CardioGraphe

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December 2, 2022 Arineta Ltd. % Tanya Shalem Director QA&RA 15 Halamish Street Caesarea. 3088900 ISRAEL Re: K213465 Trade/Device Name: SpotLight Duo Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: November 4, 2022 Received: November 4, 2022 Dear Tanya Shalem: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 2022.12.02 10:54:01 -05'00' Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K213465 Device Name SpotLight Duo Indications for Use (Describe) The SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial. Cine and Cardiac scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for X-ray Computed Tomography imaging of organs that fit in the scan field of view, including cardiac and vascular CT imaging. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures. Type of Use (Select one or both, as applicable) 図 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}------------------------------------------------ # 510(k) SUMMARY Arineta's SpotLight Duo #### Submitter Arineta Ltd. 15 Halamish Street Caesarea 3088900 Israel Tel: +972-4-6374000 Fax: +972-4-6277006 Contact Person: Tanya Shalem, VP of QA&RA Date Prepared: August 12, 2022 Name of Device: SpotLight Duo Common or Usual Name: Computed Tomography X-ray System Regulation Medical Specialty: Radiology Regulation Number: 892.1750 Regulatory Class: Class II Product Code: JAK #### Predicate Devices | Device Name | Manufacturer | 510(k) Number | |---------------|-------------------|---------------| | SpotLight CT | Arineta Ltd. | K161066 | | Revolution CT | GE Healthcare LLC | K133705 | #### Device Description The SpotLight Duo is a multi-slice (192 detector rows), dual tube CT scanner consisting of a gantry, patient table, operator console, power distribution unit (PDU) and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software for operator interface and image handling. As in other CT scanned subject is irradiated by X rays and a detector array measures attenuation data of X rays that have been attenuated by the subject from multiple view angles. This is achieved by rotation source and the detector about the subject while acquiring the attenuation data. A computer is used to reconstruct cross sectional images of the subject from the attenuation data. {4}------------------------------------------------ The primary predicate, SpotLight CT (K161066), reconstructs high resolution images up to Field of View (FOV) 250mm. Scout images used for patient positioning and scan planning are reconstructed and displayed at a wide FOV larger than 250mm. The primary changes in the modified SpotLight Duo device include two optional configurations: - 1. Wide FOV reconstructs high resolution images up to 450mm FOV. 10 HR detector modules replace LR detector modules (as in the primary predicate) on one wing of the detector. Therefore, there are 33 HR modules instead of 23 HR modules. Although the HR part of the detector is asymmetric, the device is capable of imaging the entire FOV of 450mm at high resolution when acquiring data for 360° of rotation. The data from the LR wing is still used to avoid truncation artifacts. - 2. Extended FOV reconstructs high resolution images up to 250mm FOV and 250-450mm low resolution FOV with no change to the detector. - . Both configurations include software adaptation to 450mm FOV. The software is modified to support data acquisition with the modified detector, reconstruction at larger FOV, scan modes and protocols according to confiquration. - . There is an additional minor adaptation to collimator to support wide FOV collimation (250mm/450mm). # Intended Use The SpotLight Duo is intended to be used for body, cardiac and vascular X-ray Computed Tomography applications. # Indications for Use The SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for X-ray Computed Tomography imaging of organs that fit in the scan field of view, including cardiac and vascular CT imaging. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures. # Technological Characteristics The system generates images through computed reconstruction of data acquired at different view angles of the rotating gantry, while irradiating the scanned subject by two alternating X-ray sources. The gantry rotates at up to 0.24 seconds per rotation and can acquire up to 560 overlapping 0.5mm slices of image data in a single axial scan with a maximum total coverage of 140mm in the z direction. While the basic scanner (SpotLight CT) covers a field of view (FOV) of 450mm, the radiation outside {5}------------------------------------------------ 250mm (or 160mm) FOV is attenuated, providing diagnostic image quality up to 250mm FOV. With the Extended and Wide Field of View configurations, the system is adapted to provide standard resolution (STD) or high resolution (HR) diagnostic images at FOV 450mm. The system can be operated in axial (partial or full scan), cine, cardiac and ECG gated modes. The SpotLight Duo features two MCS-2093 X-ray tubes to provide two X-ray sources displaced in the z axis (parallel to rotation axis). The sources are alternating using electrostatic grid control, such that the scanned subject is irradiated alternatively by two overlapping cone X-ray beams while the gantry rotates, and attenuation data is acquired by a single array detector. Image reconstruction is accomplished by a Stereo CT reconstruction algorithm based on common algorithms used in single source scanners that are modified to combine the data acquired from the two sources. A table comparing the key features of the subject and predicate devices is provided below. | | Proposed device - SpotLight<br>Duo | Primary predicate - SpotLight<br>CT (K161066) | Secondary predicate -<br>Revolution CT (K133705) | Discussion | |----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Detector<br>technology<br>and<br>geometry | Fast scintillator array coupled to<br>photodiode array.<br>33 (WFOV) or 23 (EFOV)<br>configurable high resolution (HR)<br>modules comprising 192 detector<br>rows X pitch 0.5mm (Z direction,<br>measured at scanner center).<br>10(WFOV) or 20 (EFOV)<br>configurable low resolution (LR).<br>EFOV includes 10 modules on<br>each wing while WFOV includes<br>10 modules on one wing.<br>comprising 48 detector rows X<br>pitch 2.0mm<br>Analog to digital conversion per<br>channel on the detection module.<br>1D antiscatter collimator. | Fast scintillator array coupled to<br>photodiode array.<br>23 high resolution (HR) modules<br>comprising 192 detector rows X<br>pitch 0.5mm (Z direction,<br>measured at scanner center).<br>20 low resolution (LR) modules<br>(10 on each wing) comprising 48<br>detector rows X pitch 2.0mm<br>Analog to digital conversion per<br>channel on the detection module.<br>1D antiscatter collimator. | Fast scintillator (garnet) array<br>coupled to photodiode array.<br>256 detector rows X pitch<br>0.625mm (Z direction,<br>measured at scanner center).<br>Analog to digital conversion per<br>channel on the detection<br>module.<br>2D antiscatter collimator.<br>All detectors are from the same<br>type (full FOV). | Same<br>technology and<br>sub-<br>assemblies as<br>the primary<br>predicate. The<br>proposed<br>device adds<br>optional<br>configurations<br>with wider field<br>of view (FOV)<br>than the<br>primary<br>predicate, as<br>available in the<br>secondary<br>predicate. | | Data<br>transmission<br>from rotor | Contactless transmission<br>(capacitive coupling). Rate up to<br>6.25 GBit/sec | Contactless transmission<br>(capacitive coupling). Rate up to<br>6.25 GBit/sec | Contactless transmission<br>(capacitive coupling). Rate up to<br>40 GBit/sec | Same | | Power and<br>control<br>transmission<br>to rotor | Contact less transmission | Brush contact slipring | Contact less transmission | Same as<br>secondary<br>predicate | | Rotation<br>drive | Direct drive DC motor | DC motor and belt | Direct drive DC motor | Same as<br>secondary<br>predicate | | X Ray<br>source | 2 x MCS 2093 X ray tubes by<br>Varex Imaging Corp. | 2 x MCS 2093 X ray tubes by<br>Varex Imaging Corp. | Perfomex HDwX ray tube by<br>GEHC | Same as<br>primary<br>predicate | | | Proposed device - SpotLight<br>Duo | Primary predicate - SpotLight<br>CT (K161066) | Secondary predicate –<br>Revolution CT (K133705) | Discussion | | | Single ended grounded