ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM

K050671 · Surgrx, Inc. · GEI · Apr 1, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050671
• Device Name: ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
• Applicant: Surgrx, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 1, 2005
• 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 consists of bipolar electrosurgical instruments and accessory adapters for use with electrosurgical generators. Device used in open or laparoscopic general and gynecologic surgery by surgeons. Instrument jaws grasp tissue/vessels; RF energy delivered via bipolar distal ends to seal and cut tissue. Provides hemostasis during surgical procedures. Benefits include vessel ligation and tissue dissection capabilities. System functionality and components identical to predicate.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design validation and comparison to predicate device.

Technological Characteristics

RF-powered bipolar electrosurgical instruments. Distal ends utilize bipolar energy for tissue sealing and cutting. System includes instruments and accessory adapters for use with electrosurgical generators.

Indications for Use

Indicated for open and laparoscopic general and gynecologic surgery, including urologic, reconstructive, bowel resections, Nissen fundoplication, hysterectomies, oophorectomies, and adhesiolysis. Used for vessel ligation, tissue grasping, and 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™ Vessel Sealing and Hemostasis System (K031133)

Submission Summary (Full Text)

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K050671
510(k) SUMMARY

# 1. Submitter Name and Address

SurgRx, Inc. 380 Portage Avenue Palo Alto, CA 94306 Contact: Linda Oleson Phone: [phone] xt 107 Date: 3/14/05

#### 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 Gynecologic Electrocautery and Accessories (per 21 CFR 884.4120).

# 3. Predicate Device

EnSeal™ Vessel Sealing and Hemostasis System # K031133

# 4. Device Description

EnSeal™ Vessel Sealing and Hemostasis System. The functionality and components of the System are 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 predicate devices utilizing RF powered bipolar distal ends.

## 7. Performance Data

This modification does not affect performance of the System. Additional performance testing not required.

#### 8. Conclusions

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

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Image /page/1/Picture/1 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 a stylized image of an eagle with three wavy lines extending from its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2005

Ms. Linda Oleson Director of Clinical and Regulatory Affairs, Consultant SurgRx, Inc. 380 Portage Avenue Palo Alto, California 94306

Re: K050671

K030071
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 and HGI Dated: March 14, 2005 Received: March 15, 2005

Dear Ms. Oleson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and the Medical Device Amendments, or to commerce prior to May 26, 1776, the enastinen with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosmetic Act (71ct) that do not required to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the ties labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA). it If your device is classimod (600 as 10, of the major regulations affecting your device can inay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood accments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Ficase be advised that 1 1971 is notalies over device complies with other requirements of the Act that 157A has made a determination administered by other Federal agencies. You must or any receral statutes and reginations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Cr K F art 807), labornig (21 OFA Part 820), and if applicable the electronic forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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Page 2 - Ms. Linda Oleson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you'ls ough finding of substantial equivalence of your device to a legally premative noticated. The Presults 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 If you desire spocific adviser 3 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 other general mionnation 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,

R. O'Hara kr.

Miriam C. Provost, h.D. Acting 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.

KOSOB71 510(k) number (if known):_

Device Name: SurgRx EnSeal Vessel Sealing & Hemostasis System

Indications for Use:

The SurgRx EnSeal system includes bipolar electrosurgical instruments and an r the Ourgh & Enoud of cloud of electrosurgical generators. It is intended for use accessory adapter for use with startal a onecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical mulcations for use tholude open and reconstructive, bowel resections, procedures (including urologic, «rolegal, «role procedures, Nissen fundoplication, nysterectorines, onororectomies, etc.), or any procedure where vessel ligation (cutting and admesions, odprorecomise, otel), or any of any arrant of the devices can be used on seamly), ilssuc grasping and alsociation in the same as will fit in the jaws of the instruments.

The SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be iffective 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE:)

050671

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