UPD-Y0003

{0}------------------------------------------------ # 510(k) SUMMARY MAY 1 2 2011 # ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 ### May 11, 2011 #### 1 General Information - l OLYMPUS MEDICAL SYSTEMS CORP. Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No.: 8010047 - . Stacy Abbatiello Kluesner, M.S., RAC Official Correspondent: Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy kluesner@olympus.com 를 - Shirakawa Olympus Co., Ltd. Manufacturer: 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No .: 3002808148 ### 2 Device Identification | Device Trade Name: | UPD-Y0003 | |-----------------------|-----------------------------------| | Common Name: | ENDOSCOPE POSITION DETECTING UNIT | | Regulation Number: | 21 CFR 876.1500 | | Regulation Name: | Endoscope and accessories | | Regulatory Class: | II | | Classification Panel: | Gastroenterology/Urology | | Product Code: | FDF | #### . 3 Legally Marketed Device to which Substantial Equivalence is Claimed The following table shows the primary component (part of this submission) of the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 and the device to which we claim substantial equivalence (predicate device). {1}------------------------------------------------ ## Table 12-1 Primary Component & Predicate Device of the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 | Subject Device<br>(Part of this Submission) | Predicate Device | PD's<br>510(k)<br>No. | |------------------------------------------------|---------------------------------------------|-----------------------| | ENDOSCOPE POSITION DETECTING<br>UNIT UPD-Y0003 | Endoscope Contour Detection Device<br>3DX45 | K002749 | #### ঞ্চ Device Description <Device Description Summary> This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient. The device detects the magnetic field generated by magnetic coils built directly into the endoscope or the probe inserted into the endoscope's instrument channel. #### < Operating Principle of the subject device> This device consists of the ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003) and a RECEIVER DISH (MAJ-1868). The RECEIVER DISH is connected to the UPD-Y0003 via a RECEIVER DISH CABLE (MAJ-1875 or MAJ-1927). The ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003) supplies "driving" signals to the source coils in 1) the endoscope or probe, 2) the Hand Coil and 3) the Reference Plate. The endoscope and probe have plural source coils. The Hand Coil has one source coil. The Reference Plate has plural source coils. The driving signals are sent to each source coil. The driving signal is delivered to the endoscope or probe through a UPD CABLE (MAJ-1881). The driving signal is delivered to the Hand Coil through an integrated cable and the Reference Plate through an integrated cable. When the source coils receive the driving signal, a magnetic field is generated. The magnetic field is then detected by the sense coils built into the RECEIVER DISH. The signals detected by each sense coil are processed in the UPD-Y0003. The UPD-Y0003 calculates the spatial coordinates for the specific source coil. This calculation is repeated for every source coil built into the endoscope or probe. The UPD-Y0003 then creates the visual image of the endoscope on the monitor, by then putting the spatial coordinates of the multiple source coils in order (distal to proximal) and connects them. Akin to the methodology described above, the same process takes place for the reference plate and hand coil. The spatial coordinates data obtained from the source coils in the reference plate are used to create the standard plane of endoscope's position. The source coil in the "hand coil" is used to create an independent reference point in the field of view, as displayed on the video monitor. {2}------------------------------------------------ <Fundamental technology modifications> The following two modifications were made to the fundamental technology of the Subject Device from the Predicate Device's: 1) The mechanism to drive the source coils 2) Calculation method of the spatial coordinate of each source coil ## 5 Indications for Use This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient. <Patient population> Patients who require colonoscopy except as follows: -Patients with a pacemaker -Pregnant women ## 6 Comparison of Technological Characteristics ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 is basically identical to its predicate device in intended use, and similar in specifications. Comparison between the subject and predicate devices is shown in Table 12-2. ### Table 12-2 Comparison of Specifications Subject Device: ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 Predicate Device: Endoscope Contour Detection Device Olympus 3DX45 (K002749) Main unit | Specifications | Subject Device<br>ENDOSCOPE POSITION<br>DETECTING UNIT UPD-Y0003 | Predicate Device<br>System Controller Unit<br>X301811 | |----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Rated voltage | Voltage: 100-240V AC ±10%<br>Frequency: 50/60Hz ±1Hz | Voltage: 120V AC ±10%<br>Frequency: 50/60Hz ±1Hz | | Power consumption | 110VA | 480VA | | Unit composition | Monitor and receiver dish are<br>separated. | Monitor, receiving unit and the main<br>unit are built in one unit. | | Dimensions | 370(W) x 482(D) x 81(H)mm | 490(W) x 500(D) x 1820(H) mm | | Weight | 9kg | 59kg | | Specification for Scope<br>Model display | -The Display now shows the<br>insertion portion even where a<br>source coil is not installed, areas<br>outside the detection area, and<br>areas in which a source coil is<br>broken, | -Displayed in a shaft shape or in a<br>polygonal line graph.