(246 days)
The Spectral CT on Rails is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The Spectral CT on Rails system acquires one CT dataset – composed of data from a higher-energy detected x-ray spectrum and a lower- energy detected x-ray spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number.
This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology.
The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*.
The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
*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 proposed Spectral CT on Rails System is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The proposed Spectral CT on Rails System consists of three main components: a rotating gantry that slides on a carriage in the horizontal direction, stationary patient support and an operator console for scan control and image reconstruction. On the gantry, the main active components are the X-ray HV power supply, the X-ray tube and the detection system. The fundamental design and characteristics of the main components used in the proposed Spectral CT on Rails System, are identical to the cleared to market primary predicate device, Spectral CT System (K203020). The proposed Spectral CT on Rails System consists of main components that are similar to the cleared for market primary predicate device, Spectral CT (K203020) Gantry. The Gantry consists of the following main internal units: Stator - a fixed mechanical frame that carries HW and SW Rotor - A rotating circular stiff frame that is mounted in and supported by the stator. X-Ray Tube (XRT) and its power Generator, and the upper beam mechanism – fixed to the Rotor frame Rails - the rails system includes a carriage which the gantry sits on so that it may be moved back and forth on the rails horizontally relative to a stationary patient support that the patient lays on. The moving gantry functionality has previously been cleared in, Philips CT Big Bore Sliding Gantry Configuration (K181797), secondary predicate device. Data Measurement System (DMS) – a detectors array, fixed to the rotor in front of the XRT.
Console - A computer and display that interfaces between the system and the user. Common Image Reconstruction Unit (CIRS) – a dedicated powerful image reconstruction system
In addition to the above components and the operating software, the system includes: Workstation hardware and software for data acquisition and image display, manipulation, storage, and filming; as well as post-processing into views other than the original axial images. Spectral Reconstruction System Spectral CT Viewer.
Here's a breakdown of the acceptance criteria and study information for the Philips Medical Systems Nederland B.V. Spectral CT on Rails (K212875), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Spectral CT K203020) rather than listing explicit quantitative acceptance criteria for each image quality metric. Instead, the acceptance criterion for the Spectral CT on Rails is that its performance is "equivalent" to the predicate device.
| Feature / Acceptance Criterion | Reported Device Performance (Spectral CT on Rails) |
|---|---|
| Technological Characteristics | |
| Application | Identical to predicate device (Head, Body, Cardiac) |
| Scan Regime | Identical to predicate device (Continuous Rotation) |
| Scan Field of View | Identical to predicate device (Up to 500 mm) |
| Scan modes | Identical to predicate device (Surview, Axial-after-Axial, Dynamic Scan, Helical Scan) |
| Spatial Resolution | Identical to predicate device (16 lp/cm max (high mode), 13 lp/cm max (standard mode)) |
| Low Contrast Resolution (20 cm Catphan phantom) | Identical to predicate device (4 mm @ 0.3% @ 25 mGy CTDIvol) |
| Minimum Scan Time | Identical to predicate device (0.18 sec for 240° rotation, 0.27 sec for 360° rotation) |
| Number of Slices | Identical to predicate device (Up to 128 slices of 0.625 mm) |
| Scan Coverage | Identical to predicate device (Scanner Center of Rotation (COR) is up to 80 mm) |
| Noise in Standard Mode (21.6 cm water-equivalent) | Identical to predicate device (0.27% at 27 mGy) |
| Image Matrix | Identical to predicate device (Up to 1024 x 1024) |
| Display (Pixels) | Identical to predicate device (1024 x 1280) |
| Communication | Identical to predicate device (Compliance with DICOM 3.0) |
| Detectors Type & Material | Identical to predicate device (NanoPanel Prism, Solid-state yttrium-based scintillator, GOS + Photodiode) |
| DMS Detector & Structure | Identical to predicate device (8 cm - Dual-Layer scintillator, up to 128 detector rows, Spherical DMS structure) |
| Detector & Collimation Structure | Identical to predicate device (0.625 mm and various combinations listed) |
| Slice thickness | Identical to predicate device (Various options: 0.67 - 10 mm for helical, 0.625 – 20 for axial) |
| Gantry rotation speed | Identical to predicate device (0.27 sec - 1.5 sec (360°), 0.18 sec, 0.2 sec (240°)) |
| Bore size | Identical to predicate device (800 mm) |
| Operator Controls on Gantry | Identical to predicate device (Touch Panel Controls) |
| Eclipse Collimation | Identical to predicate device (A-Plane) |
| Generator and Tube Power / kV Setting / mA Range | Identical to predicate device (120kW, 80 100 120 140 kVp, 10-1000 mA) |
| Focal Spot | Identical to predicate device (x- and z-deflection) |
| Conventional Reconstruction Speed | Identical to predicate device (40 images per second) |
| X-Ray Tube Type | Identical to predicate device (iMRC) |
| Couch (Patient Support) | Substantially Equivalent (Couch is stationary, Gantry slides horizontally; predicate couch was mobile). Acceptance: This change does not introduce new hazards, has no effect on safety/effectiveness, and moving gantry functionality was previously cleared (K181797). |
| Horizontal Movements, min increments | Identical to predicate device (0.1mm) |
| Horizontal position precision planning | Identical to predicate device (0.1mm) |
| Horizontal speed | Different (Max Speed = 200 mm/sec for proposed; 600 mm/sec for predicate). Acceptance: This difference does not raise new questions for safety/effectiveness, and moving gantry functionality was previously cleared (K181797). |
| Collision envelope | Identical to predicate device (25 mm gap met, operator monitors motion) |
| Technical Basis for Collection of two CT Spectra | Identical to predicate device (Dual Layer DMS (Spectral Detector)) |
