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

Device Description

The AEON Endoscopic Powered Stapler system is composed of the AEON Endoscopic Powered Stapler Handle ("Powered Handle") and AEON Endoscopic Stapler Reloads ("Reloads"). The AEON Endoscopic Powered Stapler places two, triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The Powered Handle may be reloaded and fired up to 20 times in a single procedure. The Powered Handle is available in three different lengths (60mm, 160mm and 260mm) and the Reloads are available in multiple staple sizes to accommodate various tissue thicknesses.

The AEON Endoscopic Powered Stapler uses software to control the operation of the stapler and is AC powered. The device is sterile packaged and is labeled for single use.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the AEON™ Endoscopic Powered Stapler focuses on demonstrating substantial equivalence to predicate devices, primarily for an expanded indication to include thoracic applications. However, it does not contain the detailed information typically found in a study report proving a device meets specific acceptance criteria, especially for AI/ML-driven devices.

Based on the provided text, here's an analysis of the acceptance criteria and the study that supports it, with the caveat that many details commonly sought for AI/ML device evaluations are not present in this document.

Acceptance Criteria and Study for AEON™ Endoscopic Powered Stapler (Thoracic Applications)

The core "acceptance criteria" discussed in this document revolve around demonstrating substantial equivalence for the expanded indication of "thoracic surgery." This implies that the device, when used for this new application, performs safely and effectively without raising new questions of safety or efficacy. Since the device itself is a mechanical surgical stapler with software control, the criteria are likely related to the mechanical performance and clinical outcomes.

The document explicitly states that the expanded Indications for Use for thoracic applications are supported by real-world evidence data.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary for a mechanical device with software control, the "acceptance criteria" are implied by the claim of substantial equivalence and the successful real-world evidence for thoracic applications. Specific quantitative performance metrics typical for AI/ML (e.g., sensitivity, specificity, AUC) are not directly stated. Instead, the acceptance criteria are implicitly that the device is "safe and effective for use for thoracic applications" without adverse events or performance issues that would preclude clearance.

Acceptance Criterion (Implied)	Reported Device Performance (Summary of Real-world Evidence)
Safety for Thoracic Applications	The real-world evidence data concluded that the device is safe for use for thoracic applications.
Effectiveness for Thoracic Applications	The real-world evidence data concluded that the device is effective for use for thoracic applications.
No new questions of safety/efficacy	The submission aims to demonstrate substantial equivalence, implying no new safety or efficacy concerns compared to the predicate/reference devices for this expanded indication.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample size (number of patients, procedures, or stapler uses) used in the real-world evidence data.
Data Provenance: The data is described as "Real-world evidence data." The document does not specify the country of origin of this data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For a surgical stapler's clinical performance, "ground truth" would typically relate to clinical outcomes assessed by surgeons or other medical professionals.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described. This type of study is typically relevant for diagnostic imaging AI systems where human readers interpret images with or without AI assistance. The AEON™ Endoscopic Powered Stapler is a surgical instrument, not a diagnostic AI. The document states "human factors testing is not applicable to support the expanded Indications for Use," further indicating that comparative studies with human action are not central to this particular clearance process.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

The device is a powered surgical stapler that uses software to control its operation. While the software itself might have undergone standalone validation, the performance described (safety and effectiveness for thoracic applications) would inherently involve the device operating with a human surgeon in the loop. A standalone "algorithm only" performance in the context of surgical stapling would be largely meaningless without the mechanical components and user interaction. The document implies that the device's overall performance, including its software-driven functions, was evaluated in real-world use for thoracic applications.

7. The Type of Ground Truth Used

For "real-world evidence data" supporting the safety and effectiveness of a surgical stapler for thoracic applications, the ground truth would most likely be derived from:

Clinical Outcomes Data: This would include metrics like incidence of staple line failure, leaks, bleeding, tissue trauma, successful resection/transection, complication rates, and patient recovery within a thoracic surgical context.
Surgeon Assessments: Evaluations by operating surgeons regarding ease of use, stapler performance, and observed tissue response.

