(42 days)
No
The document describes standard CT technology and image processing techniques, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a diagnostic tool for visualization and analysis of anatomical and pathological structures, and for diagnostic imaging, not for treatment.
Yes
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 and to be used for diagnostic imaging". It also mentions 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 hardware components such as 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 text, the IQon Spectral CT is not an IVD (In Vitro Diagnostic) device.
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.
- IQon Spectral CT Function: The description clearly states that the IQon Spectral CT is a Computed Tomography X-Ray System that produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. It works by scanning the patient's body with X-rays and analyzing the attenuation of those X-rays.
- No Sample Analysis: The device does not analyze samples taken from the body. It analyzes the interaction of X-rays with the body.
Therefore, the IQon Spectral CT falls under the category of medical imaging devices, not in vitro diagnostics.
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 spectrum. The two spectra may be used to analyse 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 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 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 IQon Spectral CT 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 device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories. The proposed IQon Spectral CT System includes the detector array, which is identical to the currently marketed and predicate device – Philips IQon Spectral CT System (K163711).
The proposed IQon Spectral CT System consists of three main components, that are identical to the currently marketed and predicate device. Philips IQon Spectral CT System (K163711) - 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 proposed IQon Spectral CT System includes workstation hardware and software for data acquisition; image display, manipulation, storage, and filming, as well as post-processing for 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 (CT)
Anatomical Site
body, anatomical and pathological structures, lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professional, diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology as part of treatment preparation and radiation therapy planning.
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 proposed IQon Spectral CT system and demonstrates compliance with the following International and FDA recognized consensus standards and FDA guidance document(s).
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint) (FDA Recognition Number: 19-4)
- IEC 60601-1-2:2014: (FDA Reorganization Number :19-8)
- IEC 60601-1-3:2008+A1:2013 (FDA Recognition Number: 12-269)
- IEC 60601-1-6:2010 +A1: 2013 (FDA Recognition Number: 5-89)
- IEC 60601-2-44:2009/AMD2:2016 (FDA Recognition Number: 12-302)
- IEC 62304:2006 + A1: 2015 (FDA Recognition Number: 13-79)
- ISO 10993-1:2009/Cor.1:2010 (FDA Recognition Number: 2-220)
- ISO 14971 2nd Edition. (FDA Recognition Number: 5-40)
- 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).
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 system or sub-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. Design verification also includes Image Quality verification and risk analysis risk mitigation testing.
The traceability between the requirements, the hazard mitigations and the test protocols are described in the Traceability Matrix. The Traceability Matrix also shows the overall test results per requirement and per hazard mitigation. The results of the functional and non-functional regression tests as well as the user interface verification are provided in the Traceability Matrix. The detailed results are provided in the Full System Verification Test Report.
Non-Clinical design validation testing covered the intended use and commercial claims as well as usability testing with representative intended users. Validation testing included clinical workflow validation and service validation.
All these tests were used to support substantial equivalence of the proposed IQon Spectral CT System and demonstrate that the proposed IQon Spectral CT System
- complies with the aforementioned international and FDA-recognized consensus standards and/or FDA device specific guidance document, and;
- Meets the acceptance criteria and is adequate for its intended use.
The proposed IQon Spectral CT system did not require any external clinical study. The clinical evaluation of workflow was conducted via simulated use testing and is accounted for in the summary of "Non-Clinical Testing" section of the summary. Sample clinical images were provided with this submission, which were reviewed and evaluated by certified radiologists. All images were evaluated to have good image quality.
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.
