The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, thoracic and urologic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.

Device Description

The AEON™ Endoscopic Stapler places two triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The size of the staples and staple line length are based on the selection of the Stapler Reload.

This 510(k) revises the labeling, including indications, contraindications, and warnings, for the AEON Endoscopic Stapler.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AEON™ Endoscopic Stapler. The submission aims to revise the labeling of the existing device, specifically expanding its indications for use.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria for the AEON™ Endoscopic Stapler in the context of expanding its indications. Instead, the performance data section focuses on "safety and effectiveness" as the overarching goal for the revised labeling.

Acceptance Criteria (Implied)	Reported Device Performance
Safety for use in liver, spleen, and pancreas	No complications associated with the AEON™ Endoscopic Stapler in these organs.
Effectiveness for use in liver, spleen, and pancreas	No complications associated with the AEON™ Endoscopic Stapler in these organs.
Substantial equivalence to predicate device	The proposed device is demonstrated to be as safe and as effective as the predicate device based on performance testing, intended use, and technological characteristics. The only difference is modified labeling.

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

Sample Size: The document does not specify an exact numerical sample size for the retrospective clinical studies. It vaguely refers to "the results of the retrospective clinical studies."
Data Provenance: The studies are described as "retrospective clinical studies." There is no mention of the country of origin.

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

The document does not provide information about the number or qualifications of experts used to establish ground truth for the retrospective clinical studies.

4. Adjudication method for the test set:

The document does not mention any adjudication method for the retrospective clinical studies.

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:

This is not applicable as the device is a mechanical stapler, not an AI-assisted diagnostic tool or an imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is mentioned or relevant.

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

This is not applicable as the device is a mechanical stapler.

7. The type of ground truth used:

For the retrospective clinical studies, the ground truth appears to be outcomes data in terms of observed complications or lack thereof during real-world surgical use. The statement "no complications associated with the AEON™ Endoscopic Stapler" suggests that the absence of adverse events served as the evidence for safety and effectiveness in the expanded indications.

8. The sample size for the training set:

This is not applicable as a training set is typically associated with machine learning or AI models. The studies described are retrospective clinical studies of a mechanical device.

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

This is not applicable for the reasons mentioned in point 8.

Summary

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April 21, 2023

Lexington Medical Inc. Rainer Maas Director of QA/RA 23 Crosby Drive Bedford, Massachusetts 01730

Re: K222210

Trade/Device Name: AEON Endoscopic Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: March 17, 2023 Received: March 17, 2023

Dear Rainer Maas:

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,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.04.21 08:07:48 -04'00'

Mark Trumbore, Ph.D. 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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Indications for Use

510(k) Number (if known) K222210

Device Name AEON™ Endoscopic Stapler

Indications for Use (Describe)

The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses. The instrument may also be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney, and spleen.

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

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Submitter Information

Lexington Medical, Inc. 23 Crosby Drive Bedford, Massachusetts 01730 USA

2. Contact Person

Rainer Maas Position: Director of QA/RA Tel: +1 978-273-1946 Email: rainer@lexington-med.com

3. Date Prepared

03/16/2023

4. Proposed Device Identification

Device Name: AEON™ Endoscopic Stapler Device Common Name: Stapler Classification Name: Staple, Implantable Classification Regulation: 21 CFR 878.4750, 21 CFR 878.4740 Device Class: II Classification Panel: General & Plastic Surgery Primary Product Code: GAG Secondary Product Code: GDW

5. Predicate Device Identification

510(k) Number: K201882 Product Name: AEON™ Endoscopic Stapler Manufacturer: Lexington Medical Inc.

Predicate Device:

510(k) Number: K201882 Product Name: AEON™ Endoscopic Stapler Manufacturer: Lexington Medical, Inc.

Reference Device:

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510(k) Number: K163454 Product Name: The ENDOPATH ECHELON and ECHELON FLEX families of endoscopic linear cutters and reloads Manufacturer: Ethicon Endo-surgery, LLC

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6. Device Description

This 510(k) revises the labeling, including indications, contraindications, and warnings, for the AEON Endoscopic Stapler.

7. Indications For Use

8. Technological Characteristics

The AEON™ Endoscopic Stapler is identical to the predicate device with the exception of modified labeling.

	Proposed Device	Predicate Device
ITEM	AEON Endoscopic Stapler	AEON Endoscopic StaplerK201882 (currently marketeddevice)
Product Code	GAG, GDW	GDW
Regulation No.	21 CFR 878.475021 CFR 878.4740	21 CFR 878.4750
Class	II	II
Indications for Use	The AEON™ EndoscopicStapler has applications ingeneral, abdominal,gynecologic, pediatric, andthoracic for resection,transection, and creation ofanastomoses. The instrumentmay be used for transection andresection of liver substance,hepatic vasculature, biliarystructures, pancreas, kidney andspleen.	The AEON™ EndoscopicStapler has applications ingeneral, abdominal,gynecologic, pediatric, andthoracic surgery for resection,transection, and creation ofanastomoses.
Configuration	Same	Tissue Stop
		Anvil
		Cut Line
		Blade
		Cartridge
Operation Principle	Same	Manual

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Cutting Mechanism	Same	Linear Knife
Suture Length	Same	30, 45, 60mm
Open Staple Height	Same	2.0, 2.5, 3.25, 4.0, 5.0mm
Staple Material	Same	Titanium
Stapler Materials	Stainless Steel, Polycarbonate	Stainless Steel, Polycarbonate
Single Patient Use &Disposable	Same	Yes
Labeling	Conforms to 21 CFR Part 801	Conforms to 21 CFR Part 801

9. Performance Data

A combination of real-world evidence and published clinical studies was provided to support the revised labeling.

The real-world evidence addressed the safety and effectiveness of the AEON™ Endoscopic Stapler in the liver, spleen, and pancreas. The results of the retrospective clinical studies show no complications associated with the AEON™ Endoscopic Stapler thus concluding the device safe and effective for use in expanded indications.

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10. Conclusion

The proposed device, the AEON™ Endoscopic Stapler, is demonstrated to be as safe and as effective as the predicate device based on performance testing, intended use, and technological characteristics.

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.