The Signia™ stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single-use reloads and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges, has 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 the pancreas.

The Signia™ stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 curved tip single-use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.

The Signia™ stapler, when used with Endo GIA™ single use Radial Reloads 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 the pancreas.

The Signia™ stapler. when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement or Tri-Staple™ 2.0 single use reinforced reloads 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. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of the pancreas.

Device Description

The Signia™ Stapler is a battery powered microprocessor controlled surgical stapler that provides push-button powered maneuverability and firing of compatible Covidien stapling reloads. The Signia™ Stapler is composed of the Signia™ Power Handle, Signia™ Power Shell, and Signia™ Linear Adapter. System accessories include the Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, and Signia™ Single Bay Charger.

The User controls the Signia™ Stapler via button presses on the Handle and receives feedback status and other information from the Handle via its OLED Display, LED indicator and audible annunciator. Pushbutton / Toggle switches on the Handle are provided for:

Stapling activation: Advancing the Firing Rod / Clamping / Unclamping .
Left and Right Articulation .
Clockwise and Counter Clockwise Rotation .

When the appropriate buttons are pressed, the Signia™ Stapler software initiates stapling (firing), articulation or rotation operation by turning on the appropriate motor. The motors have built-in encoders which provide shaft position information. The software controls motor speed and position using encoder pulses. Since it is possible to press multiple keys simultaneously, software must be able to process them and take appropriate actions.

The Signia™ Stapier is compatible with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single use reloads, and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges.

The Signia™ Stapler when used with the abovementioned family of Endo GIA™ reloads is a surgical device for stapling and cutting tissues. The Signia™ Stapler is intended to be used by medical professionals qualified in the transportation, cleaning, sterilization, and use of surgical devices.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding the Covidien Signia™ Stapler, a surgical stapler. It describes the device, its intended use, and the tests performed to demonstrate its substantial equivalence to a predicate device.

There is no information in the provided document about AI implementation, acceptance criteria for AI performance, clinical study results proving device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.

The document does list various tests performed (Lifecycle Reliability, Cleaning Validation, Aseptic Barrier, Functional Performance, Usability, Biocompatibility, Electrical Safety, EMC/EMI) to show that the Signia™ Stapler is substantially equivalent to a predicate device (iDrive™ Ultra Powered Handle with Endo GIA™ Adapter) based on its technological and performance characteristics, and not based on AI performance or clinical performance data.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving AI device performance, as the document pertains to a traditional medical device (stapler) and its substantial equivalence without mention of AI.

To directly answer your specific points based only on the provided text, many are "Not Applicable" or "Not Provided":

A table of acceptance criteria and the reported device performance:
- Not Provided. The document states that "Qualitative and quantitative data were obtained and used to compare the Signia™ Stapler to the predicate iDrive Ultra™ Powered Handle with Endo GIA™ Adapter," and that "The design differences were found to not affect safety or performance through applicable design verification activities that showed conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing." However, specific acceptance criteria for these tests or the quantitative performance results are not detailed in this summary. It's focused on "substantial equivalence" to a predicate device without specific performance metrics listed in this public summary.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Provided. The document mentions "Functional Performance Test Bench and Animal" studies but does not specify sample sizes or data provenance (country, retrospective/prospective nature).
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 hardware surgical device, not an AI or diagnostic device that requires expert-established ground truth on a test set in the manner described for AI. The "ground truth" would be the engineering specifications and performance capabilities of the device itself and its predicate.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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 device. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable in the context of AI. For a surgical stapler, the ground truth relates to its mechanical and functional performance, safety standards, and equivalence to a legally marketed predicate device. This would typically involve engineering specifications, material properties, mechanical testing results (e.g., staple formation, tissue compression, firing force), and possibly animal studies for functional performance.
The sample size for the training set:
- Not Applicable. No AI training set is mentioned or implied.
How the ground truth for the training set was established:
- Not Applicable. No AI training set is mentioned or implied.

In summary, the provided FDA document is a regulatory letter concerning the substantial equivalence of a physical surgical stapler, not an AI-powered medical device. Therefore, the questions related to AI performance, test sets, ground truth establishment by experts, and MRMC studies are not addressed by this document.