0
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January 24, 2020
Philips Medical Systems, Nederland B.V. % Nimit Shah Regulatory Affairs Specialist Veenpluis 4-6 Best, 5684 PC THE NETHERLANDS
Re: K193454
Trade/Device Name: IQon Spectral CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: December 11, 2019 Received: December 13, 2019
Dear Nimit Shah:
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
1
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 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 (OS) 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,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193454
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 analyse 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 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 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 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
PHILIPS BG Diagnostic Imaging
SECTION 5 510(K) SUMMARY
HA300-006-05 Revision: 01 Status: Approved Page: 1 of 5
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: December 11, 2019
- Manufacturer: Philips Medical Systems Nederland B.V. Veenpluis 4-6. 5684 PC BEST The Netherlands Establishment Registration Number: 3015777306
- Primary Contact Person: Nimit Shah Regulatory Affairs Specialists Phone: 440-869-4409 E-mail: nimit.shah@philips.com
- Secondary Contact Douglas Kentz Person: Director of Regulatory Affairs Phone: (262) 389-7369 E-mail: douglas.kentz@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: ll Primary Product Code: JAK Secondary Product Code: Not Applicable Trade Name: Philips IQon Spectral CT Predicate Device: Manufacturer: Philips Medical Systems (Cleveland), Inc. 510(k) Clearance: K163711 Classification Name: Computed Tomography x-Ray System Classification Regulation: 21CFR §892.1750 Radiology Classification Panel: Class II Device Class: Product Code: JAK
4
PHILIPS BG Diagnostic lmaqinq
CT/AMI
Device Description:
The proposed IQon Spectral CT 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 device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories. The proposed IQon Spectral CT System includes the detector array, which is identical to the currently marketed and predicate device – Philips IQon Spectral CT System (K163711).
The proposed IQon Spectral CT System consists of three main components, that are identical to the currently marketed and predicate device. Philips IQon Spectral CT System (K163711) - 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 proposed IQon Spectral CT System includes workstation hardware and software for data acquisition; image display, manipulation, storage, and filming, as well as post-processing for views other than the original axial images. Patient supports (positioning aids) are used to position the patient.
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 Intended Use: 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 analyse 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 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 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.
5
SECTION 5 510(K) SUMMARY
| CT/AMI | Page: 3 of 5 |
|---|---|
| Technological | |
| Characteristics | The main components (detection system, the reconstruction 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 currently marketed and predicate device, Philips IQon Spectral CT (K163711) |
| The design, and the fundamental scientific technology provided with the proposed IQon Spectral CT System is identical to the currently marketed and predicate device, Philips IQon Spectral CT (K163711). | |
| This 510(k) submission addresses the change of indication for use statement and minor modifications that were implemented in the currently marketed and predicate device Philips IQon Spectral CT (K163711). These minor modifications changes include labelling clarification, hardware obsolescence issues and software defect fixes/improvements, that were implemented since clearance of the predicate device. The additional changes that were introduced are as follows. The following changes do not impact device safety and effectiveness. Updated Indication for Use Statement: This update is only for clarification purposes by adding well known specific indications for use that are covered under the general indication for use statement. The currently marketed predicate device Philips IQon Spectral CT (K163711) is being used for diagnostic imaging in radiology, interventional radiology and cardiology and in oncology as part of treatment preparation and radiation therapy planning. The fundamental scientific technology and design of the proposed IQon Spectral CT system is identical with the currently marketed and predicate device Philips IQon Spectral CT System (K163711). Additional Optional Bariatric Couch (Patient Support)Hardware Options: 2nd CIRS Rack (Dual CIRS Rack – For Faster reconstruction) and Host Extension Kit (provides the ability to migrate the host from its default location in the control room within the Host Rack to the technical room within the CIRS rack. Both of these hardware options do not affect device safety and effectiveness. Electron Density: This is spectral CT image generated from an IQon spectral acquisition. A dedicated algorithm uses spectral data to estimate the electron density (ED) of each voxel. This change does not impact device safety and effectiveness and also does not alter intended use of the device. Calcium Suppression Index: This is HU-based spectral CT image generated from an IQon Spectral acquisition. A dedicated algorithm uses spectral data to identify and suppress calcium that normally overlays the underlying tissue. This change does not impact device safety and effectiveness and also does not alter intended use of the device. Based on the information provided above, the proposed IQon Spectral CT System is considered substantially equivalent to the currently marketed and predicate device Philips IQon Spectral CT System (K163711), in terms of fundamental scientific technology. | |
| Summary of Non- | |
| Clinical Performance | |
| Data: | Non-clinical performance testing has been performed on the proposed IQon Spectral CT system and demonstrates compliance with the following International and FDA recognized consensus standards and FDA guidance document(s). IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint) (FDA Recognition Number: 19-4)IEC 60601-1-2:2014: (FDA Reorganization Number :19-8)IEC 60601-1-3:2008+A1:2013 (FDA Recognition Number: 12-269) |
6
CT/AMI
- IEC 60601-1-6:2010 +A1: 2013 (FDA Recognition Number: 5-89) ●
- IEC 60601-2-44:2009/AMD2:2016 (FDA Recognition Number: 12-302) ●
- IEC 62304:2006 + A1: 2015 (FDA Recognition Number: 13-79) ●
- ISO 10993-1:2009/Cor.1:2010 (FDA Recognition Number: 2-220) ●
- ISO 14971 2nd Edition. (FDA Recognition Number: 5-40) .
