The Endo GIA™ Staplers with Endo GIA™ Single Use Duet TRS™ Reloads with Tri-Staple™ Technology have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

Device Description

This 510(k) shall describe a new Reload cartridge with Tri-Staple™ technology for use with the currently marketed Endo GIA™ Stapler. The new Duet TRS™ Reload with Tri-Staple™ Technology bears the identical design characteristics as the Endo GIA™ Reloads with Tri-Staple™ Technology described in predicate submissions K083519 and K090419 with the exception that the Reloads have pre-attached staple line reinforcement material which is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material is supplied on each Reload undyed (natural) and is secured to the anvil and cartridge with BIOSYN™ synthetic absorbable suture.

The Endo GIA™ Duet TRS™ Reload with Tri-Staple™ Technology when used with the Endo GIA™ Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows.

Duet TRS™ Reloads with Tri-Staple™ Technology place two sets of triple-staggered rows of titanium staples along with two layers of absorbable tissue reinforcement material (one layer on cartridge side and one layer on anvil side) and simultaneously divide the tissue and tissue reinforcement material between the two sets of triple-staggered rows. These Reloads have a stepped cartridge configuration whereby for each set of triple-staggered rows, the staples in the outer row are a taller height than the staples in the middle row which in turn are a taller height than the staples in the inner row closest to the cut line. The size of the staples is determined by the selection of the appropriate single use Reload.

AI/ML Overview

The document describes the Endo GIA™ Duet TRS™ Reload with Tri-Staple™ Technology, which is a new reload cartridge for the existing Endo GIA™ Stapler. This device is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses, including liver substance, hepatic vasculature, and biliary structures.

Here’s an breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Bench Tests	Deemed safe and effective, performs as intended (comparable to predicates)	Evaluated: Firing force, staple line pull apart strength, staple formation
In Vivo Tests	Deemed safe and effective, performs as intended (comparable to predicates)	Evaluated: Staple formation, hemostasis, burst strength, lung air leak
Staple Line Reinforcement Material	Retain measurable mechanical strength through 14 days; absorption complete between 90-110 days.	Studies indicate the material can be expected to meet these criteria.
Biocompatibility	All components in accordance with ISO Standard 10993-1.	All components are comprised of materials that are in accordance with ISO Standard 10993-1.
Substantial Equivalence	Substantially equivalent to predicate devices with regard to stapling and staple line reinforcement technologies.	The device is substantially equivalent with regard to these technologies.

Note: The document states that the evaluations were conducted "to demonstrate that the ...device... is safe and effective and performs as intended." While specific numerical acceptance criteria are not explicitly listed in this summary, the successful completion of these tests and the FDA's clearance (K103263) imply that the device met the established criteria for safety and effectiveness, likely by demonstrating equivalence to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes for the bench or in vivo test sets. It simply states that "Bench and in vivo performance evaluations were conducted." The data provenance is not explicitly mentioned (e.g., country of origin). The testing would be considered prospective as it was conducted to demonstrate the safety and effectiveness of the new device for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies described are performance tests (bench and in vivo) rather than studies requiring expert interpretation for ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable as the described studies are performance tests (bench and in vivo) and not studies involving expert adjudication of findings.

5. 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

This information is not applicable. The device is a surgical stapler reload, not an AI-assisted diagnostic or therapeutic tool that would typically involve a multi-reader multi-case study for human reader performance improvement.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as the device is a medical device (surgical stapler reload), not an algorithm. The "standalone" performance here would refer to the device's functional performance, which was assessed through bench and in vivo tests.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would be established by validated engineering and material science standards and measurements (e.g., precise force measurements, visual inspection of staple formation, tensile strength testing).

For the in vivo tests, the "ground truth" would be established by direct observation and measurement in animal models (as is common for such medical device testing), assessing outcomes like proper staple formation, lack of bleeding (hemostasis), and structural integrity (burst strength, absence of air leaks).

8. The Sample Size for the Training Set

This information is not applicable. This device is a mechanical surgical stapler reload, not a machine learning or AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this type of medical device.

Summary

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4103262

page 1(

510(k) Summary of Safety and Effectiveness

SUBMITTER:	Surgical Devices, a global business unitof Tyco Healthcare Group LP (d/b/a Covidien)60 Middletown AvenueNorth Haven, CT 06473
	Tel. No.: (203) 492-5352

NOV 2 2 2010

CONTACT PERSON: Frank Gianelli Senior Associate, Regulatory Affairs
DATE PREPARED: November 2, 2010

TRADE/PROPRIETARY NAME: Endo GIA™ Stapler

COMMON/USUAL NAME: Surgical Stapler with Implantable Staples

CLASSIFICATION NAME: Staples, Implantable

PREDICATE DEVICE(S). Endo GIA™ Stapler (K083519, K093410, K101444, K080898)

DEVICE DESCRIPTION: This 510(k) shall describe a new Reload cartridge with Tri-Staple™ technology for use with the currently marketed Endo GIA™ Stapler. The new Duet TRS™ Reload with Tri-Staple™ Technology bears the identical design characteristics as the Endo GIA™ Reloads with Tri-Staple™ Technology described in predicate submissions K083519 and K090419 with the exception that the Reloads have pre-attached staple line reinforcement material which is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material is supplied on each Reload undyed (natural) and is secured to the

Studies indicate that the staple line reinforcement material can be expected to retain measurable mechanical strength through 14 days and absorption should be complete between 90 and 110 days.

anvil and cartridge with BIOSYN™ synthetic absorbable suture.

INTENDED USE:

The Endo GIA™ Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

Note: The Endo GIA™ Duet TRS™ Reload with Tri-Staple™ Technology is intended for use with the Endo GIA™ Stapler and does not carry a separate indication from the stapling device.

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TECHNOLOGICAL CHARACTERISTICS:

Endo GIA™ Duet TRS™ Reloads with Tri-Staple™ Technology are substantially equivalent to the predicate devices with regard to the stapling and staple line reinforcement technologies.

MATERIALS:

PERFORMANCE DATA:

All components of the Endo GIA™ Duet TRS™ Reload with Tri-Staple™ Technology are comprised of materials that are in accordance with ISO Standard 10993-1.

Bench and in vivo performance evaluations were conducted to demonstrate that the Endo GIA™ Duet TRS™ Reload with Tri-Staple™ Technology when used with the Endo GIA™ Stapler is safe and effective and performs as intended.

The, bench tests performed evaluated firing force, staple line pull apart strength and staple formation. The in vivo tests performed evaluated staple formation, hemostasis, burst strength and lung air leak.

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Image /page/2/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 image of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Covidien % Mr. Frank Gianelli Senior Associate, Regulatory Arfairs 60 Middletown Avenue North Haven, Connecticut 06473

NOV 2 2 2010

Re: K103263

Trade/Device Name: Endo GIA™ Single Use Duet TRS™ Reload with Tri-Staple" Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: November 2, 2010 Received: November 4, 2010

Dear Mr. Gianelli:

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

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Page 2 - Mr. Frank Gianelli

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 (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 Pan 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.15809.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 tolloffree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Sincerely yours,

Mark N. Molloy

Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .

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Indications for Use

NOV 2 2 2010

KIO 3263 510(k) Number (if known):

Endo GIA™ Single Use Duet TRS™ Reload with Tri-Staple™ Device Name: Technology

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MKM
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103263

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.