The document does not explicitly state the specific type of ground truth, but these are the most probable types for this device and its application.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of the expanded indications or real-world evidence. This is expected given that the clearance is for a mechanical device with software control, not an AI/ML diagnostic algorithm that typically relies on extensive training data. The software within the stapler likely has deterministic control logic rather than learning algorithms that require large training datasets in the typical AI sense.

9. How the Ground Truth for the Training Set was Established

Since a "training set" is not mentioned or described in the context of the device's software learning or the expanded indications, the method for establishing its ground truth is not applicable here. The software control functions were likely verified and validated through a design control process, not machine learning model training.

Summary

FDA 510(k) Clearance Letter - AEON™ Endoscopic Powered Stapler

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 11, 2025

Lexington Medical, Inc.
Sharon Timberlake
Head of Global Regulatory Affairs & Quality
23 Crosby Drive
Bedford, Massachusetts 01730

Re: K251482
Trade/Device Name: AEON™ Endoscopic Powered Stapler
Regulation Number: 21 CFR 878.4740
Regulation Name: Surgical Stapler
Regulatory Class: Class II
Product Code: GAG, GDW
Dated: May 9, 2025
Received: May 14, 2025

Dear Sharon Timberlake:

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 (the 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 available 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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K251482 - Sharon Timberlake
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251482 - Sharon Timberlake
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assistance/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,

TEK N. LAMICHHANE -S

Tek N. Lamichhane, Ph.D.
Assistant Director
DHT4B: Division of Plastic and Reconstructive 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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K251482

Device Name: AEON™ Endoscopic Powered Stapler

Indications for Use (Describe)

The AEON™ Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection and resection 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

Traditional 510(k) Premarket Notification

AEON™ Endoscopic Powered Stapler

510(k) Summary

K251482

This 510(k) Summary is prepared in accordance with the requirements of 21 CFR 807.92

1. Date Prepared

July 11, 2025

2. Submitter & 510(k) Owner Information

Submitter: Lexington Medical, Inc.
23 Crosby Drive
Bedford, Massachusetts 01730

Official Correspondent: Sharon L. Timberlake, MSHS, RAC, CCRA
Head of Global Regulatory Affairs & Quality
Telephone: (617) 957-1434
Email: sharon.timberlake@lexington-med.com

3. Device Information

Trade Name: AEON™ Endoscopic Powered Stapler
Common Name: Surgical Stapler
Classification Name: Implantable Staple, Surgical Stapler
Regulation Number: 21 CFR 878.4740, 21 CFR 878.4750
Regulation Class: II
Primary Product Code: GAG
Secondary Product Code: GDW

4. Predicate & Reference Device Identification

Predicate Device

Trade Name: AEON™ Endoscopic Stapler
510(k) Number: K222210
Common Name: Surgical Stapler
Classification Name: Implantable Staple, Surgical Stapler
Regulation Number: 21 CFR 878.4740, 21 CFR 878.4750
Regulation Class: II
Primary Product Code: GAG
Secondary Product Code: GDW

Reference Device

Trade Name: AEON™ Endoscopic Powered Stapler
510(k) Number: K234039
Common Name: Surgical Stapler
Classification Name: Implantable Staple, Surgical Stapler
Regulation Number: 21 CFR 878.4740, 21 CFR 878.4750
Regulation Class: II
Primary Product Code: GAG
Secondary Product Code: GDW

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Traditional 510(k) Premarket Notification

AEON™ Endoscopic Powered Stapler

5. Device Description

The AEON Endoscopic Powered Stapler uses software to control the operation of the stapler and is AC powered. The device is sterile packaged and is labeled for single use.

