(96 days)
No
The summary describes standard CT technology and image processing techniques, with no mention of AI or ML. The "Spectral Reconstruction System" and "materials analysis" are described in terms of analyzing energy dependence of attenuation coefficients and chemical composition, which are physics-based principles, not AI/ML.
No.
The device is described as a diagnostic tool for visualization and analysis of anatomical and pathological structures, and for aiding in the early detection of lung cancer, which are diagnostic rather than therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures." Additionally, it mentions its use for "low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer."
No
The device description explicitly states it is a "whole-body computed tomography (CT) X-Ray System" and lists multiple hardware components including a gantry, patient couch, operator console, x-ray tube, and detection system. While it includes software, it is not solely software.
Based on the provided information, the IQon Spectral CT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body. They are used to diagnose diseases or other conditions.
- IQon Spectral CT Function: The IQon Spectral CT is a medical imaging device that uses X-rays to create cross-sectional images of the body. It directly examines the patient's body, not specimens taken from the body.
- Intended Use: The intended use clearly states it's for producing images of the body and analyzing the composition of body materials and/or contrast agents within the body. It also mentions low dose CT lung cancer screening, which is an in-vivo imaging procedure.
Therefore, the IQon Spectral CT falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The IQon Spectral CT 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 IQon 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 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.
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 (comma separated list FDA assigned to the subject device)
JAK
Device Description
The IQon Spectral CT 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 xray transmission data is reconstructed by computer into crosssectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories. The IQon Spectral CT includes the detector array previously described in K133674 "Philips IQon Spectral CT".
The IQon Spectral CT consists of three main components - a scanner system that includes a rotating gantry, a movable patient couch, and an operator console for 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.
In addition to the above components and the software operating them, 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. Patient supports (positioning aids) are used to position the patient.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-Ray
Anatomical Site
Body, Lung
Indicated Patient Age Range
Not Found
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)
Non-clinical performance testing has been performed on the IQon Spectral CT System and demonstrates compliance with the following international and FDA-recognized consensus standards:
- IEC 60601-1:2005+A1:2012 (FDA reorganization number :19-4)
- IEC 60601-1-2:2007 (FDA reorganization number :19-1)
- IEC 60601-1-3 Edition 2.0:2008 (FDA reorganization number :12-210)
- IEC 60601-1-6:2010 (FDA reorganization number :5-85)
- IEC 60601-2-44:2009 (FDA reorganization number :12-257)
- ISO 14971 Application of risk management to medical devices (2007) (FDA/CDRH reorganization number :5-40)
Device specific 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, document number 337)
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014).
Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results. The addition of lung cancer screening to the IFU statement was supported with a comparative assessment of image quality and technological characteristics to the devices cleared for this use in K153444.
Clinical verification and or validation test results: Not Found (The IQon Spectral CT System did not require a clinical study because substantial equivalence to the currently marketed and predicate device, Philips IQon Spectral CT, was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing; Labeling; and Safety and effectiveness.)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2017
Philips Medical Systems (Cleveland), Inc. % Mr. Steven Goldberg Regulatory Affairs Specialist 595 Miner Road CLEVELAND OH 44143
Re: K163711
Trade/Device Name: IQon Spectral CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 15, 2017 Received: March 17, 2017
Dear Mr. Goldberg:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163711
Device Name IQon Spectral CT
Indications for Use (Describe)
The IQon Spectral CT 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 IQon 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 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.
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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Section 5 510(k) Summary
4
PHIL 1 PS
510(k) Summary – K163711 Section 5:
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | March 14, 2017 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems (Cleveland), Inc. | |
| 595 Miner Road | ||
| Cleveland, OH 44143, USA | ||
| Establishment Registration Number: 1525965 | ||
| Primary Contact | ||
| Person: | Steven Goldberg | |
| Regulatory Affairs Specialist | ||
| Phone: 972-(0)72-336-4218 | ||
| E-mail: steven.goldberg@Philips.com | ||
| Secondary | ||
| Contact Person: | Michael S. Preto | |
| Senior Manager, Regulatory Affairs | ||
| Phone: 440-483-2295 | ||
| Fax: 440-483-4918 | ||
| E-mail: Michael.preto@Philips.com | ||
| Device: | ||
| Trade Name: | IQon Spectral CT | |
| 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: | Philips IQon Spectral CT System | |
| Manufacturer: | Philips Medical Systems (Cleveland), | |
| Inc. | ||
| 510(k) Clearance: | K133674 (November 21, 2014) | |
| Classification Name: | Computed tomography x-ray system | |
| Classification | ||
| Regulation: | 21CFR §892.1750 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | JAK |
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| Reference Device: Trade Name: | Philips Multislice CT System with Low Dose CT Lung Cancer Screening |
|---|---|
| Manufacturer: | Philips |
| 510(k) Clearance: | K153444 (April 8, 2016) |
Device The IQon Spectral CT is a whole-body computed tomography Description: (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability. The acquired xray transmission data is reconstructed by computer into crosssectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories. The IQon Spectral CT includes the detector array previously described in K133674 "Philips IQon Spectral CT".
