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.

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.

AI/ML Overview

This document, a 510(k) Pre-Market Notification for the Philips IQon Spectral CT (K163711), indicates that no new clinical study was required to demonstrate substantial equivalence for the core device to its predicate (K133674). The addition of "Low Dose CT Lung Cancer Screening" to the Indications for Use was supported by a comparative assessment to another cleared device (K153444), rather than a de novo clinical study for the IQon Spectral CT itself.

Therefore, much of the requested information about acceptance criteria for a specific study conducted for this device, sample sizes for test sets, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document as it pertains to this specific 510(k) submission for the IQon Spectral CT. The document relies heavily on the substantial equivalence to previously cleared devices.

However, I can extract information related to the general acceptance of the device based on non-clinical testing and its reliance on previously cleared predicate devices.

Acceptance Criteria and Device Performance (Based on Non-Clinical Data and Substantial Equivalence)

Acceptance Criteria Category	Reported Device Performance (as per document K163711)
Compliance with recognized international standards	The IQon Spectral CT System complies with: - IEC 60601-1:2005+A1:2012 - IEC 60601-1-2:2007 - IEC 60601-1-3 Edition 2.0:2008 - IEC 60601-1-6:2010 - IEC 60601-2-44:2009 - ISO 14971:2007 (Application of risk management to medical devices)
Compliance with FDA device-specific guidance documents	The IQon Spectral CT System complies with: - Guidance for Industry and FDA Staff – "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Oct 2, 2014)
Adequacy for intended use	"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 results of these tests demonstrate that the IQon Spectral CT System met the acceptance criteria and is adequate for its intended use."
Image Quality and Technological Characteristics (for LDCT)	"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 [Philips Multislice CT System with Low Dose CT Lung Cancer Screening]." (This implies that the IQon Spectral CT's performance for LDCT was deemed comparable to a previously cleared device for that specific indication, but specific metrics are not detailed in this document).
Safety and Effectiveness	"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."

Study Details (as inferable from the document):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This 510(k) relies on non-clinical verification and validation testing, and comparative assessment to predicate devices, rather than a new clinical study. Therefore, there is no "test set" in the context of a new prospective or retrospective clinical study of patients, or information on data provenance, within this specific submission. The non-clinical tests would have involved phantom or laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable, as no new clinical test set requiring expert ground truth establishment is described in this 510(k). The "ground truth" for compliance testing would be defined by the standards and technical specifications being verified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no new clinical test set is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study is mentioned or appears to have been conducted for this 510(k) submission. The device is a CT scanner, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study for improved reader performance for this submission. The "minor improvements to some spectral algorithms" are internal technical refinements, not standalone AI algorithms for interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The IQon Spectral CT is a medical imaging device. Its function involves acquiring and processing images for interpretation by a human healthcare professional. There isn't a standalone algorithm performance evaluation described independent of the imaging system. The modifications mentioned ("minor improvements to some spectral algorithms") are part of the image generation/processing pipeline, not a separate diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical performance data, the ground truth would be the established specifications and requirements defined by the international and FDA-recognized consensus standards (e.g., image quality metrics, dose measurements in phantoms, electrical safety parameters) and the technical design requirements of the device.
- For the Low Dose CT Lung Cancer Screening indication, the ground for clinical validity would stem from the clinical literature referenced (e.g., National Lung Screening Trial) and the established inclusion criteria/protocols of governmental/professional medical societies, which inherently rely on outcomes data and pathology for nodule malignancy. The IQon Spectral CT's role is to provide the imaging data.
The sample size for the training set:
- Not applicable. This document describes a medical device clearance based on substantial equivalence and non-clinical testing, not a machine learning model requiring a training set. The "spectral algorithms" receiving "minor improvements" are likely image reconstruction and processing algorithms that have been refined based on engineering principles and potentially internal validation, not AI models trained on large datasets.
How the ground truth for the training set was established:
- Not applicable, as no training set for a machine learning model is described in this 510(k) submission.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K163711

Device Name IQon Spectral CT

Indications for Use (Describe)

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

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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 RoadCleveland, OH 44143, USAEstablishment Registration Number: 1525965
Primary ContactPerson:	Steven GoldbergRegulatory Affairs SpecialistPhone: 972-(0)72-336-4218E-mail: steven.goldberg@Philips.com
SecondaryContact Person:	Michael S. PretoSenior Manager, Regulatory AffairsPhone: 440-483-2295Fax: 440-483-4918E-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
	ClassificationRegulation:	21CFR 892.1750
	Classification Panel:	Radiology
	Device Class:	II
	Primary ProductCode:	JAK
	Secondary ProductCode:	Not applicable
Primary PredicateDevice:
	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
	ClassificationRegulation:	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:

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PHILIPS

•	Complies with the aforementioned international andFDA-recognized consensus standards, Guidance forIndustry and FDA Staff – Guidance for the Content ofPremarket Submissions for Software Contained inMedical Devices" (issued May 11, 2005, documentnumber 337), and Content of Premarket Submissionsfor Management of Cybersecurity in Medical Devices(issued October 2, 2014).
•	Meets the acceptance criteria and is adequate for itsintended use.
	Therefore, the IQon Spectral CT System is substantiallyequivalent to the currently marketed and predicate device,Philips IQon Spectral CT (K133674, Nov. 21, 2014) in terms ofsafety and effectiveness.
Summary ofClinicalPerformance Data:	The IQon Spectral CT System did not require a clinical studybecause substantial equivalence to the currently marketed andpredicate device, Philips IQon Spectral CT, was demonstratedwith the following attributes:• Indication for use;• Technological characteristics;• Non-clinical performance testing;• Labeling; and• Safety and effectiveness.
SubstantialEquivalenceSummary:	The proposed IQon Spectral CT System is substantiallyequivalent to the currently marketed and predicate device,Philips IQon Spectral CT (K133674), in terms of designfeatures, fundamental scientific technology, indications foruse, and safety and effectiveness. Also, the Low Dose CTLung Cancer Screening provided with the IQon Spectral CTSystem is substantially equivalent to the reference device,Philips Multislice CT System with Low Dose CT Lung CancerScreening (K153444, April 8, 2016). Additionally, substantialequivalence was demonstrated with non-clinical performance(verification and validation) tests, which complied with therequirements specified in the aforementioned international andFDA-recognized consensus standards. The results of thesetests demonstrate that the IQon Spectral CT System met theacceptance criteria and is adequate for its intended use.

Regulation Number and Section

§ 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.