(205 days)
Philips Big Bore system (K171850)
No
The summary describes standard CT technology with spectral capabilities and image processing techniques, but there is no mention of AI or ML.
No
The device is used for diagnostic imaging and treatment planning (radiation therapy), not for directly treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "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". It also mentions use for "low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer," which is a diagnostic application.
No
The device description explicitly states it is a "whole-body computed tomography (CT) X-ray system featuring a continuously rotating X-ray tube and detectors gantry, and multi slice capability." It also lists physical components like the gantry, patient couch, X-ray high voltage power supply, X-ray tube, and detection system. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided text, 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. They are used outside of the body ("in vitro").
- Device Function: The Spectral CT 7000 family is a Computed Tomography X-Ray System. It uses X-rays to create cross-sectional images of the body. This is an in vivo diagnostic method, meaning it is performed within the living body.
- Intended Use: The intended use clearly states the device is for producing images of the body and analyzing the composition of body materials and/or contrast agents within the body. It is used as a diagnostic tool for visualizing and analyzing anatomical and pathological structures in patients.
- Device Description: The description details the physical components of the CT scanner, including the X-ray tube, detectors, and gantry, all of which are used for imaging the patient directly.
While the device provides information about the chemical composition of body materials and contrast agents, this information is derived from the analysis of the X-ray transmission data acquired from within the body, not from a sample taken from the body.
Therefore, the Spectral CT 7000 family is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spectral CT 7000 family 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 parts, and accessories.
The Spectral CT 7000 family 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 as part of treatment preparation and radiation therapy planning. The Extended field of view images and respiratory correlated scanning (4DCT) are for treatment and radiation therapy planning/simulation usage only.
This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
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 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
Spectral CT 7500 RT 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. This system also includes signals and display equipment, patient and equipment support, components, and accessories.
The Spectral CT 7500 RT 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 provides 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. The Spectral CT 7500 RT system consists of three main components – a scanner system that includes a rotating gantry, a movable patient couch, and an operator control and image reconstruction; a Spectral Reconstruction System; and a Spectral CT Viewer. On the gantry, the main active components are the X-ray high voltage (HV) power supply, the X-ray tube, and the detection system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-Ray
Anatomical Site
head, whole body, cardiac and vascular, lung
Indicated Patient Age Range
patients of all ages
Intended User / Care Setting
trained healthcare professional / radiology, interventional radiology, cardiology, oncology
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The testing included:
- Summary of Image Quality testing for Pulmonary Gating feature:
- Conclusion of Motion Phantom Testing: The review and the analysis showed that the level O and magnitude of artifacts is similar to existing products under similar conditions and additionally that the differences seen are explainable based on design differences between the Spectral CT 7500 RT and the existing currently marketed and predicate device, Philips Big Bore system (K171850). Clinical evaluation determined the gated reconstruction is acceptable for RT simulation purposes.
- Conclusion of Spectral Phantom Testing: Review of all of the spectral results did not reveal O any significant differences between the Pulmo spectral results and the non-Pulmo chest scan that was used as a reference. This supports the conclusion that there are no significant differences in the Pulmo spectral results compared with the non-Pulmo spectral results.
- Conclusion of Clinical External Image Quality Review: Clinical images were externally O reviewed, by US board certified reviewers, grading their overall image quality for use in CT simulation for radiotherapy planning. The external IQ assessments of Pulmonary Gating 4DCT for both conventional 4DCT results and Spectral 4DCT results, were completed and the defined success criteria were met. All images were rated as satisfactory for radiation therapy planning/ simulation.
- Summary of Image Quality testing for Extended Field of View (EFOV) feature:
- O Overall Conclusion of the IQ Testing: The review achieved its goal of reviewing the results of IQ integration tests for the extended FOV feature in the proposed Spectral CT 7500 RT system. The results showed that the IQ testing meets the SRS IQ requirements. These results are only intended to support RT applications.
