ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW

K122797 · Ethicon Endo-Surgery, LLC · GEI · Jan 25, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K122797
• Device Name: ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW
• Applicant: Ethicon Endo-Surgery, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENSEAL® G2 Articulating Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with the Generator GENI 1 (GENI I). They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7mm and tissue and/or vascular bundles as large as will fit in the iaws of the instruments. The ENSEAL® G2 Articulating Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices for these procedures.

Device Story

Sterile, single-use bipolar electrosurgical instrument for open and laparoscopic surgery. Input: manual user manipulation of jaws and articulation wheel; electrical energy from GENI 1 generator. Operation: user grasps tissue with jaws; activates energy and I-BLADE knife via single button to compress, coagulate, and transect tissue. Articulation wheel allows 60° left/right end-effector angulation for improved access. Output: mechanical transection and hemostasis of vessels/tissue. Used by surgeons in OR settings. Benefits: facilitates vessel ligation and tissue dissection in confined surgical spaces.

Clinical Evidence

Performance verified through ex-vivo and in-vivo testing. Includes a 30-day chronic survival study to demonstrate safety and efficacy of the articulating end-effector and sealing/cutting performance compared to the predicate device.

Technological Characteristics

Bipolar electrosurgical instrument with integrated I-BLADE knife. 5mm diameter shaft; 35cm or 45cm lengths; 3mm curved or 5mm straight jaw options. Features articulation wheel for 60° left/right end-effector movement. Single-button energy/knife activation. Connects to GENI 1 generator. Sterile, single-use.

Indications for Use

Indicated for bipolar coagulation and mechanical transection of tissue in patients undergoing open or laparoscopic general, gynecological, urologic, thoracic, or plastic/reconstructive surgery. Suitable for vessel ligation up to 7mm and tissue/vascular bundle dissection. Contraindicated for tubal sterilization or tubal coagulation procedures.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• ENSEAL® G2 Tissue Sealers (K112033)

Submission Summary (Full Text)

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122797

JAN 2 5 2013

Ethicon Endo-Surgery, LLC, 510(k) Premarket Notification (Traditional) for ENSEAL® G2 Articulating Tissue Sealers

# 510(k) Summary

Company

Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969

### Contact

Emily Kruetzkamp, Regulatory Affairs Associate Ethicon Endo-Surgery, Inc Telephone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: September 10, 2012

#### Device Name

Trade Name: ENSEAL® G2 Articulating Tissue Sealers Common Name: Electrosurgical Cutting and Coagulation Instruments

# Classification Names

- Electrosurgical, Cutting & Coagulation & Accessories . (21 CFR 878.4400, Product code GEI)
- Electrocautery, Gynecologic and Accessories � (21 CFR 884.4120, Product code HGI)

## Predicate Device

ENSEAL® G2 Tissue Sealers, K112033

#### Device Description:

The Ethicon Endo-Surgery ENSEAL G2 Articulating Tissue Sealers are sterile, singleuse surgical instruments designed to seal and cut vessels, and to cut, grasp and dissect soft tissue during open and laparoscopic surgery.

The energy activation and knife lock are activated by a single button. The instrument shaft can be rotated using the rotation knob to facilitate visualization and enable easy access to targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL G2 Articulating Tissue Sealers include an articulation capability that allows the user to articulate the end-effector during surgical procedures.

pg. 19

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# Indication for Use:

The ENSEAL® G2 Articulating Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with the Generator GENI 1

(GENI I). They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7mm and tissue and/or vascular bundles as large as will fit in the iaws of the instruments.

The ENSEAL® G2 Articulating Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices for these procedures.

#### Technological Characteristics:

The Ethicon Endo-Surgery ENSEAL G2 Articulating Tissue Sealers components are similar to the Predicate. The ENSEAL G2 Articulating Tissue Sealers have a 5 mm diameter shaft and are available in two shaft lengths: 35 and 45cm; and two jaw types: 3mm curved jaw and 5mm straight jaw. The jaws are normally in the opened position and can be partially or fully closed by squeezing the closing handle. The jaws have atraumatic teeth for grasping and holding targeted tissue when clamped. The handles of the Subject ENSEAL G2 Articulating Tissue Sealers have an ergonomic interface for the user. Like the Predicate, the Subject devices include an integrated energy activation button. The devices use a combination of the application of bipolar electrosurgical energy in conjunction with the I-BLADE knife, to compress, coagulate, and transect tissue.

In addition to the similar technological characteristics as the Predicate, the ENSEAL G2 Articulating Tissue Sealers instrument shaft device articulates approximately 60° to the left and the right of center. The instrument shaft can be articulated using the articulation wheel to gain additional access to tissue and facilitate the user's ability to target tissue and vascular bundles up to 60°. The top of the articulation wheel has a white arrow to indicate when the device shaft is straight and not articulated. When the articulation wheel is rotated clockwise, the shaft articulates to the right; when the articulation wheel is rotated counterclockwise, the shaft articulates to the left. While articulated, the device jaws seal and cut vessels, and cut, grasp and dissect soft tissue as intended. The Subject ENSEAL G2 Articulating Tissue Sealers performance is equivalent to the Predicate ENSEAL G2 Tissue Sealers.

pg. 20

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Ethicon Endo-Surgery, LLC, 510(k) Premarket Notification (Traditional) for ENSEAL® G2 Articulating Tissue Sealers

# Performance Data:

Ex-vivo and in-vivo tests were performed to verify that the performance of the ENSEAL G2 Articulating Tissue Sealers meets the definition of substantial equivalence to the Predicate device, ENSEAL G2 Tissue Sealers. Device performance was assessed against design requirements, including a 30-day chronic survival study, to demonstrate that the Ethicon Endo-Surgery ENSEAL G2 Articulating Tissue Sealers perform as intended.

pg. 21

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

January 25, 2013

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

Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Incorporated Mrs. Emily Kruetzkamp Regulatory Affairs Associate 4545 Creek Road Cincinnati. Ohio 45242

Re: K122797

Trade/Device Name: ENSEAL® G2 Articulating Tissue Sealers Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, HGI Dated: January 16, 2013 Received: January 22, 2013

Dear Mrs. Kruetzkamp:

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 (reporting of medical

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# Page 2 - Mrs. Emily Kruetzkamp

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Peter D. Rumm-S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ethicon Endo-Surgery, LLC, 510(k) Premarket Notification (Traditional) for ENSEAL® G2 Articulating Tissue Sealers

Indications for Use Form

#### Indications for Use

510(k) Number (if known):

Device Name: ENSEAL® G2 Articulating Tissue Sealers

Indications for Use:

The ENSEAL® G2 Articulating Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with the Generator GENI 1

(GEN11). They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures. Nissen fundoplication, adhesiolysis, oophorectornies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7mm and tissue and/or vascular bundles as large as will fit in the iaws of the instruments.

The ENSEAL® G2 Articulating Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices for these procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Dwight Yen 2013.01.31 08:06:31 -05'00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K122797