The EEA™ circular stapler with Tri-Staple™ technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

Device Description

The EEA™ circular stapler with Tri-Staple™ technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis as an end-to-end, end-to-side or side-to-side anastomosis in both open and laparoscopic surgeries. The instrument is activated by squeezing the handle firmly as far as it will go.

The subject circular stapler will be offered with a medium/thick tissue range which is identified by the purple staple quide and an extra thick tissue range which is identified by the black staple guide. Staplers for medium/thick tissue deploy three height-progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples. Staplers for extra thick tissue, deploy three height-progressive rows of 4.0 mm. 4.5 mm and 5.0 mm titanium staples. The subject circular staplers are available in 25mm lumen size and 2 shaft lengths; a standard 22 cm shaft and an extra (XL) 35 cm shaft. The Tilt-Top™ anvil is available on all staplers. A blunt and a sharp tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.

Both the subject device and the predicate device (K192330 and K172361) are from the same product family Tri-Staple™ EEA™ stapler. The subject device EEA™ Circular Stapler with Tri-Staple™ Technology (lumen size 25mm) provides the surgeons a choice of additional lumen size selections to best suit the target anatomy.

The subject EEA™ Circular Stapler with Tri-Staple™ Technology is manufactured with the same patient contact materials that are utilized within the predicate device (K192330 and 172361).

In the same manner as the predicate device (K192330 and K172361), the subject EEA™ Circular Stapler with Tri-Staple™ Technology is a manual surgical stapling device that places a circular, triple staggered row of titanium staples and resects tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. An audible and tactile firing indicator will provide additional feedback of firing completion.

The subject EEA™ Circular Stapler with Tri-Staple™ Technology is a single-use device that is packaged and sterilized via ETO (Ethylene Oxide) with a 5-year shelf life, which is the same as the predicate device (K192330 and 172361).

AI/ML Overview

This document describes a 510(k) premarket notification for the "EEA Circular Stapler with Tri-Staple Technology." This notification seeks to demonstrate substantial equivalence to previously cleared devices. It primarily focuses on the device's technical and performance characteristics compared to its predicates rather than proving clinical effectiveness through a multi-reader multi-case (MRMC) study or a standalone algorithm performance study.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria with corresponding reported device performance metrics in the way one might expect for a diagnostic AI device. Instead, it describes various performance tests conducted. The "acceptance criteria" are implied to be that the subject device performs comparably to the predicate devices and existing reference devices, and that it meets established engineering and functional benchmarks for surgical staplers.

However, the document lists several performance tests that were conducted. For each of these, the implicit acceptance criterion is successful completion and/or performance comparable to the predicate/reference device.

Acceptance Criterion (Implied)	Reported Device Performance
Performance Test (In-Vitro):
Visual/Packaging Inspection: Device meets visual and packaging specifications.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
IFU Walkthrough: Device functions as described in Instructions for Use.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Safety Lock Release Force Test: Safety lock releases within specified force range.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Staple Formation on Test Medium: Staples form correctly and consistently on a test medium.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence; this is a fundamental functional test.
Anvil Retention Force Test: Anvil is retained with adequate force.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Anvil Attach Force Test: Anvil attaches correctly with specified force.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Anvil Detach Force Test: Anvil detaches correctly with specified force.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Clamping Force Test: Device applies specified clamping force.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Unclamping Force Test: Device unclamping functions as specified.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Firing Force Test: Device fires within specified force range.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Performance Test (Ex-Vivo):
Ex-Vivo Firings: Device fires successfully on ex-vivo tissue.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Knife Cut Evaluation: Knife provides a clean and complete cut.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Leak / Burst Test: Anastomosis created by stapler meets specified leak/burst pressure integrity.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Performance Test (In-Vivo):
Atraumatic Tissue Test: Stapler application is atraumatic to tissue.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Hemostasis Test: Stapler application achieves hemostasis.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Staple Formation on Tissues: Staples form correctly on in-vivo tissues.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
Chronic animal study: No differences in healing metrics or anastomotic index compared to reference.	"The chronic animal study submitted in K172361 to evaluate the performance of the subject device and reference device shows no differences in healing metrics or anastomotic index." (This refers to a study for a predicate device, and the current device is deemed to perform similarly.)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes for each of the non-clinical (in-vitro, ex-vivo, in-vivo) tests. It merely lists the types of tests performed. For the "chronic animal study," it refers to a study submitted in K172361, but doesn't detail the sample size for that study in this document.
- Data Provenance:
  - Country of Origin: Not explicitly stated for each test beyond the submitter being in "Min Hang District, Shanghai, China."
  - Retrospective or Prospective: These are primarily prospective engineering and performance tests conducted specifically for this submission, simulating device use. The animal study from K172361 would also be prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The tests described are primarily objective engineering and biological performance tests, not typically subjected to "expert ground truth" in the same way an AI diagnostic model would be. For the animal study, veterinarians or pathologists would assess outcomes, but their number and specific qualifications are not detailed here.
Adjudication method for the test set:

