The Ingenuity CT is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. The Ingenuity CT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

These scanners are intended to be used for diagnostic imaging and 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 Philips Ingenuity CT consists of three system configurations, the Philips Ingenuity CT, the Philips Ingenuity Core and the Philips Ingenuity Core128. These systems are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of Jung nodules that may represent cancer*.

The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips Ingenuity CT have the same fundamental design characteristics and are based on comparable technologies as the predicate.

The main system modules and functionalities are:

1. Gantry. The Gantry consists of 4 main internal units:
- a. Stator a fixed mechanical frame that carries HW and SW.
- b. Rotor A rotating circular stiff frame that is mounted in and supported by the stator.
- c. X-Ray Tube (XRT) and Generator fixed to the Rotor frame.
- d. Data Measurement System (DMS) a detectors array, fixed to the Rotor frame.
1. Patient Support (Couch) carries the patient in and out through the Gantry bore synchronized with the scan.
1. Console A two part subsystem containing a Host computer and display that is the primary user interface and the Common Image Reconstruction System (CIRS) - a dedicated powerful image reconstruction computer.

In addition to the above components and the software operating them, each system includes a workstation hardware and software for data acquisition, 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

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) submission for a CT scanner (Philips Ingenuity CT), which focuses on demonstrating substantial equivalence to a predicate device (Philips Plus CT Scanner), rather than establishing new performance claims with specific acceptance criteria and clinical trial results typical for entirely novel AI/ML devices. Therefore, much of the requested information, particularly regarding AI-specific performance (like effect size of human reader improvement with AI, standalone AI performance, ground truth for training AI models) is not directly present. The clinical evaluation described is a comparative image quality assessment rather than a diagnostic accuracy clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are primarily established against international and FDA-recognized consensus standards for medical electrical equipment and CT systems, and against the performance of the predicate device. The "reported device performance" refers to the successful verification against these standards and equivalence to the predicate.

Acceptance Criteria Category	Specific Criteria / Standard Met	Reported Device Performance
Safety and Essential Performance (General)	IEC 60601-1:2006 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance)	All verification tests were executed and passed the specified requirements.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2007 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests)	All verification tests were executed and passed the specified requirements.
Radiation Protection	IEC 60601-1-3 Ed 2.0:2008 (Medical electrical equipment Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic X-ray equipment)	All verification tests were executed and passed the specified requirements, including radiation metrics.
Usability	IEC 60601-1-6:2010 (Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability)	All verification tests were executed and passed the specified requirements.
Safety of X-ray Equipment (Specific)	IEC 60601-2-44:2009 (Medical electrical equipment Part 2-44: Particular requirements for the safety of X-ray equipment)	All verification tests were executed and passed the specified requirements.
Software Life Cycle Processes	IEC 62304:2006 (Medical device software Software life cycle processes)	Software Documentation for a Moderate Level of Concern (per FDA guidance) was included. All verification tests were executed and passed the specified requirements.
Risk Management	ISO 14971 (Medical devices Application of risk management to medical devices (Ed. 2.0, 2007))	Traceability between requirements, hazard mitigations and test protocols described. Test results per requirement and per hazard mitigation show successful mitigation.
Image Quality Metrics (Comparative to Predicate)	CT number accuracy and uniformity, MTF, noise reduction performance (i.e., iDose4 vs. FBP), slice thickness, slice sensitivity profiles. Diagnostic image quality for brain, chest, abdomen, pelvis/orthopedic.	Bench tests included patient support/gantry positioning repeatability and accuracy, laser alignment accuracy, CT image quality metrics testing. Sample phantom images provided. Clinical evaluation found no difference in image quality between iDose4 and FBP, with iDose4 scoring higher in most cases, maintaining diagnostic quality.
Functional and Non-Functional Requirements (System Level)	System Requirements Specification, Subsystem Requirement Specifications, User Interface Verification	Functional and non-functional regression tests, as well as user interface verification, provided in the Traceability Matrix (successful).
Clinical Validation (Workflow & Features)	Covered requirements related to clinical workflows and features.	Validation test plan executed as planned, acceptance criteria met for each requirement. All validation tests demonstrate safety and effectiveness.
Serviceability Validation	Covered requirements related to upgrade, installation, servicing, and troubleshooting.	Validation test plan executed as planned, acceptance criteria met for each requirement.
Manufacturing Validation	Covered requirements related to operations and manufacturing.	Validation test plan executed as planned, acceptance criteria met for each requirement.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" sample size in the sense of a number of clinical cases or patient images used for a diagnostic accuracy study. Instead, it refers to:

