ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS

K033421 · Erbe USA, Inc. · GEI · Oct 14, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033421
• Device Name: ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
• Applicant: Erbe USA, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 14, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ERBE BiClamp™ Open and Laparoscopic Instruments are intended for use in general surgery, laparoscopic, gynecologic, urological, and thoracic procedures where fusion of vessels or tissues is desired. The devices can be used on vessels up to 7 mm and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the instrument. The ERBE BiClamp™ Open and Laparoscopic Instruments are designed for use with an ERBE VIO Electrosurgical Generator (ESU) System having an Optional Bipolar Mode/ BiClamp™ upgrade and the multi-function receptacle. Not recommended for use with other manufacturer's generators.

Device Story

Bipolar electrosurgical instruments for vessel/tissue fusion; used with ERBE VIO Electrosurgical Generator. Input: HF electrical energy from generator; Output: thermal coagulation/desiccation of tissue held between instrument jaws. Used in OR by surgeons for general, laparoscopic, gynecologic, urological, and thoracic procedures. Instruments are reusable, non-sterile, stainless steel/plastic construction. Physician manually operates jaws to grasp tissue; generator delivers RF energy to create seal. Physician visually inspects seal integrity post-fusion. Benefits: effective vessel/tissue bundle fusion up to 7mm.

Clinical Evidence

No clinical data provided; substantial equivalence based on design verification and validation by manufacturer.

Technological Characteristics

Reusable bipolar electrosurgical instruments; stainless steel and plastic construction. Energy source: ERBE VIO Electrosurgical Generator (RF energy). Form factor: Open (200-270mm) and Laparoscopic (5mm O.D., 340mm length). Connectivity: proprietary multi-function receptacle for ERBE VIO system. Sterilization: validated cleaning and sterilization processes required.

Indications for Use

Indicated for patients undergoing general, laparoscopic, gynecologic, urological, or thoracic surgery requiring vessel or tissue bundle fusion (up to 7mm). Procedures include bowel resections, hysterectomies, Nissen fundoplication, adhesiolysis, oophorectomy, and laparoscopic cholecystectomies. Contraindicated for tubal sterilization/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

• Valleylab Inc. LigaSure™ Open and Laparoscopic Instruments (K981916)

Submission Summary (Full Text)

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# KO33421

## 510K SUMMARY - Revised August 6, 2004

| Submitted By: | OCT 1 4 2004<br>ERBE USA, Inc.<br>2225 Northwest Parkway<br>Marietta, GA 30067<br>Tel: [phone] Fax: [phone] |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Stephens, President/Consultant<br>Regulatory Resources Group, Inc. |
| 510(k) Number: | K033421 |
| Date Prepared: | August 6, 2004 |
| Common Name: | Bipolar Electrosurgical Open and Laparoscopic Instruments |
| Trade/Proprietary Name: | ERBE BiClamp™ Open and Laparoscopic Instruments |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories<br>(21CFR878.4400) and Gynecologic electrocautery and<br>accessories (21 CFR Part 884.4120) |
| Product Code: | GEI and HGI |
| Legally Marketed<br>Predicate Device: | Valleylab Inc. LigaSure™ Open and Laparoscopic<br>Instruments 510(k) Number: K981916 |

#### Device Description:

The ERBE BiClamp™ Open and Laparoscopic Instruments are used with an ERBE VIO Electrosurgical Generator (ESU) System having the Optional Bipolar Mode, BiClamp. High Frequency (HF) energy from the ESU is delivered through the jaws of the ERBE BiClamp" Instruments to coagulate/desiccate tissue. The ERBE BiClamp™ Open Instruments are made of stainless steel with plastic insulation except at the jaw surfaces (which isolates the energy to only the jaw surfaces). The ERBE BiClamp'™ Laparoscopic Instruments are made of metals and plastics with the electrical energy isolated to the jaws. They have various jaw types, which are standard in the industry. The ERBE BiClamp™ Open Instruments range in size from 200 mm (7.9 inches) to 270 mm (10.6 inches) in length with bent jaws that have a smooth surface. The ERBE BiClamp™ Laparoscopic Instruments have a 5 mm outside diameter (O.D.) and a 340 mm (13.4 inches) working length. The Instruments are provided non-sterile and are reusable (Note: The cleaning and sterilization processes have been validated and are provided in the Notes on Use to the customer.).

