IMACTIS CT-Navigation system

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the words "U.S. Food & Drug Administration" on the right. The FDA acronym is in a blue square, and the words "U.S. Food & Drug Administration" are in blue text. April 24, 2018 IMACTIS® SAS % Mady Batailh Quality Manager 5 avenue du Grand Sablon 38700 La Tronche FRANCE Re: K162314 Trade/Device Name: IMACTIS CT-NAVIGATION system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 12, 2018 Received: April 16, 2018 Dear Mady Batailh: 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 adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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}------------------------------------------------ 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. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. 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) K162314 Device Name IMACTIS® CT-NAVIGATION system The IMACTIS® CT-NAVIGATION system is used with linear instruments including but not limited to biopsy needle, aspiration needle, anesthesia needle, ablation needle. The system supports a workflow based on automated image registration of spatial mapping from image space to physical space. The system is intended for intra-operative guidance during percutaneous interventional procedure. It is intended for use by trained physicians in clinical intervention and for structures where is currently used for visualizing such procedures. The system is not intended for guidance for the head, nervous system and central circulatory system (heart included). Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for IMACTIS. The logo consists of a stylized eye symbol to the left of the word "IMACTIS". The eye symbol is a dark blue color, and the word "IMACTIS" is also dark blue. There is a registered trademark symbol to the right of the word "IMACTIS". # Traditional 510(k) Premarket Notification for IMACTIS® CT-NAVIGATION system # 510(k) SUMMARY The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92. Date Prepared: October, 4th 2017. #### Owner's information: IMACTIS® SAS 5 avenue du Grand Sablon 38700 LA TRONCHE - FRANCE Phone: +334 76 54 95 40 Fax: +334 76 54 95 61 #### Contact person: Mady Batailh Phone: +33 4 76 54 95 40 Email: quality@imactis.com #### Device information: | Trade name: | IMACTIS® CT-NAVIGATION system | |----------------------|----------------------------------------------------| | Common name: | CT stereotactic accessory | | Classification name: | Computed tomography x-ray system (21 CFR 892.1750) | | Product code: | JAK | | Class: | II | #### Panel: Radiology devices #### Legally-marketed predicate device: | Manufacturer | System Name | 510(k)<br>number | Product code | |-----------------|-------------|------------------|--------------| | EDDA-technology | IQQA® Guide | K151414 | JAK | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for IMACTIS. The logo consists of a stylized eye-shaped symbol on the left, followed by the word "IMACTIS" in a sans-serif font. The symbol and the text are in a muted blue color. There is a registered trademark symbol to the right of the word "IMACTIS". ### Device Description: The IMACTIS® CT-NAVIGATION system consists of a navigation station, specific software and a dedicated instrumentation set used in an interventional radiology room during percutaneous interventional radiological procedures performed under Computed Tomography. #### Intended Use The IMACTIS® CT-NAVIGATION system is a stereotaxic accessory for Computed Tomography systems. It displays simulated image of interventional instrument on a computer monitor screen that also shows images of the targeted organ(s) and the current and the projected future path of the interventional instrument. ### Indications for use The IMACTIS® CT-NAVIGATION system is used with linear instruments including but not limited to biopsy needle, aspiration needle, anesthesia needle, ablation needle. The system supports a workflow based on automated image registration of spatial mapping from image space to physical space. The system is intended for intra-operative guidance during percutaneous interventional procedure. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures. The system is not intended for quidance for the head, neck, central nervous system and central circulatory system (heart included). {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for IMACTIS. The logo consists of a stylized eye graphic on the left, followed by the word "IMACTIS" in a sans-serif font. The eye graphic is a blue-gray color, and the text is the same color. There is a registered trademark symbol to the right of the word "IMACTIS". # Summary of technological characteristics: | Item | IMACTIS® CT-NAVIGATION system | IQQA® Guide | SE | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----| | Tracking<br>technology | Electromagnetic tracking technology | Same | YES | | Computer<br>Hardware<br>configuration | Standard PC hardware | Same | YES | | Used by | Trained physicians | Same | | | User Interface | A graphical user interface to interact<br>with the software | Same | YES | | Patient imaging<br>display during<br>intervention | Use of acquired patient imaging for<br>anatomy structure:<br>- CT during intervention<br>- Previously acquired CT | 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 | YES | | Combined<br>Display | Combine the display of simulated<br>instrument and display of patient<br>imaging/anatomy model | Same | YES | | Clinical<br>environment to<br>be used in | Used in clinical interventions and for<br>anatomical structure where imaging is<br>currently used for visualizing such<br>procedures | Same | YES | Table 2: Summary of technological characteristics #### Testing Information and performance: The design of the device, including software, was realized according to internal design controls procedures to ensure that specified design requirements are met. #### Non clinical testing The IMACTIS® CT-NAVIGATION system was tested for electromagnetic compatibility and electrical safety according to the IEC 60601-1 and IEC 60601-1-2 standards. Biocompatibility testing was performed on components according to ISO10993 standards. Sterility of components delivered sterile was tested according to ISO11737 and ISO11607 standards. CT imaging requirements for the IMACTIS® CT-NAVIGATION system were challenged during the verification phase of the design process using 2 CT-scan series resolutions: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for IMACTIS. The logo consists of a stylized letter "m" inside of a circle on the left, followed by the word "IMACTIS" in all capital letters. The color of the logo is a muted blue. - First resolution corresponds to an axial image resolution of 0.5mm/pixel and a spacing of 1mm between slices - Second resolution corresponds to the worst accepted case, an axial image resolution of 1mm/pixel (corresponds to a field of view of 512mm) and a spacing of 2mm between images. The verification testing demonstrates that the IMACTIS® CT-NAVIGATION system performances are maintained in both cases. Regarding the system accuracy performance on the complete measurement chain (including localization system, calibration and registration accuracy), the IMACTIS® CT-NAVIGATION system was tested in rigid conditions during the verification phase of the design process, on a dedicated test bench. This bench has cylindrical holes at different positions and with different angles. A needle tool, localized by the navigation system, is positioned in those cylindrical holes. For each cylindrical hole, the accuracy is computed as the difference between the known position of the cylindrical hole and the position measured by the medical device. The system accuracy is always smaller than 2° and 2 mm. While comparing the results of the predicate device and the results of the submitted device as described above, we conclude that the IMACTIS® CT-NAVIGATION system is substantially equivalent to the predicate device in terms of accuracy in rigid conditions. # Clinical testing Additionally, a clinical testing on patients was conducted with the IMACTIS® CT-NAVIGATION system to provide feedback on the intended use and validate major functionalities by physicians. The system accuracy results on the complete measurement chain was collected on 60 patients for which the intervention was done with IMACTIS® CT-NAVIGATION system. As an information, during a clinical testing, the achieved accuracy of the IMACTIS® CT-NAVIGATION system (using the convention Median [P16%; P84%]) was of 3.8 mm [2.1; 9.9] in Per Protocol and of 4.1 mm [2.1; 11.7] in Intention To Treat. Regarding system registration performance of the predicate device, and the IMACTIS® CT-NAVIGATION system accuracy performance measured on the complete measurement chain, the IMACTIS® CT-NAVIGATION system is substantially equivalent to the predicate device Testing drawn from the nonclinical and clinical tests demonstrate that the actual device performance is substantially equivalent to the predicate device performance. The IMACTIS® CT-NAVIGATION system is as safe, as effective and performs as well as the legally marketed device. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for IMACTIS. The logo consists of a stylized eye on the left and the word "IMACTIS" on the right. The eye is a teal color, and the word "IMACTIS" is also teal. The logo is simple and modern. # Conclusion on substantial equivalence: The IMACTIS® CT-NAVIGATION system has the same intended use as the predicate device IQQA® Guide. It is substantially equivalent in the areas of technical characteristics, principles of operations and functional features. It does not raise any new questions of safety and effectiveness. The IMACTIS® CT-NAVIGATION system is substantially equivalent to IQQA® Guide.