Bench tests: These involved phantom images and physical testing of the system (e.g., patient support/gantry positioning repeatability and accuracy, laser alignment accuracy, CT image quality metrics testing). No sample size for these is given.
Clinical Evaluation: An "image evaluation" was performed involving "images of the brain, chest, abdomen and pelvis/peripheral orthopedic body areas." The number of images or patient cases used for this evaluation is not specified.
Data Provenance: Not explicitly stated, but given it's a Philips product, it's likely internal development and validation data. There is no mention of external datasets or specific countries of origin. The evaluation compares FBP and iDose4 reconstructions of the same images. The clinical evaluation implicitly relates to retrospective data as it compares reconstructed images.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: "a qualified radiologist". So, one expert.
Qualifications of Experts: Described only as "a qualified radiologist." No specific experience (e.g., years of experience, subspecialty) is provided.

4. Adjudication Method for the Test Set

The evaluation was performed by a single radiologist using a 5-point Likert scale. Therefore, no adjudication method (like 2+1, 3+1 consensus) was used as there was only one reviewer.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document describes an image evaluation by a single radiologist, not multiple readers. It also describes a comparison of image quality between reconstruction techniques (FBP vs. iDose4), not a comparison of human reader diagnostic performance with vs. without AI assistance.

Effect size of human readers improving with AI vs without AI assistance: This information is not applicable as this type of study was not performed. The study evaluated if iDose4-reconstructed images (which is an iterative reconstruction technique for image quality improvement and dose reduction, not an AI for diagnosis) maintained diagnostic quality compared to standard FBP.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, in spirit, the primary evaluation is about the algorithm's output quality. The iDose4 iterative reconstruction algorithm directly produces images without human intervention, and these images were then evaluated by a radiologist. The core of this 510(k) is about the technical performance and safety of the CT scanner and its components, including its reconstruction algorithms. The evaluation described ("image evaluation...") is a standalone assessment of the image quality produced by the iDose4 algorithm compared to standard FBP. It is not an "AI diagnostic algorithm" standalone performance, but rather an "image reconstruction algorithm" standalone performance.

7. The Type of Ground Truth Used

For the clinical image evaluation, the "ground truth" was established by the evaluation of a qualified radiologist using a 5-point Likert scale to determine if images were of "diagnostic quality" and for comparing image quality between reconstruction methods. This could be considered a form of "expert consensus," albeit from a single expert in this case. There is no mention of pathology or outcomes data being used as ground truth for this specific image quality assessment.

8. The Sample Size for the Training Set

Not applicable in the context of this 510(k) as presented.

The device (Philips Ingenuity CT) is a hardware CT scanner with associated software, including image reconstruction algorithms (like iDose4). While iterative reconstruction algorithms might involve some form of "training" or optimization during their development, the document does not speak to a "training set" in the sense of a dataset used to train a machine learning model for a specific diagnostic task that would typically be described in an AI/ML device submission. The description focuses on technical modifications and adherence to engineering and safety standards, and performance against a predicate device.

