Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler

K150026 · Ethicon Endo-Surgery, LLC · GDW · May 18, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150026
• Device Name: Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
• Applicant: Ethicon Endo-Surgery, LLC
• Product Code: GDW · General, Plastic Surgery
• Decision Date: May 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, ETS-Flex45 No-Knife Articulating Linear Stapler and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. They can be used with staple line buttressing material. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

Device Story

Endopath ETS-Flex45 instruments are sterile, single-patient-use surgical staplers; used in open or minimally invasive procedures. The cutter variant delivers staples while simultaneously dividing tissue; the no-knife variant delivers staples without tissue division. Both feature an articulation lever for bilateral jaw movement. Operated by surgeons in OR settings. The primary modification is a reload 'lock-out' feature preventing firing if the reload is missing or improperly seated. This mechanism ensures staple line integrity and prevents device misuse. The device provides a 45mm staple line; the cutter provides a 41mm cut line. Benefits include reliable tissue management and anastomosis creation during complex surgeries.

Clinical Evidence

Bench testing only. Testing included staple form quality, staple height, staple line integrity, force to close, compatibility with buttress material, and validation of the reload lock-out feature (reliability and withstand force).

Technological Characteristics

Sterile, single-patient-use mechanical surgical stapler. Features include bilateral jaw articulation and a reload 'lock-out' safety mechanism. Dimensions: 45mm staple line, 41mm cut line (cutter version). No electronic components, software, or energy sources.

Indications for Use

Indicated for patients undergoing open or minimally invasive general, gynecologic, thoracic, or pediatric surgical procedures requiring tissue transection, resection, or anastomosis creation, including liver, pancreas, kidney, and spleen procedures.

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

• Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter and Endopath® ETS- Flex45 No-Knife Articulating Linear Stapler (K070887, K061156, K020079, K002398, K961390)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 18, 2015

Ethicon Endo-Surgery, LLC Ms. Christina Canter Senior Associate, Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242

Re: K150026

Trade/Device Name: Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: April 16, 2015 Received: April 17, 2015

Dear Ms. Canter:

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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) K150026

#### Device Name

Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler

#### Indications for Use (Describe)

The Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, ETS-Flex45 No-Knife Articulating Linear Stapler and reloads are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. They can be used with staple line buttressing material. The instrument may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

| Company: | Ethicon Endo-Surgery, LLC<br>475 Calle C<br>Guaynabo, PR 00969 |
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- Christina Canter, RAC Contact: Senior Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: [phone] Fax: [phone] Email: [e-mail]
## Date Prepared: January 06, 2015

## Device Name

| Trade Name: | Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter and<br>Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Surgical Stapler |
| Classification Name: | Staple, Implantable |
| Regulation Number: | 21CFR 878.4750 |
| Product Code: | GDW |

## Marketed Predicate Device

Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter and Endopath® ETS- Flex45 No-Knife Articulating Linear Stapler (K070887, K061156, K020079, K002398, K961390)

## Device Description

The Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter is a sterile, single patient use instrument that delivers staples while simultaneously dividing tissue between rows. The instruments provide a staple line that is approximately 45 mm long and a cut line that is approximately 41 mm long. An articulation lever on the device enables bilateral movement of the instrument jaws.

The Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler is a sterile, single patient use instrument that delivers staples but does not divide tissue. The instruments provide a staple line that is approximately 45 mm long. An articulation lever on the device enables bilateral movement of the instrument jaws.

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# Indications for Use

The Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, ETS-Flex45 No-Knife Articulating Linear Stapler and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures, They can be used with staple line buttressing material. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

# Technological Characteristics

The subject devices are modifications of the legally marketed predicate devices. The primary design change is the addition of a reload 'lock-out' feature to prevent the device from being fired when a reload is improperly loaded or if no reload is placed into the device. The changes described in this submission do not affect the intended use of the devices or alter fundamental scientific technology of the devices.

## Performance Data

Bench testing including staple form quality and staple height, staple line integrity, force to close, compatibility with buttress material, lock out reliability and lockout withstand force were performed to confirm that the subject devices perform as intended and are substantially equivalent to the predicate devices.