The EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™ transoral circular stapler anvil 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.

Device Description

The EEA™ circular stapler with Tri-Staple™ technology and OrVil™ Transoral Circular Stapler Anvil is a manual, single-use device that places a circular, triple staggered row of titanium staples and resects the excess tissue. It 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 subject device is to add new product models with OrVil™ transoral circular stapler anvil to EEA™ circular stapler with Tri-Staple™ technology 21mm or 25mm XL purple or black stapler.

AI/ML Overview

This document describes the premarket notification (510(k)) for the EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil. It is a medical device, specifically a surgical stapler. The provided text, however, does not contain information about software, AI algorithms, or a study involving human readers' improvement with AI assistance.

Therefore, many of the requested points regarding acceptance criteria and study details for an AI-based device, such as sample sizes for test and training sets, expert qualifications, ground truth establishment for AI models, and MRMC studies, cannot be extracted from this document.

The document primarily focuses on demonstrating the substantial equivalence of this new device to previously cleared predicate devices through non-clinical performance data and usability evaluation.

Here's what can be extracted based on the provided text, while acknowledging the limitations for an AI-related request:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

Given that this is a mechanical surgical stapler and not an AI-driven device, the "acceptance criteria" here refer to the successful completion of various performance and safety tests to demonstrate substantial equivalence to predicate devices, rather than AI performance metrics (e.g., sensitivity, specificity).

Acceptance Criteria (based on tests performed)	Reported Device Performance (Implied as "passed" for substantial equivalence)
Performance Test (In-Vitro):
Visual/Packaging Inspection	Deemed acceptable
IFU Walkthrough	Deemed acceptable
Firing Force on Red-Skin Foam Test	Met pre-defined specifications (implied, as substantial equivalence concluded)
Staple Formation on Red-Skin Foam	Met pre-defined specifications (implied, as substantial equivalence concluded)
Suture Break Test	Met pre-defined specifications (implied, as substantial equivalence concluded)
Pulling Guide Suture Reel Removal	Met pre-defined specifications (implied, as substantial equivalence concluded)
Proximal Guide Suture Break Test	Met pre-defined specifications (implied, as substantial equivalence concluded)
Removing Guide Suture from Anvil Test	Met pre-defined specifications (implied, as substantial equivalence concluded)
Removal Force with Suture Cut in 1 leq	Met pre-defined specifications (implied, as substantial equivalence concluded)
Retention Break Force	Met pre-defined specifications (implied, as substantial equivalence concluded)
Insertion Force of Accessory Tube Fitting	Met pre-defined specifications (implied, as substantial equivalence concluded)
Retention Force of Accessory Tube Fitting	Met pre-defined specifications (implied, as substantial equivalence concluded)
Performance Test (Ex-Vivo):
Ex-vivo Rectum Firing	Met pre-defined specifications (implied, as substantial equivalence concluded)
Knife Cut Evaluation	Met pre-defined specifications (implied, as substantial equivalence concluded)
Anastomotic Leak/Burst Pressure Test	Met pre-defined specifications (implied, as substantial equivalence concluded)
Performance Test (In-Vivo):
Leak Evaluation	Met pre-defined specifications (implied, as substantial equivalence concluded)
Staple Formation	Met pre-defined specifications (implied, as substantial equivalence concluded)
Hemostasis	Met pre-defined specifications (implied, as substantial equivalence concluded)
Sterilization Assessment (ISO 11135)	Compliant
Stability Test (for single-use device)	Compliant
Biocompatibility Tests (ISO 10993-1)	Compliant
Usability Evaluation (IEC 62366-1:2015+AMD1:2020)	Safe and effective for intended users, uses, and use environments (as stated)

Study Details (Relevant to this non-AI medical device submission)

Sample size used for the test set and the data provenance:
- The document mentions "non-clinical performance data" and a series of "Performance Test (In-Vitro)", "Performance Test (Ex-Vivo)", and "Performance Test (In-Vivo)". No specific sample sizes for these tests are provided.
- Data provenance (e.g., country of origin, retrospective/prospective) is not specified for these non-clinical tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the submission describes a mechanical device. The "ground truth" for this device would be engineering specifications and functional performance.
- For the usability study, "intended users (surgeons, nurses)" evaluated the device, but the number and qualifications beyond their professional roles are not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of device testing. Performance is measured against physical 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. This is not an AI-enabled device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI-enabled device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on established engineering specifications, ASTM or ISO standards for medical devices, and successful performance in the described in-vitro, ex-vivo, and in-vivo functional tests. For the usability study, it's based on subjective and objective feedback from intended users against safety and effectiveness criteria.
The sample size for the training set:
- Not applicable. This is not an AI device that undergoes training.
How the ground truth for the training set was established:
- Not applicable. This is not an AI device that undergoes training.

