ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM

K072177 · Surgrx, Inc. · GEI · Sep 5, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072177
• Device Name: ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM
• Applicant: Surgrx, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EnSeal® Vessel Sealing and Hemostasis System is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, 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) 7 mm and bundles as large as will fit in the jaws of the instruments. The SurgRx EnSeal® Vessel Sealing and Hemostasis System 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

EnSeal® Vessel Sealing and Hemostasis System is a bipolar electrosurgical instrument used in open or laparoscopic surgery. Device connects to an electrosurgical generator to deliver energy for cutting, sealing, grasping, and dissecting tissue. Operated by surgeons in OR settings. System enables vessel ligation up to 7 mm diameter. Provides hemostasis during procedures like bowel resections, hysterectomies, and cholecystectomies. Benefits include efficient tissue management and vessel sealing, reducing need for sutures or clips.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Bipolar electrosurgical instrument; designed for use with compatible electrosurgical generators. Features jaw mechanism for tissue grasping and vessel sealing. Class II device under 21 CFR 878.4400. Product codes GEI, HGI.

Indications for Use

Indicated for patients undergoing open or laparoscopic general, gynecologic, urologic, thoracic, plastic, and reconstructive surgeries requiring vessel ligation, tissue grasping, and dissection. Suitable for 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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

SEP 5 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SurgRx, Incorporated % Ms. Linda Oleson Director of Clinical & Regulatory Affairs Consultant 101 Saginaw Drive Redwood City, California 94063

Re: K072177

Trade/Device Name: EnSeal® Vessel Sealing and Hemostasis System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HGI Dated: August 3, 2007 Received: August 6, 2007

Dear Ms. Oleson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page-2 -- Ms. Linda Oleson

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

Applicant: SurgRx, Inc.

510(k) number (if known):

Device Name: EnSeal® Vessel Sealing and Hemostasis System

Indications for Use:

The EnSeal® Vessel Sealing and Hemostasis System is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, 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) 7 mm and bundles as large as will fit in the jaws of the instruments.

The SurgRx EnSeal® Vessel Sealing and Hemostasis System 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative, Page 1 of 1
and Neurological Devices

**510(k) Number**

K01217