(258 days)
Not Found
Yes
The document explicitly mentions "DLIR AI based image reconstruction algorithm."
No.
The device is described as an imaging system used for diagnosis and therapy planning, not for direct therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures." Additionally, it is indicated for "x-ray Computed Tomography imaging," which is inherently a diagnostic imaging modality.
No
The device is described as an "option" being added to existing CT scanners (hardware). While it involves software modifications for new protocols, it is fundamentally integrated with and dependent on the physical CT scanner hardware to acquire the X-ray data and produce images. The description explicitly mentions "CT systems" and "scanners."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for producing cross-sectional images of the body using X-ray transmission data. It is used for imaging cardiovascular and thoracic anatomies and for diagnosis of disease or abnormality and planning of therapy procedures. This is characteristic of an in-vivo imaging device, not an in-vitro diagnostic device.
- Device Description: The description details a CT system and its components, which are used for imaging the inside of a living body.
- Input Imaging Modality: The input is X-ray transmission projection data, which is applied to a patient.
- Anatomical Site: The device images internal anatomical sites (cardiovascular and thoracic).
- IVD Definition: In vitro diagnostic devices are used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body. This device does not process such specimens.
While the device output is used for diagnosis, the method of obtaining that output (imaging the body directly with X-rays) places it outside the definition of an in vitro diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The section for PCCP is marked "Not Found".
Intended Use / 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 (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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes (The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option. The DLIR and ASIR-CV options are not compatible with the Low Dose Lung Cancer Screening option.)
Input Imaging Modality
X-ray Computed Tomography
Anatomical Site
cardiovascular and thoracic anatomies, including the heart, lung
Indicated Patient Age Range
all ages (DLIR is limited for patient use above the age of 2 years)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
To confirm that images are clinically acceptable for use, a clinical image quality assessment was performed by two U.S. board-certified radiologists. The data evaluated were collected from two (2) U.S sites and included Low-Dose lung screening exams scanned with Arineta's SpotLight systems. The results show that all fourteen (14) cases, representing medium and large patient sizes per AAPM guidelines (0.25 to 2.8 mGy range has not been clinically evaluated), were evaluated as diagnostic for the indications for use. Moreover, the readers reported various pathologies, including very small nodules (2mm), therefore, the images enable the detection of findings relevant to LD LCS.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing Summary:
Arineta Ltd. has conducted extensive bench testing on the Low Dose CT Lung Cancer Screening (LCS) option for the Spotlight Duo CT systems. Additional testing was conducted on Arineta's current qualified SpotLight Duo CT systems cleared in K230370 (the predicate device) and the LCS option of GE Revolution CT (the reference device) for comparison.
Non-clinical tests of the LCS protocols for Spotlight/Spotlight Duo systems have demonstrated that all image quality metrics are substantially equivalent to the predicate:
- Uniformity and CT numbers for LCS protocols are maintained in the LCS protocol, comparable to the predicate device, and are within ~3 Hounsfield Units.
- The Noise Power Spectrum (NPS) curve is comparable to the predicate device, with noise reduction slightly shifting the NPS curve to the lower frequencies in both LCS protocol and in the predicate device.
- Resolution for LCS protocols is maintained compared to the predicate device.
- Contrast to Noise Ratio (CNR) was measured using the LCS phantom, which includes nodules with different types, HU and sizes. The CNR is linearly related among the LCS protocol and the predicate device, with and without noise reduction (MBAF2). The CNR is comparable to the reference device.
- All nodule types in the Lung Phantom, including the smallest (4mm) and lowest contrast nodules, are detectable. The nodule size is similar between LCS protocol, predicate, and reference devices, and is according to the LCS phantom specification.
Clinical Testing Summary:
To confirm that images are clinically acceptable for use, a clinical image quality assessment was performed by two U.S. board-certified radiologists. The data evaluated were collected from two (2) U.S sites and included Low-Dose lung screening exams scanned with Arineta's SpotLight systems. The results show that all fourteen (14) cases, representing medium and large patient sizes per AAPM guidelines (0.25 to 2.8 mGy range has not been clinically evaluated), were evaluated as diagnostic for the indications for use. Moreover, the readers reported various pathologies, including very small nodules (2mm), therefore, the images enable the detection of findings relevant to LD LCS.
Based on the image assessment, it can be concluded that LCS using Low-Dose protocols on the SpotLight/ SpotLight Duo systems generates sufficient diagnostic-quality images.
The clinical image evaluation resulted in the expected detectability of the proposed SpotLight/ SpotLight Duo with LD LCS option, without raising any new safety and/or effectiveness concerns compared to the currently marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
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). 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------ |
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4
510(k) Summary (K241200)
Arineta's SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
I. SUBMITTER
Arineta Ltd. 15 Halamish Street Caesarea 3088900 Israel
Phone: +972-4-6374000
Contact Person: Tanya Shalem, VP of QA&RA, E-mail: tanya.shalem@arineta.com 510k Number: K241200 Date Prepared: January 13, 2025
II. 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 –
Low Dose CT Lung Cancer Screening (LD LCS) Option
for Qualified Arineta Systems | Primary Predicate devices –
The Cleared Arineta's SpotLight / SpotLight Duo
(K230370) CT X-ray System (with DLIR option) | Discussion |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | | | |
| 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 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; 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) and
subsequent literature, for further information.