9. How the Ground Truth for the Training Set was Established

Not applicable for the reasons stated above (no "training set" for an AI/ML diagnostic model described).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 8, 2016

Philips Medical Systems (Cleveland), Inc. % Ms. Susan Quick Regulatory Affairs Specialist 595 Miner Road CLEVELAND OH 44143

Re: K160743

Trade/Device Name: Philips Ingenuity CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 18, 2016 Received: July 20, 2016

Dear Ms. Quick:

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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Philips Ingenuity CT 510(k) Submission

Section 4

Indications For Use Statement

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Indications for Use

510(k) Number (if known)

K160743

Device Name Philips Ingenuity CT

Indications for Use (Describe)

*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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Philips Ingenuity CT 510(k) Submission

Section 5

510(k) Summary

Rev. 3

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510(k) Summary of Safety and Effectiveness

[As required by 21 CFR 807.92(c)]

Applicant's Name:Address:	Philips Medical Systems (Cleveland), Inc.595 Miner RoadCleveland, OH44143 USA
Contact Person:Title:Address:	Susan QuickRegulatory Affairs Specialist595 Miner RoadCleveland, OH44143 USA
Telephone number:Fax number:E-mail:	+1 440 483-3284+1 440 483-4918susan.quick@philips.com
510(k) Summary Date ofPreparation:	29-February-2016
Device Trade Name:	Philips Ingenuity CT
Common or Usual Name:	Computed Tomography X-ray system
ClassificationName:Regulation:Class:Product Code:Panel:	Computed Tomography X-ray system21 CFR 892.1750IIJAKRadiology
Primary Predicate device	K033326 - Philips Plus CT Scanner

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Indications for Use:

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.

The Philips Ingenuity CT is available in three system configurations, Ingenuity CT, Ingenuity Core, Device Description: and Ingenuity Core128

The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips Ingenuity CT have the same fundamental design characteristics and are based on comparable technologies as the predicate.

The main system modules and functionalities are:

1. Gantry. The Gantry consists of 4 main internal units:
- a. Stator a fixed mechanical frame that carries HW and SW.
- b. Rotor A rotating circular stiff frame that is mounted in and supported by the stator.
- c. X-Ray Tube (XRT) and Generator fixed to the Rotor frame.
- d. Data Measurement System (DMS) a detectors array, fixed to the Rotor frame.
1. Patient Support (Couch) carries the patient in and out through the Gantry bore synchronized with the scan.
1. Console A two part subsystem containing a Host computer and display that is the primary user interface and the Common Image Reconstruction System (CIRS) - a dedicated powerful image reconstruction computer.

Device Modifications

This 510(k) addresses the following minor changes (documented internally via a letter to file) that were implemented in the primary predicate device, Philips Plus CT System, cleared by FDA via 510(k) number K033326, (Oct. 29, 2003). Table 5-1 provides a listing of the minor changes that were implemented since clearance of the predicate device, Philips Plus CT System.

