Endo GIA™ reinforced reload with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.

Device Description

The Endo GIA™ Reinforced Reload with Tri-Staple™ Technology places two, triple-staggered rows of titanium staples with a reinforcement material and simultaneously divides the tissue and the reinforcement material between the two, triple-staggered rows. The absorbable staple line reinforcement material, comprised of a synthetic polyester composed of pure alvcolide, will be secured to the anvil and cartridge sides of the reload with four synthetic absorbable sutures. The size of the staples is determined by the selection of the 3.0-4.0 mm or 4.0-5.0 mm Reload. The Endo GIA™ Reinforced Reload with Tri-Staple™ Technology is only available in the articulating 45 mm and 60 mm length cartridges with the 3.0-4.0 mm or 4.0-5.0 mm staples, respectively.

AI/ML Overview

The provided document is a 510(k) summary for a surgical stapler device (Endo GIA™ Reinforced Reload with Tri-Staple™ Technology). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial for an AI/diagnostic device would.

Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, training set details) are not applicable to this type of medical device submission (a surgical stapler reload) and are not present in the provided text.

However, I can extract the relevant information regarding performance data and what serves as "acceptance criteria" for demonstrating substantial equivalence for this device.

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" for this device are implicitly tied to demonstrating performance comparable to the predicate device in specific bench and animal tests, ensuring safety and effectiveness. The document lists the types of tests performed; the success in these tests constitutes meeting the "acceptance criteria" for substantial equivalence. The document states that the results "demonstrate that the subject device... is substantially equivalent to the predicate device(s)."

Acceptance Criteria (Implied)	Reported Device Performance
Demonstrate safe and effective performance as intended.	Bench and animal performance evaluations were completed to verify that the device is safe and effective and performs as intended.
Prove substantial equivalence to predicate devices.	Performance tests (In Vitro and In Vivo) were conducted. The results demonstrated substantial equivalence to the predicate device(s) regarding stapling and staple line reinforcement technologies.
Biocompatibility in accordance with ISO Standard 10993-1.	All components are comprised of materials in accordance with ISO Standard 10993-1. Biocompatibility testing was performed.
Satisfactory In Vitro performance for specific parameters.	Performed tests: Insertion/removal force, Firing force, Retraction force, Staple formation, iDrive Ultra testing, Twek Pull apart, Sequential firings, Perpendicular firings, L-shaped firings. (Implicitly, the results of these tests were satisfactory for demonstrating equivalence).
Satisfactory In Vivo performance for specific parameters.	Performed tests: Atraumatic reload, Free bleed time, Air leaks, Burst, Additional firings. (Implicitly, the results of these tests were satisfactory for demonstrating equivalence).

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided summary. The tests are benchtop (in vitro) and animal (in vivo) performance evaluations.
Data Provenance: Not specified, but generally, such tests would be conducted by the manufacturer (Covidien llc) in their own labs or contract research organizations. These are prospective evaluations conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a surgical stapler, not a diagnostic device requiring expert interpretation for ground truth. Performance is assessed through objective physical and biological measurements in bench and animal studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

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

Not Applicable. This is not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is not an AI/diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth: For a surgical stapler, "ground truth" would relate to objective physical and biological parameters such as staple formation, tissue integrity, leak rates, burst pressure, and biocompatibility, as measured by standardized testing methods and instrumentation. The "truth" is established by the validated measurement methods themselves, not by expert consensus on an image or pathology.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that requires a "training set." The device is evaluated based on its physical and biological performance characteristics.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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K133938 Page 1 of 4

510(k) Summary

JAN 2 2 2014

This 510(k) summary information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.

	Submitter Information
Name:	Covidien IIc
Address:	15 Hampshire Street
	Mansfield, MA 02048
Establishment Registration:	1282497
Name of contact person:	Jose Marquez
	Regulatory Affairs Manager
	Covidien
	15 Hampshire Street
	Mansfield, MA 02048 USA
	Phone: (508) 452-4160
Date prepared:	January 22, 2014
Trade or proprietary name:	Endo GIA™ Reinforced Reload with Tri-Staple™ Technology
Common or usual name:	Surgical Stapler with Implantable Staple
Classification name:	Staple, Implantable
Classification panel:	General and Plastic Surgery (79)
Regulation:	21 CFR 878.4750
Product Code(s):	GDW, ORQ
Legally marketed devices towhich equivalence is claimed:	Endo GIA™ Stapler (K111825)NEOVEIL™ Reinforcement Staple Line Material (K130997)
Reason for 510(k) submission:	To obtain market clearance for the Endo GIA™ ReinforcedReload with Tri-Staple™ Technology.
Device description:	The Endo GIA™ Reinforced Reload with Tri-Staple™Technology places two, triple-staggered rows of titanium stapleswith a reinforcement material and simultaneously divides the

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tissue and the reinforcement material between the two, triple-The absorbable staple line reinforcement staggered rows. material, comprised of a synthetic polyester composed of pure alvcolide, will be secured to the anvil and cartridge sides of the reload with four synthetic absorbable sutures. The size of the staples is determined by the selection of the 3.0-4.0 mm or 4.0-5.0 mm Reload. The Endo GIA™ Reinforced Reload with Tri-Staple™ Technology is only available in the articulating 45 mm and 60 mm length cartridges with the 3.0-4.0 mm or 4.0-5.0 mm staples, respectively.

Endo GIA™ reinforced reload with Tri-Staple™ Technology Intended use of the device: preloaded with polyglycolic acid staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.

Summary comparing the technological characteristics of the subject and predicate devices:

Materials:

Performance Data:

GIA™ Reinforced Reload with Tri-Staple ™ The Endo Technology is substantially equivalent to the predicate devices staple line reinforcement regard to stapling and with technologies.

All components of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology are comprised of materials which are in

Bench and animal performance evaluations were completed to verify that the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology are safe and effective and perform as intended.

The tests performed to show substantial equivalence of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology to the predicate device are as follows:

. In Vitro
- Insertion/removal force o

accordance with ISO Standard 10993-1.

Firing force 0
Retraction force 0
Staple formation o
iDrive Ultra testing O
Twek Pull apart 0
Sequential firings 0
Perpendicular firings O
L-shaped firings O
In Vivo · .
- Atraumatic reload O

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Free bleed time ্ O Air leaks

. .

. . . . . . .

. .

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Burst o
Additional firings o
Biocompatibility .

Conclusion:

The results of the tests performed demonstrate that the subject device, Endo GIA™ Reinforced Reload with Tri-Staple™ Technology, is substantially equivalent to the predicate device(s). .

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font and is black. The background is white.

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized wing segments.

Public Health Service

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

January 22, 2014

Covidien Ilc Mr. Jose Marquez Regulatory Affairs Manager 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K133938

Trade/Device Name: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW, ORO Dated: December 20, 2013 Received: December 23, 2013

Dear Mr. Marquez:

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 - Mr. Jose Marquez

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.

For

Sincerely yours,

Joshua FDMipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510{k} Number (if known) K133938

Device Name

Endo GLA™ Reinforced Reload with Tri-Staple™ Technology

Indications for Use (Describe)

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

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

[Z] Prescription Use (Part 21 CFR 801 Subpart D)

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

FORM FDA 3881 (9/13)

Page Lof 2

PSC Publishion Screlocs (3011 443-674)

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.