K Number
K212875
Device Name
Spectral CT on Rails
Date Cleared
2022-05-13

(246 days)

Product Code
Regulation Number
892.1750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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. *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.
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.
More Information

Not Found

No
The summary describes standard CT technology and image processing techniques, with no mention of AI or ML.

No.
The device is a diagnostic tool used for visualization and analysis of anatomical and pathological structures, not for treating conditions.

Yes

The 'Intended Use / Indications for Use' section explicitly states that the information generated by the device "may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures."

No

The device description explicitly details multiple hardware components, including a rotating gantry, X-ray tube, detectors, patient support, and operator console. While it includes software for control and image processing, it is fundamentally a hardware-based system.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The Spectral CT on Rails is an imaging system that uses X-rays to create cross-sectional images of the body. It analyzes the attenuation of X-rays through tissues to provide diagnostic information. This is an in vivo diagnostic method, meaning it is performed on a living organism.
  • Intended Use: The intended use clearly states that the device is used to produce images of the body and analyze anatomical and pathological structures in patients. It does not mention testing samples taken from the body.

Therefore, the Spectral CT on Rails is a medical imaging device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for 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.

*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.

Product codes

JAK

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography X-Ray

Anatomical Site

Body
Anatomical and pathological structures
Lung (for cancer screening)

Indicated Patient Age Range

All ages

Intended User / Care Setting

Trained healthcare professional

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of Non-clinical Performance Data:

  • Study Type: Compliance with International and FDA recognized Norf Offiniour's standards and FDA guidance document(s).

    • Standards: IEC 60601-1:2005 + A1: 2012, IEC 60601-1-2:2014, IEC 60601-1-3:2008+A1:2013, IEC 60601-1-6:2010 +A1: 2013, IEC 60601-2-44:2009/AMD2:2016, IEC 60825-1:2014, IEC 62304:2006 + A1: 2015, IEC 62366-1:2015, ISO 10993-1:2018, ISO 14971:2007.
    • Guidance Documents: 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).
    • Key Results: Device complies with standards and guidance documents. Design Verification planning and testing was conducted at the sub-system and at the system level, demonstrating that the systems meet the established system and sub-system level design input requirements. 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.
  • Study Type: Image Quality testing - Anthropomorphic phantom image review testing

    • Purpose: To summarize and provide the outcome of anthropomorphic phantom image scans reviews for the proposed Spectral CT on Rails and to compare its image quality to the primary predicate device Spectral CT (K203020) utilizing anthropomorphic phantom scans.
    • Method: An anthropomorphic phantom was scanned on both the proposed Spectral CT on Rails and the cleared to market primary predicate device Spectral CT (K203020) using the same protocols. Scan types represented anticipated usage of the proposed device, with CCT (continuous CT) interventional scan types expected to be a primary use. Each scan was reviewed to determine if the two scanners produced comparable image quality.
    • Key Results: 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. Image quality was equivalent after reviewing clinical scenarios.
  • Study Type: Image Quality testing - Image quality performance testing

    • Purpose: 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: Image quality performance was measured on physics image quality test phantoms. CT number, uniformity, noise, spatial resolution, low contrast resolution, slice thickness, and accuracy of spectral results, etc., were compared between scans performed on the proposed Spectral CT on Rails and the predicate device.
    • Key Results: No significant image quality performance difference was observed on images acquired from the proposed Spectral CT on Rails (gantry moving, angiography system couch) compared to those from the primary predicate device Spectral CT (K203020) (couch moving, CT couch). The test successfully met the related system requirements, which are the same as those for the predicate device. 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.

