AEON Endoscopic Stapler

K182380 · Lexington Medical, Inc. · GDW · Nov 28, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K182380
• Device Name: AEON Endoscopic Stapler
• Applicant: Lexington Medical, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Nov 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

The AEON Endoscopic Stapler is a sterile, single-use surgical instrument used for tissue resection, transection, and anastomosis. It functions by placing two, triple-staggered rows of titanium staples while simultaneously dividing tissue along a central line. The device consists of a handle and a reload, with staple size and line length determined by the selected reload. It is operated by a surgeon in clinical settings such as the OR. The device provides mechanical tissue closure and division, aiding in surgical procedures. The modification adds a 2.0mm staple height reload option and specific contraindications regarding tissue thickness and anatomical sites. The healthcare provider uses the device to achieve secure tissue approximation and separation, directly impacting surgical outcomes by facilitating efficient tissue management.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included firing and retraction force, formed staple shape, suture line burst pressure in porcine intestine, and tensile strength of the staple line for each reload size.

Technological Characteristics

Implantable titanium staples (Unalloyed Titanium per ASTM F67). Sterile, single-use endoscopic stapler. Mechanical actuation. Ethylene Oxide (ETO) sterilization (SAL 10^-6). No software or electronic components.

Indications for Use

Indicated for patients undergoing general, abdominal, gynecologic, pediatric, or thoracic surgery requiring resection, transection, or anastomosis. Contraindicated for use on the heart, central circulatory system, or central nervous system. 2.0 mm staples are contraindicated for use on the aorta or tissue that compresses to less than 0.75 mm.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• AEON™ Endoscopic Stapler (K173443)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Email: [e-mail]

## 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 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."

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- 2) "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.