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. The instrument is activated by squeezing the handle firmly as far as it will go. The subject circular stapler is available in 21mm lumen size and 2 shaft lengths; a standard 22 cm shaft and an XL 35 cm shaft. The staplers are offered in 2 staple sizes, medium/thick and extra thick. Staplers with medium/thick staple size (purple) deploy three height-progressive rows of 3.0 mm. 3.5 mm and 4.0 mm titanium staples. Staplers with extra thick staple size (black) deploy three heightprogressive rows of 4.0 mm. 4.5 mm and 5.0 mm titanium staples. The low profile 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.

AI/ML Overview

The provided document is a 510(k) summary for a surgical stapler. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain the specific acceptance criteria or the detailed results of a study proving the device meets those criteria, particularly in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document states that a "Chronic animal study performed to evaluate the performance of the subject device and the reference device shows no differences in healing metrics or anastomotic index, and the results demonstrate that the acceptance criteria were met." However, it does not explicitly list these acceptance criteria or the detailed reported device performance. It also mentions "Performance Test (In-Vitro)", "Performance Test (Ex-Vivo)", and "Performance Test (In-Vivo)", but again, it does not provide the acceptance criteria for these tests nor the quantitative results demonstrating compliance.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's what can be gathered, with caveats for missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that acceptance criteria were met for a chronic animal study, but it does not explicitly state what those acceptance criteria are nor does it provide a quantitative report of the device's performance against them.
For the in-vitro and ex-vivo performance tests, it lists the types of tests performed (e.g., Safety Lock Release Force Test, Leak/Burst Test, Staple Formation on Test Medium) but does not provide specific acceptance criteria values (e.g., "Force must be X N to Y N") or the measured performance values for the device.

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

Chronic Animal Study (In-Vivo): The document states a "Chronic animal study" was performed. It implies the performance of the subject device (EEA™ Circular Stapler with Tri-Staple™ Technology, 21mm lumen size) was compared to a reference device (EEA™ Circular Stapler with DST Series™ Technology, K062850, 21mm lumen size).
Sample Size: Not explicitly stated for either the animal study or other performance tests.
Data Provenance: The studies were performed to support a 510(k) submission by Covidien (part of Medtronic). Given Covidien's global operations, the country of origin for the data is not specified. The animal study would be prospective, as it involves evaluating a device's performance. The in-vitro and ex-vivo tests would also be prospective.

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

This information is not provided as the document describes performance testing of a mechanical device, not an AI/diagnostic device where expert interpretation of data is typically a ground truth component. In this context, "ground truth" would be objective measurements from tests.

4. Adjudication method for the test set

This information is not provided as it's not relevant for mechanical device performance testing where objective measurements are taken rather than subjective interpretations needing adjudication.

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 is not relevant. The device is a surgical stapler, not an AI diagnostic tool that assists human readers.

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

Not applicable. The device is a surgical stapler, not an algorithm.

7. The type of ground truth used

For mechanical performance tests, the "ground truth" would be established by:
- Objective measurements: e.g., force measurements (Safety Lock Release Force, Clamping Force, Firing Force), visual inspections against defined criteria (Visual/Packaging Inspection, Staple Formation), and functional tests (Leak/Burst Test, Knife Cut Evaluation).
- Healing metrics and anastomotic index: For the chronic animal study, these would be the observed outcomes measured by qualified personnel (e.g., veterinary pathologists, surgeons) according to defined protocols.

8. The sample size for the training set

Not applicable. The device is a mechanical surgical stapler. There is no AI component that requires a "training set."

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

Not applicable. No training set for an AI model.

Summary of Missing Information:

The most crucial missing information, according to your request, is a detailed table showing:

Specific quantitative acceptance criteria for each performance test (e.g., minimum/maximum force values, leak rates, staple formation dimensions, healing scores).
The actual quantitative results obtained from the subject device during these tests, demonstrating that it met those criteria.