- O Conclusion of Clinical External Image Quality Review: Clinical images were externally reviewed, by US board certified reviewers, grading their overall image quality for use in CT simulation for radiotherapy planning. The external IQ assessment of eFOV was completed and the defined success criteria were met. All images were rated as satisfactory for radiation therapy planning/ simulation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing has been performed on the proposed Spectral CT 7500 RT system and demonstrates compliance with International and FDA recognized consensus standards and FDA Performance guidance documents. Design verification planning and testing were conducted at the system is tested against the System Requirements Specifications (SRS) and the Sub-System Requirement Specifications (SSRS). System and sub-system verification activities demonstrate the system meet the established system and sub-system level design input requirements. The traceability between the requirements, the hazard mitigations, and the test protocols are described in the traceability matrix. Design Validation tests the user needs and intended use that are documented in the top-level User Requirement Specification (PRS). The validation testing covered new features, clinical validation, and serviceability validation. All the validation tests as per validation plan were performed and acceptance criteria met for each of the requirements. The detailed verification and validation results are provided in the full system verification and validation reports. Non-clinical design validation testing demonstrates that the proposed Spectral CT 7500 RT system can be used as defined in its clinical workflow and intended use.
Summary of Image Quality testing for Pulmonary Gating feature:
- Conclusion of Motion Phantom Testing: The review and the analysis showed that the level and magnitude of artifacts is similar to existing products under similar conditions and additionally that the differences seen are explainable based on design differences between the Spectral CT 7500 RT and the existing currently marketed and predicate device, Philips Big Bore system (K171850). Clinical evaluation determined the gated reconstruction is acceptable for RT simulation purposes.
- Conclusion of Spectral Phantom Testing: Review of all of the spectral results did not reveal any significant differences between the Pulmo spectral results and the non-Pulmo chest scan that was used as a reference. This supports the conclusion that there are no significant differences in the Pulmo spectral results compared with the non-Pulmo spectral results.
- Conclusion of Clinical External Image Quality Review: Clinical images were externally reviewed, by US board certified reviewers, grading their overall image quality for use in CT simulation for radiotherapy planning. The external IQ assessments of Pulmonary Gating 4DCT for both conventional 4DCT results and Spectral 4DCT results, were completed and the defined success criteria were met. All images were rated as satisfactory for radiation therapy planning/ simulation.
Summary of Image Quality testing for Extended Field of View (EFOV) feature:
- Overall Conclusion of the IQ Testing: The review achieved its goal of reviewing the results of IQ integration tests for the extended FOV feature in the proposed Spectral CT 7500 RT system. The results showed that the IQ testing meets the SRS IQ requirements. These results are only intended to support RT applications.
- Conclusion of Clinical External Image Quality Review: Clinical images were externally reviewed, by US board certified reviewers, grading their overall image quality for use in CT simulation for radiotherapy planning. The external IQ assessment of eFOV was completed and the defined success criteria were met. All images were rated as satisfactory for radiation therapy planning/ simulation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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October 18, 2024
Philips Medical Systems Technologies Ltd. % Siwar Assi Regulatory Affairs Specialist Advanced Technology Center, Building 34, MATAM Haifa. 3100200 ISRAEL
Re: K240844
Trade/Device Name: Spectral CT 7500 RT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: March 27, 2024 Received: September 16, 2024
Dear Siwar Assi:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240844
Device Name Spectral CT 7500 RT
Indications for Use (Describe)
The Spectral CT 7000 family 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 parts, and accessories.
The Spectral CT 7000 family 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 as part of treatment preparation and radiation therapy planning. The Extended field of view images and respiratory correlated scanning (4DCT) are for treatment and radiation therapy planning/simulation usage only.
This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
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 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. The word is likely a brand name or logo.