| Spectral Base Images | Identical to predicate device (Low-energy, High-energy, Photoelectric, Compton Scatter) |
| Spectral results available [kVp] | Identical to predicate device (100kVp, 120kVp, 140kVp) |
| Spectral Results Images | Identical to predicate device (Monoenergetic, Materials Basis/Density Pairs, Effective Atomic Number, Material Separation/Differentiation, Attenuation Curves, Density Measurements/Visualization, Reduction of Beam Hardening, Reduction of Calcium Blooming, Calcium Suppression Index, Electron Density, Cardiac) |
| Cardiac reconstruction method | Identical to predicate device (Standard ECG Gated, Motion Compensated Reconstruction (MCR) (optional)) |
| Virtual Tilt Viewer (VTV) | Identical to predicate device (Yes) |
| HOST Drives | Identical to predicate device (One 256 GB SSD, one 6 TB 7200 RPM HDD) |
| Host Infrastructure | Identical to predicate device (Windows 10) |
| CIRS Computers | Identical to predicate device (CIRS Rack with two HP Z8 servers, option for two additional) |
| CPUs | Identical to predicate device (In each HP Z8: Dual Intel Gold 6230 with 20 cores at 2.1GHz each) |
| CIRS Drives | Identical to predicate device (In each HP Z8: 512GB NVMe SSD, Two 2TB NVMe SSDs) |
| Interventional features and controls (Dose alerts) | Enhanced from active interruption to passive indication. Acceptance: Workflow improvement, follows NEMA XR-25 (2019) standard, successfully verified, no new safety/effectiveness questions. |
| Interventional features and controls (Check scan) | Enhanced to link helical scan to CCT scan. Acceptance: Workflow improvement, user comport, successfully verified, no new safety/effectiveness questions. |
| Interventional features and controls (Patient info) | Enhanced to reuse patient info from compatible Angio system. Acceptance: Workflow improvement, successfully verified, no new safety/effectiveness questions. |
| Interventional features and controls (Errors/warnings) | Enhanced to display rail system errors/warnings on IVC box. Acceptance: Usability improvement, successfully verified, no new safety/effectiveness questions. |
| Interventional features and controls (Display Layouts/Roadmaps) | Enhanced to offer multiple display layouts (1, 3, or 5 images) with 0, 1, or 2 reference images. Acceptance: Usability improvement, successfully verified, no new safety/effectiveness questions. |
| Interventional features and controls (Real time CCT locations on Surview) | Enhanced to display indicators (Current Gantry position, Last CCT, Active Viewport) on reference surview. Acceptance: Usability improvement, successfully verified, no new safety/effectiveness questions. |
| Interventional features and controls (Mirror options harmonization) | Enhanced to apply selected orientation for all completed and successive results. Acceptance: Workflow improvement, user comport, successfully verified, no new safety/effectiveness questions. |
| Interventional features and controls (Start Helical Scan/CCT from Exam/Control Room) | Enhanced to start Helical scan with CCT Pedal and CCT Single shot with CT Box Manual button. Acceptance: Workflow improvement, user comport, successfully verified, no new safety/effectiveness questions. |
| Interventional features and controls (Scan Position on Plan Viewer) | Enhanced to automatically update scan plan box to match selected bookmark position. Acceptance: Usability improvement, successfully verified, no new safety/effectiveness questions. |
| Interventional features and controls (Multi Planner Results (MPR) Improvements) | Enhanced to automatically generate oblique results for subsequent scans based on a previous scan. Acceptance: Workflow improvement, easy setup, successfully verified, no new safety/effectiveness questions. |
| Interventional features and controls (Push all images in one request) | Enhanced to allow user to send all images together to a remote device. Acceptance: Data connectivity improvement, successfully verified, no new safety/effectiveness questions. |
| Interventional features and controls (Scan ruler improvements) | Enhanced to hide/unhide SW Interventional Controls in Console UI. Acceptance: Usability improvement, successfully verified, no new safety/effectiveness questions. |
| Interventional features and controls (Control Laser from Consoles) | Enhanced to control laser markers from the console UI (in addition to IVC and gantry panel). Acceptance: Workflow improvement, user comport, successfully verified, no new safety/effectiveness questions. |
| Overall Safety and Effectiveness | Demonstrated to be as safe and effective as the predicate device, with no new safety and/or effectiveness concerns. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Anthropomorphic Phantom Image Review Testing: Not explicitly stated, but it involved "an anthropomorphic phantom" scanned on both the proposed device and the predicate device. It implies a single phantom, however, multiple "scans" were performed.
- Sample Size for Image Quality Performance Testing: Not explicitly stated, but involved "physics image quality test phantoms" scanned on both devices. It implies multiple phantoms covering different image quality metrics.
- Data Provenance: The data is generated internally by Philips through testing of their devices (proposed and predicate). It is not retrospective or prospective clinical data from patients but rather non-clinical phantom-based image quality data. The country of origin of the data is not specified beyond being Philips' internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Anthropomorphic Phantom Image Review Testing: The review was performed to "determine if the two scanners produced comparable image quality." It does not specify the number or qualifications of experts involved in this review. It states "After the review of the clinical scenarios it was concluded..." This suggests a qualitative assessment by an unnamed reviewer(s).
- Image Quality Performance Testing: This involved quantitative measurements on physics phantoms. Ground truth is established by the known physical properties and measurement methods for metrics like CT number, uniformity, noise, spatial resolution, etc., rather than expert reader consensus. Therefore, no "experts" in the sense of radiologists establishing ground truth for clinical cases are mentioned for this type of test.
