(400 days)
Not Found
No
The summary describes standard CT image reconstruction and processing techniques, with no mention of AI or ML algorithms for image analysis, diagnosis, or other functions.
No.
The device is used for imaging (diagnosis of disease or abnormality) and planning of therapy procedures, not for administering therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures," which directly indicates its use as a diagnostic device.
No
The device description explicitly states it is a multi-slice CT scanner consisting of hardware components like a gantry, patient table, operator console, and power distribution unit, in addition to software.
Based on the provided text, the SpotLight Duo is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- SpotLight Duo's Function: The description clearly states that the SpotLight Duo produces cross-sectional images of the body by using X-ray transmission data. It directly images organs within the body.
- No Mention of Specimens: There is no mention of collecting or analyzing specimens from the patient.
Therefore, the SpotLight Duo falls under the category of medical imaging devices, specifically a Computed Tomography (CT) scanner, rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
JAK
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.
Mentions image processing
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission projection data (Computed Tomography)
Anatomical Site
body, whole organs, heart, cardiac, vascular
Indicated Patient Age Range
patients of all ages
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
The performance evaluation used a variety of test methods, phantoms and scan conditions. Various mathematical, physics and statistical analyses were performed to demonstrate that performance specifications are met. The tests evaluated image quality and dose performance. Image quality evaluation included evaluation of artifacts, spatial resolution, low contrast detectability, noise, and uniformity and CT number accuracy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
The electromagnetic compatibility of the SpotLight Duo was tested and was found to be in compliance with the requirements of the following standards:
- IEC 60601-1:2005+AMD1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and test
- IEC 60601-1-3:2008+AMD1:2013 Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 60601-2-44:2009/AMD1:2012 Medical electrical equipment Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
SpotLight Duo was tested and is in compliance with AAMI/ES 60601-1, IEC 60601-1 Ed. 3 and its associated collateral standards and particular standards, 21CFR Subchapter J and NEMA XR-25, XR-28 and XR-29.
The device was developed under a rigorous quality system and has successfully completed design control activities, including risk management, verification and validation.
The performance evaluation used a variety of test methods, phantoms and scan conditions. Various mathematical, physics and statistical analyses were performed to demonstrate that performance specifications are met. The tests evaluated image quality and dose performance. Image quality evaluation included evaluation of artifacts, spatial resolution, low contrast detectability, noise, and uniformity and CT number accuracy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
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)
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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:
-
- 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.
-
- 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
Duo | Primary predicate - SpotLight
CT (K161066) | Secondary predicate -
Revolution CT (K133705) | Discussion |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Detector
technology
and
geometry | Fast scintillator array coupled to
photodiode array.
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
Analog to digital conversion per
channel on the detection module.
1D antiscatter collimator. | Fast scintillator array coupled to
photodiode array.
23 high resolution (HR) modules
comprising 192 detector rows X
pitch 0.5mm (Z direction,
measured at scanner center).
20 low resolution (LR) modules
(10 on each wing) comprising 48
detector rows X pitch 2.0mm
Analog to digital conversion per
channel on the detection module.
1D antiscatter collimator. | Fast scintillator (garnet) array
coupled to photodiode array.
256 detector rows X pitch
0.625mm (Z direction,
measured at scanner center).
Analog to digital conversion per
channel on the detection
module.
2D antiscatter collimator.
All detectors are from the same
type (full FOV). | Same
technology and
sub-
assemblies as
the primary
predicate. The
proposed
device adds
optional
configurations
with wider field
of view (FOV)
than the
primary
predicate, as
available in the
secondary
predicate. |
| 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 | Contactless transmission
(capacitive coupling). Rate up to
40 GBit/sec | Same |
| Power and
control
transmission
to rotor | Contact less transmission | Brush contact slipring | Contact less transmission | Same as
secondary
predicate |
| Rotation
drive | Direct drive DC motor | DC motor and belt | Direct drive DC motor | Same as
secondary
predicate |
| 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. | Perfomex HDwX ray tube by
GEHC | Same as
primary
predicate |
| | Proposed device - SpotLight
Duo | Primary predicate - SpotLight
CT (K161066) | Secondary predicate –
Revolution CT (K133705) | Discussion |
| | Single ended grounded rotating
anode | Single ended grounded rotating
anode | Single ended grounded rotating
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
modulation in X direction | 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 | Small, large and extra-large
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
motion | Motorized vertical and horizontal
motion | Motorized vertical and
horizontal motion | Same |
| | Optional lateral motion | Optional lateral motion | Optional lateral motion. | |
| | Cantilever carbon fiber patient
cradle. | Cantilever carbon fiber patient
cradle. | Cantilever carbon fiber patient
cradle. | |
| Image
reconstructio
n hardware | Multicore PC and GPU | Multicore PC and GPU | Multicore PC and GPU | Same |
| Image
reconstructio
n algorithm | Modified FDK cone beam
algorithm adapted for dual tubes
geometry. | Modified FDK cone beam
algorithm adapted for dual tubes
geometry. | GE proprietary VHD cone beam
algorithm. | Same
algorithm as
primary
predicate. |
| | Adaptive filter to reduce
directional noise in low level raw
data (MBAF) | Adaptive filter to reduce
directional noise in low level raw
data (MBAF) | Iterative reconstruction
algorithm (ASIR-V). | The primary
predicate
reconstructs
high resolution
images up to
FOV250mm. |
| | Iterative reconstruction algorithm
(ASIR-CV) | Iterative reconstruction algorithm
(ASIR-CV) | | |
| | For WFOV configuration,
adapted to reconstruct high
resolution images according to
detector configuration, lower
resolution images outside FOV
covered by high resolution
detectors. | Adapted to reconstruct high
resolution images up to
FOV250mm, lower resolution
images outside FOV250mm | | The proposed
device
reconstructs
high resolution
images
according to
optional
configuration, |
| | For extended FOV configuration,
adapted to reconstruct high
resolution images up to
FOV250mm, lower resolution
images outside FOV250mm. | | | up to
FOV450mm,
as the
secondary
predicate. |
| | Proposed device - SpotLight Duo | Primary predicate - SpotLight CT (K161066) | Secondary predicate - Revolution CT (K133705) | Discussion |
| 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 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 cables components
Table top made of carbon fiber reinforced resin
Covers made pf molded polymers and reinforced resins
Oil in X-ray tube and detector cooling systems
Detector scintillators made of GE proprietary garnet scintillator | 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
Laser alignment lights: gantry bore external lasers.