The Signial of intelligent loading units and Tri-Staple™ 2.0 intelligent cartridges have applications in abdominal, gyncologic, pediatric and thorneie surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and for transection and resection of panereas.

Device Description

The Signia™ Intelligent Loading Units and Tri-Staple™ 2.0 Intelligent Cartridges place staggered rows of titanium staples and simultaneously divides the tissue so that three staggered rows of staples are placed on either side of the cut line. The size of the staples is determined by the selection of the following single use Tri-Staple™ 2.0 Intelligent Cartridges:

Tri-Staple™ 2.0 Intelligent Cartridge, Extra Thin/Vascular:

· Cartridge color: Gray three rows of 2.0 mm titanium staples on either side of the cut line.
Tri-Staple TM 2.0 Intelligent Cartridge, Vascular/Thin:
· Cartridge color: White three rows of 2.5 mm titanium staples on either side of the cut line.
The Tri-Staple™ 2.0 Intelligent Cartridge is available in 45 mm and 60 mm lengths. Tri-Staple™ 2.0 Intelligent Cartridges are able to be loaded into the Signia™ Intelligent Loading Unit of corresponding length by the User. Signia™ Intelligent Loading Units may be used up to twelve times in the same procedure. Signia™ intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Cartridges, similar to the predicate devices, are compatible with Covidien's GIA™ Universal staplers, Endo GIA™ Universal staplers, Endo GIA™ Ultra Universal staplers, iDrive™ Ultra powered staplers with Endo GIA™ adapters and Signia™ staplers with Signia™ linear adapters.

In the recently cleared Signia™ Staplers and Signia™ Linear Adapters (K160176), the communication of the Tri-Staple™ 2.0 Cartridges and Signia™ Loading Units with the Signia™ Stapler was announced, leading to the addition of the "Intelligent" descriptor in the Trade/Proprietary Name of the devices noted above.

AI/ML Overview

The provided text is a 510(k) summary for the Tri-Staple™ 2.0 Intelligent Cartridges. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical performance data. Therefore, the document does not contain the information requested regarding acceptance criteria for an AI/device, a study proving device meets acceptance criteria, sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or grand truth establishment methods for an AI system.

The document describes the device, its intended use, technological characteristics, and a series of non-clinical tests performed to demonstrate safety and performance in comparison to a predicate device. These tests primarily evaluate mechanical properties, material biocompatibility, and electrical safety, not the performance of an AI or diagnostic algorithm.

Here's a breakdown of what is present in the document, and why it doesn't fit the requested format for an AI/diagnostic device's acceptance criteria and study:

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

This document discusses "applicable technical design specifications and performance requirements" and "applicable medical device performance standards" but does not provide a specific table of acceptance criteria and reported performance for an AI component. The tests listed are for the mechanical and material aspects of a surgical stapler cartridge.

2. Sample size used for the test set and the data provenance:

The document mentions "bench tests using simulated tissue medium" and "in vivo and ex vivo tests using canine animal models." It does not provide specific sample sizes for these tests in the context of an "AI test set" or give details on data provenance (country of origin, retrospective/prospective). The tests are for the physical device itself.

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):

This information is not applicable as the submission is not for a diagnostic AI device requiring expert-established ground truth. The "ground truth" for the stapler relates to its mechanical function, hemostasis, and staple formation, assessed through engineering and animal studies.

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

Not applicable; this relates to human expert review in diagnostic studies, which is not described here.

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:

No MRMC study was done, as this is not an AI diagnostic device. The submission explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."

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

Not applicable; "standalone performance" typically refers to an AI algorithm's diagnostic accuracy. The "intelligent" descriptor for the cartridges refers to communication between the cartridge and the stapler, not an AI algorithm performing a diagnostic task.

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

The "ground truth" for this device would be objective measurements from manufacturing specifications, bench testing (e.g., staple formation integrity, knife cutting completeness, firing force), and animal studies (e.g., visual assessment of hemostasis, burst pressure measurements). It's not a diagnostic ground truth like pathology or expert consensus.

8. The sample size for the training set:

Not applicable. This device is a surgical stapler cartridge, not an AI model requiring a training set.

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

Not applicable for the same reason as above.

In summary, the provided document is an FDA 510(k) summary for a surgical device (stapler cartridges) demonstrating substantial equivalence through non-clinical performance and technological characteristics, not an AI or diagnostic device requiring the types of studies and ground truth methodologies described in your prompt.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right.

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

December 5, 2016

Covidien LLC Ms. Rebecca Brewer Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473

Re: K163098

Trade/Device Name: Tri-Staple™ 2.0 Intelligent Cartridges Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: November 4, 2016 Received: November 7, 2016

Dear Ms. Brewer:

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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K163098

Device Name Tri-Staple TM 2.0 Intelligent Cartridge

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.4

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStatt@ida.hhs.gov

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number

FORM FDA 3881 (8/14)

Page 1 of 1

POUD BARORING Corner (197) 411 (21) 11) 121; 12

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510(k) Summary of Safety and Effectiveness

Date Prepared:

November 4, 2016

Submitter:

Covidien 60 Middletown Avenue North Haven, CT 06473

Contact:

Rebecca Brewer Requlatory Affairs Specialist Telephone: (203) 492-5299 (203) 492-5029 Fax: Email: rebecca.j.brewer@medtronic.com

Name of Device:

Trade/Proprietary Name:	Tri-Staple™ 2.0 Intelligent Cartridges
Common Name:	Surgical Stapler with Implantable Staples
Classification Name:	Staples, Implantablea. Panel no and product code: 79 GDWb. Regulation no: 21 CFR 878.4750
Predicate Device:	Endo GIA™ Reloads with Tri-Staple™ Technology

