(245 days)
Not Found
Yes
The document explicitly mentions "Deep Learning Image Reconstruction (DLIR) algorithm is a deep learning technology-based software sub-system" and "DLIR Al based image reconstruction algorithm". Deep learning is a subset of machine learning and artificial intelligence.
No
Explanation: The device is described as an X-ray Computed Tomography (CT) system intended to produce cross-sectional images for diagnosis of disease or abnormality and for planning of therapy procedures. It is an imaging device, not a device that provides therapy.
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." This directly indicates its role in the diagnostic process.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a CT scanner that produces cross-sectional images of the body by using X-ray transmission data. It directly images the patient's internal anatomy.
- Intended Use: The intended use is to produce images for the diagnosis of disease or abnormality and for planning therapy procedures, based on the in vivo imaging of the patient.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient.
Therefore, this device falls under the category of medical imaging devices rather than In Vitro Diagnostic devices.
No
The input letter does not explicitly state that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
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, 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 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.
Product codes
JAK
Device Description
The SpotLight / SpotLight Duo (with DLIR option) 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 and software for operator interface and image handling. The Deep Learning Image Reconstruction (DLIR) algorithm is a deep learning technology-based software sub-system that is integrated into the image reconstruction software. As in other CT scanners, a 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 of the radiation 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
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
X-ray Computed Tomography
Anatomical Site
cardiovascular and thoracic anatomies, including the heart, head, body
Indicated Patient Age Range
patients of 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
The proposed DLIR feature was evaluated in a retrospective blinded image evaluation that uses clinical cases acquired by SpotLight / CardioGraphe, using previous software versions. The clinical cases are of different anatomies, using different types of scans, from patients with a wide range of BMIs and clinical features. The data was collected from various SpotLight / CardioGraphe scanners, and the raw data was reconstructed using the DLIR algorithm. Data was collected from multiple clinical sites with at least 50% of the cases performed in the US. Five (5) certified CT readers (3 radiologists and 2 cardiologists. 4 out 5 are US board certified) examined the reconstructed series of different exams. Each exam was reviewed using standard (ASiR-CV) and alternative (DLIR) methods. The data was coded to avoid readers' bias.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing: Bench tests were performed by applying DLIR and ASIR on phantoms: water phantoms, CATPHAN, and QA phantom. Both 250mm and 450mm FOV were tested. For small body (pediatric) scans, a small water phantom and CATPHAN inserts without the housing were used with a clinical pediatric protocol. For large body scans, a large water phantom was used. The tests included image noise (pixel standard deviation), low contrast detectability, water HU accuracy, image flatness (uniformity), spatial resolution, linearity (contrast scale), streak artifact suppression, and noise power spectrum (NPS). Generalizability tests of DLIR in different scan and reconstruction parameters were also performed. In addition, image quality was performed by applying DLIR and ASIR on clinical data, including evaluation of pixel-wise noise magnitude, HU accuracy and high-contrast edge sharpness, in FOV 250 mm and FOV 450 mm. The bench test results demonstrate that use of DLIR decreases pixel-wise noise magnitude without losing features, changing High-contrast spatial resolution. The tests performed in this IQ report concluded with passed results and demonstrate that DLIR is substantially equivalent to ASIR in all defined parameters, including pixel-wise noise magnitude, HU accuracy and high-contrast spatial resolution.
Clinical Testing: A retrospective blinded image evaluation was conducted using clinical cases acquired by SpotLight / CardioGraphe with previous software versions. The cases represented different anatomies, scan types, and patients with a wide range of BMIs and clinical features. Raw data was collected from multiple clinical sites (at least 50% in the US) and reconstructed using the DLIR algorithm. Five certified CT readers (3 radiologists and 2 cardiologists, 4 out of 5 US board certified) examined the reconstructed series for different exams, comparing standard (ASiR-CV) and alternative (DLIR) methods. The data was coded to prevent reader bias. DLIR was found to provide diagnostic image quality that is not inferior to ASiR.
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
October 13, 2023
Image /page/0/Picture/1 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
% John Smith Official Correspondent Hogan Lovells US LLP 555 Thirteenth Street, NW WASHTINGTON, DC 20004-1109
Re: K230370
Trade/Device Name: SpotLight/SpotLight Duo (with DLIR option) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 8, 2023 Received: September 8, 2023
Dear John Smith:
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.
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).
1
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.
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 mediation-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,
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
2
510(k) Number (if known) K230370
Device Name SpotLight / SpotLight Duo (with DLIR option)
Indications for Use (Describe)
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, 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 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.