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).
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 system or sub-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. Design verification also includes Image Quality verification and risk analysis risk mitigation testing.
The traceability between the requirements, the hazard mitigations and the test protocols are described in the Traceability Matrix. The Traceability Matrix also shows the overall test results per requirement and per hazard mitigation. The results of the functional and non-functional regression tests as well as the user interface verification are provided in the Traceability Matrix. The detailed results are provided in the Full System Verification Test Report.
Non-Clinical design validation testing covered the intended use and commercial claims as well as usability testing with representative intended users. Validation testing included clinical workflow validation and service validation.
All these tests were used to support substantial equivalence of the proposed IQon Spectral CT System and demonstrate that the proposed IQon Spectral CT System
- complies with the aforementioned international and FDA-recognized . consensus standards and/or FDA device specific guidance document, and;
- Meets the acceptance criteria and is adequate for its intended use. .
Therefore, the Proposed IQon Spectral CT is substantially equivalent to the currently marketed and predicate device Philips IQon Spectral CT (K163711) in terms of safety and effectiveness.
7
| PHILIPS
BG Diagnostic
Imaging
CT/AMI | SECTION 5 510(K) SUMMARY | HA300-006-05
Revision: 01
Status: Approved
Page: 5 of 5 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Summary of Clinical
Performance Data: | The proposed IQon Spectral CT system did not require any external clinical study.
The clinical evaluation of workflow was conducted via simulated use testing and is
accounted for in the summary of "Non-Clinical Testing" section of the summary. The
substantial equivalence to the currently marketed and predicate device Philips IQon
Spectral CT (K163711) was demonstrated with the following attributes: | |
| | • | Indication for use; |
| | • | Technological characteristics; |
| | • | Non-clinical performance testing; and |
| | • | Safety and effectiveness. |
| | Sample clinical images were provided with this submission, which were reviewed
and evaluated by certified radiologists. All images were evaluated to have good
image quality. | |
| Substantial
Equivalence
Conclusion: | The proposed IQon Spectral CT System is substantially equivalent to the currently
marketed predicate device IQon Spectral CT (K163711) in terms of design, features
and fundamental scientific technology. The change in indications for use statement
is only for moving from general indication for use to specific indication for use for
IQon Spectral CT. The updated Indication for Use Statement does not introduce any
new risk nor impact safety and effectiveness of the proposed IQon Spectral CT
System. | |
| | Additionally, substantial equivalence was demonstrated by non-clinical (verification
and validation) performance tests provided in this 510(k) premarket notification.
These tests demonstrate that proposed IQon Spectral CT system complies with the
requirements specified by Philips Medical Systems Nederland B.V. and the
international and FDA-recognized consensus standards and is as safe and effective
as its currently marketed and predicate device Philips IQon Spectral CT (K163711)
without raising any new safety and/or effectiveness concerns. | |