IQQA Guide

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 20, 2015 EDDA Technology % Daniel Kamm Submission Correspondent 5 Independence Way PRINCETON NJ 08540 Re: K151414 Trade/Device Name: IQQA-Guide Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 22, 2015 Received: October 27, 2015 Dear Mr. Kamm: 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 (reporting of medical device-related 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K151414 Device Name IQQA-Guide Indications for Use (Describe) The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It displays simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows an imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments. The system supports the imaging-based model derived from physician's confirmed segmentation results of patient's image scans, including intra-operative CT, pre-procedural CT, and CT or MR previously acquired before surgical procedures. Additionally, overlaying ultrasound images (when available) may be displayed with the model of patient anatomy. The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments. The system is intended for intra-operative guidance for surgical procedures. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # EDDA Technology 510(k) Summary K151414 5 Independence Way Princeton, NJ 08540 Tel: 609-919-9889 Fax: 609-919-9779 Contact: Xiaolan Zeng, Executive Vice President Date prepared: November 14, 2015 - 1. Identification of the Device: Proprietary - Trade Name: IQQA-Guide Common Name: Computer assisted image-guided system Classification Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulatory Class: Class II Product Code: JAK - 2. Substantially equivalent legally marketed devices: | Manufacturer | Name of the Predicate Device | FDA 510(k) Number | FDA Clearance Date | CFR/Product Code | |-------------------------------|---------------------------------------------------|-------------------|--------------------|-----------------------| | Veran Medical<br>Technologies | ig4 Image Guided System | K093995 | 01/27/2010 | 21 CFR892.1750<br>JAK | | Traxtal Technologies | ABARIS, Computer assisted,<br>image-guided system | K053610 | 04/19/2006 | 21 CFR892.1750<br>JAK | - 3. Indications for Use (intended use): The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It displays simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows an imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments. The system supports the imaging-based model derived from physician's confirmed segmentation results of patient's image scans, including intra-operative CT, pre-procedural CT, and CT or MR previously acquired before surgical procedures. Additionally, overlaying ultrasound images (when available) may be displayed with the model of patient anatomy. The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physical space. Physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments. The system is intended for intra-operative guidance for surgical procedures. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures. - 4. Description of the device: The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an imaging-based model of the patient anatomy. IOOA-Guide displays the simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows {4}------------------------------------------------ the imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments. IQQA-Guide supports the imaging-based 3D model derived from physician's confirmed segmentation results of patient's image scans, including intra-operative CT, pre-procedural CT, and CT or MR previously acquired before surgical procedures. The model of segmentation results may also be loaded from saved reports of the IQOA-BodyImaging software (K141745). Additionally, overlaying ultrasound images (when available) may be displayed with the model of patient anatomy. The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physical space. Physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments. The IQQA-Guide system consists of an EM tracking system, software, and a computer system. The system is intended for intra-operative guidance for surgical procedures. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures. The EM sensor and accessories that are compatible with the IQQA-Guide are cleared by the FDA in K092619, including eTRAXTM Needle System, General Purpose Sensor, and VirtuTRAX Instrument Navigator. They are not part of the IQQA-Guide system and are sourced separately. The compatible EM sensor and accessories are connected to the submitted device IQQA-Guide by plugging the connector part of the K092619 sensor into the receptacles on the front panel of the EM tracking system contained in the IQQA-Guide. The software contained in the submitted device IQQA-Guide (v1.0), is an upgrade from the already cleared IQQA-BodyImaging (K141745). | | Device of 510(k) submission:<br>IQQA-Guide (version 1.0) | Predicate Device:<br>ig4 Image Guided System<br>K093995 | Predicate Device:<br>ABARIS, Computer<br>assisted, image-guided<br>system K053610 | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | EDDA Technology | Veran Medical Technologies | Traxtal Technologies | | Indications for<br>Use | The IQQA-Guide System is a<br>stereotactic accessory for Computed<br>Tomography (CT). It displays<br>simulated image of interventional<br>instruments (such as biopsy needle,<br>ablation needle, probe) on a computer<br>monitor that also shows an imaging-<br>based 3D model of the patient<br>anatomy, and the current and the<br>projected future path of the<br>interventional instruments. The system<br>supports the imaging-based model<br>derived from physician's confirmed<br>segmentation results of patient's image<br>scans, including intra-operative CT,<br>pre-procedural CT, and CT or MR<br>previously acquired before surgical<br>procedures. Additionally, overlaying<br>ultrasound images (when available)<br>may be displayed with the model of<br>patient anatomy. The system supports<br>a workflow based on automated image<br>registrations of spatial mapping from<br>one image space to another image | The ig4TM Image Guided System is a<br>stereotactic accessory for Computed<br>Tomography (CT) or 3D<br>fluoroscopic x-ray systems.<br>The ig4 System is indicated for<br>interventional displaying an<br>instrument such as a biopsy needle,<br>an aspiration needle, or ablation<br>needle on a computer monitor that<br>also displays a CT-based or 3D<br>fluoroscopic X-ray-based model of<br>the target organ(s). The ig4TM<br>System is additionally indicated for<br>overlaying Ultrasound images onto<br>the model of the target organ(s). The<br>ig4TM System compensates for the<br>patient's respiratory phases.<br>The ig4TM System is intended for<br>use in clinical interventions and for<br>anatomical structures where<br>computed tomography, 3D<br>fluoroscopic x-ray, or ultrasound are<br>currently used for visualizing such<br>procedures. | ABARIS is a stereotaxic<br>accessory for Computed<br>Tomography (CT), Magnetic<br>(MR), Resonance, Ultrasound<br>(US), Positron Emission<br>Tomography (PET), Single<br>Photon Emission Computed<br>Tomography (SPECT),<br>Fluoroscopy, Endoscopy and<br>other imaging systems. It<br>displays the simulated image of<br>a tracked insertion tool such as a<br>biopsy needle, guidewire or<br>probe on a computer monitor<br>screen that shows images of the<br>target organs and the current and<br>the projected future path of the<br>interventional instrument taking<br>into account movements<br>of the patient. This is intended<br>for treatment planning and intra-<br>operative guidance for surgical<br>procedures. The device also<br>supports an image-free mode in | | | Device of 510(k) submission:<br>IQQA-Guide (version 1.0) | Predicate Device:<br>ig4 Image Guided System<br>K093995 | Predicate Device:<br>ABARIS, Computer<br>assisted, image-guided<br>system K053610 | | | space, or from image space to physical<br>space. Physician may interactively<br>adjust and confirm registration results,<br>and evaluate 3D visualization and<br>quantitative information in terms of<br>distance, size, and spatial location<br>associated with patient anatomy and<br>instruments. The system is intended<br>for intra-operative guidance for<br>surgical procedures. It is intended for<br>use by trained physicians in clinical<br>intervention and for structures where<br>imaging is currently used for<br>visualizing such procedures. | | which the proximity of the<br>interventional device is<br>displayed relative to another<br>device. The device is intended<br>to be used in clinical<br>interventions and for anatomical<br>structures where imaging is<br>currently used for visualizing<br>such procedures. The device is<br>also intended for use in clinical<br>interventions to determine the<br>proximity of one device relative<br>to another. | | Tracking<br>technology | Electromagnetic tracking<br>technology | same | same | | Computer<br>Hardware<br>Configuration | standard PC hardware | standard PC hardware | standard PC hardware | | User Interface | A graphical user interface for<br>users to interact with the<br>software, select tools and drive<br>workflow | A graphical user interface for<br>users to interact with the<br>software, select tools and<br>drive workflow | A graphical user interface<br>for users to interact with<br>the software, select tools<br>and drive workflow | | Instrument<br>display | Displaying dynamically the<br>simulated image of tracked<br>instrument | same | same | | Patient<br>imaging<br>display | Use of acquired patient<br>imaging for anatomy structure:<br>-CT during intervention<br>-CT pre-procedural<br>- Previously acquired CT, MR<br>-Ultrasound during intervention<br>when available | Use of acquired patient<br>imaging for anatomy<br>structure:<br>CT, 3D fluoroscopic X-ray,<br>ultrasound | Use of acquired patient<br>imaging for anatomy<br>structure:<br>CT, MR, PET, SPECT,<br>Ultrasound, Fluoroscopy<br>etc | | Combined<br>display | Combine the display of<br>simulated instrument and<br>display of patient<br>imaging/anatomy model | same | Same | | clinical<br>environment<br>to be used in | Used in clinical interventions<br>and for anatomical structure<br>where imaging is currently used<br>for visualizing such procedures | Used in clinical interventions<br>and for anatomical structure<br>where imaging is currently<br>used for visualizing such<br>procedures | For all stages of surgery.<br>Including hospital<br>operating rooms,<br>outpatient surgery centers<br>and procedure rooms | | Used by | For use by trained physicians | same | same | # 5. Comparison with predicate devices - IFU and Technological characteristics {5}------------------------------------------------ {6}------------------------------------------------ IQQA-Guide has the same intended use and similar technological/functional features as the predicate devices in providing tools and workflow designs to support physician users to visualize and evaluate tracked interventional instrument with respect to patient imaging data. The IQQA-Guide device is utilized only by trained professionals. The trained professionals, providing ample opportunity for competent human intervention interpret images and information being displayed. They are competent to determine whether the images and information being displayed can be useful in the decision of patient management. Physicians make all final patient management decision. IQQA-Guide and predicate devices are substantially equivalent in the areas of technical characteristics, principles of operation, and functional features. IQQA-Guide does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. - 6. Safety and Effectiveness: The IQQA-Guide labeling contains instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device. Risk Management is ensured via the company's design control and risk management procedures. Potential hazards are controlled via development and verification and validation testing. The device complies with the following standards: | | Standards No. | Standards Organization | Standards Title | Version | Date | |---|----------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------| | 1 | PS 3.1 - 3.18<br>(2009) | NEMA | Digital Imaging and Communications in<br>Medicine (DICOM) Set | 3 | 2009 | | 2 | ANSI/AAMI/IEC<br>60601-1 | ANSI/AAMI/IEC | Medical Electrical Equipment – Part 1: General<br>Requirements for<br>Basic Safety and Essential Performance (Third<br>Edition, Amendment 1 2012). | 3Ed | 2012 | | 3 | ANSI/AAMI/IEC<br>60601-1-2 | ANSI/AAMI/IEC | Medical Electrical Equipment,<br>Part 1-2: General Requirements for Safety and<br>Essential Performance - Collateral Standard:<br>Electromagnetic Disturbances – Requirements<br>and Tests. 4th Ed. (2014). | 4th Ed | 2014 | # 7. Testing Information and Performance: All product specifications were verified and validated. Testing was performed according to internal company procedures and applicable standards. The system was tested for electromagnetic compatibility and electrical safety according to the IEC60601-1 and IEC 60601-1-2 standards. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals. Additionally, to supplement system and software validation for IQQA-Guide, the company has conducted testing at clinical site. The purpose of the testing is to have physicians use the IQQA- {7}------------------------------------------------ Guide during clinical interventional procedures, validate major functionalities provided by the system, and provide feedback along the line of the intended use of the system. Regarding system registration performance, experiments involving intervention on phantoms showed accuracy of 2.35±1.23mm and 2.23±0.82mm at two hospital sites respectively, and experiments involving patient studies showed accuracy of 4.62±3.07mm and 4.9±1.9mm at two hospital sites respectively. In all instances, test results support the conclusion that actual device performance satisfies the design intent. #### 8. Conclusion The IQQA-Guide has the same intended use as the predicate devices. Test results demonstrate that the device is safe, effective, and does not raise any new potential safety risks. In all material respects, the IQQA-Guide is substantially equivalent to the predicate devices.