4. Adjudication Method for the Test Set:
- For the anthropomorphic phantom image review, the document simply states "Each scan was reviewed to determine if the two scanners produced comparable image quality" and "it was concluded that the image quality... was equivalent." No specific adjudication method (e.g., 2+1, 3+1) is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No MRMC comparative effectiveness study was done. The submission states: "The subject of this premarket submission, the proposed Spectral CT on Rails did not require clinical studies to support equivalence Clinical Performance Data." The studies performed were non-clinical image quality comparisons.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The Spectral CT on Rails is a complete computed tomography x-ray system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" doesn't directly apply here in the way it would for an AI-powered diagnostic software. The device's performance, as a system, was evaluated.
- However, the image quality performance testing can be considered an objective, quantitative assessment of the system's output (images) without human interpretation influencing the primary metrics being measured (CT number, noise, spatial resolution, etc.). The anthropomorphic phantom review has a human qualitative component, but the quantitative image quality metrics are standalone.
7. The Type of Ground Truth Used:
- Phantom-based Ground Truth: For the "Image quality performance testing," the ground truth is established by the known physical characteristics of the test phantoms (e.g., Catphan phantom for low contrast resolution) and the objective physical measurements performed on the acquired images.
- Qualitative Comparison for Anthropomorphic Phantom: For the "Anthropomorphic phantom image review testing," the ground truth for "comparable image quality for typical clinical applications" is based on a qualitative review, implicitly against established expectations for CT image quality and the predicate device's performance.
8. The Sample Size for the Training Set:
- This submission describes a hardware and software system ("Spectral CT on Rails"), not an AI/Machine Learning model that requires a "training set" in the conventional sense. The "training" for such a system typically involves engineering design, development, and validation against specifications, not data-driven machine learning training. Therefore, no training set sample size is applicable or provided.
9. How the Ground Truth for the Training Set was Established:
- As concluded in point 8, this question is not applicable as there is no "training set" for an AI/ML model described in this submission for this device.
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May 13, 2022
Image /page/0/Picture/1 description: The image shows 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Philips Medical Systems Nederland B.V. % Maya Tolchinsky Regulatory Affairs Specialist Veenpluis 6 Best. 5684 PC NETHERLANDS
Re: K212875
Trade/Device Name: Spectral CT on Rails Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: April 12, 2022 Received: April 15, 2022
Dear Maya Tolchinsky:
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
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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 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212875
Device Name Spectral CT on Rails
Indications for Use (Describe)
The Spectral CT on Rails is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The Spectral CT on Rails system acquires one CT dataset – composed of data from a higher-energy detected x-ray spectrum and a lower- energy detected x-ray spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number.
This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology.
The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*.
The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
*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.
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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K212875
PHILIPS BG Diagnostic Imaging
SECTION 5 510(K) SUMMARY
HA300-006-05 Revision: 01 Status: Approved Page: 1 of 21
CT/AMI
SECTION 5 510(K) SUMMARY
510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
Date Prepared: September 2, 2021
| Manufacturer: | Philips Medical Systems Nederland B.V.Veenpluis 6,5684 PC BESTThe NetherlandsEstablishment Registration Number: 3015777306 | |
|---|---|---|
| PrimaryContactPerson: | Maya TolchinskyRegulatory Affairs SpecialistPhilips Medical Systems Technologies Ltd.Phone: 972-52-8598223E-mail: maya.tolchinsky@philips.com | |
| SecondaryContactPerson: | Ilana Ben-MosheRegulatory Affairs Haifa Site LeadPhilips HealthcarePhone: 972 (52) 5233496E-mail: Ilana.Ben-Moshe@philips.com | |
| Device: | Trade Name: | Spectral CT on Rails |
| Common name: | Computed Tomography x-Ray System | |
| Classification Name: | Computed Tomography x-Ray System | |
| Classification Regulation: | 21CFR 892.1750 | |
| Classification Panel: | Radiology | |
| Device Class: | II | |
| Primary Product Code: | JAK | |
| Secondary Product Code: | Not Applicable | |
| PrimaryPredicateDevice: | Trade Name: | Spectral CT |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K203020 | |
| Classification Name: | Computed Tomography x-Ray System | |
| Classification Regulation: | 21CFR §892.1750 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | JAK | |
| SecondaryPredicateDevice: | Trade Name: | Philips CT Big Bore Sliding Gantry Configuration |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K181797 | |
| Classification Name: | Computed Tomography x-Ray System | |
| Classification Regulation: | 21CFR §892.1750 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | JAK |
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| PHILIPSBG Diagnostic ImagingCT/AMI | HA300-006-05Revision: 01Status: ApprovedPage: 2 of 21 |
|---|---|
| SECTION 5 510(K) SUMMARY | |
| Device Description: | The proposed Spectral CT on Rails System is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The proposed Spectral CT on Rails System consists of three main components: a rotating gantry that slides on a carriage in the horizontal direction, stationary patient support and an operator console for scan control and image reconstruction. On the gantry, the main active components are the X-ray HV power supply, the X-ray tube and the detection system. The fundamental design and characteristics of the main components used in the proposed Spectral CT on Rails System, are identical to the cleared to market primary predicate device, Spectral CT System (K203020). The proposed Spectral CT on Rails System consists of main components that are similar to the cleared for market primary predicate device, Spectral CT (K203020) Gantry. The Gantry consists of the following main internal units: Stator - a fixed mechanical frame that carries HW and SW Rotor - A rotating circular stiff frame that is mounted in and supported by the stator. X-Ray Tube (XRT) and its power Generator, and the upper beam mechanism – fixed to the Rotor frame Rails - the rails system includes a carriage which the gantry sits on so that it may be moved back and forth on the rails horizontally relative to a stationary patient support that the patient lays on. The moving gantry functionality has previously been cleared in, Philips CT Big Bore Sliding Gantry Configuration (K181797), secondary predicate device. Data Measurement System (DMS) – a detectors array, fixed to the rotor in front of the XRT. |
Console - A computer and display that interfaces between the system and the user. Common Image Reconstruction Unit (CIRS) – a dedicated powerful image reconstruction system
In addition to the above components and the operating software, the system includes: Workstation hardware and software for data acquisition and image display, manipulation, storage, and filming; as well as post-processing into views other than the original axial images. Spectral Reconstruction System Spectral CT Viewer.