6. Indications for Use

7. Technological Characteristics Compared to the Predicate

Surgical stapling is the technological principle for both the subject and the predicate device. Just like its predicate and reference devices, the AEON Endoscopic Powered Stapler is used in surgical procedures to staple and cut tissue for resection, transection, and creation of anastomoses. The same Reloads are attached to the subject device, predicate device and reference device for use in all surgical applications. There are no changes to the Powered Handle product specifications when compared to its predicate as a result of the expanded Indications for Use. The subject device and predicate device both share the expanded indications to include thoracic applications.

Item	AEON Endoscopic Powered Stapler (Subject Device)	AEON Endoscopic Stapler (Predicate Device)	AEON Endoscopic Powered Stapler (Reference Device)	SE
510(k) Number	Not Assigned	K222210	K234039	Yes
Product Code	GAG, GDW	GAG, GDW	GAG, GDW	Yes
Regulation Number	878.4750, 878.4740	878.4750, 878.4740	878.4750, 878.4740	Yes
Classification	II	II	II	Yes

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Traditional 510(k) Premarket Notification

AEON™ Endoscopic Powered Stapler

Item	AEON Endoscopic Powered Stapler (Subject Device)	AEON Endoscopic Stapler (Predicate Device)	AEON Endoscopic Powered Stapler (Reference Device)	SE
Indications for Use/ Intended Use	The AEON™ Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.	The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.	The AEON™ Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, and pediatric surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.	Yes
Reload Features
Tissue Stop	Tissue Stop	Tissue Stop	Tissue Stop	Yes
Anvil	Anvil	Anvil	Anvil	Yes
Cut Line	Cut Line	Cut Line	Cut Line	Yes
Knife	Knife	Knife	Knife	Yes
Cartridge	Cartridge	Cartridge	Cartridge	Yes
Operation Principle	Powered	Manual	Powered	Yes
Contains Software	Yes	No	Yes	Yes
Cutting Mechanism	Linear Knife	Linear Knife	Linear Knife	Yes
Cutting Length (mm)	26, 41, 56	26, 41, 56	26, 41, 56	Yes
Open Staple Height (mm)	2.0, 2.5, 3.25, 4.0, 5.0	2.0, 2.5, 3.25, 4.0, 5.0	2.0, 2.5, 3.25, 4.0, 5.0	Yes
Closed Staple Height (mm)	0.75, 1.0, 1.5, 1.8, 2.2	0.75, 1.0, 1.5, 1.8, 2.2	0.75, 1.0, 1.5, 1.8, 2.2	Yes
Single-Use	Yes	Yes	Yes	Yes
Sterilization Method	EO Sterilized	EO Sterilized	EO Sterilized	Yes

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Traditional 510(k) Premarket Notification

AEON™ Endoscopic Powered Stapler

8. Performance Data

Bench and Animal

Non-clinical testing (bench and animal) was not required to support the expanded Indications for Use. The subject device is identical to the reference device (K234039) in design, technological characteristics, materials, software, IEC/EMC electrical requirements, packaging and performance characteristics. Therefore, additional biocompatibility testing, sterilization validation, software validation, electrical safety and IEC/EMC testing are not required since this information has been previously reviewed in K234039. Also, MR safety information is unchanged.

The subject device and its reference device share the exact same principles of operation along with Instructions for Use and product labeling. As a result, human factors testing is not applicable to support the expanded Indications for Use.

Real-world Clinical Evidence

Real-world evidence data was provided to support the expanded Indications for Use of the subject device. The real-world evidence addressed the safety and effectiveness of the AEON™ Endoscopic Powered Stapler specific to thoracic applications. The results of the data conclude that the device is safe and effective for use for thoracic applications.

9. Conclusions

The subject device and predicate device have the same intended use and principles of operation. The subject device, predicate device and reference device utilize the same Reloads to perform their intended use. The expanded Indications for Use, namely to include thoracic applications, is supported by real-world evidence data to demonstrate substantially equivalent safety and effectiveness of the subject device when used in thoracic applications.

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.