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: | October 18, 2024 | |||
|---|---|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |||
| Veenpluis 6, | ||||
| 5684 PC BEST | ||||
| The Netherlands | ||||
| Establishment Registration Number: 3015777306 | ||||
| Primary Contact | ||||
| Person: | Siwar Assi | |||
| Regulatory Affairs Specialist | ||||
| Phone: +972-50-7494961 | ||||
| E-Mail: Siwar.Assi@philips.com | ||||
| Secondary Contact | ||||
| Person: | Carmit Shmuel | |||
| Regulatory Affairs Manager and Site Lead | ||||
| Phone: +972-54-2109054 | ||||
| E-Mail: Carmit.Shmuel@philips.com | ||||
| Device | Trade Name: | Spectral CT 7500 RT | ||
| 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 | |||
| Product Code: | JAK | |||
| 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: | 21 CFR 892.1750 | |||
| Classification Panel: | Radiology | |||
| Device Class: | Class II | |||
| Product Code: | JAK | |||
| Secondary Predicate | ||||
| Device: | Trade Name: | Philips CT Big Bore | ||
| Manufacturer: | Philips Medical Systems Nederland B.V. | |||
| 510(k) Clearance: | K171850 | |||
| Classification Name: | Computed Tomography X-ray System | |||
| Classification Regulation: | 21 CFR 892.1750 | |||
| Classification Panel: | Radiology | |||
| Device Class: | Class II | |||
| Product Code: | JAK |
6
Spectral CT 7500 RT system is a whole-body computed tomography (CT) X-ray system featuring a Device
Description: c
Description: 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. This system also includes signals and display equipment, patient and equipment support, components, and accessories.
The Spectral CT 7500 RT 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 provides 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. The Spectral CT 7500 RT system consists of three main components – a scanner system that includes a rotating gantry, a movable patient couch, and an operator control and image reconstruction; a Spectral Reconstruction System; and a Spectral CT Viewer. On the gantry, the main active components are the X-ray high voltage (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 7500 RT system are identical to the currently marketed primary predicate device, Spectral CT system (K203020). The Spectral CT 7500 RT system is a Computed Tomography X-ray system intended to produce cross-sectional Indications for Use: 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 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 atterial 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 as part of treatment preparation and radiation therapy planning. The Extended field of view images and respiratory correlated scanning (4DCT) are for treatment preparation and radiation therapy planning/simulation usage only.
This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
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.
Based on the information provided above, the proposed Spectral CT 7500 RT system is considered substantially equivalent to the currently marketed primary predicate device, Spectral CT system (K203020), in terms of Indications for Use.
7
Technological Characteristics
The proposed Spectral CT 7500 RT system consonents – a scanner system that includes a rotating gantry, a movable patient couch, and an operator console for control and image reconstruction System; and a Spectral CT Viewer. On the ganty, the main active components are the X-ray high voltage (HV) power supply, the X-ray tube, and the detection system. The design/fundamental scientific technology of both the proposed Spectral CT 7500 RT system and the currently marketed evice, Spectral CT system (K203020) are the same. The design changes (e.g. new software version and additional software features) do not change the
fundamental scientific technology of the proposed Spectral CT 7500 RT system.
