The circular stapler with DST Series™ Technology has application throughout the alimentary tract for the creation of endto-end, end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

Device Description

The Autosuture™ EEA™ Stapler is a manual, single-use device that places a circular. double staggered row of titanium staples and resects 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.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) submission regarding the acceptance criteria and study information for the Autosuture™ EEA™ Stapler.

It's important to note that this document is a 510(k) summary, which often does not include detailed study results or raw data. Instead, it summarizes the equivalence claims based on testing.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing Summary)

The provided document does not explicitly list quantitative acceptance criteria in a table format with corresponding reported performance values for each criterion. The non-clinical testing section lists various tests performed to demonstrate substantial equivalence, implying that the device met the internal acceptance criteria for these tests.

Implied Acceptance Criteria and Performance (Extracted from Non-Clinical Testing List):

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied)
Usability Engineering	Met requirements per IEC 62366-1:2015 +AMD1:2020
MRI Safety: RF Induced Heating	Met requirements per ASTM F2182-19
MRI Safety: Magnetically Induced Displacement Force	Met requirements per ASTM F2052-21
MRI Safety: Magnetically Induced Torque	Met requirements per ASTM F2213-17
MRI Safety: MR Image Artifacts	Met requirements per ASTM F2119-07
Staple Formation	Demonstrated satisfactory formation
Firing Force	Demonstrated satisfactory force within specifications
Staple Line Strength	Demonstrated satisfactory strength
Staple Line Integrity	Demonstrated satisfactory integrity
In-vivo Staple Line Hemostasis	Demonstrated satisfactory hemostasis
Biocompatibility	Met requirements per ISO 10993-1
Sterilization	Met requirements per ISO 11135
Stability/Shelf-life	Demonstrated satisfactory stability/shelf-life

Study Proving Acceptance Criteria:

The studies proving the device meets these implied acceptance criteria are the non-clinical tests listed, which were performed by Covidien. The document states:
"Testing demonstrated that the subject device, Autosuture™ EEA™ Stapler, is substantially equivalent to the predicate devices..."

Detailed Study Information:

Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for the non-clinical tests conducted. These details are typically found in the full test reports, not the 510(k) summary. Given the nature of these engineering and materials tests, they are inherently "prospective" as new tests were conducted on the subject device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable to the type of non-clinical testing described. These tests involve engineering measurements (e.g., force, material properties, sterility, biocompatibility) rather than expert interpretation of medical data (like radiology images). The "ground truth" for these types of tests is established by industry standards (ASTM, ISO, IEC) and the test methodologies themselves.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable to the non-clinical testing described. Adjudication methods like 2+1 are used for expert consensus on subjective medical assessments, which is not the nature of these engineering tests.
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, an MRMC comparative effectiveness study was not done. This device is a manual surgical stapler, not an AI-powered diagnostic or assistive tool for human readers.
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 mechanical surgical stapler and does not involve an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" is defined by established engineering and biological standards and specifications (e.g., ASTM F2182-19 for RF heating, ISO 10993-1 for biocompatibility). The device performance is measured against these objective, predefined criteria.
The sample size for the training set
- This question is not applicable. There is no "training set" as this is a mechanical medical device, not a machine learning or AI model.
How the ground truth for the training set was established
- This question is not applicable for the same reason as above; there is no training set for this type of device.

Summary of Device and Evidence Strategy:

The Autosuture™ EEA™ Stapler is a traditional mechanical surgical device. The submission strategy for its 510(k) clearance is based on substantial equivalence to previously cleared predicate devices (Autosuture™ Circular EEA Surgical Stapler K062850 and EEA Circular Stapler with Tri-Staple Technology K221005).

The primary evidence provided focuses on non-clinical performance testing to demonstrate that the subject device performs as safely and effectively as the predicate devices and meets relevant engineering, material, and safety standards. The document explicitly states, "This submission does not require clinical testing," reinforcing that the equivalence is established through physical and mechanical characteristic comparisons and associated test results, rather than clinical trials comparing patient outcomes.

