The iDrive™ Ultra powered handle and Endo GIA™ single used with Endo GIA™ single use reloads have applications in abdominal, graecological, pediatric, and thoracic surgery for resection, and creation of anastomosis. It may be used for transection and resection of liver substance, and biliary structures and for transection and resection of pancess.

The iDrive™ Ultra powered handle and Endo GLA™ adapter, when used with Endo GLA™ curved tip single use 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™ Rodial Reload with Tri-Staple™ Technology, has applications in open or minimally invasive general stoominal, gynesologic, pediative and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, it.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

The Endo GIA™ Extra Long Adapter (EGIAADAPTXL) is a longer version of our currently cleared Endo GIA™ Standard Adapter (EGIAADAPT).

The Endo GIA™ adapter converts the rotary output of the iDrive™ Ultra powered handle to linear motion, enabling compatibility with all Endo GIA™ stapling reloads units.

The iDrive™ Ultra powered handle and Endo GIA™ adapter are multi-patient reusable devices. The devices will deactivate after reaching the end of their service life.

AI/ML Overview

Here's an analysis of the acceptance criteria and study for the device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a Special 510(k) Premarket Notification for a modified medical device. In this context, "acceptance criteria" and "device performance" are primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than establishing de novo performance targets. The criteria for demonstrating substantial equivalence are typically based on showing that the new device performs as safely and effectively as the predicate, especially given that the changes are minor (in this case, an "Extra Long Adapter" for an existing powered stapler system).

Here's a table summarizing the characteristics compared and the stated outcome for performance:

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Endo GIA™ Extra Long Adapter)
Intended Use (IFU)	Same as predicate device (K121510/K123318)	Same
System Component	Indicated for use with iDrive™ Ultra Powered Stapling System	Same
Materials	Comprised of materials evaluated in accordance with ISO 10993-1:2009	Same (No change in materials from previous device). All materials are in accordance with ISO 10993-1.
Configuration	Delivers two sets of triple staggered rows of titanium staples, divides tissue via single use reload, initiated by buttons on powered handle.	Same
Labeling	Universal adapter IFU	Unchanged (universal adapter IFU)
Articulation & Rotation	Function as intended to achieve surgical goals.	Verified successful performance through in-vitro testing.
Staple Formation	Consistent and appropriate staple formation.	Verified successful performance through in-vitro testing.
Knife Cutting Performance	Effective and safe tissue cutting.	Verified successful performance through in-vitro testing.
Lifecycle Reliability	Maintain functionality over its service life.	Verified successful performance through in-vitro testing.
Electrical Safety	Compliant with relevant electrical safety standards.	Verified successful performance through testing.
Biocompatibility	Biologically safe for patient contact.	Verified successful performance through testing (and stated "All materials are in accordance with ISO 10993-1").

The overall acceptance criterion for this 510(k) submission is that the Endo GIA™ Extra Long Adapter is substantially equivalent to the legally marketed predicate device (Endo GIA™ Adapter K121510) and does not raise new questions of safety or effectiveness. The reported device performance, demonstrated through the listed in-vitro tests, aims to prove this substantial equivalence.

Study Information:

Sample Size Used for the Test Set and Data Provenance:
- The document states "In-vitro testing supports the intended use of this device includes: Articulation and rotation verification, Staple formation verification, Knife cutting performance verification, Lifecycle reliability test."
- No specific sample sizes (e.g., number of staples, number of cycles) are provided for these in-vitro tests.
- The data provenance is not explicitly stated in terms of country of origin, but "in-vitro testing" implies lab-based, benchtop testing rather than human clinical data. It is inherently prospective for the device being tested.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This type of information is generally not applicable to in-vitro performance testing of a mechanical surgical stapler adapter. The "ground truth" for these tests (e.g., proper staple formation, successful cutting) is based on engineering specifications and established performance standards for such devices, not expert consensus interpretation of medical images or patient outcomes.
Adjudication Method for the Test Set:
- Not applicable as the testing involves objective mechanical and electrical performance verification against engineering specifications, not subjective assessments requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret data, often with and without AI assistance. This device is a surgical instrument adapter, not a diagnostic tool.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the described in-vitro testing is a form of standalone performance assessment. The device's mechanical, electrical, and material characteristics are tested independently to ensure they meet engineering specifications and function as intended without a human operator's variable input being part of the performance assessment itself. While a human operates the device, the tests are designed to evaluate the device's inherent functional capabilities.
Type of Ground Truth Used:
- The "ground truth" for the in-vitro tests (articulation, rotation, staple formation, knife performance, lifecycle, electrical safety, biocompatibility) is based on engineering specifications, established industry standards (like ISO 10993-1), and acceptable performance thresholds for surgical stapling devices. It is not based on expert consensus, pathology, or patient outcomes data in this context.
Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or AI models that require a "training set" in the conventional sense. The "training" for such devices involves engineering design, prototyping, and iterative testing, not data-driven model training.
How the Ground Truth for the Training Set Was Established:
- Not applicable for the reasons stated above.