In summary: The provided document is a 510(k) summary for a traditional mechanical surgical stapler. It does not involve AI or any of the detailed study methodologies typically associated with AI/software medical device submissions. Therefore, most of the questions relating to AI performance, data sets, and expert evaluations cannot be answered from this text.

Summary

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August 16, 2023

Covidien Angela Van Arsdale Sr. Regulatory Affairs Manager 60 Middletown Ave North Haven, Connecticut 06473

Re: K232126

Trade/Device Name: EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: July 17, 2023 Received: July 17, 2023

Dear Angela Van Arsdale:

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.

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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 and Part 809: 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.

Mark Trumbore Digitally signed by Mark
Trumbore -S Date: 2023.08.16 10:36:28 -5 -04'00' Mark Trumbore, Ph.D.

Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team 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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Indications for Use:

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510(k) Summary

Transoral Circular Stapler Anvil

General and Plastic Surgery

GAG, GDW

Class II

TRIEEAXL21MTORVIL, TRIEEAXL21XTORVIL,

TRIEEAXL25MTORVIL, TRIEEAXL25XTORVIL

Stapler, Surgical and Staple, Implantable

21 CFR 878.4740 and 21 CFR 878.4750

Surqical stapler with implantable staples

Date Prepared:

July 17, 2023

Submitter:

Helen Chen Covidien Rooms 501, 502, 601, 602, No.3 building No.2388 Chen Hang Road Min Hang District, Shanghai, 201114, China Senior Requlatory Affairs Specialist Phone: +86 21 3323 0135 Email: helen.chen2@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: EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™

Proprietary/Trade Name:

Model Numbers:

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

Predicate Device:

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

Reference Device:

Proprietary/Trade Name: 510(k) Number:

EEATM Circular Stapler with Tri-Staple™ Technology K221771. K221005 Stapler, Surgical and Staple, Implantable 21 CFR 878.4740 and 21 CFR 878.4750 GAG. GDW 79 Class || General and Plastic Surgery Surgical stapler with implantable staples

DST Series™ EEA™ OrVil™ K093402

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

Staple. Implantable 21 CFR 878.4750 GDW 79 Class II General and Plastic Surgery Staple Anvil Accessory

Device Description:

OrVil™ Transoral Circular Stapler Anvil

The OrVil™ transoral circular stapler anvil comes with the anvil head secured in the tilted position. The anvil assembly is mounted on a 90 cm long PVC delivery tube and is secured to the tube with a retention suture. An advancing proximal guide suture is attached to the anvil assembly to facilitate proximal control. The advancing proximal guide suture is supplied in a reel and can be deployed as needed. When used with the EEA™ circular stapler with Tri-Staple™ technology 21mm or 25 mm XL purple or black stapler, a circular, three staggered row of titanium staples is placed. Immediately after staple formation, the stapler knife blade resects the excess tissue, creating a circular anastomosis. The diameter of the is 21 mm or 25 mm, depending on the device selected. The OrVil™ anvil is permanently affixed to the center rod and cannot be removed from the center rod. The 21mm and 25mm OrVil™ transoral circular stapler anvil is designed to be used with the corresponding 21mm or 25mm EEA™ circular stapler with Tri-Staple™ technology.

The OrVil™ Transoral Circular Stapler Anvil is essentially the same as the reference device DST Series™ EEA™ OrVil™ cleared under K093402.

EEA™ Circular Stapler with Tri-Staple™ Technology

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 diameter of the is determined by the selection of the 21 mm or 25mm stapler. The EEA™ circular stapler with Tri-Staple™ technology XL has a 35 cm shaft and is utilized with the OrVil™ transoral circular stapler anvil. 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 stapler is supplied without an anvil and the OrVil™ transoral circular stapler anvil packaged in a kit is utilized.

The stapler (without OrVil™ transoral circular stapler anvil part) is exactly the same as the predicate device EEA™ Circular Stapler with Tri-Staple™ Technology cleared under K221771 and K221005.