The following table 1 lists the technological characteristics differences for the proposed Spectral CT 7500 RT system:
Table 1 Modifications made to the proposed device, Spectral CT 7500 RT system as compared to the currently marketed primary predicate device, Spectral CT system (K203020)
| Design Feature | Description |
|---|---|
| Pulmonary Gating 4DCT | Pulmonary gated scanning is a new feature that allows CT scan data to be collected along with the patient's breathing signal in order to allow the CT data to be reconstructed into specific phases of breathing. This allows patient anatomy to be visualized during a breathing cycle to allow for breathing motion of both the target as well as organs at risk to be compensated for during radiation therapy treatment planning. |
| Extended Field of View (EFOV) | EFOV is a feature that allows for a maximum reconstructed FOV of up to 800mm for non-gated Helical scans for RT simulation purposes only. |
| Table 2 Technological Characteristics Comparison | |||
|---|---|---|---|
| Device Feature | Currently Marketed Primary Predicate | ||
| Device: Spectral CT system (K203020) | Proposed Device: | ||
| Spectral CT 7500 RT system | Conclusion | ||
| Technological Characteristics | |||
| Application | Head, Body and Cardiac | Head, Body and Cardiac | Identical, therefore, substantially |
| equivalent | |||
| Scan regime | Continuous Rotation | Continuous Rotation | Identical, therefore, substantially |
| equivalent | |||
| Scan Field of View | Up to 500 mm | Up to 800 mm | Substantially Equivalent. |
| Both the proposed device and the | |||
| predicate device include a Scannable Field | |||
| of View (SFOV) of 500mm used for | |||
| reconstructed images. | |||
| The improvement of the FOV in the | |||
| proposed device for up to 800mm | |||
| (Extended Field of View (EFOV)) is planned | |||
| for Radiation Therapy Planning | |||
| procedures and is similar from a | |||
| technology perspective to the secondary | |||
| currently marketed secondary predicate | |||
| device, Philips Big Bore system (K171850). | |||
| The SFOV was successfully verified and | |||
| validated and does not raise new | |||
| questions on safety and/or effectiveness. | |||
| No. of slices | Up to 128 slices of 0.625 mm | Up to 128 slices of 0.625 mm | Identical, therefore, substantially |
| equivalent | |||
| Scan modes | Surview | ||
| Axial-after-Axial | |||
| Dynamic Scan | |||
| Helical Scan | Surview | ||
| Axial-after-Axial | |||
| Dynamic Scan | |||
| Helical Scan | Identical, therefore, substantially | ||
| equivalent | |||
| 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, substantially | ||
| equivalent | |||
| 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, substantially | ||
| equivalent | |||
| Scan coverage | Scanner Center of Rotation (COR) is up to | ||
| 80 mm | Scanner Center of Rotation (COR) is up to 80 mm | Identical, therefore, substantially | |
| equivalent | |||
| Low contrast resolution | |||
| (32cm body CTDI | |||
| phantom) | 4 mm @ 0.3% @ 25 mGy CTDIvol | 4 mm @ 0.3% @ 25 mGy CTDIvol | Identical, therefore, substantially |
| equivalent | |||
| Noise in (as standard | |||
| mode measured on 21.6 | |||
| cm water-equivalent) | 0.27% at 27 mGy | 0.27% at 27 mGy | Identical, therefore, substantially |
| equivalent | |||
| Image Matrix | Up to 1024 x 1024 | Up to 1024 x 1024 | Identical, therefore, substantially |
| equivalent | |||
| Display | 1024 x 1280 | 1024 x 1280 | Identical, therefore, substantially |
| equivalent | |||
| Communication | Compliance with DICOM 3.0 | Compliance with DICOM 3.0 | Identical, therefore, substantially |
| equivalent | |||
| Detectors | |||
| Type | Nano Panel Prism | Nano Panel Prism | Identical, therefore, substantially |
| equivalent | |||
| Material | Solid-state yttrium-based scintillator, GOS + Photodiode | Solid-state yttrium-based scintillator, GOS + Photodiode | Identical, therefore, substantially equivalent |
| DMS Detector Spectral CT 7500 | 8 cm - Dual-Layer scintillator, up to 128 detector rows | 8 cm - Dual-Layer scintillator, up to 128 detector rows | Identical, therefore, substantially equivalent |
| DMS structure | Spherical DMS structure | Spherical DMS structure | Identical, therefore, substantially equivalent |
| Collimation | 0.625 mm and various combinations, 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, substantially equivalent | ||