- The Spectral CT on Rails is a Computed Tomography X-Ray System intended to produce cross-Indications sectional images of the body by computer reconstruction of x-ray transmission data taken at for Use: different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
The Spectral CT on Rails system acquires one CT dataset - composed of data from a higherenergy detected x-ray spectrum and a lower- energy detected x-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number.
This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology.
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CT/AMI
The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*.
The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
*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.
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| PHILIPSBG Diagnostic Imaging | SECTION 5 510(K) SUMMARY | HA300-006-05Revision: 01 |
|---|---|---|
| CT/AMI | Status: ApprovedPage: 4 of 21 |
The main components (detection system, the reconstruction and the x-ray system) that are used in the proposed Spectral CT on Rails Technological System have the same fundamental design characteristics and are based on the seared to market primary predicate Characteristics device, Spectral CT System (K203020).
The design fundamental scientific technology of both the proposed Spectral CT on Rails System and the cleared to market primary predicate device, Spectral CT System (K203020) are the same. The design changes (e.g. patient support, horizontal motion range) do not change the fundamental scientific technology of the proposed Spectral CT on Rails System.
The following table lists the technological characteristics differences for the proposed Spectral CT on Rails
| Table 05-1 | |
|---|---|
| Modifications made to the proposed device, Spectral CT on Rails as compared tothe Primary predicate device, Spectral CT (K203020) | |
| Design feature | Description |
| Couch | The proposed Spectral CT on Rails is not installed with a couch thatcan be controlled by the CT system. |
| HorizontalMovement | The Proposed Spectral CT on Rails moves the rotating gantrytowards the patient who is positioned on a couch that is stationary inthe horizontal axis; whereas the primary predicate system therotating gantry was stationary and the couch was mobile in thehorizontal axis. |
| Horizontal MotionRange | The Proposed Spectral CT on Rails has a larger range of horizontalmotion that allows the user to move the Gantry away from couch toa parking position |
| InterventionalFeatures | The proposed Spectral CT on Rails has enhanced interventional andinterventional control features |
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| Table 05-2. Technological Characteristics Comparison | ||||
|---|---|---|---|---|
| DeviceFeature | Primary Predicate Device:Spectral CT (K203020) | Proposed Device: Spectral CT onRails | Conclusion | |
| Application | Head, Body and Cardiac | Head, Body and Cardiac | Identical, therefore substantiallyequivalent. | |
| Scan Regime | Continuous Rotation | Continuous Rotation | Identical, therefore substantiallyequivalent. | |
| Scan Field of View | Up to 500 mm | Up to 500 mm | Identical, therefore substantiallyequivalent. | |
| Scan modes | SurviewAxial-after-AxialDynamic ScanHelical Scan | SurviewAxial-after-AxialDynamic ScanHelical Scan | Identical, therefore substantiallyequivalent. | |
| Spatial Resolution | 16 lp/cm max (high mode)13 lp/cm max (standard mode) | 16 lp/cm max (high mode)13 lp/cm max (standard mode) | Identical, therefore substantiallyequivalent. | |
| Low ContrastResolution (20 cmCatphan phantom) | 4 mm @ 0.3% @ 25 mGyCTDIvol | 4 mm @ 0.3% @ 25 mGy CTDIvol | Identical, therefore substantiallyequivalent. | |
| Minimum Scan Time | 0.18 sec for 240° rotation,0.27 sec for 360° rotation | 0.18 sec for 240° rotation,0.27 sec for 360° rotation | Identical, therefore substantiallyequivalent. | |
| Number of Slices | Up to 128 slices of 0.625 mm | Up to 128 slices of 0.625 mm | Identical, therefore substantiallyequivalent. | |
| Scan Coverage | Scanner Center of Rotation(COR) is up to 80 mm | Scanner Center of Rotation (COR) isup to 80 mm | Identical, therefore substantiallyequivalent. | |
| Noise in StandardMode (as measuredon 21.6 cm water-equivalent) | 0.27% at 27 mGy | 0.27% at 27 mGy | Identical, therefore substantiallyequivalent. | |
| Image Matrix | Up to 1024 x 1024 | Up to 1024 x 1024 | Identical, therefore substantiallyequivalent. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| DeviceFeature | Primary Predicate Device:Spectral CT (K203020) | Proposed Device: Spectral CT onRails | Conclusion | |
| Display (Pixels) | 1024 x 1280 | 1024 x 1280 | Identical, therefore substantiallyequivalent. | |
| Communication | Compliance with DICOM 3.0 | Compliance with DICOM 3.0 | Identical, therefore substantiallyequivalent. | |
| Detectors | NanoPanel Prism | NanoPanel Prism | Identical, therefore substantiallyequivalent. | |
| Type | NanoPanel Prism | NanoPanel Prism | Identical, therefore substantiallyequivalent. | |
| Material | Solid-state yttrium-basedscintillator, GOS + Photodiode | Solid-state yttrium-based scintillator,GOS + Photodiode | Identical, therefore substantiallyequivalent. | |
| DMS Detector | 8 cm - Dual-Layer scintillator, upto 128 detector rows | 8 cm - Dual-Layer scintillator, up to128 detector rows | Identical, therefore substantiallyequivalent. | |
| DMS structure | Spherical DMS structure | Spherical DMS structure | Identical, therefore substantiallyequivalent. | |
| Detector structure | 0.625 mm and variouscombinations, such as:2x0.625, 16x0.625, 32x0.625,64x0.625, 96x0.625, 112x0.625,128x0.625 mm | 0.625 mm and various combinations,such as:2x0.625, 16x0.625, 32x0.625,64x0.625, 96x0.625, 112x0.625,128x0.625 mm. | Identical, therefore substantiallyequivalent. | |
| Collimation | 2x0.625, 16x0.625, 32x0.625,64x0.625, 96x0.625, 112x0.625,128x0.625 mm | 2x0.625, 16x0.625, 32x0.625,64x0.625, 96x0.625, 112x0.625,128x0.625 mm. | Identical, therefore substantiallyequivalent. | |