This information is not provided. Adjudication methods (e.g., 2+1, 3+1) are typically relevant for subjective evaluations or labeling in AI or clinical trial contexts. For engineering performance tests, results are usually based on objective measurements against pre-defined specifications.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic accuracy or physician performance with AI assistance, which is not applicable to a surgical stapler device. The device is a manual surgical instrument, not an AI or diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. This device is a manual surgical stapler, not an algorithm or an AI-powered system. Therefore, standalone algorithm performance is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the performance tests would be defined by engineering specifications, physical measurements, and biological outcomes. For example:
- In-vitro tests: Measured forces, dimensions, visual inspection against specification.
- Ex-vivo tests: Measured burst pressure, visual inspection for knife cut completeness, visual assessment of staple formation.
- In-vivo/Animal study: Histopathological analysis (pathology), gross observation of healing, assessment of anastomotic integrity, and physiological outcomes (referred to as "healing metrics or anastomotic index").
The sample size for the training set:

Not applicable. This device is a mechanical surgical instrument, not an AI or machine learning model that requires a training set.
How the ground truth for the training set was established:

Not applicable. As above, there is no training set for a mechanical surgical stapler.

Summary

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January 21, 2021

Covidien Katherine Choi Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473

Re: K202507

Trade/Device Name: EEA Circular Stapler with Tri-Staple Technology Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: December 18, 2020 Received: December 22, 2020

Dear Ms. Choi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202507

Device Name

EEATM Circular Stapler with Tri-Staple™ Technology

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Date Prepared:

Jan 19, 2021

Submitter:

Leo Chen Covidien Rooms 501, 502, 601, 602, No.3 building No.2388 Chen Hang Road Min Hang District, Shanghai, 201114, China

Contact:

Katherine Y. Choi (U.S. Agent) on behalf of Leo Chen Covidien 60 Middletown Avenue North Haven, CT 06473, USA Senior Principal Regulatory Affairs Specialist Telephone: (917) 841-6315 Fax: (203) 492-5029 Email: katherine.y.choi@medtronic.com

Name of Device:

EEATM Circular Stapler with Tri-Staple™ Technology Proprietary/Trade Name: Model Numbers: TRIEEA25MT, TRIEEA25XT, TRIEEAXL25MT, TRIEEAXL25XT Classification Name: Staple, Implantable Regulations Number: 21 CFR 878.4750 Product Codes: GDW FDA Panel Number: 79 Device Class: Class II Review Panel: General and Plastic Surgery Common Name: Surgical Stapler

Predicate Device:

Proprietary/Trade Name: 510(k) Number: Classification Name: Requlations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:

EEATM Circular Stapler with Tri-Staple™ Technology K192330, K172361 Staple, Implantable 21 CFR 878.4750 GDW / GDW, GAG 79 Class II General and Plastic Surgery Surgical Stapler

Reference Device:

Proprietary/Trade Name: 510(k) Number: Classification Name: Requlations Number:

EEATM Circular Stapler with DST Series™ Technology K062850 Staple, Implantable 21 CFR 878.4750

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Product Codes:	GDW, GAG
FDA Panel Number:	79
Device Class:	Class II
Review Panel:	General and Plastic Surgery
Common Name:	Surgical Stapler

Device Description:

The subject EEA™ Circular Stapler with Tri-Staple™ Technology is manufactured with the same patient contact materials that are utilized within the predicate device (K192330 and 172361).

Indications for Use:

The EEA™ Circular Stapler with Tri-Staple™ Technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries.

Technological and Performance Characteristics:

The subject device EEA™ circular stapler with Tri-Staple™ technology (lumen size 25mm) is substantially equivalent to the predicate device K192330/K172361 (lumen size 28mm, 31mm and 33mm) regarding the fundamental stapling technologies employed, intended use and indications for use. All EEA™ circular staplers with Tri-Staple™ technology are single-use manual circular staplers that have application throughout the alimentary tract for the creation of end-to-end, endto-side and side-to-side anastomoses in both open and laparoscopic surgeries.

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The Tri-Staple™ technology used in the subject device is fundamentally the same as the predicate device K192330/K172361. The subject circular staplers are available in 25mm lumen size, meanwhile, the predicates are available in 3 lumen sizes 28mm. 31mm and 33mm. That's why a reference device K062850 offering 25mm lumen size is to be introduced as control device in performance testing.

