OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167

{0}------------------------------------------------ Ko 73207 Page 1 of 5 ## 510(k) Summary 5 | | | | MAY - 8 2008 | |--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------|----------------| | Applicant: | Celon AG medical instruments<br>Rheinstrasse 8<br>14513 Teltow<br>Germany | | | | | Phone: +49-3328-3519-0<br>Fax: +49-3328-3519-23<br>Establishment Registration Number: 3003724334 | | | | Contact Person: | Ms. Laura Storms-Tyler<br>Olympus America Inc.<br>3500 Corporate Parkway<br>PO Box 610<br>Center Valley, PA 18034-0610<br>USA | | | | | Phone: (484) 896-5688<br>Fax: (484) 896-7128<br>Email: laura.storms-tyler@olympus.com<br>Establishment Registration Number: 2429304 | | | | Manufacturer: | Celon AG medical instruments<br>Rheinstrasse 8<br>14513 Teltow<br>Germany | | | | | Phone: +49-3328-3519-0<br>Fax: +49-3328-3519-23<br>Establishment Registration Number: 3003724334 | | | | Date Prepared: | April 25, 2008 | | | | 510(k) Number: | K073207 | | | | Common Name: | Electrosurgical System | | | | Trade Name: | Olympus Electrosurgical System | | | | Classification Name:<br>Regulation No:<br>Product Code:<br>Device Class: | Electrosurgical cutting and coagulation device and accessories<br>878.4400<br>GEI<br>II | | | | Legally Marketed<br>Predicate Devices: | Trade Name | 510(k) | Applicant | | | Erbe VIO ESU (Model<br>VIO 300 D) with Ac-<br>cessories | K023886 | Erbe USA, Inc. | {1}------------------------------------------------ Ko 7.3.207 Page 2 of 5 | | ERBE EIP 2 | Reg. No.: 880.5475;<br>Product Code: FQH | Erbe Elektromedizin GmbH | |--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------| | Trade Name: | Olympus ESG-100 | | | | Common Name: | Electrosurgical Unit (ESU) | | | | Classification Name:<br>Regulation No:<br>Product Code:<br>Device Class: | Electrosurgical cutting and coagulation device and accessories<br>878.4400<br>GEI<br>II | | | | Legally Marketed<br>Predicate Devices: | Trade Name | 510(k) | Applicant | | | ERBOTOM ICC 200 | K933157 | Erbe USA, Inc. | | | Erbe VIO ESU (Model VIO<br>300 D) with Accessories | K023886 | Erbe USA, Inc. | | Trade Name: | Olympus AFU-100 | | | | Common Name: | Peristaltic Pump Unit (PPU) | | | | Classification Name:<br>Regulation No:<br>Product Code:<br>Device Class: | Pump, air, non-manual, for endoscope<br>876.1500<br>FEQ<br>II | | | | Legally Marketed<br>Predicate Devices: | Trade Name | 510(k) | Applicant | | | OLYMPUS ENDOSCOPIC<br>FLUSHING PUMP MODEL<br>OFP-1 | K000948 | KeyMed (Medical &<br>Industrial Equip-<br>ment), Ltd. | | | ERBE EIP 2 | Listed under regu-<br>lation number:<br>880.5475;<br>Product code: FQH | Erbe Elek-<br>tromedizin GmbH | | Device Description: | The Olympus Electrosurgical System is an electrosurgical system con-<br>sisting of the Olympus ESG-100 electrosurgical generator, in conjunc-<br>tion with the footswitch and the peristaltic flushing pump Olympus<br>AFU-100. The Olympus ESG-100 is designed to perform monopolar<br>and bipolar functions in the operating arena. The AFU-100 flushing<br>pump is intended for irrigation of instruments or irriga-<br>tion/flushing/cleansing of tissue surfaces and wounds supporting en-<br>doscopic diagnosis or therapy.<br>Olympus ESG-100 | | | The ESG-100 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. It has two displays. One display shows the selected power level, the 300002 {2}------------------------------------------------ 073207 page 3 of 5 other display shows the currently selected program mode. Buttons are used to set the power level or to change the modes. Different connectors allow connecting mono- and bipolar electrosurgical instruments, a neutral electrode, a footswitch, or an ancillary pump. The maximum output power is 120 W. Application Modes: Monopolar Cut: Three continuous cutting modes (Cut 1, Cut 2, and Cut 3) for standard tissue cutting; two intermittent cutting modes (PulseCut Slow and PulseCut Fast) for slow and controlled tissue cutting. Monopolar Coagulation: One mode for standard coagulation procedures (SoftCoag); two modes for forced coagulation (ForcedCoag 1, Forced Coag 2). Bipolar Cut: Three continuous cutting modes for standard tissue cutting applications (Cut 1, Cut 2, and Cut 3). Bipolar Coagulation: Three bipolar coagulation modes (SoftCoag, RFCoag, RFCoag + RCAP). SoftCoag is used for standard coagulation and hemostasis. RFCoag is used for controlled coagulation. It features acoustic resistance feedback and an automatic end of procedure detection. RFCoag + RCAP is especially suited for deep tissue coagulation without significant tissue desiccation; it also features an end of procedure detection. The modes have preset power levels that may be customized by the user in a defined range. Design: The design of the Olympus ESG-100 complies with the following standards: - IEC 60601-1 UL 60601-1 IEC 60601-1-2 IEC 60601-1-4 IEC 60601-1-6 IEC 60601-2-2 ISO 14971 ## Olympus AFU-100 The AFU-100 peristaltic flushing pump employs tubing to deliver fluid to the tissue/mucosa. Sterile liquids (e.g. isotonic saline solution) thus remain sterile, provided that a sterile tube set is used. {3}------------------------------------------------ 73207 Page 4 of 5 The maximum flow rate is 270 ml and 600 ml per minute with two different tube sets offered as single use items (see Figure 2). In addition, three memory buttons provide fast access to preset flow levels. The AFU-100 can be connected to the electrosurgical generator ESG-100 by an interface, allowing operation of the peristaltic pump unit by a special button of the electrosurgical unit's footswitch. The pump rotor is equipped with a protective cover, which automatically stops the rollers from rotating if it is opened while the peristaltic pump unit is activated, and thus prevents possible injuries. Design: The design of the Olympus AFU-100 complies with the following standards: - IEC 60601-1 UL 60601-1 IEC 60601-1-2 IEC 60601-1-4 IEC 60601-1-6 ISO 14971 Accessories A-Cord: The A-cord is used to connect active instruments to the Olympus ESG-100. P-Cord: The P-cord is used to connect a neutral electrode to the Olympus ESG-100. Footswitch (ESG-100): The footswitch of the ESG-100 is connected with a cable to the generator. It has a yellow CUT and a blue COAG pedal. An additional button allows switching between the application modes or to activate the pump flow, if an ancillary pump unit is connected. Footswitch (AFU-100): The footswitch is an optional accessory to the AFU-100. It has one pedal to activate and deactivate the pump. Pump Tube: There are two different sizes of pump tubes available. The tubes are inserted into the pump head and connect the liquid source with the surgical instrument. The Olympus Electrosurgical System is an electrosurgical system con-Intended Use: sisting of the Olympus ESG-100 electrosurgical generator, in conjunction with the footswitch and the peristaltic flushing pump Olympus AFU-100. The Olympus ESG-100 is designed to perform monopolar and bipolar functions in the operating arena. The AFU-100 flushing pump is intended for irrigation of instruments or irrigation/flushing/cleansing of tissue surfaces and wounds supporting endoscopic diagnosis or therapy. The Olympus Electrosurgical System has the same indication state-Comparison to Prediment as the predicate system consisting of ERBE VIO 300 D with Accate Devices: 30004 {4}------------------------------------------------ to 73207 Page 5 of 5 cessories and ERBE EIP 2. In addition, these two systems have similar technological characteristics. The subject ESG-100 has the same indication statement, the same intended use statement and similar technological characteristics as the predicates ICC 200 and VIO 300 D. The ENDO CUT mode of the predicate ICC 200 offers an equivalent to the PulseCut slow / fast of the subject ESG-100. The predicate VIO 300 D and the subject ESG-100 are suitable for bipolar cutting. There are minor differences in the output characteristics and the quantity of the application modes, the maximum output power, or the handling, but they do not change the safety and effectiveness or result in new potential risks. The subject Olympus AFU-100 has the same indication statement and similar technological characteristics as the predicate Olympus OFP-1. It also has the same intended use and technological characteristics as the Erbe EIP 2. However, the EIP 2 has been registered under a different product code. Nevertheless the intended use statements and the technological characteristics of the predicates EIP 2 and OFP-1 are substantial equivalent to the Olympus AFU-100. The data show that the differences between the subject Olympus Electrosurgical System and the predicate devices do not affect the safety and effectiveness, as no changes were incorporated in the intended use, in the performance, and in the physical principles that the system is based upon. Therefore, no additional tests are necessary for evaluation of safety and efficacy. Nevertheless bench tests of the subject ESG-100 and the predicate devices ICC 200 and VIO 300 D were performed and demonstrate substantial equivalence. Conclusion: 300005 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY -8 2008 Celon AG Medical Instruments % Olympus America, Inc. Ms. Laura Storms-Tyler VP, Regulatory Affairs & Quality Assurance 3500 Corporate Parkway P.O. Box 610 Center Valley, Pennsylvania 18034-0610 Re: K073207 Trade/Device Name: Olympus Electrosurgical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, FEQ Dated: April 29, 2008 Received: May 5, 2008 Dear Ms. Storms-Tyler: 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 {6}------------------------------------------------ Page 2 - Ms. Laura Storms-Tyler 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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indications for Use 4 K073207 510(k) Number (if known): Device Name: Olympus Electrosurgical System ## Indications For Use: The Olympus Electrosurgical System is an electrosurgical system consisting of the Olympus ESG-100 electrosurgical generator, in conjunction with the footswitch and the peristaltic flushing pump Olympus AFU-100. The Olympus ESG-100 is designed to perform monopolar and bipolar functions in the operating arena. The AFU-100 flushing pump is intended for irrigation of instruments or irrigation/flushing/cleansing of tissue surfaces and wounds supporting endoscopic diagnosis or therapy. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Neil R. P. Ogden for mxm Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices | 510(k) Number | K073207 | |---------------|---------| |---------------|---------| 300000