| Slice thickness | Various slice thickness optionsavailable in the range of 0.67 - 10mm for helical mode and 0.625 –20 for axial mode. | Various slice thickness optionsavailable in the range of 0.67 - 10 mmfor helical mode and 0.625 - 20 foraxial mode. | Identical, therefore substantiallyequivalent. | |
| Scan field of view | Up to 500 mm | Up to 500 mm | Identical, therefore substantiallyequivalent. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| DeviceFeature | Primary Predicate Device:Spectral CT (K203020) | Proposed Device: Spectral CT onRails | Conclusion | |
| Gantry | ||||
| Gantry rotationspeed | 0.27 sec -1.5 sec (360° rotation)0.18 sec, 0.2 sec (240° rotation) | 0.27 sec -1.5 sec (360° rotation)0.18 sec, 0.2 sec (240° rotation) | Identical, therefore substantiallyequivalent. | |
| Bore size | 800 mm | 800 mm | Identical, therefore substantiallyequivalent. | |
| Operator Controlslocated on Gantry | Touch Panel Controls | Touch Panel Controls | Identical, therefore substantiallyequivalent. | |
| Eclipse Collimation | A-Plane | A-Plane | Identical, therefore substantiallyequivalent. | |
| Generator and Tube | ||||
| Power | 120kW | 120kW | Identical, therefore substantiallyequivalent. | |
| kV Setting | 80 100 120 140 | 80 100 120 140 | Identical, therefore substantiallyequivalent. | |
| mA Range | 10-1000 | 10-1000 | Identical, therefore substantiallyequivalent. | |
| Focal Spot- SmartFocal Spot | x- and z-deflection | x- and z-deflection | Identical, therefore substantiallyequivalent. | |
| ConventionalReconstructionSpeed | 40 images per second | 40 images per second | Identical, therefore substantiallyequivalent. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| DeviceFeature | Primary Predicate Device:Spectral CT (K203020) | Proposed Device: Spectral CT onRails | Conclusion | |
| X-Ray Tube Type | iMRC | iMRC | Identical, therefore substantiallyequivalent. | |
| Couch (Patient Support) | ||||
| Couch | Noah Couch | Couch is stationary in the horizontalaxis, Gantry slides horizontally withrails system | Substantially Equivalent. Theproposed Spectral CT on Rails doesnot use a couch that is controlled bythe CT system to move the patientduring scanning. Instead, thesystem controls gantry movementduring scanning. This operationalchange does not introduce newhazards and has no effect on thesafety or effectiveness of thedevice. The moving gantryfunctionality has previously beencleared in, Philips CT Big BoreSliding Gantry Configuration(K181797), secondary predicatedevice. | |
| HorizontalMovements,minimum increments | 0.1mm | 0.1mm | Identical, therefore substantiallyequivalent. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| DeviceFeature | Primary Predicate Device:Spectral CT (K203020) | Proposed Device: Spectral CT onRails | Conclusion | |
| Horizontal positionprecision planning | 0.1mm | 0.1mm | Identical, therefore substantiallyequivalent. | |
| Horizontal speed | Maximum Speed = 600 mm/secMinimum Speed = 1 mm/sec | Maximum Speed = 200 mm/secMinimum Speed = 1 mm/sec | Substantially Equivalent. Thegantry movement is limited by thegantry drive mechanism which is lessthan the couch drive mechanism ofthe primary predicate device SpectralCT (K203020) this difference doesnot raise new questions for safetyand effectiveness. The moving gantryfunctionality has previously beencleared in, Philips CT Big BoreSliding Gantry Configuration(K181797), secondary predicatedevice. | |
| Collision envelope | 25 mm gap requirement is met.Operator is monitoring motion ofcouch in relation to the gantry. | 25 mm gap requirement is met.Operator is monitoring the motion ofthe sliding gantry in relation to thestationary couch. | Identical, therefore substantiallyequivalent. | |
| General (Spectral) | ||||
| Technical Basis forCollection of two CTSpectra | Dual Layer DMS (SpectralDetector) | Dual Layer DMS (Spectral Detector) | Identical, therefore substantiallyequivalent. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| DeviceFeature | Primary Predicate Device:Spectral CT (K203020) | Proposed Device: Spectral CT onRails | Conclusion | |
| Spectral BaseImages | Low-energy High-energy Photoelectric Compton Scatter | Low-energy High-energy Photoelectric Compton Scatter | Identical, therefore substantiallyequivalent. | |
| Spectral resultsavailable [kVp] | 100kVp 120kVp 140kVp | 100kVp 120kVp 140kVp | Identical, therefore substantiallyequivalent. | |
| Spectral ResultsImages | Monoenergetic Materials Basis/Density Pairs, such as l / H2O l / Ca Ca / Uric Acid Effective Atomic Number Material Separation/ Differentiation Attenuation Curves Density Measurements/Visualization Reduction of Beam Hardening Reduction of Calcium Blooming Calcium Suppression Index Electron Density Spectral results for Cardiac | Monoenergetic Materials Basis/Density Pairs, such as l / H2O l / Ca Ca / Uric Acid Effective Atomic Number Material Separation/ Differentiation Attenuation Curves Density Measurements/Visualization Reduction of Beam Hardening Reduction of Calcium Blooming Calcium Suppression Index Electron Density Spectral results for Cardiac | Identical, therefore substantiallyequivalent. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| Device | Primary Predicate Device: | Proposed Device: Spectral CT on | Conclusion | |
| Feature | Spectral CT (K203020) | Rails | ||
| General (conventional and spectral) | ||||
| Cardiacreconstructionmethod | • Standard ECG GatedReconstruction method• Motion CompensatedReconstruction (MCR)(optional feature) | • Standard ECG GatedReconstruction method• Motion CompensatedReconstruction (MCR) (optionalfeature) | Identical, therefore substantiallyequivalent. | |
| Virtual Tilt Viewer(VTV) (optionalfeature) | Yes | Yes | Identical, therefore substantiallyequivalent. | |
| General | ||||
| HOST Drives | One 256 GB SSD for the OS andConsole Software plus one 6 TB7200 RPM HDD for results | One 256 GB SSD for the OS andConsole Software plus one 6 TB 7200RPM HDD for results | Identical, therefore substantiallyequivalent. | |
| Host Infrastructure | Windows 10 | Windows 10 | Identical, therefore substantiallyequivalent. | |
| CIRS Computers | • CIRS Rack that contains twoHP Z8 servers.Option for two additional HP Z8Servers in the same rack. | • CIRS Rack that contains two HPZ8 servers.Option for two additional HP Z8Servers in the same rack. | Identical, therefore substantiallyequivalent. | |