Without these specifics, we can only state that the document asserts "acceptance criteria were met" without revealing what those criteria were or how the device performed against them numerically.

Summary

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November 30, 2022

Covidien Leo Chen Principal Regulatory Affairs Specialist Rooms 501, 502, 601, 602, No.3 building No.2388 Chen Hang Road Shanghai. China

Re: K221771

Trade/Device Name: EEA Circular Stapler with Tri-Staple Technology Regulation Number: 21 CFR 878.4740 Regulation Name: Surgical Stapler Regulatory Class: Class II Product Code: GAG, GDW Dated: October 28, 2022 Received: November 4, 2022

Dear Leo Chen:

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 co mmerce 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 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/cdrl-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,

MarkTrumbore -S	Digitally signed byMark Trumbore -S
	Date: 2022.11.3015:32:48 -05'00'

Mark Trumbore, PhD Assistant Director DHT4A: Division of General 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 Drug Administration

Indications for Use

510(k) Number (if known) K221771

Device Name

EEATM Circular Stapler with Tri-StapleTM 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 K221771

Date Prepared:

Nov 28, 2022

Submitter:

Leo Chen Covidien Rooms 501, 502, 601, 602, No.3 building No.2388 Chen Hang Road Min Hang District, Shanghai, 201114, China Principal Regulatory Affairs Specialist Telephone: +86 21 3323 0182 Email: leo.chen@medtronic.com

US Contact:

Angela Van Arsdale Covidien 60 Middletown Avenue North Haven, CT 06473, USA Sr. Regulatory Affairs Manager Email: angela.vanarsdale@medtronic.com

Name of Device:

Proprietary/Trade Name:	EEA™ Circular Stapler with Tri-Staple™ Technology
Model Numbers:	TRIEEA21MT, TRIEEA21XT, TRIEEAXL21MT, TRIEEAXL21XT
Classification Name:	Stapler, Surgical; Staple, Implantable
Regulations Number:	21CFR 878.4740, 21 CFR 878.4750
Product Codes:	GAG, GDW
FDA Panel Number:	79
Device Class:	Class II
Review Panel:	General and Plastic Surgery
Common Name:	Surgical stapler with implantable staples

Primary Predicate Device:

Proprietary/Trade Name:	EEATM Circular Stapler with Tri-StapleTM Technology
510(k) Number:	K202507
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 with implantable staples

Secondary Predicate Device:

Proprietary/Trade Name:	EEATM Circular Stapler with Tri-StapleTM Technology
510(k) Number:	K221005

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Classification Name: Requlations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:

Reference Device:

Proprietary/Trade Name: 510(k) Number: Classification Name: Regulations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:
Stapler, Surgical; Staple, Implantable 21CFR 878.4740, 21 CFR 878.4750 GAG, GDW 79 Class II General and Plastic Surgery Surgical stapler with implantable staples

EEA™ Circular Stapler with DST Series™ Technology K062850 Staple, Implantable 21 CFR 878.4750 GDW, GAG 79 Class II General and Plastic Surgery Surgical stapler with implantable staples

Device Description:

Both the subject device and the predicate device (K202507 and K221005) are from the same product family Tri-Staple™ EEA™ stapler. The subject device EEA™ Circular Stapler with Tri-Staple™ Technology (lumen size 21mm) provides the surgeons a choice of additional lumen size selection 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 (K202507 and K221005).

In the same manner as the predicate device (K202507 and K221005), 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 (K202507 and K221005).