| Slice thicknesses | Various slice thickness options are available in the range of 0.67 - 10 mm for helical mode and 0.625 - 20 for axial mode | Various slice thickness options are available in the range of 0.67 - 10 mm for helical mode and 0.625 - 20 for axial mode | Identical, therefore, substantially equivalent |
| Gantry | |||
| Gantry rotation speed | 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, substantially equivalent | ||
| Bore size | 800 mm | 800 mm | Identical, therefore, substantially equivalent |
| Operator Controls located on Gantry | Touch Panel Controls | Touch Panel Controls | Identical, therefore, substantially equivalent |
| Eclipse Collimation | A-Plane | A-Plane | Identical, therefore, substantially equivalent |
| Generator and Tube Performance | |||
| Power | 120kW | 120kW | Identical, therefore, substantially equivalent |
| kV Setting | 80 100 120 140 | 80 100 120 140 | Identical, therefore, substantially equivalent |
| mA Range | 10-1000 | 10-1000 | Identical, therefore, substantially equivalent |
| Focal spot - Smart Focal | |||
| Spot | Identical, therefore, substantially | ||
| x- and z-deflection | x- and z-deflection | equivalent | |
| Couch | |||
| Couch | Noah Couch | Noah Couch | Identical, therefore, substantially |
| equivalent | |||
| Couch Vertical Range | Minimum Height - 430 mm | Minimum Height - 430 mm | Identical, therefore, substantially |
| equivalent | |||
| Couch Horizontal Range | -2143 mm | -2143 mm | Identical, therefore, substantially |
| equivalent | |||
| Scannable Surview | |||
| Range | 1940mm | 1940mm | Identical, therefore, substantially |
| equivalent | |||
| Scannable axial Range | 2000mm | 2000mm | Identical, therefore, substantially |
| equivalent | |||
| Scannable helical Range | 1900mm | 1900mm | Identical, therefore, substantially |
| equivalent | |||
| Couch Speed Range | 1 mm/sec – 600 mm/sec | 1 mm/sec – 600 mm/sec | Identical, therefore, substantially |
| equivalent | |||
| Acceleration | 800 mm/Sec^2 | 800 mm/Sec^2 | Identical, therefore, substantially |
| equivalent | |||
| Couch Max Load | |||
| Capacity | High Performance: 675 lbs. (307 kg) | ||
| Utilizing RTP flat tabletop optional | |||
| accessory: 628 lbs. (285 kg) | High Performance: 675 lbs. (307 | ||
| kg) | |||
| Utilizing RTP flat tabletop | |||
| optional accessory: 628 lbs. (285 | |||
| kg) | Identical, therefore, substantially | ||
| equivalent | |||
| Couch accessories | Infant Cradle, Paper roller, Varian Camera | ||
| Adaptor, Oncology flat tabletop | Infant Cradle, Paper roller, Varian | ||
| Camera Adaptor, Oncology flat | |||
| tabletop | Identical, therefore, substantially | ||
| equivalent | |||
| Clinical Applications: Dose Tools | |||
| Cardiac reconstruction | |||
| method | Standard ECG Gated Reconstruction | ||
| method | Standard ECG Gated | ||
| Reconstruction method | Identical, therefore substantially | ||
| equivalent. | |||
| Motion Compensated Reconstruction | |||
| (MCR) (optional feature) | Precise Cardiac (optional feature) | Note: this is identical to the MCR | |
| algorithm in the currently marketed | |||
| primary predicate device, Spectral CT | |||
| system (K203020) except of the name. | |||
| Virtual Tilt Viewer (VTV) | |||
| (optional feature) | Yes | Yes | Identical, therefore, substantially |
| equivalent | |||
| Pulmonary Gating 4DCT | |||
| (Four-Dimensional | |||
| Computed Tomography) | No | Yes | Substantially Equivalent. The proposed |
| device, Spectral CT 7500 RT system | |||
| introduces Pulmonary gated scanning | |||
| which allows image acquisition of the | |||
| esophagus and abdomen area while the | |||
| patient is breathing. The Pulmonary gated | |||
| scan feature is planned for Radiation | |||
| Therapy Planning procedures and is | |||
| similar from a technological perspective to | |||
| the secondary currently marketed | |||
| secondary predicate device, Philips Big | |||
| Bore system (K171850). The Pulmonary | |||
| gating was successfully verified and | |||
| validated and does not raise new | |||
| questions on safety and/or effectiveness. | |||
| General | |||
| Technical Basis for | |||
| Collection of two CT | |||
| Spectral | Dual Layer DMS (Spectral Detector) | Dual Layer DMS (Spectral | |
| Detector) | Identical, therefore, substantially | ||
