SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM

K043008 · Surgrx, Inc. · GEI · Nov 17, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K043008
• Device Name: SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
• Applicant: Surgrx, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 17, 2004
• 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-60 generator/controller; used in open or laparoscopic general and gynecologic surgery. Device inputs include tissue/vessels placed within instrument jaws; system applies RF energy to seal and cut vessels up to 7mm and tissue bundles. Operated by surgeons in clinical settings. Output is mechanical tissue separation and hemostasis via thermal sealing. Benefits include efficient vessel ligation and tissue dissection during complex surgical procedures. System functionality is consistent with predicate technology.

Clinical Evidence

Bench testing and live animal studies performed to validate design specifications and ensure intended function. No human clinical trial data provided.

Technological Characteristics

Bipolar electrosurgical instruments; RF-powered distal ends; RF-60 generator/controller; compatible with standard electrosurgical generators via accessory adapter. Designed for open and laparoscopic use.

Indications for Use

Indicated for 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 requiring vessel ligation, tissue grasping, and dissection. Suitable for vessels up to 7 mm and tissue bundles fitting within instrument jaws. Contraindicated for tubal sterilization or tubal coagulation.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "SURGRX" in white letters on a black oval background. The letters are bold and sans-serif. The letters appear to be slightly distressed, with some small areas of the letters missing. The oval is oriented horizontally.

NOV 17 2004

## 510(k) SUMMARY

#### 1. Submitter Name and Address

K04 300

SurgRx, Inc. 380 Portage Avenue Palo Alto, CA 94306 Contact: Linda Oleson Phone: [phone] xt 107 Date: 10/28/04

### 2. Device Name

Trade name: EnSeal Vessel Sealing & Hemostasis System (with RF-60 generator/controller)

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

The RF-60 generator/controller which is used in conjunction with the EnSeal System. The functionality and remaining components of the System are the same.

#### 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

Preclinical laboratory (bench & live animal studies) 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 devices based on results of design validation. We believe that the RF-60 generator/controller used in conjunction with the EnSeal devices is safe and effective and substantially equivalent to the predicate devices.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes on its wing, symbolizing service, knowledge, and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 2004

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

Re: K043008

Ko43000
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 29, 2004 Received: November 1, 2004

Dear Ms. Oleson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be devermined 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 commerce pror to rita) 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Cosmeter For (100) in the device, subject to the general controls provisions of the Act. The r ou may, aroney in one of the Act include requirements for annual registration, listing of general bonation profictive, 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 such additional controls. Existing major regulations affecting your device can may or sueyeer to back as a suese as 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 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.

{2}------------------------------------------------

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 with and w yourse of substantial equivalence of your device to a legally promative noticated.com - 11:22 Links.
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 If you desire specific acreeliance at [phone]. Also, please note the regulation entitled, Connect the Ories of Course 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 micronational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use Statement

Applicant: SurgRx, Inc.

1043008 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 accessory adapter for use with standard electrosurgical generators. 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 faparoscopic 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 & 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 801.109) ાર

Over-The-Counter Use

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

al. Restorative,

Page 1 of 1

B-1

**510(k) Number** K043008