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 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 triple-staggered 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.

AI/ML Overview

The provided text describes the AEON Endoscopic Powered Stapler and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria and study results in the format requested.

Specifically, the document lists various performance tests conducted (e.g., staple height and formation, staple line strength, ex-vivo leak-burst pressure testing, software verification and validation, animal testing for hemostasis, human factors testing, electrical safety, EMC, biocompatibility, sterilization, packaging, and shelf-life validations). However, it does not provide a table of specific acceptance criteria or reported device performance against those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them with the specified details. The document states that "The results of testing and evaluation listed above demonstrate that the subject AEON Endoscopic Powered Stapler is substantially equivalent to the predicate device," but it does not expand on the quantitative results or specific conditions.

Here's what I can extract from the provided text, and what is missing:

What is (partially) available in the text:

1. A table of acceptance criteria and the reported device performance: This is not provided in the text. The document lists types of tests performed but not the specific criteria or quantitative results.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the listed tests.
- Data Provenance:
  - "Animal testing was performed to assess In vivo confirmation of staple line hemostasis..." (Implies animal data).
  - "Human Factors testing was executed..." (Implies human user data).
  - Other tests are non-clinical (e.g., bench testing, software V&V).
  - Country of origin for data is not mentioned.
  - Retrospective or prospective nature of data is not specified.
3. 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): Not mentioned in the provided text for any test.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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: Not applicable, as this device is a surgical stapler, not an AI-assisted diagnostic tool for "human readers." Human factors testing was performed but not in an MRMC comparative effectiveness study context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is an "Endoscopic Powered Stapler" which is a physical surgical tool controlled by software. Software verification and validation testing was done for the algorithm, but this isn't a standalone diagnostic algorithm in the typical sense of this question. Its performance is integrated into the device's function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For "Staple line hemostasis," the ground truth was assessed in vivo in animal testing, implying direct observation of physiological outcomes.
- For other non-clinical tests (e.g., staple height, strength, leak-burst), the ground truth would be physical measurements and engineering specifications.
8. The sample size for the training set: Not applicable, as this is hardware with integrated software, not a machine learning model that requires a "training set" in the common understanding. Software verification and validation primarily involve testing against requirements rather than training on data.
9. How the ground truth for the training set was established: Not applicable for the same reason as point 8.

In summary, the provided FDA 510(k) clearance letter and summary discuss the device and the types of non-clinical, software, animal, and human factors testing performed to demonstrate substantial equivalence, but it does not elaborate on the specific acceptance criteria, quantitative performance results, or detailed methodologies of these studies as requested. These details would typically be found in the manufacturer's full 510(k) submission, which is more comprehensive than the publicly available summary.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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: (617) 209-9817

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 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 EndoscopicPowered Stapler	AEON EndoscopicStapler	The ECHELONENDOPATH / ECHELONFLEX
ITEM	Subject Device(K234039)	Predicate Device(K222210)	Reference Device (K163454)	SE
510(k)Number	K234039	K222210	K163454	Yes
Product Code	GDW, GAG	GDW, GAG	GDW	Yes
RegulationNo.	878.4750, 878.4740	878.4750, 878.4740	878.4750	Yes
Class	II	II	II	Yes
	AEON EndoscopicPowered Stapler	AEON EndoscopicStapler	The ECHELONENDOPATH / ECHELON
			FLEX
ITEM	Subject Device(K234039)	Predicate Device(K222210)	Reference Device (K163454)	SE
Indicationsfor Use	The AEON EndoscopicPowered Stapler hasapplications in general,abdominal,gynecologic, andpediatric surgery forresection, transection,and creation ofanastomoses. Theinstrument may be usedfor transection andresection of liversubstance, hepaticvasculature, biliarystructures, pancreas,kidney and spleen.	The AEON EndoscopicStapler has applicationsin general, abdominal,gynecologic, pediatric,and thoracic surgery forresection, transection,and creation ofanastomoses. Theinstrument may also beused for transection andresection of liversubstance, hepaticvasculature, biliarystructures, pancreas,kidney, and spleen.	The ENDOPATH ECHELON andECHELON FLEX families ofEndoscopic Linear Cutters andReloads are intended fortransection, resection, and/orcreation of anastomoses. Theinstruments have application inmultiple open or minimallyinvasive general, gynecologic,urologic, thoracic, and pediatricsurgical procedures. They can beused for staple line or tissuebuttressing materials. Theinstruments may also be used fortransection and resection of liverparenchyma (hepatic vasculatureand biliary structures), pancreas,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
OperationPrinciple	Powered	Manual	Powered	Yes
CuttingMechanism	Linear Knife	Linear Knife	Linear Knife	Yes
CuttingLength	26, 41, 56mm	26, 41, 56mm	42, 53mm	Yes
Open StapleHeight	2.0, 2.5, 3.25, 4.0,5.0mm	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 StapleHeight	0.75, 1.0, 1.5, 1.8,2.2mm	0.75, 1.0, 1.5, 1.8, 2.2mm	0.75, 1.0, 1.5, 1.8, 2.0, 2.3mm	Yes
Single PatientUse	Yes	Yes	Yes	Yes
SterilizationMethod	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.

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.