ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS

{0}------------------------------------------------ 510K SUMMARY Page 1 of ② Submitted By: ERBE USA, Inc. 2225 Northwest Parkway Marietta, GA 30067 Tel: 770-955-4400 Fax: 770-955-2577 Contact Person: Julie Stephens, President/Consultant Regulatory Resources Group, Inc. 510(k) Number: Date Prepared: January 20, 2006 510(k) Number: K033421 510(k) Number: K981916 Common Name: Bipolar Electrosurgical Open and Laparoscopic Instruments Electrosurgical cutting and coagulation device and accessories Valleylab Inc. LigaSure™ Open and Laparoscopic Instruments, (21 CFR 878.4400) and Gynecologic electrocautery and ERBE BiClamp™ Open and Laparoscopic Instruments, ERBE BiClamp™ Open and Laparoscopic Instruments Trade/Proprietary Name: Classification Name: accessories (21 CFR Part 884.4120) GEI and HGI Product Code: Legally Marketed Predicate Devices: Device Description: The ERBE BiClamp™ Open and Laparoscopic Instruments are used with and The ENDL brolann - Open and estem having the Optional Bipolar Mode, BiClamp - High Electrosuly(HF) energy from the ESU is delivered through the jaws of the ERBE BiClamp™ Frequency (HP) energy Trom the LOO is deliverou inveagn the juro of instruments are made mistrainless steel with plastic and ceramic insulation except at the jaw surfaces (which isolates of stamess steel with plastic and ocranion onesperation onesperation of the from the energy to only the jaw sandoo): The inches) in length with bent jaws that have a smooth 200 Thin (7.9 Inches) to 210 thin (10.0 Inches) in tong-in to made of metals and plastics with Surface: The ENDE Drolainp of Lapiaws. They have various jaw types, which are standard in the industry. The ERBE BiClamp™ Laparoscopic Instruments have a 5 mm outside diameter the Industry. The ERDE Groump - aspirity length. The Instruments are provided non-sterile (O.D.) and a o to him (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 The CNDE Drolanip - Open and Limblogical, and thoracic procedures where fusion of vessels surgery, laparoooople, gynoevices 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 will in the jawe of the in the vessels placed between the jaws of the instrument. The ERBE BiClamp™ Open and Laparoscopic Instruments are designed for use with an ERBE The ERDE Siolamp - Open one Espail System having an Optional Bipolar Mode/ BiClamp™ {1}------------------------------------------------ K060170 Page 2 of 2 #### 510K SUMMARY 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, The Indications for use with Open mother including the more is performed including such and thoracic procedures where rasion of research and abdominal), Nissen procedures - ac - besiolysis (lysis of adhesions), oophorectomy, etc. The indications for use with Laparoscopic Instruments include: all laparoscopic procedures The Midtations Tor use with Euparooosplo mot threacic surgery) where fusion of vessels or (including gynecologic, general, arongisures as bowel resections, hysterectornies (both vaginal and abdominal), laparoscopic cholecystectomies (gall bladder procedures), Nissen (both vaginal and esiolysis (lysis of adhesions), oophorectomy, etc. CAUTION: Vessel fusion can be affected by patient factors such as age, elasticity of vessels, CAO HON. Vessel walls, etc.; therefore, the physician should review each vessel fusion for seal integrity. This device is not effective for use in tubal sterlization/tubal coagulation for sterilization purposes. ## Similarities and Differences of the Proposed Devices to the Predicate Devices Comparison/Substantial Equivalence): #### Similarities The ERBE BiClamp™ Open Instruments have similar physical and dimensional characteristics as the predicate devices. They have the same basic technological onaracteristics and the intended use is the same. There are no changes to the ERBE BiClamp™ Laparoscopic Instruments. #### Differences within this 510(k) The ERBE BiClamp™ Open Instruments are different in that the jaws have a sealed ceramic coating around the outside jaw area. This new coating around the outside of the jaws gives the instrument a greater resistance to hospital cleaning and sterilization techniques. The jaw area has the greatest susceptibility to wear due to the removal of blood and tissue. There are no changes to the ERBE BiClamp™ Laparoscopic Instruments. All the instrument design changes 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, prio into of operation, and technological characteristics as the predicate devices that were previously cleared for market in a 510(k). The ERBE BiClamp™ Open Instruments differ only in that they have a sealed ceramic coating around the outside of the jaw area that has a greater durability with regards to cleaning and sterilization. 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. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the United States Department of Health and Human Services. The seal features an abstract design of an eagle with three stripes representing the three levels of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 6 2006 ERBE USA, Inc. c/o Ms. Julie Stephens Consultant Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, Georgia 30004 Re: K060170 K000170 Trade/Device Name: ERBE BiClamp™ Open and Laproscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 20, 2006 Received: January 25, 2006 Dear Ms. Stephens: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(t) premeined 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 cherosule) to regally manatise promotive provide Americal posice American Carlos Free de Frys commence prof to May 20, 1978, in eccordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvine controls provisions of the Act. The You may, therefore, market the devices, belyer to the general controls provisions of tactice, 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 It may be subject to such additional control - Lines 800 to 898. In addition, FDA can be found in the Court of Features concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I DTT 3 issuality to rour device complies with other requirements of the Act that I DA has made a acternmadations administered by other Federal agencies. You must of any I cueral statutes and regulations as annuding, but not limited to: registration and listing (21 Comply with an the Act 31equirements) neart 801 ); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200) 1050 fornit in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Ms. Stephens This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hankemig your artial equivalence of your device to a 'cegally premarket notification. "The I DA Intuing of bassification 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 80) ), please If you desire specific advice for your de rice on on one see note the regulation entitled, Contact the Office of Comphance at (21 CFR Part 807.97). You may able in the of Small "Misoranding by Teleficate to premaince notifications of the Act from the Division of Small other general information on your responsentation at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Prosideri/industry/support/industry/support/index.html. Sincerely yours, Sincerely yours, C. Huck N. Mcllwee, III Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K Obol 70 Device Name: ERBE BiClamp™ Open and Laparoscopic Instruments Indications For 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. 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), 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<br>(Part 21 CFR 801 Subpart D) | <b>X</b> | |-------------------------------------------------|----------| | AND/OR | | | Over-The-Counter Use<br>(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) Page 1 of 1 (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number.