rotating<br>anode | Single ended grounded rotating<br>anode | Single ended grounded rotating<br>anode | | | | Anode angle 13 degrees | Anode angle 13 degrees | Anode angle 10.5 degrees | | | | 1.0 MHU anode heat capacity | 1.0 MHU anode heat capacity | 5.5 MHU anode heat capacity | | | | Grid controlled focal spot<br>modulation in X direction | Grid controlled focal spot<br>modulation in X direction | Grid controlled focal spot<br>modulation in X direction | | | | Small and large focal spots | Small and large focal spots | Small, large and extra-large<br>focal spots | | | | Max kVp: 140 kV | Max kVp: 140 kV | Max kVp: 140 kV | | | | Max power: 72 KW | Max power: 72 KW | Max power: 103 KW | | | Patient table | Motorized vertical and horizontal<br>motion | Motorized vertical and horizontal<br>motion | Motorized vertical and<br>horizontal motion | Same | | | Optional lateral motion | Optional lateral motion | Optional lateral motion. | | | | Cantilever carbon fiber patient<br>cradle. | Cantilever carbon fiber patient<br>cradle. | Cantilever carbon fiber patient<br>cradle. | | | Image<br>reconstructio<br>n hardware | Multicore PC and GPU | Multicore PC and GPU | Multicore PC and GPU | Same | | Image<br>reconstructio<br>n algorithm | Modified FDK cone beam<br>algorithm adapted for dual tubes<br>geometry. | Modified FDK cone beam<br>algorithm adapted for dual tubes<br>geometry. | GE proprietary VHD cone beam<br>algorithm. | Same<br>algorithm as<br>primary<br>predicate. | | | Adaptive filter to reduce<br>directional noise in low level raw<br>data (MBAF) | Adaptive filter to reduce<br>directional noise in low level raw<br>data (MBAF) | Iterative reconstruction<br>algorithm (ASIR-V). | The primary<br>predicate<br>reconstructs<br>high resolution<br>images up to<br>FOV250mm. | | | Iterative reconstruction algorithm<br>(ASIR-CV) | Iterative reconstruction algorithm<br>(ASIR-CV) | | | | | For WFOV configuration,<br>adapted to reconstruct high<br>resolution images according to<br>detector configuration, lower<br>resolution images outside FOV<br>covered by high resolution<br>detectors. | Adapted to reconstruct high<br>resolution images up to<br>FOV250mm, lower resolution<br>images outside FOV250mm | | The proposed<br>device<br>reconstructs<br>high resolution<br>images<br>according to<br>optional<br>configuration, | | | For extended FOV configuration,<br>adapted to reconstruct high<br>resolution images up to<br>FOV250mm, lower resolution<br>images outside FOV250mm. | | | up to<br>FOV450mm,<br>as the<br>secondary<br>predicate. | | | Proposed device - SpotLight Duo | Primary predicate - SpotLight CT (K161066) | Secondary predicate - Revolution CT (K133705) | Discussion | | Construction Materials | Metal parts (mostly steel and aluminum)<br>Lead and tungsten for X-ray shielding<br>PCB, electronic components and electronic cables components<br>Table top made of carbon fiber reinforced resin<br>Covers made pf molded polymers and reinforced resins<br>Oil in X-ray tubes cooling systems<br>Detector scintillators made of CdWO4 and Gadolinium Oxysulfide (GOS) used in other legally marketed CT scanners | Metal parts (mostly steel and aluminum)<br>Lead and tungsten for X-ray shielding<br>PCB, electronic components and electronic cables components<br>Table top made of carbon fiber reinforced resin<br>Covers made pf molded polymers and reinforced resins<br>Oil in X-ray tubes cooling systems<br>Detector scintillators made of CdWO4 and Gadolinium Oxysulfide (GOS) used in other legally marketed CT scanners | Metal parts (mostly steel and aluminum)<br>Lead and tungsten for X-ray shielding<br>PCB, electronic components and electronic cables components<br>Table top made of carbon fiber reinforced resin<br>Covers made pf molded polymers and reinforced resins<br>Oil in X-ray tube and detector cooling systems<br>Detector scintillators made of GE proprietary garnet scintillator | Same | | Energy sources | Wall supply 380 to 480 V 3 phase<br>Max power demand 115 kVA<br>Max X ray power (total for two tubes) 72kW<br>Laser alignment lights: gantry bore external lasers. <0.1mW per laser beam<br>Three lead ECG trigger module, powered by medical