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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 21mm) is substantially equivalent to the predicate device K202507 and K221005 (lumen sizes 25mm, 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 singleuse manual circular staplers that have 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 Tri-Staple™ technology used in the subject device is fundamentally the same as the predicate device K202507 and K221005. The subject circular staplers are available in 21mm lumen size. meanwhile, the predicates are available in 4 lumen sizes 25mm, 31mm and 33mm. That's why a reference device K062850 offering 21mm 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 use, 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 DeviceK221771	Predicate Device		Reference DeviceK062850
		K202507	K221005
		EEATM Circular Stapler with Tri-StapleTM Technology		EEATM Circular Stapler withDST SeriesTM Technology
Manufacturer	Same aspredicate device.	Covidien		Covidien
Indications forUse	Same aspredicate device.	The EEATM Circular Stapler with Tri-StapleTM Technologyhas application throughout the alimentary tract for thecreation of end-to-end, end-to-side and side-to-sideanastomoses in both open and 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.
OperationMethod	Same aspredicate device.	Manual		Manual
Features	Subject DeviceK221771	Predicate DeviceK202507	K221005	Reference DeviceK062850
	EEATM Circular Stapler with Tri-StapleTM Technology		EEATM Circular Stapler with Tri-StapleTM Technology	EEATM Circular Stapler withDST SeriesTM Technology
AnatomicalSite	Same aspredicate device.	Alimentary tract	Alimentary tract	Alimentary tract
SurgicalApproach	Same aspredicate device.	Open and laparoscopic	Open and laparoscopic	Open and laparoscopic
Staple Rows	Same aspredicate device.	3 staggered rows of staples with different staple height ineach staple row	3 staggered rows of staples with different staple height ineach staple row	2 staggered rows of stapleswith same staple height ineach staple row
Staple GuideColor	Same aspredicate device.	BlackPurple	BlackPurple	Aqua (21mm)
Staple Size(open legheight)	Same aspredicate device.	Black staple guide:4.0mm,4.5mm,5.0mmPurple staple guide:3.0mm,3.5mm,4.0mm	Black staple guide:4.0mm,4.5mm,5.0mmPurple staple guide:3.0mm,3.5mm,4.0mm	Aqua (21mm):4.8mm, 4.8mm3.5m, 3.5mm
Lumen Sizes	21mmSame asreference device(21mm), which isselected to be thecontrol device inthe performancetesting.	25mm	25mm/28mm/31mm/33mm	21mm
Staple Material	Same aspredicate device.	Titanium per ASTM F67 Grade I	Titanium per ASTM F67 Grade I	Titanium per ASTM F67Grade I
Stapler Length	Same aspredicate device.	Standard length: 22cmExtra length XL: 35cm	Standard length: 22cmExtra length XL: 35cm	Standard length: 22cmExtra length XL: 35cm
AudibleFeedback	Same aspredicate device.	Yes	Yes	Yes
Anvil Head	Same aspredicate device.	3 staggered rows of anvil bucket, lipless design	3 staggered rows of anvil bucket, lipless design	2 staggered rows of anvilbucket, lipped design
Safety Lever	Same aspredicate device.	Red color	Red color	White color
Key PartsMaterials	Same aspredicate device.	Knife: Stainless SteelAnvil: Stainless SteelTube: Aluminum	Knife: Stainless SteelAnvil: Stainless SteelTube: Aluminum	Knife: Stainless SteelAnvil: Stainless SteelTube: Aluminum
Biocompatibility	Same aspredicate device.	Evaluated per ISO 10993-1 series and FDAbiocompatibility guidance	Evaluated per ISO 10993-1 series and FDAbiocompatibility guidance	Evaluated per ISO 10993-1series
Single Use	Same aspredicate device.	Yes	Yes	Yes
Disposable	Same aspredicate device.	Yes	Yes	Yes
Sterile	Same aspredicate device.	Ethylene oxide	Ethylene oxide	Ethylene oxide
Shelf Life	Same aspredicate device.	5 years	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.

Performance Test (In-Vitro) 1.
- 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
1. Performance Test (Chronic)

Chronic animal study performed to evaluate the performance of the subject device and the reference device shows no differences in healing metrics or anastomotic index, and the results demonstrate that the acceptance criteria were met.

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 (K202507 and K221005) 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.