#### Intended Use:

The ERBE BiClamp™ Open and Laparoscopic Instruments are intended for use in general surgery, laparoscopic, gynecologic, urological, and thoracic procedures where fusion of vessels or tissues is desired. The devices can be used on vessels up to 7 mm and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the instrument.

The ERBE BiClamp™ Open and Laparoscopic Instruments are designed for use with an ERBE VIO Electrosurgical Generator (ESU) System having an Optional Bipolar Mode/ BiClamp™ upgrade and the multi-function receptacle. Not recommended for use with other manufacturer's generators.

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K033421 (pg 2 of 2)

### 510K SUMMARY - Revised August 6, 2004

The indications for use with Open Instruments include: general surgery, gynecologic, urological. and thoracic procedures where fusion of vessels and tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.

The indications for use with Laparoscopic Instruments include: all laparoscopic procedures (including gynecologic, general, urological, and thoracic surgery) where fusion of vessels or tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), faparoscopic cholecystectomies (gall bladder procedures), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.

CAUTION: Vessel fusion can be affected by patient factors such as age, elasticity of vessels, thickness of vessel walls, etc.; therefore, the physician should review each vessel fusion for seal integrity. This device is not effective for use in tubal sterilization/tubal coaqulation for sterilization purposes.

Similarities and Differences of the Proposed Devices to the Predicate Devices Comparison/Substantial Equivalence):

#### Similarities

The ERBE BiClamp™ Open and Laparoscopic Instruments have similar physical and dimensional characteristics as the predicate devices. They have the same basic technological characteristics and the intended use is the same.

#### Differences

The ERBE BiClamp™ Open and Laparoscopic Instruments are different in that all of the product line components or parts are provided non-sterile and reusable: where as. the electrodes of the predicate's Open Instruments and Laparoscopic Instruments are sterile, single use. The ERBE BiClamp Open and Laparoscopic Instruments do not have closure mechanisms to hold the instrument closed (or clamped), where as, the predicate devices have closure mechanisms.

All the instrument designs have been verified or validated in design control by ERBE Elektromedizin GmbH.

#### Conclusion:

The ERBE BiClamp™ Open and Laparoscopic Instruments have the same intended use, principles of operation, and technological characteristics as the predicate devices that were previously cleared for market in a 510(k).

The ERBE BiClamp™ Open and Laparoscopic Instruments differ only in that all the instruments and their parts are reusable and they do not have a closure mechanism to hold the instruments closed.

In conclusion, there are no issues with the ERBE BiClamp™ Open and Laparoscopic Instruments that would raise additional safety or efficacy issues when compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

OCT 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ERBE USA, Inc. c/o Ms. Julie Stephens Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K033421

Trade/Device Name: ERBE BiClamp™ Open and Laparoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 23, 2004 Received: September 24, 2004

Dear Ms. Stephens:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o no ro ro ro row a your 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 for associated in the 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). and Cosmetic fore, market the device, subject to the general controls provisions of the Act. The r ou may, are every inions 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 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. Julie Stephens

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/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

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## Indications for Use - REVISED August 6, 2004

## 510(k) Number (if known): K033421

Device Name: ERBE BiClamp™ Open and Laparoscopic Instruments

Indications For Use:

The ERBE BiClamp™ Open and Laparoscopic Instruments are intended for use in general The ERDE Dronalip - Opecologic, urological, and thoracic procedures where fusion of vessels surgery, laparoscopies, griesers, and e used on vessels up to 7 mm and bundles as large as of this us is a donrod. The instrument. A vessel fusion is created by the application of bipolar will in in the juve of argy (coagulation) to the vessels placed between the jaws of the instrument.

The ERBE BiClamp™ Open and Laparoscopic Instruments are designed for use with an ERBE VIO Electrosurgical Generator (ESU) System having an Optional Bipolar Mode/ BiClamp™ upgrade and the multi-function receptacle. Not recommended for use with other manufacturer's generators.

The indications for use with Open Instruments include: general surgery, gynecologic, urological, and thoracic procedures where fusion of vessels and tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.

The indications for use with Laparoscopic Instruments include: all laparoscopic procedures (including gynecologic, general, urological, and thoracic surgery) where fusion of vessels or (incrading gracess), bootegory book procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholecystectomies (gall bladder procedures), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.

CAUTION: Vessel fusion can be affected by patient factors such as age, elasticity of vessels, thickness of vessel walls, etc.; therefore, the physician should review each vessel fusion for seal integrity. This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uriam C. Phiorrst

Page 1 of 1

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

510(k) Number K63342/