ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH

K101520 · Ethicon Endo-Surgery, Inc. · GEI · Dec 10, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101520
• Device Name: ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EnSeal LCJ Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of tissue during open procedures. It is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open, general and gynecological surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open, general, 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) 7 mm and bundles as large as will fit in the jaws of the instruments. The EnSeal Tissue Sealing Device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

Device Story

Sterile, single-patient-use bipolar electrosurgical instrument; used in open surgical procedures (general, gynecological, urologic, thoracic, plastic/reconstructive). Operated by surgeons to grasp, dissect, and transect tissue; seals vessels up to 7 mm. Device connects to an external electrosurgical generator to deliver bipolar energy for coagulation; mechanical transection performed via integrated blade. Provides surgeons with improved ergonomics, shaft, and jaw geometry compared to predicate. Clinical benefit includes efficient vessel ligation and tissue management during surgery.

Clinical Evidence

Bench and animal testing performed to verify device functionality and design specifications. No human clinical trial data provided.

Technological Characteristics

Bipolar electrosurgical instrument; sterile, single-patient-use. Features include ergonomic handle, shaft, and jaw assembly. Energy source: external electrosurgical generator. No software or electronic processing components described.

Indications for Use

Indicated for patients undergoing open, general, gynecological, urologic, thoracic, plastic, and reconstructive surgical procedures requiring vessel ligation, tissue grasping, and dissection. Compatible with vessels up to 7 mm. 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

• SurgRx EnSeal Tissue Sealers (K072177)

Submission Summary (Full Text)

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K101520
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### 510(k) SUMMARY

Ethicon Endo-Surgery, Inc Company DEC 1 0 2010 4545 Creek Road Cincinnati, OH 45242 Contact Ruth Ann Wood Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Phone: [phone] FAX: [phone] Email: [e-mail]

Date Prepared May 28, 2010

#### Device Name

- Trade Name: Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer .
- Common or Usual Name: Electrosurgical open instruments and accessories .
- Classification name: Electrosurgical Cutting and Coagulation Device and Accessories . (per 21 CFR section 878.4400) and Gynecologic Electrocautery and Accessories (per 21 CFR 884.4120).

### Predicate Devices

SurgRx EnSeal Tissue Sealers, K072177

#### Device Description

The Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer is a sterile, single patient use device. The functionality is the same as the predicate devices.

### Intended Use

The EnSeal LCJ Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of tissue during open procedures.

It is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open, general and gynecological surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open, general, gynecological 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) 7 mm and bundles as large as will fit in the jaws of the instruments.

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K101520
page ② of 2

The EnSeal Tissue Sealing Device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

# Technological Characteristics

The Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer is the same as the predicate devices in that they are electrosurgical bipolar vessel sealing instruments used to cut and seal vessels, cut, grasp and dissect tissues during surgery, and utilize the same technology. Differences with the device in this submission are improved ergonomic handle, larger shaft, jaw diameter, and jaw length/shape.

## Performance Data

Bench and animal testing was performed to ensure the devices function as intended and meet design specifications.

#### Conclusions

Based on performance testing and functional similarities to the predicate devices, the Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer devices are substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ethicon Endo-Surgery, Inc. % Ms. Ruth Ann Wood 4545 Creek Road ML#132 Cincinnati, Ohio 45242

DEC 1 0 2010

Re: K101520

Trade/Device Name: Ethicon Endo-Surgery EnSeal® LCJ Tissue Sealer Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HGI Dated: December 2, 2010 Received: December 3, 2010

Dear Ms. Wood:

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, Or to 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 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.

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Page 2 - Ms. Ruth Ann Wood

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,

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

Enclosure

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DEC 1 0 2010

510(k) number (if known):_K | 0 |5 2 o

Device Name: Ethicon Endo-Surgery EnSeal® LCJ Tissue Sealer

The EnSeal LCJ Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of tissue during open procedures.

It is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open, general and gynecological surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open, general, 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) 7 mm and bundles as large as will fit in the jaws of the instruments.

The EnSeal Tissue Sealing Device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

Prescription Use X (Per 21 CFR 801 Subpart D AND/OR

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

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

Office of Device Evaluation (ODE) Concurrence of CDRH.

Division Sign-Off

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101520

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