SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option

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January 13, 2025 Arineta Ltd. % Tanya Shalem VP QA&RA 15 Halamish St. Caesarea, 3088900 ISRAEL Re: K241200 Trade/Device Name: SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: April 30, 2024 Received: December 13, 2024 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 (the Act) that do not require approval of a premarket approval application (PMA). 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See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/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, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K241200 #### Device Name SpotLight/ SpotLight Duo with Low Dose Lung Cancer Screening Option #### Indications for Use (Describe) The SpotLight / 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 cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLR is limited for patient use of 2 years). 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 cardiovascular and thoracic anatomies that fit in the scan field-of-view. The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols (for medium and large patients) that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) - resources and technical specification American Association of Physicists in Medicine (AAPM) - Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option. 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) | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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DEVICE Name of Device: SpotLight/ SpotLight Duo with Low Dose Lung Cancer Screening Option Common Name: System, X-ray, Tomography, Computed Classification Name: Computed tomography x-ray system Regulation Number: 892.1750 Product Code(s): JAK ## III. PREDICATE DEVICE Predicate Device Name: SpotLight/ SpotLight Duo (with DLIR option) Manufacturer: Arineta Ltd. 510(k) Number: K230370 Common Name: System, X-ray, Tomography, Computed Classification Name: Computed tomography x-ray system Regulation Number: 892.1750 Product Code(s): JAK {5}------------------------------------------------ ## IV. DEVICE DESCRIPTION The Low Dose Lung Cancer Screening (LD LCS) option is an indication being added to the existing Arineta scanners for SpotLight and SpotLight Duo, previously cleared by the FDA (K230370, K213465). There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied. This option includes scan protocols with CTDI that comply with AAPM's requirements for Low Dose Lung Cancer Screening. No Hardware modifications and minor Software modifications (for compatibility with the Low-Dose Lung Cancer Screening protocols) are required for the subject device, which includes the following LD LCS protocol characteristics: • Lung Cancer Screening protocols for medium and large patients according to AAPM's definitions. · Lung Cancer Screening protocols option will be activated by service or production personnel (no need for additional installation, option activation only). ## V. INTENDED USE The SpotLight Computed Tomography X-ray system is intended for head, body, cardiac and vascular X-ray computed tomography applications. ## VI. INDICATIONS FOR USE The SpotLight / 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 cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). 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 transaxial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view. The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols (for medium and large patients) that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) - resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) - Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) {6}------------------------------------------------ and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures. ## VII. INDICATIONS FOR USE COMPARISON The proposed devices do not constitute a new intended use. There is a minor change in the indication for use - the addition of the LD LCS Option, references to ACR and AAPM guidelines, and specific DLIR and ASIR-CV limitations for that option. ### VIII. TECHNOLOGICAL COMPARISON The technological characteristics of the SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening (LD LCS) option and the predicate currently marketed SpotLight/ SpotLight Duo are substantially the same, with no functional, performance, feature, or design changes, except for the added LD LCS scan protocols. The proposed LD LCS option has substantially the same reconstruction technology compared to the predicate currently marketed device. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option, as reflected in the Indications for Use. There is no new technology related to these LCS protocols or their operation. There are no significant differences that may raise new issues of safety or effectiveness. The proposed LD LCS scan protocols have low dose characteristics for medium and large patients and comply with the relevant AAPM CTDI dose values. These parameters were chosen to optimize image quality while minimizing the dose. The determination of substantial equivalence of the proposed new LD LCS protocols to the cleared predicate device was further evaluated on the bench testing. The new LDCT LCS protocols for Arineta systems were tested and validated by using traditional Image Quality (IQ) metrics on standard phantoms, and compared to the IQ results of the cleared predicate standard dose device. The results indicate maintaining the proposed device's LD LCS protocols for all IQ metrics, including accuracy, uniformity, resolution, contrast scale, and NPS frequencies. Testing was also performed using a semi-anthropomorphic clinical simulation lung phantom where the CNR and nodule sizing comparisons were performed for Arineta systems using their new LDCT LCS protocols. The results showed that the nodules' level of conspicuity and accurate sizing were maintained for the proposed device LDCT LCS protocols. Therefore, it indicated that the proposed devices LD LCS protocols and predicate devices were substantially equivalent. A table comparing the key features of the subject and predicate device is provided below. {7}------------------------------------------------ | | Proposed devices –<br>Low Dose CT Lung Cancer Screening (LD LCS) Option<br>for Qualified Arineta Systems | Primary Predicate devices –<br>The Cleared Arineta's SpotLight / SpotLight Duo<br>(K230370) CT X-ray System (with DLIR option) | Discussion | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | | | | | Indications for use | The SpotLight / SpotLight Duo is intended to produce cross-<br>sectional images of the body by computer reconstruction of<br>X-ray transmission projection data taken at different angles.