Clinical Performance Data:

  • The subject device did not require clinical studies to support equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s):

K203020, K181797

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

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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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

2

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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3

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 BEST
The Netherlands
Establishment Registration Number: 3015777306 | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Primary
Contact
Person: | Maya Tolchinsky
Regulatory Affairs Specialist
Philips Medical Systems Technologies Ltd.
Phone: 972-52-8598223
E-mail: maya.tolchinsky@philips.com | |
| Secondary
Contact
Person: | Ilana Ben-Moshe
Regulatory Affairs Haifa Site Lead
Philips Healthcare
Phone: 972 (52) 5233496
E-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 |
| Primary
Predicate
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
Predicate
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 |

4

| PHILIPS
BG Diagnostic Imaging
CT/AMI | HA300-006-05
Revision: 01
Status: Approved
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.

5

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.

6

| PHILIPS
BG Diagnostic Imaging | SECTION 5 510(K) SUMMARY | HA300-006-05
Revision: 01 |
|----------------------------------|--------------------------|-----------------------------------|
| CT/AMI | | Status: Approved
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
the Primary predicate device, Spectral CT (K203020)
Design featureDescription
CouchThe proposed Spectral CT on Rails is not installed with a couch that
can be controlled by the CT system.
Horizontal
MovementThe Proposed Spectral CT on Rails moves the rotating gantry
towards the patient who is positioned on a couch that is stationary in
the horizontal axis; whereas the primary predicate system the
rotating gantry was stationary and the couch was mobile in the
horizontal axis.
Horizontal Motion
RangeThe Proposed Spectral CT on Rails has a larger range of horizontal
motion that allows the user to move the Gantry away from couch to
a parking position
Interventional
FeaturesThe proposed Spectral CT on Rails has enhanced interventional and
interventional control features

