgical stapler system accessory, the iDrive™ Ultra reusable manual adapter tool, and non-significant changes to the iDrive™ Ultra powered handle and Endo GIA™ adapter. However, the document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria in terms of quantitative performance metrics.

The document states: "Verification and validation activities were performed and these activities are described in Section 11: Declarations of Conformity and Summary Reports. These evaluations demonstrate that the iDrive™ Ultra reusable manual adapter tool, and the iDrive™ Ultra system as a whole, functions as intended." Unfortunately, "Section 11: Declarations of Conformity and Summary Reports" is not included in the provided text.

Based on the information given, I cannot provide a table of acceptance criteria and reported device performance or answer most of the specific questions about the study design, sample sizes, expert involvement, or ground truth.

Here's what can be extracted:

Device Name: iDrive™ Ultra reusable manual adapter tool (accessory) and iDrive™ Ultra powered handle and Endo GIA™ adapter (system).
Intended Use: The manual adapter tool is for operating an Endo GIA™ adapter manually, completing a firing, retracting the knife, opening jaws, and articulating a reload. It is not intended to initiate a reload firing or for patient contact.
Safety: The manual adapter tool is comprised of materials that are in accordance with ISO 10993-1.

Regarding your specific points, based only on the provided text:

A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states "Verification and validation activities were performed" and "These evaluations demonstrate that... [the device] functions as intended," but it does not list specific measurable acceptance criteria or their corresponding performance results.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. This information is not present in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Cannot be provided. There is no mention of a test set with human-established ground truth in this type of mechanical device submission. The verification/validation would likely involve engineering tests, functional tests, and material biocompatibility tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Cannot be provided. This concept is generally relevant for AI/diagnostic devices where human interpretation is critical for ground truth, not for the functional testing of a mechanical surgical stapler.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document describes a mechanical surgical device and an accessory, not an AI or diagnostic imaging device. Therefore, MRMC studies and "human readers" improving with "AI assistance" are not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be explicitly determined from the provided text. For mechanical devices, "ground truth" would typically refer to established engineering specifications, mechanical tolerances, material properties, and functional requirements. For example, a stapler's ground truth might be "all staples fire successfully," "staple formation meets specifications," or "clamping force is within tolerance." The text only vaguely refers to "functions as intended."
The sample size for the training set:
- Not applicable / Cannot be provided. This device is not an AI/machine learning model, so there is no "training set" in that context.
How the ground truth for the training set was established:
- Not applicable / Cannot be provided. As above, no training set for an AI model is involved.

In summary: The provided 510(k) summary focuses on device description, intended use, and substantial equivalence to a predicate device. It confirms that verification and validation activities were performed and demonstrated the device functions as intended, but it explicitly omits the details of those activities and their specific results, referring to an external "Section 11: Declarations of Conformity and Summary Reports" which is not included. This type of submission for a mechanical device typically does not involve the kinds of studies (e.g., MRMC, AI performance) that your detailed questions are tailored for.

Summary

{0}------------------------------------------------

DEC 1 8 2012

510(k) Summary of Safety and Effectiveness

SUBMITTER:

Covidien IIc 60 Middletown Avenue North Haven, CT 06473 Tel. No .: (203) 492-5352

K123318
Page 1/2

CONTACT PERSON:

Sarah Rizk Senior Product Specialist, Requlatory Affairs

. DATE PREPARED:

October 19, 2012

Staples, Implantable

(K121510)

TRADE/PROPRIETARY NAME: iDrive™ Ultra powered handle and Endo GIA™ adapter

iDrive™ Ultra powered handle and Endo GIA™ adapter

Surgical Stapler with Implantable Staples

COMMON/USUAL NAME:

CLASSIFICATION NAME:

PREDICATE DEVICE(S):

DEVICE DESCRIPTION:

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

Covidien Special 510(k) Premarket Notification

INTENDED USE:

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K123318 page 2/2 COVIDIEN

The iDrive™ Ultra powered handle and Endo GIA™ adapter, when used with the Endo GIA™ Radial Reload with Tri-Staple™ Technology, has applications in open or minimally invasive general 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 and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

The iDrive™ Ultra reusable manual adapter tool is a reusable, handheld device that can be used to operate an Endo GIA™ adapter manually. It can be used to complete a firing, retract the knife and open the jaws, and to articulate an Endo GIA™ reload. It is not intended to initiate a reload firing.

The iDrive™ Ultra reusable manual adapter tool is not intended for patient contact. The iDrive™ Ultra reusable manual adapter tool are comprised of materials that are in accordance with ISO 10993-1.

Verification and validation activities were performed and these activities are described in Section 11: Declarations of Conformity and Summary Reports. These evaluations demonstrate that the iDrive™ Ultra reusable manual adapter tool, and the iDrive™ Ultra system as a whole, functions as intended.

TECHNOLOGICAL CHARACTERISTICS:

MATERIALS:

PERFORMANCE DATA:

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping, abstract bird-like shapes, possibly representing human figures or wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-002

December 18, 2012

COVIDIEN, Formerly US Surgical A Division Of Tyco % Ms. Sarah Rizk Regulatory Affairs Product Specialist 60 Middletown Avenue North Haven, Connecticut 06473

Re: K123318

Trade/Device Name: IDrive" Ultra powered handle and Endo GIA™ adapter Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: December 06, 2012 Received: December 11, 2012

Dear Ms. Rizk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 -- Ms. Sarah Rizk

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123318

Device Name: iDrive™ Ultra powered handle and Endo GIA™ adapter

Indications For Use:

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

Prescription Use x AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123318

Regulation Number and Section

§ 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.