AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)

K234039 · Lexington Medical, Inc. · GAG · May 7, 2024 · General Hospital

Device Facts

• Record ID: K234039
• Device Name: AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)
• Applicant: Lexington Medical, Inc.
• Product Code: GAG · General Hospital
• Decision Date: May 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4740
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.

Device Story

AEON Endoscopic Powered Stapler is an endoscopic linear cutter and reload system; simultaneously cuts and staples tissue using two, triple-staggered rows of titanium staples. System comprises a powered handle and disposable reloads; handle is AC-powered and supports up to 20 firings per procedure. Used in OR settings by surgeons for resection, transection, and anastomosis creation. Software controls stapler operation. Device provides mechanical tissue transection and staple deployment; benefits include consistent staple formation and hemostasis. Single-use, sterile-packaged (EO).

Clinical Evidence

Bench testing only. Included staple height/formation, staple line strength/integrity, ex-vivo leak-burst pressure, articulation deflection, obstruction/lockout, functional lifecycle, and deployment pressure testing. Software verification/validation performed (enhanced documentation level). Animal testing conducted for in-vivo hemostasis confirmation. Human factors testing performed per FDA guidance. Electrical safety and EMC testing per IEC 60601-1 and IEC 60601-1-2. Biocompatibility, sterilization, packaging, and shelf-life validations completed.

Technological Characteristics

Powered endoscopic linear cutter; titanium staples; AC-powered; EO sterilization. Features include anvil, cut line, knife, and cartridge. Available in multiple handle lengths and staple sizes. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Software-controlled operation.

Indications for Use

Indicated for patients undergoing general, abdominal, gynecologic, or pediatric surgery requiring resection, transection, or creation of anastomoses, including procedures involving liver substance, hepatic vasculature, biliary structures, pancreas, kidney, and spleen.

Regulatory Classification

Identification

Surgical stapler for external use: A specialized prescription device used to deliver compatible staples to skin during surgery. Surgical stapler for internal use: A specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

Special Controls

*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.

Predicate Devices

• AEON Endoscopic Stapler (K222210)

Reference Devices

• ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm (K163454)

Submission Summary (Full Text)

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May 07, 2024

Lexington Medical, Inc. Sali Gully Sr. Regulatory Affairs Specialist 23 Crosby Drive Bedford, Massachusetts 01730

## Re: K234039

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: December 20, 2023 Received: December 21, 2023

Dear Sali Gully:

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.

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).

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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 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-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 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.

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-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Tek Tek N. N. Lamichhane -S Lamichhane -S Date: 2024.05.07
104'00' Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and 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

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# Indications for Use

510(k) Number (if known) K234039

Device Name AEON™ Endoscopic Powered Stapler

#### Indications for Use (Describe)

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 of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR Part 807.92, the following summary of information is provided:

## A. Submitter Information:

Sali Gully Sr. Regulatory Affairs Specialist Lexington Medical, Inc. 23 Crosby Drive Bedford, Massachusetts 01730, USA Telephone: [phone]

Date Prepared: May 7, 2024

## B. Device Information

| Trade or Proprietary 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 |

## C. Predicate Devices

510(k) number: K222210 Product Name: AEON Endoscopic Stapler Manufacturer: Lexington Medical Inc. Classification Name: Surgical Stapler, Implantable Staple Regulation Number: 21 CFR 878.4740, 21 CFR 878.4750 Product Code: GAG, GDW Regulation Class: II

## Reference Device

510(k) number: K163454 Product Name: ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm Manufacturer: ETHICON ENDO-SURGERY, LLC Classification Name: Implantable Staple Regulation Number: 21 CFR 878.4750 Product Code: GDW Regulation Class: II

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## D. Device Description

The AEON Endoscopic Powered Stapler system is an endoscopic linear cutter and reload system that simultaneously cut and staple tissue. The AEON Endoscopic Powered Stapler places two, triple-staggered rows of titanium staples while simultaneously transecting between the two triplestaggered rows of staples.

The AEON Endoscopic Powered Stapler system is composed of an AEON Endoscopic Powered Stapler Handle and the AEON Endoscopic Stapler Reloads. Multiple staple handle lengths and multiple staple sizes are available to accommodate various tissue thicknesses.

The AEON Endoscopic Powered Stapler uses software to control operation of the stapler and is AC powered. The device is sterile packaged (Ethylene Oxide) and single use. The AEON Endoscopic Powered Stapler Handle may be reloaded and fired up to 20 times in a single procedure.