| equivalent | |||
| Spectral Base Images | Low energy | ||
| High-energy | |||
| Photoelectric | |||
| Compton Scatter | Low energy | ||
| High-energy | |||
| Photoelectric | |||
| Compton Scatter | Identical, therefore, substantially | ||
| equivalent | |||
| Spectral results | |||
| available [kVp] | 100kVp | ||
| 120kVp | |||
| 140kVp | 100kVp | ||
| 120kVp | |||
| 140kVp | Identical, therefore, substantially | ||
| equivalent | |||
| Spectral Results Images | Monoenergetic | ||
| Materials Basis/Density Pairs, such as | |||
| I / H2O | |||
| I / Ca | |||
| Ca / Uric Acid | |||
| Effective Atomic Number | Monoenergetic | ||
| Materials Basis/Density Pairs, | |||
| such as | |||
| I / H2O | |||
| I / Ca | |||
| Ca / Uric Acid | |||
| Effective Atomic Number | Identical, therefore, substantially | ||
| equivalent | |||
| 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 | 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 | |||
| Host Drives | 256GB OS disk plus one 7.68TB PCIE NVMe | ||
| SSD | 256GB OS disk plus one 7.68TB | ||
| PCIE NVMe SSD | Identical, therefore, substantially | ||
| equivalent | |||
| Host Infrastructure | Windows 10 | Windows 10 | Identical, 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 | |||
| CIRS CPUs | In 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 | |||
| CIRS Drives | In 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 Controls | Yes | Yes | Identical, therefore, substantially |
| equivalent |
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Based on the information provided above, the proposed Spectral CT 7500 RT system is considered to the currently marketed primary predicate device, Spectral CT system (K203020), in terms of fundamental scientific technology.
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Summary of Non-clinical performance testing has been performed on the proposed Spectral CT 7500 RT system and Non-Clinical demonstrates compliance with the following International and FDA recognized consensus standards and FDA Performance guidance document(s): (e.g., see below)
- Data:
- IEC 60601-1:2005 A1:2012 A2:2020: Medical electrical equipment -- Part 1: General requirements for . safety and essential performance (FDA recognition number: 19-49).
- . IEC 60601-1-2:2014 A1:2020: Medical electrical equipment -- Part 1-2: General reguirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (FDA recognition number: 19-36).
- . IEC 60601-1-3:2008 A2:2021: Medical electrical equipment -- Part 1: General requirements for safety -- 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment. (FDA recognition number: 12-336).
- IEC 60601-1-6:2010 A1:2013 A2:2020: Medical electrical equipment -- Part 1-6: General requirements for safety - Collateral standard: Usability (FDA recognition number: 5-132).
- . IEC 60601-2-28:2017: Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis (FDA recognition number: 12-309).
- IEC 60601-2-44:2009 A1:2012 A2:2016: Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (FDA recognition number: 12-302).
- . IEC 60825-1:2014 ISH1:2017 ISH2:2017: Safety measures, Light hazards, Lasers, Wavelengths, Eyes, Warning devices, Mathematical calculations, Medical equipment, Light emission, Marking, Hazards, Symbols, Instructions for use, Physiological effects (human body), Classification systems, Definitions, Occupational safety (FDA recognition number: 12-273).
- IEC 62304:2006 + A1:2015: Medical device software - Software life-cycle processes (FDA recognition number: 13-79).
- IEC 62366-1:2015 A1:2020: Medical devices - Application of usability engineering to medical devices (FDA recognition number: 5-129).
- ISO 14971:2019: Medical devices - Application of risk management to medical devices (FDA recognition number: 5-125).
- . ISO 10993-1:2018: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (FDA recognition number: 2-258)
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).
- . Guidance for Industry and FDA Staff – Content of Premarket Submissions for Device Software Functions (issued June 14, 2023).
- . Pediatric Information for X-ray Imaging Device Premarket Notifications - Guidance for Industry and Food and Drug Administration Staff (November 28, 2017)
- . Guidance for Industry and FDA Staff - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued September 27, 2023).