| CPUs | In CIRS each HP Z8: Dual IntelGold 6230 with 20 cores at2.1GHz each. | In each HP Z8: Dual Intel Gold 6230with 20 cores at 2.1GHz each. | Identical, therefore substantiallyequivalent. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| DeviceFeature | Primary Predicate Device:Spectral CT (K203020) | Proposed Device: Spectral CT onRails | Conclusion | |
| CIRS Drives | In each HP Z8:512GB NVMe SSD for OS andCIRS software,Two 2TB NVMe SSDs for rawdata. | In each HP Z8:512GB NVMe SSD for OS and CIRSsoftware,Two 2TB NVMe SSDs for raw data. | Identical, therefore substantiallyequivalent. | |
| Interventionalfeatures and controls | An on-screen indication crossed80% & 100% of the accumulatedCTDIVol threshold during theexamination will actively appeareach time the dose crosses thethreshold | An on-screen indication crossed 80%& 100% of the accumulated CTDIVolthreshold during the examination willpassively appear each time the dosecrosses the threshold | Substantially Equivalent.The proposed enhanced featureintroducesa workflow improvement by allowingthe on-screen indications to bepassive and not interrupt to theinterventional scans. The featureaddition was made according to theDose alerts standardNEMA XR-25 (2019).This enhancement feature does notalter the fundamental design, wassuccessfully verified and does notraise new questions on safetyand/or effectiveness. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| DeviceFeature | Primary Predicate Device:Spectral CT (K203020) | Proposed Device: Spectral CT onRails | Conclusion | |
| There is no Check scan as thehelical scan is not linked to theCCT scan. | The Check scan is a helical scan thatis linked to a CCT scan. This linking isa user selection under All Parameters | Substantially Equivalent. Theproposed enhanced featureintroducesa workflow improvement by allowinga quick switching between CCT andhelical scans. This contributes to theuser comport to operate the systemfrom the clinical exam room.This enhancement feature does notalter the fundamental design, wassuccessfully verified and does notraise new questions on safetyand/or effectiveness. | ||
| Interventionalfeatures and controls | The operator enters the patientinformation to the CT systembefore each scan | When patient information is enteredinto a compatible Angio system, thesame information can be used by theCT system. A prompt is sent to the CTconsole and when performing the CTscan all the patient information will beavailable and can be edited if required | Substantially Equivalent. Theproposed enhanced featureintroduces a workflow improvementby enabling the user to reusepatient information. Thisenhancement feature does not alterthe fundamental design, wassuccessfully verified, and does notraise new questions on safetyand/or effectiveness. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| DeviceFeature | Primary Predicate Device:Spectral CT (K203020) | Proposed Device: Spectral CT onRails | Conclusion | |
| The CT system status, errors andwarnings are shown only in theconsole and not shown in the IVCbox. | Rail system related Errors andwarnings are added to the existingtraffic light system in the console andthose same errors and warnings arealso displayed on the hardwareInterventional Controls box (IVC). | Substantially Equivalent. Theproposed enhanced featureintroduces a usability improvementby adding the errors and warningsnotifications to be presented on theIVC display. This enhancementfeature does not alter thefundamental design, wassuccessfully verified, and does notraise new questions on safetyand/or effectiveness. | ||
| Interventionalfeatures and controls | The user only be able to displaythe acquired anatomy usingvarious display layouts with 1 or 3images per shot and 0,1reference images. | Multiple Display Layouts andRoadmaps allows the user to displaythe acquired anatomy using variousdisplay layouts with 1, 3 or 5 imagesper shot. User can choose from adefined set of display layouts for 1/3/5images with 0,1 or 2 reference imagesfrom IVC or Console | Substantially Equivalent. Theproposed enhanced featureintroduces a usability improvementby enhancing the display layoutoptions. This enhancement featuredoes not alter the fundamentaldesign, was successfully verifiedand does not raise new questionson safety and/or effectiveness. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| Device | Primary Predicate Device: | Proposed Device: Spectral CT on | Conclusion | |
| Feature | Spectral CT (K203020) | Rails | ||
| The user can only display thesurview of the currentexamination as a referenceimage. | Real time CCT locations on Surviewallows the user to display the surviewof the current examination as areference image. In addition, the usercan also select to display indicators onthat reference surview displayindicators of:• Current Gantry position showingdetector coverage (labeled "CurrentPosition")• Last scan Position with detectorcoverage (labeled "Last CCT")• The selected view port's Imageposition (labeled "Active Viewport"). | Substantially Equivalent. Theproposed enhanced featureintroduces a usability improvementby enhancing the display options onthe surview. This enhancementfeature does not alter thefundamental design, wassuccessfully verified and does notraise new questions on safetyand/or effectiveness. | ||
| Interventionalfeatures and controls | The user needs to set orientationon each scan preformed. | Mirror options harmonization acrossviewers feature allows the user toapply selected orientation for all thecompleted results and successiveresults.In addition, the user can Rotate orReset the option in CCT/ResultsViewer from both Context Menu andToolbox | Substantially Equivalent. Theproposed enhanced featureintroduces a workflow improvementfor user comport by allowing theorientation settings to be fixed onmultiple results. This enhancementfeature does not alter thefundamental design, wassuccessfully verified, and does notraise new questions on safetyand/or effectiveness. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| DeviceFeature | Primary Predicate Device:Spectral CT (K203020) | Proposed Device: Spectral CT onRails | Conclusion | |
