The EEATM 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-sicle anastomoses in both open and laparoscopic surgeries.

Device Description

The EEA™ circular stapler with Tri-Staple™ technology (Black) places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis as an endto-end, end-to-side and side-to-side anastomoses 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 for an extra thickness range, which is identified by the black staple guide. Staplers with extra thick staple size 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 3 lumen sizes 28, 31. 33mm and 2 shaft lengths a standard 22 cm shaft and an XL 35 cm shaft. The Tilt-Top™ anvil is available on all staplers. A blunt tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.

The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) is manufactured with patient contact materials (stainless steel, titanium) that are utilized within the predicate devices (K172361 and K062850).

The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) is a manual device which is utilized by approximating tissue, instrumentation activation by squeezing the handle firmly as far as it will go, audible and tactile firing indicator upon completion of the staple firing and removal of the device from the surgical field in the same manner as the predicate devices (K172361 and K062850).

The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) 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 devices (K172361 and K062850).

AI/ML Overview

The provided text describes the 510(k) summary for the EEA™ Circular Stapler with Tri-Staple™ Technology (Black). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study. As such, the information typically found for such a study (like sample sizes for test sets, ground truth establishment, MRMC studies, or training set details) is not present.

However, the document lists various non-clinical performance tests conducted to support substantial equivalence, and for these tests, it states that "The acceptance criteria of each test within the In-Vitro section has been satisfied and results deemed acceptable," and "All units evaluated yielded comparable or better results in accordance with the acceptance criteria for Ex-Vivo test" and "In-Vivo acute test." This implies that internal acceptance criteria were established and met for these non-clinical evaluations.

Here's a breakdown of the available information based on your request, with an emphasis on what is not explicitly stated as well:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of defined acceptance criteria alongside quantitative performance results for the device. Instead, it makes general statements about meeting "acceptance criteria" and yielding "comparable or better results" for the non-clinical tests.

Test Category	Acceptance Criteria (Not explicitly quantified in the document)	Reported Device Performance
In-Vitro Tests	- Visual inspection criteria (?)	- Satisfied acceptance criteria for visual inspection, safety lock release
	- Safety lock release force criteria (?)	force, staple formation, anvil attach/detach force, clamping force,
	- Staple formation criteria (?)	unclamping force, and firing force.
	- Anvil attach/detach force criteria (?)
	- Clamping/unclamping force criteria (?)
	- Firing force criteria (?)
Ex-Vivo Tests	- Firings criteria (?)	- All units yielded comparable or better results in accordance with
	- Knife cut evaluation criteria (?)	acceptance criteria for ex-vivo firings, knife cut evaluation, and
	- Leak / Burst test criteria (?)	leak/burst tests.
In-Vivo Studies	- Atraumatic tissue test criteria (?)	- All units yielded comparable or better results in accordance with
	- Hemostasis test criteria (?)	acceptance criteria for in-vivo acute tests (atraumatic tissue,
	- Staple formation on tissues criteria (?)	hemostasis, staple formation on tissues).
	- Chronic survival study criteria (?)	- Chronic animal study showed no differences in healing metrics or
		anastomotic index compared to predicate.
Human Factors	- Device performance meets user needs criteria (?)	- Validated device performance, mitigated potential use errors, validated
	- Mitigated use errors criteria (?)	training and instruction. Demonstrates substantial equivalence.
	- Training/Instruction validation criteria (?)
Biocompatibility	- Followed ISO 10993-1 and FDA guidance (?)	- Results support the subject devices are biocompatible.
Sterilization	- Sterility Assurance Level ($\leq 10^{-6}$)	- Achieved minimum SAL of $10^{-6}$.
	- ETO residual limits (?)	- ETO residual test performed.
Stability/Shelf-life	- Functional test after aging for 5 years (?)	- Results support a 5-year shelf life.

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

Test Set Sample Size: Not specified for any of the performance tests.
Data Provenance: The studies were conducted by Covidien, the manufacturer. The document doesn't specify countries of origin for the data (e.g., for animal studies). The studies are non-clinical, implying they were conducted in a laboratory or animal model setting and are inherently prospective for the device being tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The performance tests described (e.g., force tests, burst tests, tissue evaluations) likely rely on objective measurements and established scientific protocols rather than expert consensus on a "ground truth" as might be seen in diagnostic imaging studies.

4. Adjudication method for the test set

Not applicable and not provided. The nature of the non-clinical performance tests (e.g., measuring forces, evaluating staple formation) typically involves objective measurements against pre-defined criteria, not adjudication by multiple independent reviewers.

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. This type of study is relevant for AI/diagnostic imaging devices. The EEA™ Circular Stapler is a surgical device, and its evaluation does not involve "human readers" or "AI assistance" in this context.

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

No. This is not applicable to a physical surgical stapler. The device is operated by a human, and its performance is evaluated in conjunction with human use (e.g., human factors/usability testing).