## E. Indications for Use

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

## F. Technological Characteristics

Surgical stapling is the technological principle for both the subject and the predicate devices. Instrumentation is used for transection, and/or creation of anastomoses. Overall, the subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, indications, material composition, principle of operation, function, and packaging. Additionally, the reference device is used to support the performance testing for powered stapler applications.

| | AEON Endoscopic<br>Powered Stapler | AEON Endoscopic<br>Stapler | The ECHELON<br>ENDOPATH / ECHELON<br>FLEX | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| ITEM | Subject Device<br>(K234039) | Predicate Device<br>(K222210) | Reference Device (K163454) | SE |
| 510(k)<br>Number | K234039 | K222210 | K163454 | Yes |
| Product Code | GDW, GAG | GDW, GAG | GDW | Yes |
| Regulation<br>No. | 878.4750, 878.4740 | 878.4750, 878.4740 | 878.4750 | Yes |
| Class | II | II | II | Yes |
| | AEON Endoscopic<br>Powered Stapler | AEON Endoscopic<br>Stapler | The ECHELON<br>ENDOPATH / ECHELON | |
| | | | FLEX | |
| ITEM | Subject Device<br>(K234039) | Predicate Device<br>(K222210) | Reference Device (K163454) | SE |
| Indications<br>for Use | The AEON Endoscopic<br>Powered Stapler has<br>applications in general,<br>abdominal,<br>gynecologic, and<br>pediatric surgery for<br>resection, transection,<br>and creation of<br>anastomoses. The<br>instrument may be used<br>for transection and<br>resection of liver<br>substance, hepatic<br>vasculature, biliary<br>structures, pancreas,<br>kidney and spleen. | The AEON Endoscopic<br>Stapler has applications<br>in general, abdominal,<br>gynecologic, pediatric,<br>and thoracic surgery for<br>resection, transection,<br>and creation of<br>anastomoses. The<br>instrument may also be<br>used for transection and<br>resection of liver<br>substance, hepatic<br>vasculature, biliary<br>structures, pancreas,<br>kidney, and spleen. | The ENDOPATH ECHELON and<br>ECHELON FLEX families of<br>Endoscopic Linear Cutters and<br>Reloads are intended for<br>transection, resection, and/or<br>creation of anastomoses. The<br>instruments have application in<br>multiple open or minimally<br>invasive general, gynecologic,<br>urologic, thoracic, and pediatric<br>surgical procedures. They can be<br>used for staple line or tissue<br>buttressing materials. The<br>instruments may also be used for<br>transection and resection of liver<br>parenchyma (hepatic vasculature<br>and biliary structures), pancreas,<br>kidney and spleen. | Yes |
| Reload | Tissue Stop | Tissue Stop | Tissue Stop | Yes |
| Features | Anvil | Anvil | Anvil | Yes |
| | Cut Line | Cut Line | Cut Line | Yes |
| | Knife | Knife | Knife | Yes |
| | Cartridge | Cartridge | Cartridge | Yes |
| Operation<br>Principle | Powered | Manual | Powered | Yes |
| Cutting<br>Mechanism | Linear Knife | Linear Knife | Linear Knife | Yes |
| Cutting<br>Length | 26, 41, 56mm | 26, 41, 56mm | 42, 53mm | Yes |
| Open Staple<br>Height | 2.0, 2.5, 3.25, 4.0,<br>5.0mm | 2.0, 2.5, 3.25, 4.0, 5.0mm | 2.0, 2.6, 3.6, 3.8, 4.1, 4.2 mm | Yes |
| Closed Staple<br>Height | 0.75, 1.0, 1.5, 1.8,<br>2.2mm | 0.75, 1.0, 1.5, 1.8, 2.2mm | 0.75, 1.0, 1.5, 1.8, 2.0, 2.3mm | Yes |
| Single Patient<br>Use | Yes | Yes | Yes | Yes |
| Sterilization<br>Method | EO Sterilized | EO Sterilized | Gamma Sterilized | Yes |

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## G. Performance Data

Nonclinical testing was performed to demonstrate that the subject AEON Endoscopic Powered Stapler is substantially equivalent to predicate devices. The following testing or engineering rationale were provided in support of the substantial equivalence determination:

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- Staple height and formation -
- -Staple line strength
- Staple line integrity -
- Ex-vivo leak-burst pressure testing -
- -Articulation deflection
- -Obstruction and lockout testing
- -Functional lifecycle testing
- Deployment pressure -
- Design validation -

Software verification and validation testing was conducted, and software related documentation (enhanced documentation level) was provided per the FDA Guidance Document Content of Premarket Submissions for Device Software Functions.

Animal testing was performed to assess In vivo confirmation of staple line hemostasis in accordance with the FDA Guidance Document Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgerv.

Human Factors testing was executed in accordance with the FDA Guidance Document Applying Human Factors and Usability Engineering to Medical Devices.

Electrical safety and EMC testing were conducted on the subject device and the subject device complies with the IEC 60601-1 standard for safety and effectiveness and the IEC 60601-1-2 standard for EMC.

Additionally, biocompatibility of materials was assessed, and sterilization, packaging, distribution and shelf-life validations were executed.

The results of testing and evaluation listed above demonstrate that the subject AEON Endoscopic Powered Stapler is substantially equivalent to the predicate device.

## H. Conclusions

The comparison of intended use and technological characteristics along with the non-clinical data support the safety and performance of the device. The hardware and software verification and validation demonstrate that the AEON Endoscopic Powered Stapler performs as intended in the specified use conditions.