| The user can use the CCT pedalonly to start interventional Scans,and the CT Box Manual buttonis supporting only spiral scans | Start Helical Scan from Exam Roomand CCT from Control Room featureallows the user to start Helical scanusing CCT Pedal. In addition, the usercan start CCT Single shot using CTBox Manual button | Substantially Equivalent. Theproposed enhanced featureintroduces a workflow improvementfor user comport to performadditional scans from the examroom and the control room. Thisenhancement feature does not alterthe fundamental design, wassuccessfully verified, and does notraise new questions on safetyand/or effectiveness. | ||
| Interventionalfeatures and controls | The positioning of the plan boxwas not updated automaticallyfollowing the selected bookmarkposition during plan. | Scan Position on Plan Viewer featureprovides an automatically update ofthe scan plan box to match theselected bookmark position – ScanPosition, Work Position or One of theNeedle positions - as selected in thesoftware Interventional Controls | Substantially Equivalent. Theproposed enhanced featureintroduces a usability improvementby providing automatic update to theplan box which helps the userperform the interventional scan.This enhancement feature does notalter the fundamental design, wassuccessfully verified and does notraise new questions on safetyand/or effectiveness. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| DeviceFeature | Primary Predicate Device:Spectral CT (K203020) | Proposed Device: Spectral CT onRails | Conclusion | |
| Interventionalfeatures and controls | To create oblique images, theuser needs to load eachcorresponding image into theSlab Viewer. | Multi Planner Results (MPR)Improvements provides an additionalcapability in the Slab Viewer. The usercan set an oblique view based on aprevious scan, the same oblique resultview are automatically generated forany subsequent scans for the samepatient | Substantially Equivalent. Theproposed enhanced featureintroduces a workflow improvementby enable easy setup and copyingofcomplex oblique-angle MPRs. Thisenhancement feature does not alterthe fundamental design, wassuccessfully verified, and does notraise new questions on safetyand/or effectiveness. | |
| Interventionalfeatures and controls | Reconstructed images are sentimage by image to the remotedevice | Push all images in one request featureprovides a user preference to enablethe user to send all the imagestogether to a remote device | Substantially Equivalent. Theproposed enhanced featureintroduces data connectivityimprovement by the adding theability to push all images in onerequest.This enhancement feature does notalter the fundamental design, wassuccessfully verified, and does notraise new questions on safetyand/or effectiveness. | |
| Table 05-2. Technological Characteristics Comparison | ||||
| Device | Primary Predicate Device: | Proposed Device: Spectral CT on | Conclusion | |
| Feature | Spectral CT (K203020) | Rails | ||
| User will not be able to hide andunhide the SW InterventionalControls in the Console userinterface | Scan ruler improvements featureallows the user to hide and unhide theSW Interventional Controls in theConsole user interface | Substantially Equivalent. Theproposed enhanced featureintroduces a Usability improvement.This enhancement feature does notalter the fundamental design, wassuccessfully verified and does notraise new questions on safetyand/or effectiveness. | ||
| Interventionalfeatures and controls | User can turn on or turn off thelaser markers only in the IVC,gantry panel. | Control Laser from Consoles featureallows the user to turn on or turn offthe laser markers from the consoleuser interface (in addition to the IVCand gantry panel). | Substantially Equivalent. Theproposed enhanced featureintroduces a workflow improvementby adding the option to control thelaser from the gantry, IVC panel andconsole. This helps the usercomport to operate the system fromthe clinical exam room. Thisenhancement feature does not alterthe fundamental control mechanism,was successfully verified, and doesnot raise new questions on safetyand/or effectiveness. |
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PHILIPS BG Diagnostic Imaging
SECTION 5 510(K) SUMMARY
G Diagnostic Imagin
HA300-006-05 Revision: 01 Status: Approved Page: 8 of 21
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CT/AMI
SECTION 5 510(K) SUMMARY
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SECTION 5 510(K) SUMMARY
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SECTION 5 510(K) SUMMARY
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CT/AMI
SECTION 5 510(K) SUMMARY
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CT/AMI
SECTION 5 510(K) SUMMARY
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Summary of Non-clinical performance testing has been performed on the proposed Spectral CT on Rails Non-Clinical system and demonstrates compliance with the following International and FDA recognized Norf Offiniour's standards and FDA guidance document(s). Data:
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1: 2012: ● Medical electrical equipment - Part 1: General requirements for safety and essential performance
- . IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- . IEC 60601-1-3:2008+A1:2013: Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
- IEC 60601-1-6:2010 +A1: 2013: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability
- IEC 60601-2-44:2009/AMD2:2016: Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
- IEC 60825-1:2014 -Safety of laser products. Part 1: Equipment classification and requirements (pursuant to FDA Laser Notice 56 (May 2019) Laser Products)
- IEC 62304:2006 + A1: 2015: Medical device software Software life-cycle processes ●
- IEC 62366-1:2015: Medical devices - Part 1: Application of usability engineering to medical devices ISO 10993-1:2018: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- . ISO 14971:2007 Medical devices - Application of risk management to medical devices
Device Specific Guidance Document:
- . Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005)
- . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014).