Trade/Proprietary Name:	Endo GIA™ Reloads with Tri-Staple™ Technology, Signia™ LoadingUnits with Tri-Staple™ 2.0 cartridges and Signia™ Stapler
Common Name:	Surgical Stapler with Implantable Staples
Classification Name:	Staples, Implantable, (79 GDW, 21 CFR 878.4750)
510(k) Number:	K111825, K151163, K160176
Manufacturer:	Covidien

Device Description:

Device Desoription.
The Signia™ Intelligent Loading Units and Tri-Staple™ 2.0 Intelligent Cartridges place staggered rows of titanium staples and simultaneously divides the tissue so that three staggered rows of staples are placed on either side of the cut line. The size of the staples is determined by the selection of the following single use Tri-Staple™ 2.0 Intelligent Cartridges:

Tri-Staple™ 2.0 Intelligent Cartridge, Extra Thin/Vascular:

· Cartridge color: Gray three rows of 2.0 mm titanium staples on either side of the cut line.
Tri-Staple TM 2.0 Intelligent Cartridge, Vascular/Thin:
· Cartridge color: White three rows of 2.5 mm titanium staples on either side of the cut line.
The Tri-Staple™ 2.0 Intelligent Cartridge is available in 45 mm and 60 mm lengths. Tri-Staple™ 2.0 Intelligent Cartridges are able to be loaded into the Signia™ Intelligent Loading Unit of corresponding length by the User. Signia™ Intelligent Loading Units may be used up to twelve times in the same procedure. Signia™ intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Cartridges, similar to the predicate devices, are compatible with Covidien's GIA™ Universal staplers, Endo GIA™ Universal staplers, Endo GIA™ Ultra Universal staplers, iDrive™ Ultra powered staplers with Endo GIA™ adapters and Signia™ staplers with Signia™ linear adapters.

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Intended Use:

Intention ook in abdominal, gynecologic, pediatic and thoracic surgery for resection and creation and creation of In aborninal, gynoologic, be used for transection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.

Note: The Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Cartridges are intended for use with GIA™ Universal staplers, Endo GIA™ Universal staplers, Endo GIA™ Intended for as the on on on on one of staplers with Endo GIA™ adapters and Signia™ staplers with Signia™ linear adapters and do not carry a separate indication from the stapling devices.

Technological and Performance Characteristics:

reomiological and Porrorn Inits with Tri-Staple™ 2.0 Intelligent Cartridges (Gray and White) are Olghia - Intelligent Edulny only iii Gray Articulating Reload ("Gray Reload ("Gray Reload" from ട്രീയിട്ടിലിന് സ്വീകരിച്ച ക്രിക്കും പ്രവർത്തിച്ച് അവരുന്നു. പ്രവർശനം ("Vhite ("Vhite
this point forward) and Endo GIA™ AutoSuture™ Universal Articulating Courter ("Vhite this point forward) and Endo GIA - AutoSulute - Onliversal - Andrewith - Prix - Prixo
Reload" from this point forward), and the Signia™ Loading Units with Tri-Staple™ 2.0 Ca ("Purple" and "Tan") in regard to the stapling technologies employed.

Qualitative and quantitative data were obtained and used to compare the Tri-Staple™ 2.0 Gray and White cartridges to the predicate Endo GIA™ Reloads.

All aspects were found to be identical, with the exception of the following characteristics:

1. Construct change:
- Tri-Staple™ 2.0 Intelligent Cartridge, Extra Thin/Vascular:
  - · Cartridge color: Gray three rows of 2.0 mm titanium staples on either side of the cut line.

Tri-Staple™ 2.0 Intelligent Cartridge, Vascular/Thin:

· Cartridge color: White three rows of 2.5 mm titanium staples on either side of the cut line.
1. Material Change

Addition of an alternate flux material used in the cartridge distal chip assembly.

1. Material Change
- New colorant formulation in material of the gray and white cartridges.

The design differences were found to not affect safety or performance through applicable design verification activities that showed continued conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing.

Tests performed to evaluate and compare technological and performance characteristics:

1. Bench tests using simulated tissue medium was performed to evaluate the following technological and performance characteristics in order to confirm the safety and efficacy of the Tri-Staple™ 2.0 Gray and White Cartridges for use with Signia™ Loading Units:
- Staple formation .
- Knife cutting .
- Cartridge insertion/removal forces .
- Trocar Insertion/Removal Force .
- Clamp/Unclamp forces .
- Firing force .
- Lockout force .
- Retraction force .
- � iDrive Ultra Powered Firing

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K163098

Proximal Chip Communication .
Shield retention Force .
1. In vivo and ex vivo tests using canine animal models were performed to evaluate the following performance characteristics
- . Acute hemostasis
- . Acute air leak
- Burst pressure .
- Staple formation .
- Tissue grasping and trauma .
1. Usability Tests
Biocompatibility tests in accordance with ISO Standard 10993-1 were performed to 4. Diocompairity tests in accordants with tape in 2.0 Gray and White Cartridges are committ that new components that are in accordance with ISO Standard 10993-1 for their intended patient contact profile.
Electrical Safety Tests per IEC 60601-1 5.
EMC/EMI Tests per IEC 60601-1-2 6.

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

Conclusion:

Through the comparison of technological and performance characteristics and the results of Through the Companson of technological una portunities one of ound to be substantially equivalent to the predicate devices.

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.