The DLIR and ASIR-CV options 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. | The SpotLight / SpotLight Duo (with DLIR option) 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 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 device output is useful for diagnosis of disease or
abnormality and for planning of therapy procedures. | The indications for use are
similar, with the same
indications for the entire
device, except for minor
differences; the indications
for use for the proposed
SpotLight/SpotLight Duo
devices include Low Dose
Lung Cancer Screening
Option with additional
references to ACR and
AAPM guidelines, and
specific DLIR and ASIR-CV
limitation for that option. LCS
indication for use does not
constitute a new intended
use for the CT. |
| | Proposed devices -
Low Dose CT Lung Cancer Screening (LD LCS) Option
for Qualified Arineta Systems | Primary Predicate devices -
The Cleared Arineta's SpotLight / SpotLight Duo
(K230370) CT X-ray System (with DLIR option) | Discussion |
| Technological Characteristics | | | |
| Detector technology
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)
modules comprising 192 detector rows X pitch 0.5mm (Z
direction, measured at scanner center). | 33 (WFOV) or 23 (EFOV) configurable high resolution (HR)
modules comprising 192 detector rows X pitch 0.5mm (Z
direction, measured at scanner center). | |
| | 10 (WFOV) or 20 (EFOV) configurable low resolution (LR).
EFOV includes 10 modules on each wing while WFOV
includes 10 modules on one wing. comprising 48 detector
rows X pitch 2.0mm | 10 (WFOV)-20 (EFOV) configurable low resolution (LR).
EFOV includes 10 modules on each wing while WFOV
includes 10 modules on one wing. comprising 48 detector
rows X pitch 2.0mm | |
| | Analog to digital conversion per channel on the detection
module. | Analog to digital conversion per channel on the detection
module. | |
| | 1D antiscatter collimator. | 1D antiscatter collimator. | |
| Data transmission
from rotor | Contactless transmission (capacitive coupling). Rate up to
6.25 GBit/sec | Contactless transmission (capacitive coupling). Rate up to
6.25 GBit/sec | Same |
| Power and control
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 | 1.0 MHU anode heat capacity | |
| | Grid controlled focal spot modulation in X direction | Grid controlled focal spot modulation in X direction | |
| | Small and large focal spots | Small and large focal spots | |
| | Max kVp: 140 kV | Max kVp: 140 kV | |
| | Max power: 72 KW | Max power: 72 KW | |
| Patient table | Motorized vertical and horizontal motion. | Motorized vertical and horizontal motion. | Same |
| | Optional lateral motion | Optional lateral motion. | |
| | Cantilever carbon fiber patient cradle. | Cantilever carbon fiber patient cradle. | |
| | Proposed devices -
Low Dose CT Lung Cancer Screening (LD LCS) Option
for Qualified Arineta Systems | Primary Predicate devices -
The Cleared Arineta's SpotLight / SpotLight Duo
(K230370) CT X-ray System (with DLIR option) | Discussion |
| Image reconstruction
hardware | Multicore PC and GPU | Multicore PC and GPU | Same |
| Image reconstruction
algorithm | Modified FDK cone beam algorithm adapted for dual tubes
geometry.
Adaptive filter to reduce directional noise in low level raw
data (MBAF).
Non-local means algorithm MBAF2 (optional).
For WFOV configuration, adapted to reconstruct high
resolution images according to detector configuration, lower
resolution images outside FOV covered by high resolution
detectors.
For extended FOV configuration, adapted to reconstruct high
resolution images up to FOV250mm, lower resolution
images outside FOV250mm. | Modified FDK cone beam algorithm adapted for dual tubes
geometry.
Adaptive filter to reduce directional noise in low level raw
data (MBAF).
Non-local means algorithm MBAF2 (optional).
For WFOV configuration, adapted to reconstruct high
resolution images according to detector configuration, lower
resolution images outside FOV covered by high resolution
detectors.
For extended FOV configuration, adapted to reconstruct high
resolution images up to FOV250mm, lower resolution
images outside FOV250mm.
ASIR-CV or DLIR AI based image reconstruction algorithm. | Substantially the same
reconstruction technology,
except the ASIR-CV and AI-
based DLIR image
reconstruction algorithms.
The proposed LD LCS
option is not compatible with
DLIR and ASIR-CV.
The LD LCS option is
available with or without
MBAF2. |
| Construction Materials | Metal parts (mostly steel and aluminum)
Lead and tungsten for X-ray shielding
PCB, electronic components and electronic cables
components
Table top made of carbon fiber reinforced resin
Covers made pf molded polymers and reinforced resins
Oil in X-ray tubes cooling systems
Detector scintillators made of CdWO4 and Gadolinium
Oxysulfide (GOS) used in other legally marketed CT
scanners | Metal parts (mostly steel and aluminum)
Lead and tungsten for X-ray shielding
PCB, electronic components and electronic cable
components
Table top made of carbon fiber reinforced resin
Covers made pf molded polymers and reinforced resins
Oil in X-ray tubes cooling systems
Detector scintillators made of CdWO4 and Gadolinium
Oxysulfide (GOS) used in other legally marketed CT
scanners | Same |
| Energy sources | Wall supply 380 to 480 V 3 phase
Max power demand 115 kVA
Max X ray power (total for two tubes) 72kW | Wall supply 380 to 480 V 3 phase
Max power demand 115 kVA
Max X ray power (total for two tubes) 72kW | Same |
| | Proposed devices -
Low Dose CT Lung Cancer Screening (LD LCS) Option
for Qualified Arineta Systems | Primary Predicate devices -
The Cleared Arineta's SpotLight / SpotLight Duo
(K230370) CT X-ray System (with DLIR option) | Discussion |
| | Laser alignment lights: gantry bore external lasers.