Design verification planning and testing were conducted at the system is tested against the System Requirements Specifications (SRS) and the Sub-System Requirement Specifications (SSRS). System and sub-system verification activities demonstrate the system meet the established system and sub-system level design input requirements.
The traceability between the requirements, the hazard mitigations, and the test protocols are described in the traceability matrix.
Design Validation tests the user needs and intended use that are documented in the top-level User Requirement Specification (PRS). The validation testing covered new features, clinical validation, and
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serviceability validation. All the validation tests as per validation plan were performed and acceptance criteria met for each of the requirements.
The detailed verification and validation results are provided in the full system verification and validation reports. Non-clinical design validation testing demonstrates that the proposed Spectral CT 7500 RT system can be used as defined in its clinical workflow and intended use.
- . Summary of Image Quality testing for Pulmonary Gating feature:
- Conclusion of Motion Phantom Testing: The review and the analysis showed that the level O and magnitude of artifacts is similar to existing products under similar conditions and additionally that the differences seen are explainable based on design differences between the Spectral CT 7500 RT and the existing currently marketed and predicate device, Philips Big Bore system (K171850). Clinical evaluation determined the gated reconstruction is acceptable for RT simulation purposes.
- Conclusion of Spectral Phantom Testing: Review of all of the spectral results did not reveal O any significant differences between the Pulmo spectral results and the non-Pulmo chest scan that was used as a reference. This supports the conclusion that there are no significant differences in the Pulmo spectral results compared with the non-Pulmo spectral results.
- Conclusion of Clinical External Image Quality Review: Clinical images were externally O reviewed, by US board certified reviewers, grading their overall image quality for use in CT simulation for radiotherapy planning. The external IQ assessments of Pulmonary Gating 4DCT for both conventional 4DCT results and Spectral 4DCT results, were completed and the defined success criteria were met. All images were rated as satisfactory for radiation therapy planning/ simulation.
- Summary of Image Quality testing for Extended Field of View (EFOV) feature: ●
- O Overall Conclusion of the IQ Testing: The review achieved its goal of reviewing the results of IQ integration tests for the extended FOV feature in the proposed Spectral CT 7500 RT system. The results showed that the IQ testing meets the SRS IQ requirements. These results are only intended to support RT applications.
- O Conclusion of Clinical External Image Quality Review: Clinical images were externally reviewed, by US board certified reviewers, grading their overall image quality for use in CT simulation for radiotherapy planning. The external IQ assessment of eFOV was completed and the defined success criteria were met. All images were rated as satisfactory for radiation therapy planning/ simulation.
All these tests were used to support substantial equivalence of the subject device and demonstrate that the proposed Spectral CT 7500 RT system:
- Complies with the aforementional and FDA-recognized consensus standards and/or . FDA guidance document, and;
- Meets the acceptance criteria and is adequate for its intended use.
Therefore, the proposed Spectral CT 7500 RT system is substantially equivalent to the currently marketed primary predicate device, Spectral CT system (K203020), in terms of safety and effectiveness.
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Summary of The proposed Spectral CT 7500 RT system did not require clinical study since substantial equivalence to the Clinical primary currently marketed primary predicate device Spectral CT system (K203020) was demonstrated with Performance the following attributes:
Data:
- Indication for use;
- . Technological characteristics;
- Non-clinical performance testing; and
- Safety and effectiveness.
The proposed Spectral CT 7500 RT system is substantially equivalent to the currently marketed primary Substantial predicate device, Spectral CT system (K203020), in terms of indications for use, technological characteristics Equivalence Conclusion: and principles of operation.
The minor technological differences between the proposed Spectral CT 7500 RT system and currently marketed primary predicate device, Spectral CT system (K203020), raise no new issues of safety or effectiveness. Non-clinical performance data demonstrate that the proposed Spectral CT 7500 RT system performs as expected and in a manner that is substantially equivalent to its predicate device. Thus, the proposed Spectral CT 7500 RT system is substantially equivalent.