- Pediatric Information for X-ray Imaging Device Premarket Notifications - Guidance for Industry and Food and Drug Administration Staff (November 28, 2017)
Design Verification planning and testing was conducted at the sub-system and at the system level. The sub-systems are tested against the sub-system requirements specifications (SSRS) and the system level verification is conducted against the system requirement specifications (SRS). System and sub-system verification activities demonstrate the systems meet the established system and sub-system level design input requirements. System and sub-system level requirements may be verified by manual test, automated test, inspection/analysis, or any combination of the three.
The traceability between the requirements, the hazard mitigations and the test protocols are described in the traceability matrix.
The detailed verification results are provided in the Full System Verification Test Report. The results of the summative usability validation indicate that the proposed Spectral CT on Rails system has been found to be adequately safe and effective for the intended users, uses and use environments.
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CT/AMI
I Summary of Image Quality testing
Image quality comparison testing was performed between the proposed Spectral CT on Rails system and the cleared to market primary predicate Spectral CT (K203020).Two sets of Image Quality comparison testing were performed:
- Anthropomorphic phantom image review testing
- Image quality performance testing ●
Anthropomorphic phantom image review testing
- . Purpose: The purpose of the test was to provide a summary and outcome of the anthropomorphic phantom image scans reviews for the proposed Spectral CT on Rails. In addition to compare image quality of the proposed Spectral CT on Rails to the cleared to market primary predicate device Spectral CT (K203020) image quality utilizing anthropomorphic phantom scans.
- Method and configurations: An anthropomorphic phantom was scanned on both ● scanners, the proposed Spectral CT on Rails and the cleared to market primary predicate device Spectral CT (K203020) using the same protocols. The scan types selected were determined to represent the anticipated usage of the proposed Spectral CT on Rails, with the CCT (continues CT) interventional scan types expected to be one of the primary uses for the scanner. Each scan was reviewed to determine if the two scanners produced comparable image quality.
- . Summary results and Conclusion: The CCT anthropomorphic phantom scans on the proposed Spectral CT on Rails were found to have equivalent Image Quality as the scans from the cleared to market primary predicate device Spectral CT (K203020) for typical clinical applications. After the review of the clinical scenarios it was concluded that the image quality of the anthropomorphic phantom scans scanned on the proposed Spectral CT on Rails scanner was equivalent to the image quality of the cleared to market primary predicate device Spectral CT (K203020).
Image quality performance testing
- . Purpose: The purpose of the image quality performance testing was to evaluate the image quality of the proposed Spectral CT on Rails system as compared to the cleared to market primary predicate device Spectral CT (K203020).
- . Method and configurations: The image quality performance is measured on physics image quality test phantoms. Image quality performance: CT number, uniformity, noise, spatial resolution, low contrast resolution, slice thickness, and accuracy of spectral results, etc., have been compared between the scans performed on the proposed Spectral CT on Rails and cleared to market primary predicate device Spectral CT (K203020).
- Summary and results: No significant image quality performance difference has been observed on images acquired from the proposed Spectral CT on Rails (the gantry was moving during the scan and an angiography system couch was used to support the phantom) to those acquired from the 510(k) cleared to market primary predicate device Spectral CT (K203020) (the couch was moving during the scan and the CT couch was used to support phantom). The test successfully met the related system requirements of the proposed Spectral CT on Rails which are the same system requirements as those of cleared to market primary predicate device Spectral CT (K203020).
- . Conclusion: The image quality of the proposed Spectral CT on Rails system is equivalent to the image quality of the 510(k) cleared to market primary predicate Spectral CT (K203020) system in terms of the quantitative image quality metrics.
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The proposed Spectral CT on Rails was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.
The test results in this 510(k) premarket notification demonstrate that the proposed Spectral CT on Rails
- I Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
- Meets the acceptance criteria and is adequate for its intended use.
Therefore, the proposed Spectral CT on Rails is substantially equivalent to the cleared to market primary predicate device, Spectral CT System (K203020) in terms of safety and effectiveness.
Summary of The subject of this premarket submission, the proposed Spectral CT on Rails did not require clinical studies to support equivalence Clinical Performance Data:
The proposed Spectral CT on Rails System is substantially equivalent to the cleared to Substantial market primary predicate device, Spectral CT System (K203020), in terms of indications for Equivalence use, design features, fundamental scientific technology, and safety and/or Conclusion: effectiveness.
Additionally, substantial equivalence was demonstrated with non-clinical performance testing. The non-clinical performance tests (including image quality assessment testing) provided in this 510(k) premarket notification demonstrate that the proposed Spectral CT on Rails system is as safe and effective as its primary predicate device Spectral CT (K203020) without raising any new safety and/or effectiveness concerns.
§ 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.