Summary

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September 30, 2022

Covidien Sanja Jahr Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473

Re: K221003

Trade/Device Name: Autosuture EEA Stapler (DST Serie EEA Stapler) Regulation Number: 21 CFR 878.4740 Regulation Name: Surgical Stapler Regulatory Class: Class II Product Code: GAG, GDW Dated: August 5, 2022 Received: August 8, 2022

Dear Sanja Jahr:

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 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 (OS) 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/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.

Mark Trumbore Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Autosuture™ EEATM Surgical Stapler

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a lighter blue cross in the center, and the word "COVIDIEN" in blue, sans-serif font to the right of the square. The logo is simple and modern, and the colors are calming and professional.

Section 5: 510(k) Summary

Date Prepared:

August 5, 2022

Submitter:

Sanja Jahr Covidien 60 Middletown Avenue North Haven, CT 06473, USA Principal Regulatory Affairs Specialist 203-492-8415 sanja.jahr@medtronic.com

Alternate contact:

Angela Van Arsdale Covidien 60 Middletown Avenue North Haven, CT 06473, USA Sr. Regulatory Affairs Manager 203-492-5787 angela.vanarsdale@medtronic.com

Subject Device:

Proprietary/Trade Name:

Classification Name: Regulations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:
Autosuture™ EEA™ Stapler (DST Series™ EEA™ Stapler) Staple, Implantable and Stapler, Surqical 21 CFR 878.4750 and 21 CFR 878.4740 GDW. GAG 79 Class II General and Plastic Surgery Stapler with implantable staple

Primary Predicate Device:

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

Autosuture™ Circular EEA Surgical Stapler K062850 Staple, Implantable 21 CFR 878.4750 GDW, GAG 79 Class II General and Plastic Surgery Stapler with implantable staple

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Image /page/4/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a white rectangle inside and a light blue vertical line running through the center. To the right of the square is the word "COVIDIEN" in a bold, sans-serif font, also in blue.

Additional Predicate Device:

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

EEA Circular Stapler with Tri-Staple Technology K221005, K202507, K192330, K172361 Staple, Implantable 21 CFR 878.4750 GDW 79 Class II General and Plastic Surgery Stapler with implantable staple

Device Description:

The Autosuture™ EEA™ Stapler is a manual, single-use device that places a circular. double staggered row of titanium staples and resects excess tissue. It has 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.

Indications for Use:

The 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.

Technological Characteristics:

In regards to intended use, material, design, and operational principles, the subject device, Autosuture™ EEA™ Stapler, is identical to the predicate Autosuture™ EEA™ Stapler (K062850).

Non-clinical testing:

The below non-clinical testing was performed.

. Application of usability engineering to medical devices per IEC 62366-1:2015 +AMD1:2020
Standard Test Method for Measurement of Radio Frequency Induced Heating On . or Near Passive Implants During Magnetic Resonance Imaging per ASTM F2182-19
Standard Test Method for Measurement of Magnetically Induced Displacement . Force on Medical Devices in the Magnetic Resonance Environment per ASTM F2052-21
Standard Test Method for Measurement of Magnetically Induced Torque on . Medical Devices in the Magnetic Resonance Environment per ASTM F2213-17
Standard Test Method for Evaluation of MR Image Artifacts from Passive ● Implants per ASTM F2119-07
. Staple formation
Firing force
Staple line strength
Staple line integrity ●
In-vivo staple line hemostasis ●

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Image /page/5/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white square inside, and a blue vertical line running through the center. To the right of the square is the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional.

Biocompatibility per ISO 10993-1 .
. Sterilization per ISO 11135
Stability/Shelf-life

Testing demonstrated that the subject device, Autosuture™ EEA™ Stapler, is substantially equivalent to the predicate devices, Autosuture™ Circular EEA Surgical Stapler and EEA Circular Stapler with Tri-Staple Technology (K062850 and K221005, respectively).

Clinical Testing:

This submission does not require clinical testing.

Conclusion:

Based upon the supporting data summarized above, the subject device, Autosuture™ EEA™ Stapler, is substantially equivalent to the predicate devices, Autosuture™ Circular EEA Surgical Stapler and EEA Circular Stapler with Tri-Staple Technology.

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.