CLARITY OBP SYSTEM

{0}------------------------------------------------ JAN 3 0 2012 K11332 # 510(k) Summary December 28, 2011 | Trade/Device Name: | Clarity™ OBP System | |---------------------------------|---------------------------------------------------| | Common Name: | Patient positioning system, ultrasound | | Regulation/Classification Name: | Medical charged-particle radiation therapy system | | | (21 CFR 892.5050, Product Code IYE) | | | Radionuclide radiation therapy system | | | (21 CFR 892.5750, Product Code IWB) | | | Radiation therapy simulation system | | | (21 CFR 892.5840, Product Code KPQ) | | Regulatory Class: | Class II | | Review Panel: | Radiology | | Submitter/Manufacturer: | Elekta Ltd. | | Establishment Registration No: | 3004747535 | | Address: | 2050 Bleury, Suite 200 | | | Montreal, Quebec, Canada H3A 2J5 | | | Tel: (+1) 514.985.2442 | | | Fax: (+1) 514.985.2662 | | Contact: | Tony Falco, PhD | ## Introduction This 510(k) Summary has been prepared in accordance with 21 CFR 807.92. It summarizes device safety and effectiveness information to provide an understanding of the basis for a determination of substantial equivalence of the Clarity™ OBP System. # Predicate Device Information The Clarity™ OBP System is substantially equivalent to the following legally marketed devices in the United States: - Restitu™ (K041937; Nov 16, 2004; Product Codes: IYE, IWB, KPQ) Resonant Medical Inc. . - IKOEngelo™ (K083591; Dec 29, 2008; Product Code: KPQ) IKOEtech, LLC . - MIM 4.1 (SEASTAR) (K071964; Sep 26, 2007; Product Code LLZ) MIMvista Corporation . ## Intended Use The Clarity™ OBP System is intended for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft-tissue anatomy to support radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment. {1}------------------------------------------------ #### Elekta Ltd. # Device Description The Clarity™ OBP System integrates medical diagnostic ultrasound and optical position tracking to acquire and reconstruct three-dimensional ultrasound (3DUS) images of soft-tissue anatomy for use in external beam radiation therapy. During the course of radiation therapy, the Clority™ OBP System offers a non-ionizing means for daily localization of target anatomical structures. The Clarity™ OBP System comprises the following functional components: - The 3DUS imaging station (typically one in the CT-simulation room and one in the treatment . room}, including the 3DUS console with an integrated computer system and opticallytracked ultrasound probes, patient/couch position tracking tools, and a ceiling-mounted optical tracking system. - . A multimodality phantom, for 3DUS image calibration to the room's coordinate system defined by the corresponding room lasers, and for daily verification of system integrity. - . One or more dedicated workstation computer systems for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, and monitoring of treatment progress. - . A dedicated central server computer system (typically combined with a workstation), which houses the patient database and provides for interoperability with other imaging and treatment planning/simulation systems using the DICOM 3/RT protocol. All networked Clarity™ OBP System stations are configured to run the same software version. The software interface is designed to 'walk' the user through a sequence of steps (or "course") to acquire 3DUS scans in the planning position, import planning CT data and fuse with 3DUS, define the structure of interest and approve a baseline positioning reference, acquire another 3DUS in the treatment position to determine target displacement relative planning-day position, and adjust patient positioning prior to treatment. The 3DUS data may be exported through DICOM to a third-party virtual simulator or treatment planning system (TPS). Different courses are defined in the software (e.g., "Prostate", "General", "QC") to help classify patients in the database and to present the user with default choices and settings, tailored for the target anatomy (e.g. prostate, bladder, liver, uterus & cervix, breast, head & neck) and daily QC tasks. Such configurations include probe type, scan settings, contouring and assisted segmentation tools, and alert values for large target misalignments. The Clarity™ OBP System provides the option for hand-held ultrasound scanning or automated scanning with a motorized probe. The user can select the probe and scanning method that is most appropriate for the given target anatomy and the patient's clinical presentation. The autoscan probe comes with a probe holder apparatus and a remote control console, specifically designed to facilitate transperineal imaging of the prostate and surrounding soft tissues. The Clarity™ OBP System also includes an optional web-based interface for remote review of treatment session data and positioning reference images. {2}------------------------------------------------ ### Comparison with Predicate Devices The Clarity™ OBP System incorporates software and system engineering improvements that have been implemented since the first release of the Restitu™ device (K041937), aiming to improve device usability and reinforce device safety. System engineering changes include the integration of a high-performance computer system and technologically advanced diagnostic ultrasound in the 3DUS Console, and the use of passive optical tracking technology. The current system offers the option for automated scanning with a motorized (autoscan) probe, as well as for traditional manual scanning with hand-held ultrasound probes offered by the predicate device. The current components have the same intended use and are manufactured to the same recognized safety standards and regulatory requirements as those in the predicate device. Improvements to the software interface include predefined "courses" tailored for the target anatomy and daily QC tasks, advanced editing tools for image registration and fusion, dedicated workspaces for structure contouring and definition of positioning references, and a web-based interface for remote review of patient data. Multimodality image co-registration and fusionvisualization capabilities, equivalent to those cleared for use with the IKOEngelo™ (K083591) and MIM 4.1 (SEASTAR) (K071964) software devices, have been added to assist with contouring and definition of a positioning reference. Despite the technological differences, the Clarity™ OBP System is substantially equivalent with the predicate devices in design, functions, and operating principles for the intended use, and does not raise new questions of safety or effectiveness. ## Verification and Validation Testing To address any potential safety and effectiveness concerns with the integration of the new technology in the Clarity OBP System, we have performed a systematic review and verification of design requirements and validation of essential performance, following a comprehensive hazard analysis and risk assessment process in compliance with regulatory guidance and recognized consensus standards. Software and system testing has been conducted in house and in clinical settings under conditions of simulated use. The verification test results demonstrate that this next-generation device fulfills design and risk management requirements, and performs well in accordance with established specifications for its intended use. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol to the right of the text. The text is arranged in a circular fashion around the symbol. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Dr. Tony Falco. PhD Official Correspondent Elekta. Ltd. 2050 Bleury, Suite 200 MONTREAL QUEBEC H3A 2J5 CANADA JAN 3 0 2012 Re: K111332 Trade/Device Name: ClarityTM OBP System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE, IWB, and KPQ Dated: December 28, 2011 Received: January 3, 2012 #### Dear Dr. Falco: 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of {4}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 nredicate 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html. Sincerely Yours, Mary Pastel Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Traditional 510(k) - Clarity OBP System # Indications for Use Statement 510(k) Number: K111332 Clarity™ OBP System Device Name: #### Indications for Use: The Clarity™ OBP System is intended for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft-tissue anatomy to support radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment. **Prescription Use** (Per 21 CFR 801 Subpart D) ✓ OR Over-The-Counter Use (Per 21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Mary Pastel (Division Sign-Off) Division of Radiologica Office of In Vitro Division of Hadlological Device Evaluation and Sc K111332 510K.