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PHILIPS

Table 5-1
Table of minor changes that were implemented to the primary predicate device, Philips Plus CT
System
Design feature	Description
Dell 670 host to Dell 690 host	End of life components, no change in functionality
New CIRS computersGenerator, kV Settings	80KW and four kV settings (adding 100kV): the functionality is the same as onthe 60KW generator and the addition of the 100 kV provides another settingthat may be useful in standard scanning.
Generator Tube	MRC Ice Tube (880) Identical tube technology, the two tubes share the sameanode, cathode, bearing, anode drive, and electrical interfaces, but differ inhousing.
Detector	40 to 64 slices - The move to 64 slices was the addition of physical detectorsincreasing the total number of slices to 64.64 to 128 slices - With a reconstruction process and reduction in ("windmill")artifacts, 128 slices can be achieved from the 64 detectors.The NanoPanels of the predicate and the Ingenuity Core are the same, theNanoPanel Elite is a revision of the NanoPanel with slight performanceimprovements but still has the same product specifications.
Gantry Covers andControls	Gantry Covers & Controls, CT Control Box: new cover design for gantrycontrol/display panels, simplified CT control box for cost reduction.
Load and Unload FootPedals	Load and Unload foot pedals allow the operator to move the patient couch tothe load or unload position using a foot pedal thus improving patient handlingefficiency by freeing the operator's hands to prepare, restrain, or release thepatient. The functionality was available in the predicate device through theGantry panel buttons.
DMS Cover	Redesigned DMS cover for improved airflow and ventilation
Interventional CouchControl	Philips' interventional couch control, Panning Handle & Joystick, improvesoperational efficiency during CT-guided interventional procedures throughtableside control of longitudinal movements for patient positioning. Thefunctionality was available in the predicate device through the Gantry panelbuttons.
IQ Improvement - HeadCentering Application	The Head Centering Application helps to improve the brain image quality bygiving the user the option to change the bed vertical position (height) afterplanning on Surview without forcing the user to re-plan the scan.
FDOM (DoseModulation)	Dose Modulation function has been cleared on the Brilliance iCT submissionK131773. This function modulates the tube current based on patient bodysymmetry change. FDOM incorporates the features of Z-DOM and D-DOM anddoes not introduce new hazards, but only supports a mode which combinesangular and longitudinal modulation.
Low Dose Ring ArtifactReduction	Low Dose Ring Artifact Reduction is not a software feature or a softwarealgorithm. This occurs when scanning at a low dose and/or scanning largeattenuation objects. This was improved by making a change to the datacollection process in the Detector Module System (DMS) which was achievedwith the NanoPanel Elite detector. There is no new technology beingintroduced.
Pulmonary Gating	Is similar to the pulmonary gating of the AcQSim Multislice CT,K033357. Retrospective gating (tagging) was added to enhance the ease of usewithout significantly changing the device's safety and effectiveness.
CCT (Axial Step &Shoot)	The Step&Shoot (APEX) option is identical to the Axial Cardiac feature clearedin "Brilliance Volume" CT system K060937.
Table 5-1
Table of minor changes that were implemented to the primary predicate device, Philips Plus CT System
Design feature	Description
SyncRight	SyncRight has been cleared on the Ingenuity Digital PET/CT submissionK123599. SyncRight is used in conjunction with the SAS to improve clinicalworkflow of contrast enhanced scanning. The SyncRight feature is supported bythe communication between the injector and the CT scanner, to improve clinicalworkflow of contrast enhanced scanning.
Dose Management	The iDose4 feature has been cleared most recently on the Brilliance iCTsubmission K131773. iDose4 is an iterative reconstruction technique thatimproves image quality through artifact prevention and increased spatialresolution at low dose. It is comparable to the present Adaptive Filteringtechniques and edge enhancing features used on the Brilliance 64.
iPatient	iPatient has been most recently cleared on the IQon Spectral CT submissionK133674. iPatient was originally called "results driven scanning", this softwareplatform allows the operator to plan the required reconstruction results prior tothe scan, without the need to go through the 2D images and re-recons. Itenables the system to provide scan acquisition coverage based on the plannedresults. It does not affect image reconstruction or clinical algorithms, but onlyimproves and simplifies the clinical workflow.
Reconstruction DuringReady	Reconstruction During Ready has been cleared on the IQon Spectral CTsubmission K133674. This feature enables image construction of previousscans when the system is in "ready-for-scan' mode. The feature does not affectimage reconstruction algorithms, but only reconstruction timing.
IMR	The IMR reconstruction feature has been cleared under K123576 for any PhilipsCT system with the stated minimum operational parameters. This is apurchasable option. The IMR (K123576) reconstruction feature is intended asan alternative to standard reconstruction methods (filtered back projection) forthe reconstruction of CT scanner data to produce diagnostic images. The IMRreconstruction feature is designed to reduce image noise, increase high-contrast spatial resolution, and improve low contrast detectability. IMR isdesigned to reduce dose required for diagnostic CT imaging. Image qualityimprovements and dose reduction depend on the clinical task, patient size,anatomical location, and clinical practice.
iBrain/head filters	Brain/head reconstruction filters have been cleared on the IQon Spectral CTsubmission K133674. They work to improve Low Contrast Detectability byimproving the Contrast to Noise Ratio (CNR) in brain images. The filtersincrease the contrast of white matter vs. gray matter resulting in better whitematter/gray matter separation in brain scans.
Orthopedic Metal ArtifactReduction (O-MAR)	O-MAR stands for orthopedic metal artifact reduction. This post processingcapability reduces metal induced artifacts and is directed for large orthopedicsmetals that cause photon starvation of the rays that pass through the metalobject. Comparable to the MX 16-slice feature, K091195.
Advanced BrainPerfusion	This application was cleared under Brain Perfusion Option K033677 for use onthe Philips Brilliance Workspace of a CT system. This Philips BrillianceWorkspace is currently being used on the Philips Ingenuity CT.
Advanced VesselAnalysis (AVA)Comprehensive CardiacAnalysis (CCA)	These features were cleared under Brilliance CT, Private Practice CVConfiguration CT Scanner K042293. The Philips Ingenuity CT and the BrillianceCT, Private Practice have the same CT functionality and both are using thesame predicate device, the Philips Plus CT K033326. This feature functions thesame on the Philips Ingenuity CT as it does on the Brilliance CT, PrivatePractice.