7. The type of ground truth used

For the non-clinical tests (in-vitro, ex-vivo), the "ground truth" would be the objective measurements compared against pre-defined engineering specifications and performance standards for the device and its predicates. For the in-vivo animal study, the "ground truth" for healing metrics and anastomotic index would be based on pathology and standard clinical assessments of tissue healing and integrity in the animal model.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physical surgical tool, not an AI algorithm that requires a "training set."

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

This information is not applicable and not provided, as there is no AI training set for this device.

Summary

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January 23, 2020

Covidien Frank Gianelli Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473

Re: K192330

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 16, 2019 Received: December 19, 2019

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. 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 medical devices and radiation-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. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Dnug Administration

Indications for Use

510(k) Number (if known)

K192330

Device Name

EEATM Circular Stapler with Tri-Staple™ Technology

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)
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510(k) Summary

Date Prepared:

January 20, 2020

Submitter:

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

Contact:

Frank Gianelli (U.S. Agent) on behalf of Sarah Tanq Covidien 60 Middletown Avenue North Haven, CT 06473, USA Senior Regulatory Affairs Specialist Telephone: (203) 492-5352 Fax: (203) 492-5029 frank.j.gianelli@medtronic.com Email:

Name of Device:

Proprietary/Trade Name: EEATM Circular Stapler with Tri-Staple™ Technology (Black) Model Numbers: TRIEEA28XT, TRIEEA31XT, TRIEEA33XT, TRIEEAXL28XT, TRIEEAXL31XT, TRIEEAXL33XT Classification Name: Staple, Implantable Requlations Number: 21 CFR 878.4750 Product Codes: GDW, GAG FDA Panel Number: 79 Device Class: Class II Review Panel: General and Plastic Surgery Common Name: Surgical Stapler

Predicate Devices:

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

Additional Predicate Device: Proprietary/Trade Name: 510(k) Number: Classification Name:

EEA™ Circular Stapler with Tri-Staple™ Technology (Purple) K172361 Staple, Implantable 21 CFR 878.4750 GDW, GAG 79 Class II General and Plastic Surgery Surgical Stapler

EEA™ Circular Stapler with DST Series™ Technology K062850 Staple, Implantable

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Regulations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:

21 CFR 878.4750 GDW, GAG 79 Class II General and Plastic Surgery Surgical Stapler

Device Description:

Indications for Use:

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

Technoloqical Characteristics:

The subject new devices EEA™ circular stapler with Tri-Staple™ technology (Black) are substantially equivalent to primary predicate device K172361 EEA™ Circular Stapler with Tri-Staple™ Technology (Purple) and the additional predicate device K062850 EEA™ circular stapler with DST Series™ technology regarding the fundamental stapling technologies employed, intended use and indications for use. All of them are single-use manual circular staplers that have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-toside anastomoses in both open and laparoscopic surgeries.

The Tri-Staple™ technology used in the subject devices are fundamentally the same as the primary predicate device K172361 with the exception that the subject devices deploy 3 height progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples for use in extra thick tissue applications and is identified by the black staple quide. Conversely, the primary predicate devices

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deploy 3 height progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples for use in medium/thick tissue applications and is identified by the purple staple quide. That's why an additional predicate offering for an extra thick tissue thickness is introduced as control device in performance testing.

The additional predicate device K062850 EEA™ circular stapler with DST Series™ technology deploy 2 staggered rows of 4.8mm staples, for use in extra thickness range similar to the subject device. A series of comparison testing has been conducted between the subject new devices and the additional predicate devices and is provided in this submission.

Substantial Equivalent:

The subject devices have the same intended use and indications for use as the predicate devices.

They are similar 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 similar in design, materials and are sterilized via ethylene oxide.

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

	Subject Device	Primary Predicate Device(K172361)	Additional Predicate Device (K062850)
Features	EEATM Circular Stapler withTri-StapleTM Technology(Black)	EEATM Circular Stapler withTri-StapleTM Technology(Purple)	EEATM Circular Stapler withDST SeriesTM Technology
Manufacturer	Covidien	Covidien	Covidien
Constructional	Image: EEA Circular Stapler with Tri-Staple Technology (Black)	Image: EEA Circular Stapler with Tri-Staple Technology (Purple)	Image: EEA Circular Stapler with DST Series Technology
Indications for Use	The EEATM Circular Staplerwith Tri-StapleTM Technologyhas application throughoutthe alimentary tract for thecreation of end-to-end, end-to-side and side-to-sideanastomoses in both openand laparoscopic surgeries.	The EEATM Circular Staplerwith Tri-StapleTM Technologyhas application throughoutthe alimentary tract for thecreation of end-to-end, end-to-side and side-to-sideanastomoses in both openand laparoscopic surgeries.	The EEATM Circular Staplerwith DST SeriesTMTechnology has applicationthroughout the alimentarytract for the creation of end-to-end, end-to-side and side-to-side anastomoses in bothopen and laparoscopicsurgeries.
Operation Method	Manual	Manual	Manual
Anatomical Site	Alimentary tract	Alimentary tract	Alimentary tract
Surgical Approach	Open and laparoscopic	Open and laparoscopic	Open and laparoscopic
Staple Rows	3 staggered rows of stapleswith different staple height ineach staple row	3 staggered rows of stapleswith different staple height ineach staple row	2 staggered rows of stapleswith same staple height ineach staple row

