OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES

{0}------------------------------------------------ #### 510(k) Summary of Safety and Effectiveness SMDA # KO21852 This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807 subpart E, Section 807.92. #### A. Sponsor /Manufacturer Name and Address - 1. Applicant Olympus Optical Co., Ltd. 2-3-1 Shinjuku Monolis Nishi-shinjuku Shinjuku-ku, Tokyo, Japan, 163-0914 Establishment registration number : 8010047 - Initial Importer 2. Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 E stablishment registration number : 2429304 - 3. Contact Person Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 - Tel 631-844-5688 Fax 631-844-5416 #### B. Device Name, Common Name - 1. Common/Usual Name Electrosurgical Unit and its ancillary equipment. - 2. Device Name - Olympus PSD-20 Electrosurgical System and its associated accessories - 3. Classification 21 CFR 876.4300 Endoscopic electrosurgical unit and accessories, Class II #### C. Identification of the predicate or legally marketed device The following devices are substantially equivalent devices in consideration to its characteristics or specifications. | Model Name | 510(k) | Applicant | |------------------------------------------------------------------------------------------------|---------|---------------------------| | Olympus PSD-20 Electrosurgical<br>Unit and its associated accessories<br>(For GI application ) | K970797 | Olympus Optical Co., Ltd. | #### D. Device Description - 1. Summary {1}------------------------------------------------ This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for bronchial endoscopic treatment (cutting and coagulating. Recommended endoscopes for this instrument are Olympus's series BF series, and Olympus's electrosurgical instruments such as electrosurgical snare, hot biopsy forceps. Other Olympus electrosurgical devices or instruments can be used with this subject device. Be sure to check compatibility for each device in each instrument's instruction manual. The PSD-20 unit offers Monopolar output modes; 5 Cut modes (PURE, BLEND 1/2/3/4), 1 Coagulation mode. (NORMAL COAGULATION), It offers several features to ensure the safe operation of the unit. For example, the voltage output level setting and a monitor circuit detect irreqularity or improper connections. ### 2. Design This device has been designed to be comply with the following voluntary standards. - · IEC 60601-1 - · IEC 60601-2-2 - · IEC 60601-2-18 - · IEC 60601-1-2 (EMC) #### 3. Materials There aren't any patient contacting material in PSD-20 itself. Some ancillary equipment have patient contact materials, however there are no new patient contacting material in those devices. ### 4. Technology This device does not have any special technology or characteristic i.e. this device is intended to provide electrical power to accessories (such as biopsy) via the use of high frequency electrical current waveform passing into the tissue during endoscopic bronchial treatment. #### E. Indication for Use This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for bronchial endoscopic treatment (cutting and coagulating) including: - Hemostasis of superficial bleeding - Treatment of benign turnors like papillomatosis, granulomas, polyps, lipomas and hemangiornas in the trachea and bronchi - Recanalization of malignant stenoses - Treatment of Cicatricial stenoses of the respiratory tract {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # FEB 1 1 2003 Olympus Optical Co., Ltd. c/o Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157 Re: K021852 Trade/Device Name: Olympus PSD-20 Electrosurgical System and Its Associated Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 12, 2002 Received: November 13, 2002 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 (P.MA), 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. {3}------------------------------------------------ Page 2 - o Ms. Laura Storms-Tyler 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Muriam C. Provost Felia 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 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and slightly distressed, giving it a textured appearance. Below the word, there is a line of smaller, illegible text that appears to be a description or tagline associated with the brand name. ## Indication for Use Statement KO21852 510(k) Number(if known): Net assigned yet. Device Name: Olympus PSD-20 Electrosurgical System and its associated accessories #### Indications for Use : This instrument has been designed to be used with Olympus recommended Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment for bronchial endoscopic treatment (cutting and coagulating) including: - Hemostasis of superficial bleeding - - Treatment of benign tumors like papillomatosis, granulomas, polyps, lipomas and hemangiomas in the trachea and bronchi - Recanalization of malignant stenoses - - Treatment of Cicatricial stenoses of the respiratory tract ﯩ (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Prescription 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Numb