Substantial Equivalent:

The subject new product models have the same intended use and indications for use as the predicate device.

They are same in fundamental scientific technology in that they are all sterile, single used, handheld, manual surgical instruments equipped with titanium staples intended to be used during open or laparoscopic surgical procedures of the alimentary tract, to create anastomoses (end-to-end, end-to-side, or side-to-side) via intraluminal (within the lumen) resection. The subject and predicate devices are same in design, materials and are sterilized via ethylene oxide, but different in lumen size.

The below table further summarizes the similarities and differences between the subject and predicate devices.

Features	Subject Device	Predicate Device		Reference Device
		K192330	K172361	K062850
	EEA™ Circular Stapler with Tri-Staple™ Technology			EEA™ Circular Stapler with DST Series™ Technology
Manufacturer	Same as predicate device.	Covidien		Covidien
Indications for Use	Same as predicate device.	The EEA™ Circular Stapler with Tri-Staple™ Technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.		The EEA™ Circular Stapler with DST Series™ Technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
Operation Method	Same as predicate device.	Manual		Manual
Anatomical Site	Same as predicate device.	Alimentary tract		Alimentary tract
Surgical Approach	Same as predicate device.	Open and laparoscopic		Open and laparoscopic
Staple Rows	Same as predicate device.	3 staggered rows of staples with different staple height in each staple row		2 staggered rows of staples with same staple height in each staple row
Features	Subject Device	Predicate Device		Reference Device
		K192330	K172361	K062850
		EEA™ Circular Stapler with Tri-Staple™ Technology		EEA™ Circular Stapler with DST Series™ Technology
Staple GuideColor	BlackPurpleSame as predicatedevice.	Black	Purple	White (25mm)
Staple Size(open legheight)	Black staple guide:4.0mm,4.5mm,5.0mmPurple staple guide:3.0mm,3.5mm,4.0mmSame as predicatedevice.	Black staple guide:4.0mm,4.5mm,5.0mm	Purple staple guide:3.0mm,3.5mm,4.0mm	White staple (25mm)guide:4.8mm, 4.8mm3.5m, 3.5mm
Lumen Sizes	25mmSame as referencedevice (25mm lumensize), which is selectedto be the control devicein the performancetesting.	28mm/31mm/33mm		25mm
Staple Material	Same as predicatedevice.	Titanium per ASTM F67 Grade I		Titanium per ASTM F67Grade I
Stapler Length	Same as predicatedevice.	Standard length: 22cmExtra length XL: 35cm		Standard length: 22cmExtra length XL: 35cm
AudibleFeedback	Same as predicatedevice.	Yes		Yes
Anvil Head	Same as predicatedevice.	3 staggered rows of anvil bucket, liplessdesign		2 staggered rows of anvilbucket, lipped design
Safety Lever	Same as predicatedevice.	Red color		White color
Key PartsMaterials	Same as predicatedevice.	Knife: Stainless SteelAnvil: Stainless SteelTube: Aluminum		Knife: Stainless SteelAnvil: Stainless SteelTube: Aluminum
Biocompatibility	Same as predicatedevice.	Evaluated per ISO 10993-1 series and FDA2016 biocompatibility guidance		Evaluated per ISO10993-1 series
Single Use	Same as predicatedevice.	Yes		Yes
Disposable	Same as predicatedevice.	Yes		Yes
Sterile	Same as predicatedevice.	Ethylene oxide		Ethylene oxide
Shelf Life	Same as predicatedevice.	5 years		5 years

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Tests performed to evaluate and compare technological and performance characteristics:

Non-clinical performance data - the following testing has been performed to demonstrate substantial equivalence to the predicate device.

1. Performance Test (In-Vitro)
- . Visual/Packaging Inspection
- IFU Walkthrough
- . Safety Lock Release Force Test
- . Staple Formation on Test Medium
- Anvil Retention Force Test
- Anvil Attach Force Test
- Anvil Detach Force Test ●
- Clamping Force Test .
- Unclamping Force Test ●
- . Firing Force Test
1. Performance Test (Ex-Vivo)
- Ex-Vivo Firinas
- Knife Cut Evaluation ●
- . Leak / Burst Test
1. Performance Test (In-Vivo)
- Atraumatic Tissue Test ●
- Hemostasis Test ●
- . Staple Formation on Tissues

The chronic animal study submitted in K172361 to evaluate the performance of the subject device and reference device shows no differences in healing metrics or anastomotic index.

Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies.

Conclusion:

Based upon the supporting data summarized above, we concluded that the subject device EEA™ Circular Stapler with Tri-Staple™ Technology is substantially equivalent to the legally-marketed device (K192330 and K172361) and does not raise different questions or additional risks of safety and effectiveness than 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.