ENSEAL PTC TISSUE SEALING DEVICE

K063097 · Surgrx, Inc. · GEI · Oct 18, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063097
• Device Name: ENSEAL PTC TISSUE SEALING DEVICE
• Applicant: Surgrx, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SurgRx EnSeal devices are intended for use during open or laparoscopic general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue and/or seal vessels during surgery. The SurgRx EnSeal Vessel Sealing & 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 & Hemostasis System comprises bipolar electrosurgical instruments and RF generator; used in open or laparoscopic general and gynecologic surgery. Device functions by applying RF energy to distal instrument tips to cut and seal vessels, grasp, and dissect tissue. Operated by surgeons in OR settings. Output is thermal energy for hemostasis and tissue division; enables vessel ligation up to 7 mm. System provides clinical benefit by facilitating efficient tissue management and vessel sealing during surgical procedures. No software or automated algorithms described.

Clinical Evidence

Bench testing only. Preclinical laboratory and performance tests were conducted to ensure device functionality and adherence to design specifications.

Technological Characteristics

Electrosurgical instrument utilizing RF-powered bipolar distal ends. Designed for open and laparoscopic use. No software or complex algorithm components described.

Indications for Use

Indicated for open and laparoscopic general and gynecological surgical procedures (e.g., bowel resections, hysterectomies, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomies) or any procedure requiring vessel ligation, tissue grasping, and dissection. Applicable for vessels up to 7 mm and tissue bundles fitting within instrument jaws. 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™ Vessel Sealing and Hemostasis System (K061526)

Submission Summary (Full Text)

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OCT 1 8 2006

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#### 1. Submitter Name and Address

SurgRx, Inc. 101 Saginaw Drive Redwood City, CA 94063 Contact: Linda Oleson Phone: [phone] ext 107 Date: 10/6/06

#### 2. Device Name

Trade name: EnSeal Vessel Sealing & Hemostasis System

Common name: Electrosurgical open and laparoscopic instruments and accessories

Classification name: Electrosurgical Cutting and Coagulation Device and Accessories (per 21 CFR section 878.4400) and Gynery and Generalian Books and Rocessories (per 21 CFR 884.4120).

#### 3. Predicate Device

EnSeal™ Vessel Sealing and Hemostasis System # K061526

#### 4. Device Description

EnSeal™ Vessel Sealing and Hemostasis System. The functionality of the System is the same as the predicate device.

#### 5. Intended Use

The SurgRx EnSeal devices are intended for use during open or laparoscopic general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue and/or seal vessels during surgery. The SurgRx EnSeal Vessel Sealing & 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.

#### 6. Technological Characteristics

The EnSeal electrosurgical instruments are the same as the predicate devices utilizing RF powered bipolar distal ends.

## 7. Performance Data

Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications.

### 8. Conclusions

The EnSeal System is equivalent to the predicate device based on results of design validation. We believe that the EnSeal devices are safe and effective and substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 8 2006

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

Re: K063097

Trade/Device Name: SurgRx EnSeal Vessel Sealing & 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: October 6, 2006 Received: October 10, 2006

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 CFPA Part 807); labeling (21 CFR Part 801); 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. Linda S.M. Oleson

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 logally 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.

P.R. M.N. Muller

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): K063097

Device Name: SurgRx EnSeal Vessel Sealing & Hemostasis System

Indications for Use:

The SurgRx EnSeal system includes bipolar electrosurgical instruments and a radiofrequency 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 unlake polluding and reconstructive, bowel resections, hysterectomies, cholecysted, theracter, plactions and resolunts, bowel resedunts.
edbacialysis contrasses in the secures, 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 & 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
(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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

and Neurologic

510(k) Number _K063045