7

Table 05-2. Technological Characteristics Comparison
Device
FeaturePrimary Predicate Device:
Spectral CT (K203020)Proposed Device: Spectral CT on
RailsConclusion
ApplicationHead, Body and CardiacHead, Body and CardiacIdentical, therefore substantially
equivalent.
Scan RegimeContinuous RotationContinuous RotationIdentical, therefore substantially
equivalent.
Scan Field of ViewUp to 500 mmUp to 500 mmIdentical, therefore substantially
equivalent.
Scan modesSurview
Axial-after-Axial
Dynamic Scan
Helical ScanSurview
Axial-after-Axial
Dynamic Scan
Helical ScanIdentical, therefore substantially
equivalent.
Spatial Resolution16 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 substantially
equivalent.
Low Contrast
Resolution (20 cm
Catphan phantom)4 mm @ 0.3% @ 25 mGy
CTDIvol4 mm @ 0.3% @ 25 mGy CTDIvolIdentical, therefore substantially
equivalent.
Minimum Scan Time0.18 sec for 240° rotation,
0.27 sec for 360° rotation0.18 sec for 240° rotation,
0.27 sec for 360° rotationIdentical, therefore substantially
equivalent.
Number of SlicesUp to 128 slices of 0.625 mmUp to 128 slices of 0.625 mmIdentical, therefore substantially
equivalent.
Scan CoverageScanner Center of Rotation
(COR) is up to 80 mmScanner Center of Rotation (COR) is
up to 80 mmIdentical, therefore substantially
equivalent.
Noise in Standard
Mode (as measured
on 21.6 cm water-
equivalent)0.27% at 27 mGy0.27% at 27 mGyIdentical, therefore substantially
equivalent.
Image MatrixUp to 1024 x 1024Up to 1024 x 1024Identical, therefore substantially
equivalent.
Table 05-2. Technological Characteristics Comparison
Device
FeaturePrimary Predicate Device:
Spectral CT (K203020)Proposed Device: Spectral CT on
RailsConclusion
Display (Pixels)1024 x 12801024 x 1280Identical, therefore substantially
equivalent.
CommunicationCompliance with DICOM 3.0Compliance with DICOM 3.0Identical, therefore substantially
equivalent.
DetectorsNanoPanel PrismNanoPanel PrismIdentical, therefore substantially
equivalent.
TypeNanoPanel PrismNanoPanel PrismIdentical, therefore substantially
equivalent.
MaterialSolid-state yttrium-based
scintillator, GOS + PhotodiodeSolid-state yttrium-based scintillator,
GOS + PhotodiodeIdentical, therefore substantially
equivalent.
DMS Detector8 cm - Dual-Layer scintillator, up
to 128 detector rows8 cm - Dual-Layer scintillator, up to
128 detector rowsIdentical, therefore substantially
equivalent.
DMS structureSpherical DMS structureSpherical DMS structureIdentical, therefore substantially
equivalent.
Detector structure0.625 mm and various
combinations, such as:
2x0.625, 16x0.625, 32x0.625,
64x0.625, 96x0.625, 112x0.625,
128x0.625 mm0.625 mm and various combinations,
such as:
2x0.625, 16x0.625, 32x0.625,
64x0.625, 96x0.625, 112x0.625,
128x0.625 mm.Identical, therefore substantially
equivalent.
Collimation2x0.625, 16x0.625, 32x0.625,
64x0.625, 96x0.625, 112x0.625,
128x0.625 mm2x0.625, 16x0.625, 32x0.625,
64x0.625, 96x0.625, 112x0.625,
128x0.625 mm.Identical, therefore substantially
equivalent.
Slice thicknessVarious slice thickness options
available in the range of 0.67 - 10
mm for helical mode and 0.625 –
20 for axial mode.Various slice thickness options
available in the range of 0.67 - 10 mm
for helical mode and 0.625 - 20 for
axial mode.Identical, therefore substantially
equivalent.
Scan field of viewUp to 500 mmUp to 500 mmIdentical, therefore substantially
equivalent.
Table 05-2. Technological Characteristics Comparison
Device
FeaturePrimary Predicate Device:
Spectral CT (K203020)Proposed Device: Spectral CT on
RailsConclusion
Gantry
Gantry rotation
speed0.27 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 substantially
equivalent.
Bore size800 mm800 mmIdentical, therefore substantially
equivalent.
Operator Controls
located on GantryTouch Panel ControlsTouch Panel ControlsIdentical, therefore substantially
equivalent.
Eclipse CollimationA-PlaneA-PlaneIdentical, therefore substantially
equivalent.
Generator and Tube
Power120kW120kWIdentical, therefore substantially
equivalent.
kV Setting80 100 120 14080 100 120 140Identical, therefore substantially
equivalent.
mA Range10-100010-1000Identical, therefore substantially
equivalent.
Focal Spot- Smart
Focal Spotx- and z-deflectionx- and z-deflectionIdentical, therefore substantially
equivalent.
Conventional
Reconstruction
Speed40 images per second40 images per secondIdentical, therefore substantially
equivalent.
Table 05-2. Technological Characteristics Comparison
Device
FeaturePrimary Predicate Device:
Spectral CT (K203020)Proposed Device: Spectral CT on
RailsConclusion
X-Ray Tube TypeiMRCiMRCIdentical, therefore substantially
equivalent.
Couch (Patient Support)
CouchNoah CouchCouch is stationary in the horizontal
axis, Gantry slides horizontally with