grade power supply through the system PDU | Wall supply 380 to 480 V 3 phase<br>Max power demand 115 kVA<br>Max X ray power (total for two tubes) 72kW<br>Laser alignment lights: gantry bore external lasers. <0.1mW per laser beam<br>Three lead ECG trigger module, powered by medical grade power supply through the system PDU | Wall supply 380 to 480 V 3 phase<br>Max power demand 150 kVA<br>Max X ray power 103kW<br>Laser alignment lights: gantry bore internal and external lasers. <0.1mW per laser beam<br>Four lead ECG trigger module | Same | | Software | The SpotLight is provided with software in three domains:<br>Console softwareImage reconstruction softwareEmbedded software<br>The software is modified to support data acquisition with the modified detector, reconstruction at larger FOV, scan modes and protocols according to configuration. | The SpotLight is provided with software in three domains:<br>Console softwareImage reconstruction softwareEmbedded software | The Revolution CT is provided with software serving same functionalities as the proposed device and complying with same standards. | Substantially the same | | | Proposed device – SpotLight<br>Duo | Primary predicate – SpotLight<br>CT (K161066) | Secondary predicate –<br>Revolution CT (K133705) | Discussion | | Max<br>Rotation<br>speed | 250 RPM (0.24 sec per rotation) | 250 RPM (0.24 sec per rotation) | 214 RPM (0.28 sec per rotation)<br>Gantry supports 300 RPM (0.2<br>sec per rotation) | The<br>differences in<br>performance of<br>the proposed<br>device and<br>primary<br>predicate are<br>optional higher<br>image<br>resolution at<br>FOV larger<br>than 250mm in<br>lieu of<br>FOV160mm<br>collimation. | | Min scan<br>time | 0.16 sec (partial), 0.24 sec (full<br>scan) – FOV up to 250mm<br>0.24 sec (full scan) – HR imaging<br>at FOV above 250mm for<br>asymmetric detector | 0.16 sec (partial), 0.24 sec (full<br>scan) | 0.28 sec (full scan) | | | Max axial<br>coverage in<br>a single axial<br>scan | 140mm (280 slices x 0.5mm<br>pitch) | 140mm (280 slices x 0.5mm<br>pitch) | 160mm (256 slices x 0.625mm<br>pitch) | than 250mm in<br>lieu of<br>FOV160mm<br>collimation. | | Field of View<br>(FOV) | High resolution images at<br>configurable FOV between<br>250mm and 450mm<br>Lower resolution in the FOV<br>between HR coverage and<br>450mm | 250mm or 160mm at high<br>resolution<br>Optional, up to 450mm with<br>lower resolution outside FOV<br>250mm | Up to 500mm | The proposed<br>device and the<br>secondary<br>predicate offer<br>a larger HR<br>FOV. | | Max spatial<br>resolution | 17.5 lp/cm cutoff at center<br>10.0 lp/cm cutoff at radius above<br>125mm (outside FOV 250mm)<br>covered by HR detectors<br>7.0 Ip/cm cutoff at radius above<br>125mm (outside FOV 250mm)<br>covered by LR detectors | 17.5 lp/cm cutoff at center<br>7.0 lp/cm cutoff at radius above<br>125mm (outside FOV 250mm) | 21.4 lp/cm (cutoff) | | | Bore size | 60 cm | 60 cm | 80 cm | Same as<br>primary<br>predicate | | Max Patient<br>weight | 227 Kg (500 lbs) | 227 Kg (500 lbs) | 227 Kg (500 lbs) | Same as<br>primary<br>predicate | | Add on parts<br>and<br>accessories | Built in trigger ECG (Ivy<br>Biomedical CTM300 K083854)<br>Operator console table and/or<br>chair<br>Integrated Injector (Bayer<br>Connect.CT K182273, K173773)<br>Various table accessories<br>Bar code reader<br>USB data storage device | Built in trigger ECG (Ivy<br>Biomedical CTM300 K083854)<br>Operator console table and/or<br>chair<br>Integrated Injector (Bayer<br>Connect.CT K182273, K173773)<br>Various table accessories<br>Bar code reader | Operator console table<br>Enhanced Injector Class IV<br>NG2000 Table slickers<br>Bar code reader<br>Uninterruptible Power Supply | Same as<br>primary<br>predicate | | Proposed device – SpotLight<br>Duo | Primary predicate – SpotLight<br>CT (K161066) | Secondary predicate –<br>Revolution CT (K133705) | Discussion | | | Console Uninterruptible Power<br>Supply | Console Uninterruptible Power<br>Supply | | | | | Partial System Uninterruptible<br>Power Supply | Partial System Uninterruptible<br>Power Supply | | | | | A1 Disconnect panel | A1 Disconnect panel | | | | | 20cm Water phantom | 20cm Water phantom |…