Summary

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

April 26, 2016

Covidien Mr. Frank Gianelli Sr. Product Specialist Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06471

Re: K160176

Trade/Device Name: Signia Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: January 22, 2016 Received: January 27, 2016

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 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 yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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		Form Approved: OMB No. 0910-0120
Indications for Use		Expiration Date: January 31, 2017
See PRA Statement below.
510(k) Number (if known)	K160176
Device Name	Signia™ Stapler
Indications for Use (Describe)	The Signia™ stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™Technology, Tri-Staple™ 2.0 single-use reloads and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges,has applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation ofanastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures andfor transection and resection of the pancreas.
	The Signia™ stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 curved tip single-usereloads, can be used to blunt dissect or separate target tissue from other certain tissue.
	The Signia™ stapler, when used with Endo GIA™ single use Radial Reloads with Tri-Staple™ Technology, hasapplications in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resectionand 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 fortransection and resection of the pancreas.
	The Signia™ stapler. when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ Technology preloadedwith polyglycolic acid staple line reinforcement or Tri-Staple™ 2.0 single use reinforced reloads preloaded withpolyglycolic acid staple line reinforcement, has applications in abdominal, gynecologic, pediatric and thoracic surgery forresection, transection of tissue 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 the pancreas.
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.
	The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:
	Department of Health and Human Services
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FORM FDA 3881 (8/14)	Page 1 of 1	PSC Publishing Services (301) 443-6740
CovidienTraditional 510(k)	Signia™ Stapler	January 22, 2016Page 56

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510(k) Summary of Safety and Effectiveness

Date Prepared:

January 22, 2016

Submitter:

Covidien 60 Middletown Avenue North Haven, CT 06473

Contact:

Frank Gianelli Senior Requlatory Affairs Product Specialist Telephone: (203) 492-5352 Fax: (203) 492-5029 frank.j.gianelli@medtronic.com Email:

Name of Device:

Trade/Proprietary Name:	Signia™ Stapler
Common Name:	Surgical Stapler with Implantable Staples
Classification Name:	Staples, Implantable
	a. Panel no and product code: 79 GDW
	b. Regulation no: 21 CFR 878.4750

Predicate Device:

Trade/Proprietary Name:	iDrive™ Ultra Powered Handle with Endo GIA™ Adapter
Common Name:	Surgical Stapler with Implantable Staples
Classification Name:	Staples, Implantable, (79 GDW, 21 CFR 878.4750)
510(k) Number:	K121510
Manufacturer:	Covidien

Device Description:

Stapling activation: Advancing the Firing Rod / Clamping / Unclamping .
Left and Right Articulation .
Clockwise and Counter Clockwise Rotation .

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Intended Use:

The Signia™ Stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single-use reloads and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges, has 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 the pancreas.

The Signia™ Stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 curved tip single-use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.

The Signia™ Stapler, when used with Endo GIA™ single use Radial Reloads 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 the pancreas.

The Signia™ Stapler, when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement or Tri-Staple™ 2.0 single use reinforced reloaded with polyglycolic acid staple line reinforcement, has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue 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 the pancreas.

Note: The Signia™ Stapler is intended for use with Endo GIA™ Reloads, Endo GIA™ Reloads with Tri-Staple™ Technology, Signia™ Loading Units with Tri-Staple™ 2.0 cartridges and Tri-Staple™ 2.0 Reloads and does not carry a separate indication from these stapling devices.

Technological and Performance Characteristics:

The Signia™ Stapler is substantially equivalent to the predicate iDrive Ultra™ Powered Handle with Endo GIA™ Adapter in regard to the stapling technologies employed.

Qualitative and quantitative data were obtained and used to compare the Signia™ Stapler to the predicate iDrive Ultra™ Powered Handle with Endo GIA™ Adapter.

The design differences were found to not affect safety or performance through applicable design verification activities that showed 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. Lifecvcle Reliability Tests
1. Cleaning Validation Tests
1. Aseptic Barrier Tests
1. Functional Performance Test Bench and Animal
1. Usability Tests
Biocompatibility tests in accordance with ISO Standard 10993-1 6.

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1. Electrical Safety Tests per IEC 60601-1
1. EMC/EMI Tests per IEC 60601-1-2

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 rinough the Significancer vas found to be substantially equivalent to the predicate device.

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.