rails systemSubstantially Equivalent. The
proposed Spectral CT on Rails does
not use a couch that is controlled by
the CT system to move the patient
during scanning. Instead, the
system controls gantry movement
during scanning. This operational
change does not introduce new
hazards and has no effect on the
safety or effectiveness of the
device. The moving gantry
functionality has previously been
cleared in, Philips CT Big Bore
Sliding Gantry Configuration
(K181797), secondary predicate
device.
Horizontal
Movements,
minimum increments0.1mm0.1mmIdentical, therefore substantially
equivalent.
Table 05-2. Technological Characteristics Comparison
Device
FeaturePrimary Predicate Device:
Spectral CT (K203020)Proposed Device: Spectral CT on
RailsConclusion
Horizontal position
precision planning0.1mm0.1mmIdentical, therefore substantially
equivalent.
Horizontal speedMaximum Speed = 600 mm/sec
Minimum Speed = 1 mm/secMaximum Speed = 200 mm/sec
Minimum Speed = 1 mm/secSubstantially Equivalent. The
gantry movement is limited by the
gantry drive mechanism which is less
than the couch drive mechanism of
the primary predicate device Spectral
CT (K203020) this difference does
not raise new questions for safety
and effectiveness. The moving gantry
functionality has previously been
cleared in, Philips CT Big Bore
Sliding Gantry Configuration
(K181797), secondary predicate
device.
Collision envelope25 mm gap requirement is met.
Operator is monitoring motion of
couch in relation to the gantry.25 mm gap requirement is met.
Operator is monitoring the motion of
the sliding gantry in relation to the
stationary couch.Identical, therefore substantially
equivalent.
General (Spectral)
Technical Basis for
Collection of two CT
SpectraDual Layer DMS (Spectral
Detector)Dual Layer DMS (Spectral Detector)Identical, therefore substantially
equivalent.
Table 05-2. Technological Characteristics Comparison
Device
FeaturePrimary Predicate Device:
Spectral CT (K203020)Proposed Device: Spectral CT on
RailsConclusion
Spectral Base
ImagesLow-energy High-energy Photoelectric Compton ScatterLow-energy High-energy Photoelectric Compton ScatterIdentical, therefore substantially
equivalent.
Spectral results
available [kVp]100kVp 120kVp 140kVp100kVp 120kVp 140kVpIdentical, therefore substantially
equivalent.
Spectral Results
ImagesMonoenergetic 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 CardiacMonoenergetic 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 CardiacIdentical, therefore substantially
equivalent.
Table 05-2. Technological Characteristics Comparison
DevicePrimary Predicate Device:Proposed Device: Spectral CT onConclusion
FeatureSpectral CT (K203020)Rails
General (conventional and spectral)
Cardiac
reconstruction
method• Standard ECG Gated
Reconstruction method
• Motion Compensated
Reconstruction (MCR)
(optional feature)• Standard ECG Gated
Reconstruction method
• Motion Compensated
Reconstruction (MCR) (optional
feature)Identical, therefore substantially
equivalent.
Virtual Tilt Viewer
(VTV) (optional
feature)YesYesIdentical, therefore substantially
equivalent.
General
HOST DrivesOne 256 GB SSD for the OS and
Console Software plus one 6 TB
7200 RPM HDD for resultsOne 256 GB SSD for the OS and
Console Software plus one 6 TB 7200
RPM HDD for resultsIdentical, therefore substantially
equivalent.
Host InfrastructureWindows 10Windows 10Identical, therefore substantially
equivalent.
CIRS Computers• CIRS Rack that contains two
HP Z8 servers.
Option for two additional HP Z8
Servers in the same rack.• CIRS Rack that contains two HP
Z8 servers.
Option for two additional HP Z8
Servers in the same rack.Identical, therefore substantially
equivalent.
CPUsIn CIRS each HP Z8: Dual Intel
Gold 6230 with 20 cores at
2.1GHz each.In each HP Z8: Dual Intel Gold 6230
with 20 cores at 2.1GHz each.Identical, therefore substantially
equivalent.
Table 05-2. Technological Characteristics Comparison
Device
FeaturePrimary Predicate Device:
Spectral CT (K203020)Proposed Device: Spectral CT on
RailsConclusion
CIRS DrivesIn each HP Z8:
512GB NVMe SSD for OS and
CIRS software,
Two 2TB NVMe SSDs for raw
data.In each HP Z8:
512GB NVMe SSD for OS and CIRS
software,
Two 2TB NVMe SSDs for raw data.Identical, therefore substantially
equivalent.
Interventional
features and controlsAn on-screen indication crossed
80% & 100% of the accumulated
CTDIVol threshold during the
examination will actively appear
each time the dose crosses the
thresholdAn on-screen indication crossed 80%
& 100% of the accumulated CTDIVol
threshold during the examination will
passively appear each time the dose
crosses the thresholdSubstantially Equivalent.
The proposed enhanced feature
introduces
a workflow improvement by allowing
the on-screen indications to be