The IQon Spectral CT consists of three main components - a scanner system that includes a rotating gantry, a movable patient couch, and an operator console for 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.
In addition to the above components and the software operating them, 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. Patient supports (positioning aids) are used to position the patient.
Device Modifications
This 510(k) addresses the minor modifications that were implemented in the currently marketed and predicate device, Philips IQon Spectral CT, cleared by FDA via 510(k) number K133674, Nov. 21, 2014. These minor changes include clarifications, materials, components, defect labeling fixes/improvements, and minor improvements to some spectral algorithms, e.g., Constant Noise Suppression, Pre Decomposition DeNoise, parameters tuning, and Iterative Bone Correction that were implemented since clearance of the currently marketed and predicate device. Philips IQon Spectral CT and do not change the indications for use of the device.
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This 510k also adds Low Dose CT Lung Cancer Screening in the Indications for Use, cleared by FDA for the reference device, Philips Multislice CT System with Low Dose CT Lung Cancer Screening via K153444, April 8, 2016.
The IQon Spectral CT is a Computed Tomography X-Ray Indications for Use: 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 IQon 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 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.
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.
Technological The main components (detection system, the reconstruction Characteristics algorithm, and the x-ray system) that are used in the proposed IQon Spectral CT System have the same fundamental design characteristics and are based on the same technologies as the
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currently marketed and predicate device, Philips IQon Spectral CT.
The design, indications for use, and the fundamental scientific technology provided with the proposed IQon Spectral CT are identical to the currently marketed and predicate device, Philips IQon Spectral CT.
Summary of Non-Non-clinical performance testing has been performed on the Clinical IQon Spectral CT System and demonstrates compliance with Performance Data: the following international and FDA-recognized consensus standards:
- International and FDA-recognized consensus ● standards:
- o IEC 60601-1:2005+A1:2012 (FDA reorganization number :19-4)
- IEC 60601-1-2:2007 (FDA reorganization O number :19-1)
- IEC 60601-1-3 Edition 2.0:2008 (FDA o reorganization number :12-210)
- IEC 60601-1-6:2010 (FDA reorganization O number :5-85)
- IEC 60601-2-44:2009 (FDA reorganization O number :12-257)
- ISO 14971 Application of risk management to o medical devices (2007) (FDA/CDRH reorganization number :5-40)
- Device specific 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, document number 337)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014).
Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results. The addition of lung cancer screening to the IFU statement was supported with a comparative assessment of image quality and technological characteristics to the devices cleared for this use in K153444.
Clinical verification and or validation test results Non demonstrate that the IQon Spectral CT System:
8
PHILIPS
| • | Complies with the aforementioned international and
FDA-recognized consensus standards, Guidance for
Industry and FDA Staff – Guidance for the Content of
Premarket Submissions for Software Contained in
Medical Devices" (issued May 11, 2005, document
number 337), and Content of Premarket Submissions
for Management of Cybersecurity in Medical Devices
(issued October 2, 2014). |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • | Meets the acceptance criteria and is adequate for its
intended use. |
| | Therefore, the IQon Spectral CT System is substantially
equivalent to the currently marketed and predicate device,
Philips IQon Spectral CT (K133674, Nov. 21, 2014) in terms of
safety and effectiveness. |
| Summary of
Clinical
Performance Data: | The IQon Spectral CT System did not require a clinical study
because substantial equivalence to the currently marketed and
predicate device, Philips IQon Spectral CT, was demonstrated
with the following attributes:
• Indication for use;
• Technological characteristics;
• Non-clinical performance testing;
• Labeling; and
• Safety and effectiveness. |
| Substantial
Equivalence
Summary: | The proposed IQon Spectral CT System is substantially
equivalent to the currently marketed and predicate device,
Philips IQon Spectral CT (K133674), in terms of design
features, fundamental scientific technology, indications for
use, and safety and effectiveness. Also, the Low Dose CT
Lung Cancer Screening provided with the IQon Spectral CT
System is substantially equivalent to the reference device,
Philips Multislice CT System with Low Dose CT Lung Cancer
Screening (K153444, April 8, 2016). Additionally, substantial
equivalence was demonstrated with non-clinical performance
(verification and validation) tests, which complied with the
requirements specified in the aforementioned international and
FDA-recognized consensus standards. The results of these
tests demonstrate that the IQon Spectral CT System met the
acceptance criteria and is adequate for its intended use. |