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Indications for Use:

Technological Characteristics:

The subject device EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil does not change the fundamental stapling technologies employed, intended use and indications for use when compared to the predicate device EEA™ circular stapler with Tri-Staple™ technology (K221771 and K221005). The subject device is adding the OrVil™ transoral circular stapler anvil to the predicate device. The OrVil™ transoral circular stapler anvil will allow the transoral delivery of the anvil to the surgical site for the creation of anastomosis.

Substantial Equivalence:

The subject device EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil are substantially equivalent to the legally marketed EEA™ Circular Stapler with Tri-Staple™ Technology since the addition of the OrVil™ transoral circular stapler anvil, does not alter the intended use, indications, or user environment of the device.

Reference Device:

In addition to the predicate device, DST Series™ EEA™ OrVil™ (K093402) was cited in this submission. Reference device (K093402) offering OrVil™ transoral circular stapler anvil was used in comparative performance testing as a control device.

Summary of Studies:

Non-clinical performance data such as performance testing has demonstrated substantial equivalence to the predicate device.

Tests performed to evaluate and compare technological and performance characteristics:

1. Performance Test (In-Vitro)
- Visual/Packaging Inspection ●
- IFU Walkthrough ●
- . Firing Force on Red-Skin Foam Test
- . Staple Formation on Red-Skin Foam
- . Suture Break Test
- . Pulling Guide Suture Reel Removal
- . Proximal Guide Suture Break Test
- . Removing Guide Suture from Anvil Test
- Removal Force with Suture Cut in 1 leq ●
- . Retention Break Force
- Insertion Force of Accessory Tube Fitting ●
- Retention Force of Accessory Tube Fitting ●
1. Performance Test (Ex-Vivo)
- Ex-vivo Rectum Firing ●
- Knife Cut Evaluation .
- Anastomotic Leak/Burst Pressure Test ●
1. Performance Test (In-Vivo)

CONFIDENTIAL

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Leak Evaluation .
Staple Formation .
. Hemostasis

Sterilization assessment per ISO 11135. Stability test for single use device.
Biocompatibility tests per ISO 10993-1 and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff Document, issued on September 4, 2020.

6. Usability

Usability evaluation in accordance with the established protocol following the requirements of IEC 62366-1:2015+AMD1:2020. Usability testing is done to allow intended users (surgeons, nurses) to evaluate the subject device in simulated use and observe or inquire about any concerns for patient safety or issues with efficacy. The subject device and its instructions for use have been found to be safe and effective for the intended users, uses, and use environments.

Conclusion:

Based upon the supporting data summarized above, Covidien concludes that the subject device EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil is substantially equivalent to the legally-marketed device (K221771, K221005) and does not raise different questions of safety and effectiveness when compared with the predicate device.

Regulation Number and Section

§ 878.4740 Surgical stapler.

(a) Surgical stapler for external use.
(1)
Identification. A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.(b) Surgical stapler for internal use.
(1)
Identification. A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.(2)
Classification. Class II (special controls). The special controls for this device are:(i) Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following:
(A) Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type;
(B) For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force;
(C) Measurement of staple line strength;
(D) Confirmation of staple line integrity; and
(E) In vivo confirmation of staple line hemostasis.
(ii) For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device.
(iii) For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed.
(iv) Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) Performance data must demonstrate the sterility of the device.
(vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling.
(viii) Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life.
(ix) Labeling of the device must include the following:
(A) Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity.
(B) Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including:
(
1 ) Avoidance of use of the stapler to staple tissue outside of the labeled limits for maximum and minimum tissue thickness;(
2 ) Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures;(
3 ) Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage;(
4 ) Avoidance of use of the stapler on the aorta;(
5 ) Establishing proximal control of blood vessels prior to stapling where practical and methods of blood vessel control in the event of stapler failure;(
6 ) Ensuring stapler compatibility with staples; and(
7 ) Risks specifically associated with the crossing of staple lines.(C) Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling.
(D) List of staples with which the stapler has been demonstrated to be compatible.
(E) Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device.
(F) Information regarding tissues on which the stapler is intended to be used.
(G) Identification of safety mechanisms of the stapler.
(H) Validated methods and instructions for reprocessing of any reusable device components.
(I) An expiration date/shelf life.
(x) Package labels must include critical information and technical characteristics necessary for proper device selection.