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 is determined by the selection of the appropriate reload that is available in two staple sizes (tan - 3.25mm, purple - 4.0mm) and in one length (60mm).

AI/ML Overview

The provided 510(k) summary for the AEON Endoscopic Stapler (K171589) does not describe an AI or software-based medical device. Therefore, the information requested regarding acceptance criteria and a study proving device meeting acceptance criteria in the context of AI/software performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment, training/test set sizes) is not applicable to this submission.

The 510(k) pertains to a physical medical device, an endoscopic stapler, and the performance data presented is focused on the device's mechanical, biological, and functional attributes.

However, I can extract information related to the device's performance testing for its physical characteristics, as detailed in the "Performance Data" section.

Here's a summary based on the provided document, addressing the closest relevant points:

1. Acceptance Criteria and Reported Device Performance (Focusing on physical/mechanical attributes):

The document lists "Performance Data" which includes various tests. While explicit acceptance criteria values are not provided in this summary, the tests themselves imply certain performance standards that the device met. The conclusion states the device "meets all design specifications."

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Mechanical/Functional Performance:
Rotation and Articulation Performance	Device performed as intended, meeting design specifications.
Safety Mechanism Performance	Device performed as intended, meeting design specifications.
Firing Force within specified range	Device performed as intended, meeting design specifications.
Retraction Force within specified range	Device performed as intended, meeting design specifications.
Proper Staple Formation	Device performed as intended, meeting design specifications.
Staple and Cut Line Length as specified	Device performed as intended, meeting design specifications.
Staple Line Pressure Test	Device performed as intended, meeting design specifications.
Staple Line Tensile Test	Device performed as intended, meeting design specifications.
Packaging & Sterility:
Package Integrity maintained	Device performed as intended, meeting design specifications.
Shelf Life maintained	Device performed as intended, meeting design specifications.
Biological Performance (In Vivo):
Burst Evaluation satisfactory	Device performed as intended, meeting design specifications.
Hemostasis Evaluation satisfactory	Device performed as intended, meeting design specifications.
Staple Formation satisfactory	Device performed as intended, meeting design specifications.
Biocompatibility (Cytotoxicity, Sensitization,	Compliant with ISO-10993-1:2009 for Biological evaluation of Medical Devices.
and Irritation/Intracutaneous Reactivity) pursuant
to ISO-10993-1:2009
Endotoxin Limit met	Device performed as intended, meeting design specifications.

2. Sample Size and Data Provenance:

Sample Size: The document does not specify the sample sizes used for each of the listed in-vitro and in-vivo tests. It only lists the types of tests performed.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be nonclinical and are likely internal company testing or conducted by contract research organizations. These are "nonclinical tests" as stated in the document.

3. Number of Experts and Qualifications for Ground Truth:

Not Applicable. This is a physical device, not an AI/software for diagnostic or image interpretation, so "ground truth" established by experts in the typical AI sense is not relevant. The "ground truth" here would be objective measurements and observations of the stapler's performance against its design specifications and safety standards.

4. Adjudication Method:

Not Applicable. As this is a physical device, there is no adjudication method in the context of interpretation or diagnosis that would apply to AI/software. Test results for mechanical and biological performance would be fact-based.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not Applicable. This type of study is relevant for AI-powered diagnostic or interpretive tools; it does not apply to a surgical stapler. The document explicitly states: "This submission does not include data from Clinical Studies."

6. Standalone Performance Study:

Partially Applicable (in a different context). The provided performance data (in-vitro and in-vivo) represents the "standalone" performance of the AEON Endoscopic Stapler itself, without human-in-the-loop performance in the sense of AI assistance. The tests focused on the device's inherent functional, mechanical, and biological properties.

7. Type of Ground Truth Used:

The "ground truth" for the nonclinical tests would be:
- Objective Measurements: E.g., measured firing force, staple length, cut line length, pressure resistance, tensile strength.
- Validated Test Methods: Adherence to established test protocols for biocompatibility (ISO-10993-1).
- Visual Inspection/Observation: For staple formation, articulation, safety mechanism function.
- Predetermined Specifications: The device's performance was compared against its design specifications that define acceptable ranges for these parameters.

8. Sample Size for the Training Set:

Not Applicable. There is no "training set" as this is a physical device, not a machine learning algorithm.

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

Not Applicable. There is no "training set" or corresponding ground truth establishment process in the context of AI for this type of device.

Summary

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November 17, 2017

Lexington Medical Inc. Donna Gasper Management Representative 11 Executive Park Dr. Billerica, Massachusetts 01862

Re: K171589

Trade/Device Name: AEON Endoscopic Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: October 13, 2017 Received: October 17, 2017

Dear Donna Gasper:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

David Krause -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) K171589

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.

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

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. 11 Executive Park Drive Billerica, Massachusetts 01862 USA

2. Contact Person

Donna L. Gasper Position: Management Representative Tel: +1 617-209-9817 Email: Donna@Lexington-Med.com

3. Date Prepared

11/16/2017

4. Device Identification

510(k) Number: K171589 Device Name: AEON™ Endoscopic Stapler Device Common Name: Stapler Classification Name: Staple, Implantable Classification Requlation: 21 CFR 878.4750 Device Class: II Classification Panel: General & Plastic Surgery Product Code: GDW

5. Predicate Device Identification

510(k) Number: K141367 Product Name: ELC Series Endoscopic Linear Cutter and Single Use Loading Unit Manufacturer: Touchstone International Medical Science Co., Ltd.

6. Reference Device Identification

Reference Device:

510(k) Number: K061095 Product Name: Auto Suture™ ENDO GIA™ Stapler Manufacturer: United States Surgical, a division of Tyco Health Group LP

7. 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 is

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determined by the selection of the appropriate reload that is available in two staple sizes (tan - 3.25mm, purple - 4.0mm) and in one length (60mm).

8. 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.

9. Technological Characteristics

The AEON™ Endoscopic Stapler is substantially equivalent to the predicate device with regards to staple technologies.

10. Performance Data

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

In Vitro:

Rotation and Articulation
Safety Mechanism Performance ●
Firing Force ●
Retraction Force
Staple Formation
Staple and Cut Line Length
Staple Line Pressure Test
Staple Line Tensile Test ●
Package Integrity
Shelf Life

In Vivo:

Burst Evaluation
Hemostasis Evaluation ●
Staple Formation
Biocompatibility (Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity per ISO-10993-1:2009 Biological evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process)
Endotoxin Limit

This submission does not include data from Clinical Studies.

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11.Materials

All materials of the AEON™ Endoscopic Stapler are similar to the predicate device ELC Series Endoscopic Linear Cutter and Single Use Loading Unit (K141367). Chemical analysis testing was performed to confirm that the implantable Titanium staples conform to ASTM F67 - 13 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications.

12. Conclusion

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

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.