SIRIO H3

{0}------------------------------------------------ November 16, 2017 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a square and the full name written out to the right of the square. MASMEC S.p.A. % Gregory Mathison President Regulatory Strategies, Inc. 3924 Cascade Beach Road Lutsen, Minnesota 55612 Re: K163643 Trade/Device Name: SIRIO H3 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: October 17, 2017 Received: October 24, 2017 Dear Mr. Gregory Mathison: 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 (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 mediation-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, 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) K163643 Device Name SIRIO H3 #### Indications for Use (Describe) SIRIO H3 is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures. SIRIO H3 is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ # 510(k) Summary This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. ## General Information | Applicant: | MASMEC S.p.A. | |------------------------|---------------------------------------------------| | Trade Name: | SIRIO H3 | | Common Name: | CT navigation system | | Classification Name: | Computed Tomography X-ray System | | 21CFR Number: | 892.1750 | | Device Classification: | Class II | | Product Code: | JAK - System, X-ray, Tomography, Computed | | Predicate Devices: | CAS-One IR from CAScination AG<br>(K152473) | | Contact | Domenico Marino<br>Director of Regulatory Affairs | | Date: | October 15, 2017 | ## Substantially Equivalent to: The SIRIO H3 is equivalent in intended use, principal of operation and technological characteristics to the CAS-One IR submitted as K152473 with Product Code JAK under 21CFR892.1750. ## Description of the device subject to premarket notification SIRIO H3 is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of needles (or similar surgical instruments), as well as in verification of theirs position and performance during Computed Tomography (CT) guided procedures. SIRIO H3 reconstructs a 3D model of the target anatomy from a data set of previously {4}------------------------------------------------ acquired CT images by means of a semiautomatic algorithm. The system components are: - the patient tool ● - the needle tool ● - direction tool - guide for needle ● - a visualization /elaboration unit ● - an infrared optical sensor mounted either on the ceiling of the CT room or on the ● visualization /elaboration unit All the tools in contact both with the skin of the patient and with the surgical instruments are sterile disposable. #### Indications for Use SIRIO H3 is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures. SIRIO H3 is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures. ## Materials All materials used in the manufacture of the SIRIO H3 Disposable Kit are suitable for this use and have been used in numerous previously cleared products. ## Non-Clinical Testing Product testing was completed and met all of the acceptance criteria. Testing included: - Electrical safety & EMC compatibility according to IEC 60601-1 and IEC 60601-1-2 were . conducted. The system was found to conform. - Dimensional & Visual inspections of the product was performed - Mechanical and Performance An accuracy test that evaluated needle insertion ● configurations of SIRIO H3 was conducted on a phantom simulation of clinical use and was shown to be accurate. Accuracy is defined as the difference between the position of the sensitized real needle and the tip of the figure-guided needle. The accuracy is ≤ 2mm / 100mm. ## Clinical Evaluation A clinical evaluation of the SIRIO H3 System was completed by the Department of Diagnostic Imaging of the University Campus of Bio-Medico of Rome. A total of 40 patients were evaluated for lung biopsy procedures. The study concluded the SIRIO H3 System performed as intended in 3D imaging, patient tool use, needle localization, and tracking system operation. {5}------------------------------------------------ ## Performance Data All necessary verification and validation testing has been performed for the SIRIO H3 to assure substantial equivalence to the predicate devices. ## Basis for Determination of Substantial Equivalence Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the SIRIO H3 is determined to be substantially equivalent to existing legally marketed devices. {6}------------------------------------------------ # Comparison of Product Features | Trade name | SIRIO H3 | CAS-One IR | SE Discussion | |-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------| | Product code | JAK | JAK | Same product code | | 510(k) number | K163643 | K152473 | | | 21CFR | 892.1750 | 892.1750 | Same CFR number | | Device Classification | II | II | Same - Class II | | Device description | SIRIO H3 is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of needles (or similar surgical instruments), as well as in verification of theirs position and performance during Computed Tomography (CT) guided procedures.