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PHILIPS

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Substantial Primary Predicate Device: Philips Plus CT System Equivalence: Manufacturer: Philips Healthcare Predicate Device k#: K033326

The design, intended use and technology provided with the proposed Philips Ingenuity CT is identical to the predicate device Philips Plus CT System.

Substantial Equivalence Comparison Table 5-2
	PrimaryPredicate DevicePhilips Plus CTScanner(K033326)	Proposed PhilipsIngenuity CT(Ingenuity CT,Ingenuity Core,Ingenuity Core128)	Comments
	Design/Fundamental Scientific Technology
Application	Head/Body	Head/Body	Identical
Scan Regime	Continuous Rotation	Continuous Rotation	Identical
No. of Slices	40	Ingenuity CTConfigurations:Ingenuity CT - 128Ingenuity Core - 64Ingenuity Core128 - 128	The move to 64 slices was theaddition of physical detectorsincreasing the total number ofslices to 64.With a reconstruction processand reduction in ("windmill")artifacts, 128 slices can beachieved from the 64 detectors.Neither of these changes affectsafety and effectiveness.
Scan Modes	SurviewAxial ScanHelical Scan	SurviewAxial ScanHelical Scan	Identical
Minimum Scan Time	0.42 sec for 360°rotation	0.42 sec for 360°rotation	Identical
Image (SpatialResolution)	24 lp/cm/max.	24 lp/cm/max.	Identical
Image Noise	0.27% at 120 kV,250 mAs, 10 mmslice thickness	0.27% at 120 kV, 250mAs, 10 mm slicethickness	Identical
Image Matrix	Up to 1024 x 1024	Up to 1024 x 1024	Identical
Display	1024 x 1280	1024 x 1280	Identical
Host Infrastructure	Windows XP	Windows 7	Identical, Windows basedcomputer running iPatientsystem software, does not affectsafety and effectiveness.
Focal Spot	Dynamic Focal Spot	Dynamic Focal Spotin X axis	Identical
Power (kW Output)	60 kW	80 kW	Generator is FDA class I,510(k) exempt, no change infunctionality, physically thesame. This change does notaffect safety and effectiveness.
Substantial Equivalence Comparison Table 5-2
	Primary PredicateDevicePhilips Plus CTScanner(K033326)	Proposed PhilipsIngenuity CT(Ingenuity CT,Ingenuity Core,128Ingenuity Core)	Comments
Design/Fundamental Scientific Technology
mA Range	30-500mA	20-665mA	The impact of increasing thetube power is an extendedmA range, difference inrange does not affect safetyand effectiveness.
kV Settings	80, 120, 140	80, 100, 120, 140	Provides another setting thatmay be useful in standardscanning, does not affectsafety and effectiveness.
Tube Type	MRC 800	MRC Ice Tube (880)	Identical tube technology, thetwo tubes share the sameanode, cathode, bearing,anode drive, and electricalinterfaces, but differ inhousing, does not affectsafety and effectiveness.
Scan Field of View	Up to 500 mm	Up to 500 mm	Identical
Detector Type	Single layer ceramicscintillator plus aphotodiode	Single layer ceramicscintillator plus aphotodiode	Identical
Gantry Tilt	$\pm 30^\circ$	$\pm 30^\circ$	Identical
Gantry Rotation Speed	143 RPM	143 RPM	Identical
Bore Size	700 mm	700 mm	Identical