<br>-The part of The insertion portion<br>where source coil is not installed is<br>not displayed. | | Display of overlapping<br>intersection area | Available | Not available | | Scope/probe/reference<br>plate/hand marker<br>Connection Indicator | Available | Not available | | Viewpoint indicator display | Select from the following:<br>-Operating image model<br>-Figure image model | Select from the following:<br>-Operating table model<br>-Coordinate axis model<br>-Simultaneous display of Operating<br>table model and Coordinate axis<br>model | | Patient data display | Patient ID, patient name, age and<br>sex. | Patient ID | | Error message display | Available | Not available | | Display rotation | -Scope model is rotated by 90<br>degrees to left and right by one<br>push of the switch.<br>-Depending on the setting on the<br>menu, scope model is rotated by<br>every 2.5 degrees vertically and<br>horizontally. | -Scope model is rotated by every<br>2.5 degrees vertically and<br>horizontally. | | Setting for the display start<br>position of the scope model<br>(Scope position) | -Setting method: Using external<br>marker or the position of the distal<br>end of the endoscope.<br>-Display start position: Bottom<br>center or top center of display. | -Setting method: Using external<br>marker.<br>-Display start position: Center of<br>display. | | Marking | Available | Not available | | Background color | The user can choose from three<br>predefined background colors. | -It is set by adjusting the RGB<br>density. | | Display of the distal end of<br>scope model | The distal end of a scope model is<br>displayed in yellow. | -The user can choose whether to<br>display the distal end of a scope<br>model in yellow or not. | | Detection of the source coil<br>wire break | Source coil wire break is detected<br>automatically and reflected on the<br>scope model display. | Manually input the number of the<br>broken source coil to reflect it on<br>the scope model display. | | Change of the display mode | Display of the scope model can be<br>set by the user:<br>-Displayed from the bottom<br>(standard setting)<br>-Displayed from the top | Not available | | Scope model thickness<br>setup | Adjustable.<br>The size of external marker<br>changes depending on the scope<br>model thickness. | Adjustable.<br>The size of external marker does<br>not change. | | Show/hide information | Show/Hide various information<br>individually. | Show/Hide information cannot be<br>set individually. It is either show or<br>hide all information. | | Saving and recalling the<br>setting | Save 20 presets. | Save only one preset. | | Patient data | Input via a communication<br>connector via video system center.<br>And patient data is displayed. | Input with Ten-key pad. And patient<br>data is displayed. | | Video signal output | -Y/C: 1<br>-SD-SDI: 1<br>-XGA: 1 | VGA: 1 | | Communication terminal | RS232C: 1 | Not available | | Receiving antenna input<br>terminal | One. | Not available | | Driving signal output<br>terminal for external marker | Two. | One. | | Driving signal output<br>terminal for reference plate | Two. | One. | | Safety standards | IEC 60601-1 Ed.2<br>IEEE Std C95.1, 2005 +<br>Amendment 1:2010 | IEC 60601-1<br>IEEE Std C95.1, 1999 | | EMC compliance | Class B | Class A | | Plate cover | REFERENCE PLATE COVER<br>MAJ-1880 is provided | Not provided | | Installation on the patient: | Fasten the reference plate with a<br>belt on the patient (body surface). | Attach the reference place on the<br>patient's body (over the gown) with<br>surgical tape. | {3}------------------------------------------------ {4}------------------------------------------------ #### 7 Summary of non-clinical testing Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment. The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern." The following standards have been applied to the ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003): -IEC 60601-1: 1988, Amendment 1: 1991, Amendment 2: 1995 -IEC 60601-1-1: 2000 -IEC 60601-2-18: 1996, Amendment 1: 2000 -IEC 60601-1-2: 2007 -ISO 14971: 2007 -IEEE Std C95.1: 2005+ Amendment 1: 2010 ## 8 Conclusion When compared to the predicate device, the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002 MAY 1 2 2011 Olympus Medical Systems Corporation c/o Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610 Re: K103312 Trade/Device Name: ENDOSCOPE POSITION DETECTION UNIT UPD-Y0003 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: April 12, 2011 Received: April 14, 2011 Dear Ms. Kluesner: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related {6}------------------------------------------------ Page 2 adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Hubert H Humphrey Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): K103312 Device Name: ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 Indications for Use: This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient. <Patient population> Patients who require colonoscopy except as follows: -Patients with a pacemaker -Pregnant women 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) | (Division Sign-Off) | |---------------------| |---------------------| | Page | |------| |------| Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number K1033/2 Page 1 of 1