Summary

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K133762 Page 1/4

JAN - 8 2014

510(k) Summary

SUBMITTER:

CONTACT PERSON:

Covidien IIc 60 Middletown Avenue North Haven, CT 06473 USA

Debra Peacock Regulatory Affairs Product Manager Covidien IIc (203) 492-6935 Phone: (203) 492-5029 Fax: e-mail: debra.peacock@covidien.com

DATE PREPARED:

PRODUCT CODE:

REGULATION NUMBER:

COMMON/USUAL NAME:

CLASSIFICATION NAME:

DEVICE DESCRIPTION:

TRADE/PROPRIETARY NAME:

Surgical Stapler with Implantable Staples

Endo GIA™ Extra Long Adapter

Staple, Implantable

12/09/13

GDW

iDrive™ Ultra and Endo GIA™ Adapter (K121510) PREDICATE DEVICES:

21 CFR 878.4750

GIA TM The Endo Extra Long Adapter (EGIAADAPTXL) is a longer version of our currently cleared Endo GIA™ Standard Adapter (EGIAADAPT).

The Endo GIA™ adapter converts the rotary output of the iDrive™ Ultra powered handle to linear motion, enabling compatibility with all Endo GIA™ stapling reloads units.

The iDrive™ Ultra powered handle and Endo GIA™ adapter are multi-patient reusable devices. The devices will deactivate after reaching the end of their service life.

devices are to be used by medical The professionals qualified in the transportation, preparation, cleaning, sterilization, and use

203-492-5000 [T]

Covidien

60 Middletown Avenue North Haven, ct 06473

Covidien Special 510(k) Premarket Notification

{1}------------------------------------------------

of surgical devices. Endo GIA™ single use loading units and reloads with Tri-Staple™ Technology are intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.

The Endo GIA™ Extra Long Adapter is being introduced to enable medical professionals with a choice of adapters for ease of access.

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 resection 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 and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Covidien

. 60 MIDDLETOWN AVENUE NORTH HAVEN, CT 06473

203-492-5000 [T]

INTENDED USE

Covidien Special 510(k) Premarket Notification

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CHARACTERISTICS:
Characteristic	ProposedEndo GIA™ Extra LongAdapter	PredicateiDrive™ Ultra and Endo GIA™Adapter(K121510/ K123318)
IFU	Same	Same
System Component	Same	Endo GIA™ adapter indicated foruse with the iDrive™ Ultra PoweredStapling System.
Materials	Same (No change inmaterials from previousdevice).	All patient-contacting componentsof the iDrive™ Ultra poweredhandle and Endo GIA™ adapter arecomprised ofmaterials that have been evaluatedin accordance with ISO 10993-1:2009, Biological Evaluation ofmedical devices - Part 1:Evaluation and Testing.
Adapter DimensionalSpecifications	14.07" (total length)1.52" (max width)	10.27" (total length)1.25" (max width)
Configuration	Same	Endo GIA™ adapter and EndoGIA™ reloads delivers two sets oftriple staggered rows of titaniumstaples and simultaneously dividesthe tissue between the two rows ofstaples via the single use reload,initiated by buttons on the poweredhandle
Labeling	Unchanged (universaladapter IFU)	Same

There are no changes in materials for the Endo MATERIALS: GIA™ Extra Long Adapter (EGIAADAPTXL) from the predicate Endo GIA™ adapter. All materials are in accordance with ISO 10993-1. PERFORMANCE DATA: Design verification studies were conducted to demonstrate that the proposed device, the Endo GIA™ Extra Long Adapter substantially equivalent to the predicate device.

Covidien

60 MIDDLETOWN AVENUE NORTH HAVEN, CT 06473

203-492-5000 [T]

TECHNOLOGICAL

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In-vitro testing supports the intended use of this device includes:

In-vitro Testing:

Articulation and rotation verification .
. Staple formation verification
. Knife cutting performance verification
. Lifecycle reliability test

Electrical safety testing Biocompatibility testing

The results of testing demonstrate that the modified Endo GIA™ Extra Long Adapter is substantially equivalent to the legally marketed Endo GIA™ Adapter (K121510).

CONCLUSION:

COVIDIEN

60 Middletown Avenue NORTH HAVEN. CT 06473

203-492-5000 [T]

(

Covidien Special 510(k) Premarket Notification

{4}------------------------------------------------

Image /page/4/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2014

Covidien Ms. Debra Peacock Regulatory Affairs Product Manager 60 Middletown Avenue North Haven, Connecticut 06473

Re: K133762

Trade/Device Name: Endo GIA™ Extra Long Adapter Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: December 9, 2013 Received: December 11, 2013

Dear Ms. Peacock:

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 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

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Page 2 - Ms. Debra Peacock

forth in the quality systems (QS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Endo GIA Extra Long Adapter

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K133762

Device Name Endo GIA™ Extra Long Adapter

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

Page Lotz

PRC Publishing Services (301) 443-6740

Covidien Special 510(k) Premarket Notification Page 25 of 111

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.