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Summary of Non-Clinical Testing:

This 510(k) premarket notification contains technical documentation, which demonstrates that the proposed Philips Ingenuity CT is substantially equivalent to the predicate device, Philips Plus CT System in terms of safety and effectiveness. Testing was performed on the proposed Philips Ingenuity CT according to the following international and FDA recognized consensus standards and FDA guidance documents:

· IEC 60601-1:2006 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-1-3 Ed 2.0:2008 Medical electrical equipment Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic X-ray equipment
· IEC 60601-1-6:2010 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
· IEC 60601-2-44:2009 Medical electrical equipment Part 2-44: Particular requirements for the safety of X-ray equipment
IEC 62304:2006 First Edition Medical device software Software life cycle processes
ISO 14971 Medical devices Application of risk management to medical devices (Ed. 2.0, 2007)
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).

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The completed bench test protocols included the above IEC standard requirements in addition to other requirements found in the main system level software requirements of the System Requirements Specification and the Subsystem Requirement Specifications as well as the identified hazard mitigations from the Safety Risk Management Report. 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.

Some of the bench tests included patient support/gantry positioning repeatability and accuracy. laser alignment accuracy, CT image quality metrics testing including CT number accuracy and uniformity within each slice for body and head. MTF. noise reduction performance of iDose*, slice thickness, slice sensitivity profiles and radiation metrics. Sample phantom images were provided to show the performance of the system in presence of implants, also when using a uniform phantom and a phantom with embedded test objects.

Software Documentation for a Moderate Level of Concern, per the FDA quidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

All verification tests were executed and passed the specified requirements, which validate that the Conclusion: subject device, Philips Ingenuity CT is substantially equivalent to the predicate device, Philips Plus CT Scanner, with regards to system performance.

Summary

of Clinical The completed validation test plan identified the tasks, deliverables, methodology, requirements Testing: and the resources for validation of the intended use and meets customer needs.

The validation testing covered clinical validation, serviceability validation, manufacturing validation and validation by analysis. The clinical validation covered requirements related to clinical workflows and features. The serviceability validation covered requirements related to upgrade, installation, servicing and troubleshooting of the system. The manufacturing validation covered requirements related to operations and manufacturing and the validation by analysis covered all other requirements that affect the end user that were not covered by the above testing.

The validation test plan was executed as planned and acceptance criteria met for each requirement. All defects were managed and closed. All validation tests demonstrate the safety and effectiveness of the Philips Inqenuity CT in its performance as a CT system. The results of this validation testing are available in the Final Validation Report.

An image evaluation was performed to compare images of the brain, chest, abdomen and pelvis/peripheral orthopedic body areas that were reconstructed using either FBP or an iterative reconstruction technique (iDose4). Images were compared using a 5 point Likert scale by a qualified radiologist to determine if the images were of diagnostic quality. Results indicated that there was no difference in image quality observed between the images reconstructed with iDose4 compared to FBP reconstruction, with images reconstructed using iDose4 scoring higher in most cases. Therefore there was no impact on diagnostic performance and images using iDose4 which is provided on the Phillips Ingenuity CT are of diagnostic quality and equivalent to FBP reconstructed images provided on the predicate system.

The proposed Philips Ingenuity CT can be used as defined in its clinical workflow and intended use.

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Overall

Based on the conformance to standards, development under Philips Medical System's quality Conclusion: system, the successful verification testing, additional engineering testing, and the clinical evaluation, Philips Medical Systems believes that the Philips Ingenuity CT is substantially equivalent to the predicate device Philips Plus CT Scanner (K033326). The proposed Philips Ingenuity CT is as safe and effective as the currently marketed and predicate device, Philips Plus CT Scanner, without raising any new safety and/or effectiveness concerns.

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.