MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE

K071728 · Surgrx, Inc. · GEI · Jul 13, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071728
• Device Name: MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE
• Applicant: Surgrx, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 13, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EnSeal™ PTC with ERBE VIO 300 D is 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 EnSeal™ PTC 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 PTC is a bipolar electrosurgical instrument used with ERBE VIO 300 D generator; designed for open and laparoscopic surgery. Device functions by delivering RF energy to distal ends to cut and seal vessels up to 7 mm and dissect tissue. Operated by surgeons in OR settings. Output is thermal energy for hemostasis and tissue division. Benefits include efficient vessel ligation and tissue management during various surgical procedures. Device is not for sterilization.

Clinical Evidence

Bench testing only. Preclinical laboratory and performance tests were conducted to ensure the device functions as intended and meets design specifications.

Technological Characteristics

Bipolar electrosurgical instrument; RF-powered distal ends; compatible with ERBE VIO 300 D electrosurgical generator. Designed for open and laparoscopic use. No specific materials or software algorithms described.

Indications for Use

Indicated for open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resection, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies) 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 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)
• ERBE VIO ESU, Model VIO 300 D (K060484)
• EnSeal PTC (K061526)

Submission Summary (Full Text)

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# KO71728 510(k) SUMMARY

### 1. Submitter Name and Address

SurgRx, Inc. 101 Saginaw Drive Redwood City, CA 94063 Contact: Linda Oleson Phone: [phone] ext 107 Date: 1/16/07

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#### 2. Device Name

Trade name: EnSeal™ PTC with ERBE VIO 300 D

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, and the ERBE VIO ESU, Model VIO 300 D, # K060484 and EnSeal PTC # K061526.

#### 4. Device Description

EnSeal™ PTC with ERBE VIO 300 D. The functionality of the device is the same as the predicate device.

#### 5. Intended Use

The EnSeal™ PTC with ERBE VIO 300 D is 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 EnSeal™ PTC 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™ PTC with ERBE VIO 300 D is the same as the predicate device 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™ PTC with ERBE VIO 300 D is equivalent to the predicate device based on results of design validation. We believe that the EnSeal™ PTC with ERBE VIO 300 D is safe and effective and substantially equivalent to the predicate device.

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#### Public Health Service

# JUL 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K071728

Trade/Device Name: EnSeal™ PTC with ERBE VIO 300D Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HGI Dated: June 22, 2007 Received: June 25, 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 S.M. 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,

Sincerely yours,

for
Mark N. Melkerson
Director

Director

Center for Devices and Radiological Health

Division of General, Restorative and Neurological Devices Office of Device Evaluation

.

Enclosure

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## Indications for Use Statement

Applicant: SurgRx, Inc.

KO71728 510(k) number (if known):

Device Name: EnSeal ™ PTC with ERBE VIO 300 D

Indications for Use:

The EnSeal™ PTC is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open or laparoscopic, general and gynerologic 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 resetting, 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 X (Per 21 CFR 801 Subpart D) AND/OR

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