Spectral CT on Rails

K212875 · Philips Medical Systems Nederland B.V. · JAK · May 13, 2022 · Radiology

Device Facts

• Record ID: K212875
• Device Name: Spectral CT on Rails
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: JAK · Radiology
• Decision Date: May 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

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.

Device Story

Spectral CT on Rails is a whole-body CT system featuring a continuously rotating gantry that slides horizontally on rails over a stationary patient support. Input: X-ray transmission data acquired at different angles and planes using a dual-layer detector (NanoPanel Prism). Operation: System acquires high- and low-energy spectra to analyze material attenuation coefficients; enables material decomposition, density, and effective atomic number quantification. Output: Cross-sectional images, material analysis, and graphical displays. Used in radiology, interventional radiology, cardiology, and oncology settings. Operated by trained healthcare professionals. Enhancements include interventional control features, passive dose alerts, and workflow integrations with angio systems. Benefits: Provides advanced material characterization and diagnostic visualization for clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance testing, including system-level verification, validation, and image quality performance testing (CT number, uniformity, noise, spatial resolution, low contrast resolution, and spectral accuracy) compared against the primary predicate.

Technological Characteristics

Whole-body CT system with sliding gantry on rails. Detectors: Dual-layer solid-state yttrium-based scintillator (GOS + Photodiode). Energy: 120kW generator, 80-140 kVp settings. Connectivity: DICOM 3.0. Software: Windows 10-based, includes spectral reconstruction and viewer. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-44, IEC 62304, ISO 10993-1, ISO 14971.

Indications for Use

Indicated for diagnostic imaging of anatomical and pathological structures in patients of all ages in radiology, interventional radiology, cardiology, and oncology. Also indicated for low-dose CT lung cancer screening for early detection of lung nodules in accordance with approved protocols.

Regulatory Classification

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.

Predicate Devices

• Spectral CT (K203020)
• Philips CT Big Bore Sliding Gantry Configuration (K181797)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <div> <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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.<br>Veenpluis 6,<br>5684 PC BEST<br>The Netherlands<br>Establishment Registration Number: 3015777306 | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Primary<br>Contact<br>Person: | Maya Tolchinsky<br>Regulatory Affairs Specialist<br>Philips Medical Systems Technologies Ltd.<br>Phone: [phone]<br>E-mail: [e-mail] | |
| Secondary<br>Contact<br>Person: | Ilana Ben-Moshe<br>Regulatory Affairs Haifa Site Lead<br>Philips Healthcare<br>Phone: [phone]<br>E-mail: [e-mail] | |
| 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 |
| Primary<br>Predicate<br>Device: | 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 |
| Secondary<br>Predicate<br>Device: | 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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| PHILIPS<br>BG Diagnostic Imaging<br>CT/AMI | HA300-006-05<br>Revision: 01<br>Status: Approved<br>Page: 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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| PHILIPS<br>BG Diagnostic Imaging | SECTION 5 510(K) SUMMARY | HA300-006-05<br>Revision: 01 |
|----------------------------------|--------------------------|-----------------------------------|
| CT/AMI | | Status: Approved<br>Page: 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 to<br>the Primary predicate device, Spectral CT (K203020) | |
| Design feature | Description |
| Couch | The proposed Spectral CT on Rails is not installed with a couch that<br>can be controlled by the CT system. |
| Horizontal<br>Movement | The Proposed Spectral CT on Rails moves the rotating gantry<br>towards the patient who is positioned on a couch that is stationary in<br>the horizontal axis; whereas the primary predicate system the<br>rotating gantry was stationary and the couch was mobile in the<br>horizontal axis. |
| Horizontal Motion<br>Range | The Proposed Spectral CT on Rails has a larger range of horizontal<br>motion that allows the user to move the Gantry away from couch to<br>a parking position |
| Interventional<br>Features | The proposed Spectral CT on Rails has enhanced interventional and<br>interventional control features |