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	Subject Device	Primary Predicate Device(K172361)	Secondary PredicateDevice (K062850)
Features	EEATM Circular Stapler withTri-StapleTM Technology(Black)	EEATM Circular Stapler withTri-StapleTM Technology(Purple)	EEATM Circular Stapler withDST SeriesTM Technology
Staple GuideColor	Black	Purple	Green
Staple Size(open leg height)	4.0mm, 4.5mm 5.0mm	3.0mm, 3.5mm, 4.0mm	4.8mm, 4.8mm
Staple Material	Titanium per ASTM F67Grade I	Titanium per ASTM F67Grade I	Titanium per ASTM F67Grade I
Lumen Sizes	28mm/31mm/33mm	28mm/31mm/33mm	28mm/31mm/33mm
Stapler Length	Standard length: 22cmExtra length XL: 35cm	Standard length: 22cmExtra length XL: 35cm	Standard length: 22cmExtra length XL: 35cm
Audible Feedback	Yes	Yes	Yes
Anvil Head	3 staggered rows of anvilbucket, lipless design	3 staggered rows of anvilbucket, lipless design	2 staggered rows of anvilbucket, lipped design
Safety Lever	Red color	Red color	White color
Key Parts	Knife: Stainless Steel	Knife: Stainless Steel	Knife: Stainless Steel
Materials	Anvil: Stainless Steel	Anvil: Stainless Steel	Anvil: Stainless Steel
	Tube: Aluminum	Tube: Aluminum	Tube: Aluminum
Biocompatibility	Evaluated per ISO 10993-1series and FDA 2016biocompatibility guidance	Evaluated per ISO 10993-1series and FDA 2016biocompatibility guidance	Evaluated per ISO 10993-1series
Single Use	Yes	Yes	Yes
Disposable	Yes	Yes	Yes
Sterile	Ethylene oxide	Ethylene oxide	Ethylene oxide
Shelf Life	5 years	5 years	5 years

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 devices.

1. Performance Test _ In-Vitro
- . Visual inspection on product, packaging and instruction for use
- . Safety lock release force test
- Staple formation on test media .
- Anvil attach force test
- . Anvil detach force test
- . Clamping force test
- . Unclamping force test
- Firing force test ●

The acceptance criteria of each test within the In-Vitro section has been satisfied and results deemed acceptable.

1. Performance Test _ Ex-Vivo
- EX-Vivo Firings .
- Knife cut evaluation .
- . Leak / Burst test

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All units evaluated vielded comparable or better results in accordance with the acceptance criteria for Ex-Vivo test, which demonstrate the substantial equivalence of the subject devices as compared to the predicate device.

1. Performance Test _ In-Vivo Study
- Atraumatic tissue test ●
- Hemostasis test ●
- Staple formation on tissues
- . Chronic survival study

All units evaluated yielded comparable or better results in accordance with the acceptance criteria for In-Vivo acute test, which demonstrate the substantial equivalence of the subject devices as compared to the predicate device.

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

1. Performance Test Human Factors/Usability per IEC 62366 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices".
- Human factors evaluation was conducted on the subject device and the predicate . devices. This testing report has been included in the predicate submission (K172361).
- . The usability testing validated the performance of the device meets identified user needs and intended use; validated potential use errors identified which have been mitigated through the product design or instruction; validate training and instruction via the proposed device Instruction for Use on device operation.
- The results of the testing demonstrate the substantial equivalence of the subject ● devices as compared to the predicate device.
1. Biocompatibility tests per ISO 10993-1 and FDA guidance "Use of international Standard ISO 10993-1" issued June 16, 2016
- Cytotoxicity test o
- Sensitization .
- Intracutaneous irritation
- . Acute system toxicity
- . Pyrogenicity

The biocompatibility test results support the subject devices are biocompatible.

1. Sterilization assessment per ISO 11135
- Overkill method used for validation ●
- ETO residual test

The sterilization validation demonstrates the sterilization cycle used for the single use devices can effectively achieve a minimum Sterility Assurance Level (SAL)of 10-6.

1. Stability/Shelf-life studies
- Aging test for 5 years shelf life ●
- . Product and packaging functional test

The stability study results support a 5-year shelf life of the single use devices.

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1. 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 intended use, technological characteristics and supporting performance data summarized above, we concluded that the new subject devices EEA™ Circular Stapler with Tri-Staple™ Technology are substantially equivalent to the legally-marketed predicate devices K172361 and K062850.

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.