The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses.

Device Description

The AEON™ Endoscopic Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from a central line. The size of the staples and staple line length are based on the selection of the Stapler Reload open staple height and staple line length. The AEON™ Endoscopic Stapler handle and reload are sterile, single use devices.

The modification presented in this 510(k) is a change in the product Instructions for Use (IFU) labeling to add the following two (2) contraindications:

1. "The AEON™ Endoscopic Stapler is contraindicated for use on the heart, central circulatory system, or central nervous system."
1. "Do not use the AEON™ Endoscopic Stapler 2.0 mm staples on the aorta, any tissue that compresses to less than 0.75 mm in thickness, or any tissue that does not comfortably compress to 0.75 mm."
  This second contraindication is associated with the addition of an AEON Endoscopic Stapler reload staple height of 2.0mm and the compressed tissue thickness contraindication associated with this staple height.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modified AEON™ Endoscopic Stapler. The modification involves adding a 2.0mm open staple height reload and an associated contraindication. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K173443), rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML device.

However, based on the provided text, I can infer the "acceptance criteria" relate to the performance of the stapler itself, and the "study" is the nonclinical performance testing conducted.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with pass/fail values. It states that the device "meets all performance specification requirements" and "shows that all stapler reload sizes meet all performance specification requirements."

Acceptance Criteria (Inferred)	Reported Device Performance
Mechanical Performance:	All reload sizes met design specifications.
- Firing force within limits	Satisfactory
- Retraction force within limits	Satisfactory
- Proper formed staple shape	Satisfactory
Tissue Sealing Performance:	All reload sizes met design specifications.
- Suture line burst pressure (porcine intestine) meets specifications	Satisfactory
- Tensile strength of staple line meets specifications	Satisfactory
Substantial Equivalence:	The modified device performs as intended and is as safe and effective as the predicate device.

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

The document does not specify the exact sample sizes (e.g., number of stapler firings, number of tissue samples) for the nonclinical tests.

Test Set Sample Size: Not explicitly stated. The text mentions "Testing consisted of the following performance tests for each stapler reload size," implying tests were conducted across the range of available reload sizes, but the quantity within each test is not given.
Data Provenance: The tests were "nonclinical tests" conducted to verify design specifications. This implies laboratory or bench-top testing, not human or animal clinical data in this submission. There is no mention of country of origin for any data related to these specific tests.

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

Not applicable. This device is a mechanical stapler, and the "tests" were performance evaluations against engineering specifications. There is no mention of human expert-established ground truth in the context of diagnostic interpretation or similar, as would be common for AI/ML devices.

4. Adjudication Method for the Test Set

Not applicable. There was no need for adjudication as the data was from objective performance measurements rather than subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This submission does not include data from Clinical Studies."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a conceptual sense. The "performance data" presented is for the device itself ("algorithm only" if the device's function is considered its 'algorithm'), without human-in-the-loop performance measurement. The testing "verified that the proposed device is as safe and as effective as the predicate device, performs as intended, and meets all design specifications."

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical performance tests would be the pre-defined design specifications and engineering requirements for a surgical stapler. These specifications dictate acceptable ranges for firing force, staple formation, burst pressure, and tensile strength.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI/ML system that undergoes a "training set" process.

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

Not applicable. As this is not an AI/ML device, the concept of a "training set" and associated ground truth establishment does not apply. The device's design and manufacturing processes are based on established engineering principles and material science.

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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, with 'ADMINISTRATION' written in a smaller font size below it.

November 28, 2018

Lexington Medical, Inc. Mr. Douglas MacBride Management Representative 11 Executive Park Drive Billerica. Massachusetts 01862

Re: K182380

Trade/Device Name: AEON Endoscopic Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: August 29, 2018 Received: August 31, 2018

Dear Mr. MacBride:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cynthia Chang -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182380

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.

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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Section 3 - 510(k) Summary

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

1. Submitter Information

Lexington Medical, Inc. 11 Executive Park Drive Billerica, Massachusetts 01862 USA

2. Contact Person

Douglas MacBride Position: Management Representative Tel: +1 617-209-9817 Email: doug@Lexington-Med.com

3. Date Prepared

11/1/2018

4. Proposed Device Identification

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

5. Predicate Device Identification

510(k) Number: K173443 Product Name: AEON™ Endoscopic Stapler Manufacturer: Lexington Medical, Inc.

6. Device Description

The modification presented in this 510(k) is a change in the product Instructions for Use (IFU) labeling to add the following two (2) contraindications:

1. "The AEON™ Endoscopic Stapler is contraindicated for use on the heart, central circulatory system, or central nervous system."

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1. "Do not use the AEON™ Endoscopic Stapler 2.0 mm staples on the aorta, any tissue that compresses to less than 0.75 mm in thickness, or any tissue that does not comfortably compress to 0.75 mm."
  This second contraindication is associated with the addition of an AEON Endoscopic Stapler reload staple height of 2.0mm and the compressed tissue thickness contraindication associated with this staple height.

7. Indications for Use Statement

The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses.

8. Substantial Equivalence

The indications for use and intended use of the modified device are identical to the predicate device.

The proposed modification and predicate device (K173443) have the same operating principle and mechanism of action. The user interface and operation instructions are identical for the modified and predicate device. The materials comprising the modified device are identical to the predicate device. Both devices fire staples made of identical Unalloyed Titanium per ASTM F67. Staple raw material, forming process, cleaning/passivation, and assembly processes are identical. Both devices are sealed in identical packaging. Both devices are sterilized with the identical Ethylene Oxide (ETO) gas sterilization cycle to a Sterility Assurance Level of 10^-6.

The proposed modification and predicate device (K173443) have the same technological characteristics, except with the minor design change of adding a 2.0mm open staple height, 45mm staple line length reload. The proposed modification does not raise any additional questions of safety and effectiveness. Testing of the proposed modification shows that all stapler reload sizes meet all performance specification requirements and that the proposed modification is substantially equivalent to the predicate device.

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9. Performance Data

The following nonclinical tests were conducted with the AEON™ Endoscopic Stapler to verify that the proposed device is as safe and as effective as the predicate device, performs as intended, and meets all design specifications:

Testing consisted of the following performance tests for each stapler reload size:

i) Firing and retraction force.
ii) Formed staple shape.
Suture line burst pressure in porcine intestine. III)
Tensile strength of staple line. iv)

This submission does not include data from Clinical Studies.

10. Materials

All materials (including the implantable Titanium staple material handling and cleaning processes, and sterilization methods of the proposed modified AEON™ Endoscopic Stapler are identical to the predicate device AEON™ Endoscopic Stapler (K173443).

11.Conclusion

The proposed device, a modified version of the AEON™ Endoscopic Stapler, is demonstrated to be as safe and as effective as the predicate device based on performance testing, and is determined to be substantially equivalent to 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.