Type of Use (Select one or both, as applicable)
മ 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 (with DLIR option)
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: February 9, 2023
Name of Device: SpotLight / SpotLight Duo (with DLIR option)
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 Device
| Device Name | Manufacturer | 510(k) Number | Regulation
Number | Product
Code |
|---------------|--------------|---------------|----------------------|-----------------|
| SpotLight Duo | Arineta Ltd. | K213465 | 892.1750 | JAK |
Device Description
The SpotLight / SpotLight Duo (with DLIR option) 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 and software for operator interface and image handling. The Deep Learning Image Reconstruction (DLIR) algorithm is a deep learning technology-based software sub-system that is integrated into the image reconstruction software. As in other CT scanners, a 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 of the radiation 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
Intended Use
SpotLight / SpotLight Duo (with DLIR option) is intended for head, body, cardiac and vascular X-ray Computed Tomography applications.
Indications for Use
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.
Technological Characteristics
Deep Learning Image Reconstruction (DLIR) is a deep learning technology-based software subsystem that is integrated into the existing image reconstruction chain of the predicate device, SpotLight Duo (K213465), as an alternative to the current cleared ASIR-CV noise reduction algorithm. The intended use of SpotLight Duo (with DLIR option) remains the same as the predicate device SpotLight Duo with ASIR-CV.
| Technological
characteristics | Proposed device - SpotLight /
SpotLight Duo (with DLIR option) | Predicate Device - SpotLight Duo
(K213465) | 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)-20 (EFOV) configurable low | 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)-20 (EFOV) configurable low | Same |
| | resolution (LR). EFOV includes 10
modules on each wing while WFOV
includes 10 modules on one wing. | resolution (LR). EFOV includes 10
modules on each wing while WFOV
includes 10 modules on one wing. | |
| Technological
characteristics | Proposed device - SpotLight /
SpotLight Duo (with DLIR option) | Predicate Device - SpotLight Duo
(K213465) | Discussion |
| | comprising 48 detector rows X pitch
2.0mm | 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). | Contactless transmission (capacitive
coupling). | Same |
| | Rate up to 6.25 GBit/sec | Rate up to 6.25 GBit/sec | |
| Power and
control
transmission to
rotor | Contact less transmission | Contact less transmission | 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. | |
| 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. | Modified FDK cone beam algorithm
adapted for dual tubes geometry. | Both devices
include ASiR-CV,
while the |
| | Adaptive filter to reduce directional
noise in low level raw data (MBAF). | Adaptive filter to reduce directional
noise in low level raw data (MBAF) | proposed device
includes DLIR as
an alternative |
| | Noise reduction algorithms:
ASIR-CV or DLIR Al based image | Iterative reconstruction algorithm (ASIR-
CV) to reduce image noise. | noise reduction
algorithm. DLIR |
| | reconstruction algorithm (DLIR only for
250mm FOV and EFOV configuration). | For WFOV configuration, adapted to
reconstruct high resolution images
according to detector configuration, | can be applied to
250mm FOV and
EFOV
configuration. |
| Technological
characteristics | Proposed device - SpotLight /
SpotLight Duo (with DLIR option) | Predicate Device - SpotLight Duo
(K213465) | Discussion |
| | 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. | 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. | The SpotLight
with DLIR
demonstrates the
product
performance
claims (LCD,
Noise, High
contrast, Spatial
resolution, NPS,
accuracy and
uniformity), as
did the SpotLight
with ASiR CV. |
| Construction
Materials | Metal parts (mostly steel and aluminum) | Metal parts (mostly steel and aluminum) | Same |
| | Lead and tungsten for X-ray shielding | Lead and tungsten for X-ray shielding | |
| | PCB, electronic components and
electronic cables components | PCB, electronic components and
electronic cables components | |
| | Table top made of carbon fiber
reinforced resin | Table top made of carbon fiber
reinforced resin | |
| | Covers made pf molded polymers and
reinforced resins | Covers made pf molded polymers and
reinforced resins | |
| | Oil in X-ray tubes cooling systems | Oil in X-ray tubes cooling systems | |
| | Detector scintillators made of CdWO4
and Gadolinium Oxysulfide (GOS) used
in other legally marketed CT scanners | Detector scintillators made of CdWO4
and Gadolinium Oxysulfide (GOS) used
in other legally marketed CT scanners | |
| Energy sources | Walt supply 380 to 480 V 3 phase | Wall supply 380 to 480 V 3 phase | Same |
| | Max power demand 115 kVA | Max power demand 115 kVA | |
| | Max X ray power (total for two tubes)
72kW | Max X ray power (total for two tubes)
72kW | |
| | Laser alignment lights: gantry bore
external lasers.