passive and not interrupt to the
interventional scans. The feature
addition was made according to the
Dose alerts standard
NEMA XR-25 (2019).
This enhancement feature does not
alter the fundamental design, was
successfully verified and does not
raise new questions on safety
and/or effectiveness.
Table 05-2. Technological Characteristics Comparison
Device
FeaturePrimary Predicate Device:
Spectral CT (K203020)Proposed Device: Spectral CT on
RailsConclusion
There is no Check scan as the
helical scan is not linked to the
CCT scan.The Check scan is a helical scan that
is linked to a CCT scan. This linking is
a user selection under All ParametersSubstantially Equivalent. The
proposed enhanced feature
introduces
a workflow improvement by allowing
a quick switching between CCT and
helical scans. This contributes to the
user comport to operate the system
from the clinical exam room.
This enhancement feature does not
alter the fundamental design, was
successfully verified and does not
raise new questions on safety
and/or effectiveness.
Interventional
features and controlsThe operator enters the patient
information to the CT system
before each scanWhen patient information is entered
into a compatible Angio system, the
same information can be used by the
CT system. A prompt is sent to the CT
console and when performing the CT
scan all the patient information will be
available and can be edited if requiredSubstantially Equivalent. The
proposed enhanced feature
introduces a workflow improvement
by enabling the user to reuse
patient information. This
enhancement feature does not alter
the fundamental design, was
successfully verified, and does not
raise new questions on safety
and/or effectiveness.
Table 05-2. Technological Characteristics Comparison
Device
FeaturePrimary Predicate Device:
Spectral CT (K203020)Proposed Device: Spectral CT on
RailsConclusion
The CT system status, errors and
warnings are shown only in the
console and not shown in the IVC
box.Rail system related Errors and
warnings are added to the existing
traffic light system in the console and
those same errors and warnings are
also displayed on the hardware
Interventional Controls box (IVC).Substantially Equivalent. The
proposed enhanced feature
introduces a usability improvement
by adding the errors and warnings
notifications to be presented on the
IVC display. This enhancement
feature does not alter the
fundamental design, was
successfully verified, and does not
raise new questions on safety
and/or effectiveness.
Interventional
features and controlsThe user only be able to display
the acquired anatomy using
various display layouts with 1 or 3
images per shot and 0,1
reference images.Multiple Display Layouts and
Roadmaps allows the user to display
the acquired anatomy using various
display layouts with 1, 3 or 5 images
per shot. User can choose from a
defined set of display layouts for 1/3/5
images with 0,1 or 2 reference images
from IVC or ConsoleSubstantially Equivalent. The
proposed enhanced feature
introduces a usability improvement
by enhancing the display layout
options. This enhancement feature
does not alter the fundamental
design, was successfully verified
and does not raise new questions
on safety and/or effectiveness.
Table 05-2. Technological Characteristics Comparison
DevicePrimary Predicate Device:Proposed Device: Spectral CT onConclusion
FeatureSpectral CT (K203020)Rails
The user can only display the
surview of the current
examination as a reference
image.Real time CCT locations on Surview
allows the user to display the surview
of the current examination as a
reference image. In addition, the user
can also select to display indicators on
that reference surview display
indicators of:
• Current Gantry position showing
detector coverage (labeled "Current
Position")
• Last scan Position with detector
coverage (labeled "Last CCT")
• The selected view port's Image
position (labeled "Active Viewport").Substantially Equivalent. The
proposed enhanced feature
introduces a usability improvement
by enhancing the display options on
the surview. This enhancement
feature does not alter the
fundamental design, was
successfully verified and does not
raise new questions on safety
and/or effectiveness.
Interventional
features and controlsThe user needs to set orientation
on each scan preformed.Mirror options harmonization across
viewers feature allows the user to
apply selected orientation for all the
completed results and successive
results.
In addition, the user can Rotate or
Reset the option in CCT/Results
Viewer from both Context Menu and
ToolboxSubstantially Equivalent. The
proposed enhanced feature
introduces a workflow improvement
for user comport by allowing the
orientation settings to be fixed on