<br><br>SIRIO H3 reconstructs a 3D model of the target anatomy from a data set of previously acquired CT images by means of a semiautomatic algorithm. The system components are:<br>the patient tool the needle tool direction tool guide for needle a visualization /elaboration unit an infrared optical sensor | The system consists of three main components:<br>A mobile navigation platform: this platform can be moved in and out of radiology rooms and is positioned next to the patient in front of the CT scanner. The platform includes two touch screens, a camera and a computer. Aiming device with trackable aiming insert: To aim the needles to their correct locations, the system uses an aiming device. The aiming device is attached to a multi-axis mechanical arm that can align the position of the aiming device around the expected needle entry position. The aiming device is first aligned to the desired entry point (translational alignment) and then alignment to the desired needle insertion angle is performed using a remote center of rotation principle (rotational alignment). There are two possible configurations of the aiming device. Instrument adapter | The device description is the same. | | | mounted<br>either on the<br>ceiling of the<br>CT room or<br>on the<br>visualization<br>/elaboration<br>unit<br>All the tools in contact<br>both with the skin of<br>the patient and with the<br>surgical instruments<br>are sterile disposable. | clamp with trackable<br>marker shield: As an<br>alternative to the aiming<br>device, trackable<br>markershields can be<br>attached directly to rigid<br>needles by means of an<br>instrument adapter.<br>Calibration of the<br>needle geometry is<br>performed with a<br>calibration unit supplied<br>by CAScination.<br>- CAS-One IR software:<br>The software provides the<br>step-by-step workflow<br>assistance for needle<br>navigation. It provides a<br>means for users to<br>precisely plan a single or<br>multiple needle<br>trajectories, navigate a<br>needle to this exact<br>position and validate the<br>inserted needle's position<br>to the planned position. | | | Intended Use | SIRIO H3 is a user<br>controlled, stereotactic<br>accessory intended to<br>assist in planning,<br>navigation and manual<br>advancement of one or<br>more instruments, as<br>well as in verification<br>of instrument position<br>and performance<br>during Computed<br>Tomography (CT)<br>guided procedures.<br>SIRIO H3 is indicated<br>for use with rigid<br>straight instruments<br>such as needles and<br>probes used in CT<br>guided interventional<br>procedures performed<br>by physicians trained<br>for CT procedures. | CAS-One IR is a user<br>controlled, stereotactic<br>accessory intended to<br>assist in planning,<br>navigation and manual<br>advancement of one or<br>more instruments, as<br>well as in verification of<br>instrument position and<br>performance during<br>Computed Tomography<br>(CT) guided<br>procedures.<br>In planning, the desired<br>needle configuration<br>and performance is<br>defined relative to the<br>target anatomy.<br>In navigation, the<br>instrument position is<br>displayed relative to the<br>patient and guidance for<br>needle alignment is<br>provided<br>while respiratory levels<br>are monitored. | Equivalent | | | | In verification, the<br>achieved instrument<br>configuration and<br>performance are<br>displayed relative to the<br>previously defined plan<br>through an overlay of<br>the pre- and post-<br>treatment image data. | | | Electrical<br>Safety | IEC 60601-1:2005 | IEC 60601-1:2005/A1<br>2012 | | | EMC | IEC 60601-1-2:2007 | IEC 60601-1-2:2007 | Equivalent | | Procedure<br>planning | Yes | Yes | Equivalent | | Navigation | Yes | Yes | Equivalent | | Respiratory<br>motion<br>control | Yes | Yes | Equivalent | | Physician<br>Intra-<br>interventional<br>verification | Yes | Yes | Equivalent | | Interventional<br>instrument<br>compatibility | Yes | Yes | Equivalent | | Sterilization | Yes - ETO | Yes - ETO | Both disposable<br>components are<br>supplied sterile. | | Single use<br>disposables | Y | Y | Equivalent | | Shelf life | 5 years | Not indicated in<br>summary | Expiry date is on the<br>product label | | Packaging | Tyvek / Poly pouch | Tyvek / Poly pouch | Equivalent | | Materials | Biocompatible | Biocompatible | Equivalent | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ## Conclusion The products are substantially equivalent as the indications for use are the same, the clinical application is the same, the materials are equivalent, the dimensions are equivalent and the tested product performance attributes are equivalent.