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| | Table 05-2. Technological Characteristics Comparison | | | |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device<br>Feature | Primary Predicate Device:<br>Spectral CT (K203020) | Proposed Device: Spectral CT on<br>Rails | Conclusion | |
| Application | Head, Body and Cardiac | Head, Body and Cardiac | Identical, therefore substantially<br>equivalent. | |
| Scan Regime | Continuous Rotation | Continuous Rotation | Identical, therefore substantially<br>equivalent. | |
| Scan Field of View | Up to 500 mm | Up to 500 mm | Identical, therefore substantially<br>equivalent. | |
| Scan modes | Surview<br>Axial-after-Axial<br>Dynamic Scan<br>Helical Scan | Surview<br>Axial-after-Axial<br>Dynamic Scan<br>Helical Scan | Identical, therefore substantially<br>equivalent. | |
| Spatial Resolution | 16 lp/cm max (high mode)<br>13 lp/cm max (standard mode) | 16 lp/cm max (high mode)<br>13 lp/cm max (standard mode) | Identical, therefore substantially<br>equivalent. | |
| Low Contrast<br>Resolution (20 cm<br>Catphan phantom) | 4 mm @ 0.3% @ 25 mGy<br>CTDIvol | 4 mm @ 0.3% @ 25 mGy CTDIvol | Identical, therefore substantially<br>equivalent. | |
| Minimum Scan Time | 0.18 sec for 240° rotation,<br>0.27 sec for 360° rotation | 0.18 sec for 240° rotation,<br>0.27 sec for 360° rotation | Identical, therefore substantially<br>equivalent. | |
| Number of Slices | Up to 128 slices of 0.625 mm | Up to 128 slices of 0.625 mm | Identical, therefore substantially<br>equivalent. | |
| Scan Coverage | Scanner Center of Rotation<br>(COR) is up to 80 mm | Scanner Center of Rotation (COR) is<br>up to 80 mm | Identical, therefore substantially<br>equivalent. | |
| Noise in Standard<br>Mode (as measured<br>on 21.6 cm water-<br>equivalent) | 0.27% at 27 mGy | 0.27% at 27 mGy | Identical, therefore substantially<br>equivalent. | |
| Image Matrix | Up to 1024 x 1024 | Up to 1024 x 1024 | Identical, therefore substantially<br>equivalent. | |
| Table 05-2. Technological Characteristics Comparison | | | | |
| Device<br>Feature | Primary Predicate Device:<br>Spectral CT (K203020) | Proposed Device: Spectral CT on<br>Rails | Conclusion | |
| Display (Pixels) | 1024 x 1280 | 1024 x 1280 | Identical, therefore substantially<br>equivalent. | |
| Communication | Compliance with DICOM 3.0 | Compliance with DICOM 3.0 | Identical, therefore substantially<br>equivalent. | |
| Detectors | NanoPanel Prism | NanoPanel Prism | Identical, therefore substantially<br>equivalent. | |
| Type | NanoPanel Prism | NanoPanel Prism | Identical, therefore substantially<br>equivalent. | |
| Material | Solid-state yttrium-based<br>scintillator, GOS + Photodiode | Solid-state yttrium-based scintillator,<br>GOS + Photodiode | Identical, therefore substantially<br>equivalent. | |
| DMS Detector | 8 cm - Dual-Layer scintillator, up<br>to 128 detector rows | 8 cm - Dual-Layer scintillator, up to<br>128 detector rows | Identical, therefore substantially<br>equivalent. | |
| DMS structure | Spherical DMS structure | Spherical DMS structure | Identical, therefore substantially<br>equivalent. | |
| Detector structure | 0.625 mm and various<br>combinations, such as:<br>2x0.625, 16x0.625, 32x0.625,<br>64x0.625, 96x0.625, 112x0.625,<br>128x0.625 mm | 0.625 mm and various combinations,<br>such as:<br>2x0.625, 16x0.625, 32x0.625,<br>64x0.625, 96x0.625, 112x0.625,<br>128x0.625 mm. | Identical, therefore substantially<br>equivalent. | |
| Collimation | 2x0.625, 16x0.625, 32x0.625,<br>64x0.625, 96x0.625, 112x0.625,<br>128x0.625 mm | 2x0.625, 16x0.625, 32x0.625,<br>64x0.625, 96x0.625, 112x0.625,<br>128x0.625 mm. | Identical, therefore substantially<br>equivalent. | |
| Slice thickness | Various slice thickness options<br>available in the range of 0.67 - 10<br>mm for helical mode and 0.625 –<br>20 for axial mode. | Various slice thickness options<br>available in the range of 0.67 - 10 mm<br>for helical mode and 0.625 - 20 for<br>axial mode. | Identical, therefore substantially<br>equivalent. | |
| Scan field of view | Up to 500 mm | Up to 500 mm | Identical, therefore substantially<br>equivalent. | |
| Table 05-2. Technological Characteristics Comparison | | | | |
| Device<br>Feature | Primary Predicate Device:<br>Spectral CT (K203020) | Proposed Device: Spectral CT on<br>Rails | Conclusion | |
| Gantry | | | | |
| Gantry rotation<br>speed | 0.27 sec -1.5 sec (360° rotation)<br>0.18 sec, 0.2 sec (240° rotation) | 0.27 sec -1.5 sec (360° rotation)<br>0.18 sec, 0.2 sec (240° rotation) | Identical, therefore substantially<br>equivalent. | |
| Bore size | 800 mm | 800 mm | Identical, therefore substantially<br>equivalent. | |
| Operator Controls<br>located on Gantry | Touch Panel Controls | Touch Panel Controls | Identical, therefore substantially<br>equivalent. | |
| Eclipse Collimation | A-Plane | A-Plane | Identical, therefore substantially<br>equivalent. | |
| Generator and Tube | |…