multiple results. This enhancement
feature does not alter the
fundamental design, was
successfully verified, and does not
raise new questions on safety
and/or effectiveness.
Table 05-2. Technological Characteristics Comparison
Device
FeaturePrimary Predicate Device:
Spectral CT (K203020)Proposed Device: Spectral CT on
RailsConclusion
The user can use the CCT pedal
only to start interventional Scans,
and the CT Box Manual button
is supporting only spiral scansStart Helical Scan from Exam Room
and CCT from Control Room feature
allows the user to start Helical scan
using CCT Pedal. In addition, the user
can start CCT Single shot using CT
Box Manual buttonSubstantially Equivalent. The
proposed enhanced feature
introduces a workflow improvement
for user comport to perform
additional scans from the exam
room and the control room. This
enhancement feature does not alter
the fundamental design, was
successfully verified, and does not
raise new questions on safety
and/or effectiveness.
Interventional
features and controlsThe positioning of the plan box
was not updated automatically
following the selected bookmark
position during plan.Scan Position on Plan Viewer feature
provides an automatically update of
the scan plan box to match the
selected bookmark position – Scan
Position, Work Position or One of the
Needle positions - as selected in the
software Interventional ControlsSubstantially Equivalent. The
proposed enhanced feature
introduces a usability improvement
by providing automatic update to the
plan box which helps the user
perform the interventional scan.
This enhancement feature does not
alter the fundamental design, was
successfully verified and does not
raise new questions on safety
and/or effectiveness.
Table 05-2. Technological Characteristics Comparison
Device
FeaturePrimary Predicate Device:
Spectral CT (K203020)Proposed Device: Spectral CT on
RailsConclusion
Interventional
features and controlsTo create oblique images, the
user needs to load each
corresponding image into the
Slab Viewer.Multi Planner Results (MPR)
Improvements provides an additional
capability in the Slab Viewer. The user
can set an oblique view based on a
previous scan, the same oblique result
view are automatically generated for
any subsequent scans for the same
patientSubstantially Equivalent. The
proposed enhanced feature
introduces a workflow improvement
by enable easy setup and copying
of
complex oblique-angle MPRs. This
enhancement feature does not alter
the fundamental design, was
successfully verified, and does not
raise new questions on safety
and/or effectiveness.
Interventional
features and controlsReconstructed images are sent
image by image to the remote
devicePush all images in one request feature
provides a user preference to enable
the user to send all the images
together to a remote deviceSubstantially Equivalent. The
proposed enhanced feature
introduces data connectivity
improvement by the adding the
ability to push all images in one
request.
This enhancement feature does not
alter the fundamental design, was
successfully verified, and does not
raise new questions on safety
and/or effectiveness.
Table 05-2. Technological Characteristics Comparison
DevicePrimary Predicate Device:Proposed Device: Spectral CT onConclusion
FeatureSpectral CT (K203020)Rails
User will not be able to hide and
unhide the SW Interventional
Controls in the Console user
interfaceScan ruler improvements feature
allows the user to hide and unhide the
SW Interventional Controls in the
Console user interfaceSubstantially Equivalent. The
proposed enhanced feature
introduces a Usability improvement.
This enhancement feature does not
alter the fundamental design, was
successfully verified and does not
raise new questions on safety
and/or effectiveness.
Interventional
features and controlsUser can turn on or turn off the
laser markers only in the IVC,
gantry panel.Control Laser from Consoles feature
allows the user to turn on or turn off
the laser markers from the console
user interface (in addition to the IVC
and gantry panel).Substantially Equivalent. The
proposed enhanced feature
introduces a workflow improvement
by adding the option to control the
laser from the gantry, IVC panel and
console. This helps the user
comport to operate the system from
the clinical exam room. This
enhancement feature does not alter
the fundamental control mechanism,
was successfully verified, and does
not raise new questions on safety
and/or effectiveness.

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CT/AMI

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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.

22

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.

23

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.