<br>The system has the capability to image cardiovascular and<br>thoracic anatomies, including the heart, in a single rotation.<br>The system may acquire data using Axial, Cine and Cardiac<br>scan techniques from patients of all ages (DLIR is limited for<br>patient use above the age of 2 years). These images may be<br>obtained either with or without contrast. This device may<br>include signal analysis and display equipment, patient and<br>equipment supports, components and accessories.<br>This device may include data and image processing to<br>produce images in a variety of trans-axial and reformatted<br>planes.<br>The system is indicated for x-ray Computed Tomography<br>imaging of cardiovascular and thoracic anatomies that fit in<br>the scan field-of-view.<br>The Low Dose CT Lung Cancer Screening Option for<br>SpotLight / SpotLight Duo is indicated for using low dose CT<br>for lung cancer screening. The screening must be conducted<br>with the established program criteria and protocols (for<br>medium and large patients) that have been approved and<br>published by a governmental body or a professional medical<br>society. Information from professional societies related to<br>lung cancer screening can be found but is not limited to:<br>American College of Radiology® (ACR) – resources and<br>technical specification; accreditation American Association of<br>Physicists in Medicine (AAPM) - Lung Cancer Screening<br>Protocols; radiation management. Please refer to clinical<br>literature, including the results of the National Lung<br>Screening Trial (N Engl J Med 2011; 365:395-409) and<br>subsequent literature, for further information.<br>The DLIR and ASIR-CV options are not compatible with the<br>Low Dose Lung Cancer Screening option.<br>The device output is useful for diagnosis of disease or<br>abnormality and for planning of therapy procedures. | The SpotLight / SpotLight Duo (with DLIR option) is intended<br>to produce cross-sectional images of the body by computer<br>reconstruction of x-ray transmission projection data taken at<br>different angles. The system has the capability to image<br>cardiovascular and thoracic anatomies, including the heart,<br>in a single rotation. The system may acquire data using<br>Axial, Cine, and Cardiac scan techniques from patients of all<br>ages (DLIR is limited for patient use above the age of 2<br>years). These images may be obtained either with or without<br>contrast. This device may include signal analysis and display<br>equipment, patient and equipment supports, components<br>and accessories.<br>This device may include data and image processing to<br>produce images in a variety of trans-axial and reformatted<br>planes.<br>The system is indicated for X-ray Computed Tomography<br>imaging of cardiovascular and thoracic anatomies that fit in<br>the scan field of view.<br>The device output is useful for diagnosis of disease or<br>abnormality and for planning of therapy procedures. | The indications for use are<br>similar, with the same<br>indications for the entire<br>device, except for minor<br>differences; the indications<br>for use for the proposed<br>SpotLight/SpotLight Duo<br>devices include Low Dose<br>Lung Cancer Screening<br>Option with additional<br>references to ACR and<br>AAPM guidelines, and<br>specific DLIR and ASIR-CV<br>limitation for that option. LCS<br>indication for use does not<br>constitute a new intended<br>use for the CT. | | | Proposed devices -<br>Low Dose CT Lung Cancer Screening (LD LCS) Option<br>for Qualified Arineta Systems | Primary Predicate devices -<br>The Cleared Arineta's SpotLight / SpotLight Duo<br>(K230370) CT X-ray System (with DLIR option) | Discussion | | Technological Characteristics | | | | | Detector technology<br>and geometry | Fast scintillator array coupled to photodiode array. | Fast scintillator array coupled to photodiode array. | Same | | | 33 (WFOV) or 23 (EFOV) configurable high resolution (HR)<br>modules comprising 192 detector rows X pitch 0.5mm (Z<br>direction, measured at scanner center). | 33 (WFOV) or 23 (EFOV) configurable high resolution (HR)<br>modules comprising 192 detector rows X pitch 0.5mm (Z<br>direction, measured at scanner center). | | | | 10 (WFOV) or 20 (EFOV) configurable low resolution (LR).<br>EFOV includes 10 modules on each wing while WFOV<br>includes 10 modules on one wing. comprising 48 detector<br>rows X pitch 2.0mm | 10 (WFOV)-20 (EFOV) configurable low resolution (LR).<br>EFOV includes 10 modules on each wing while WFOV<br>includes 10 modules on one wing. comprising 48 detector<br>rows X pitch 2.0mm | | | | Analog to digital conversion per channel on the detection<br>module. | Analog to digital conversion per channel on the detection<br>module. | | | | 1D antiscatter collimator. | 1D antiscatter collimator. | | | Data transmission<br>from rotor | Contactless transmission (capacitive coupling). Rate up to<br>6.25 GBit/sec | Contactless transmission (capacitive coupling). Rate up to<br>6.25 GBit/sec | Same | | Power and control<br>transmission to rotor | Brush contact slipring | Brush contact slipring | Same | | Rotation drive | Direct drive DC motor | Direct drive DC motor | Same | | X Ray source | 2 x MCS 2093 X ray tubes by Varex Imaging Corp. | 2 x MCS 2093 X ray tubes by Varex Imaging Corp. | Same | | | Single ended grounded rotating anode | Single ended grounded rotating anode | | | | Anode angle 13 degrees | Anode angle 13 degrees | | | | 1.0 MHU anode heat capacity…