The Philips iCT CT System 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 equipments and accessories. The iCT 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 iCT is currently available in two system configurations, iCT and iCT SP. Identical to the predicate, the Philips iCT CT System produces cross-sectional images of the body head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips iCT have the same fundamental design characteristics and are based on comparable technologies as the predicate.

The main system modules and functionalities are:

Gantry. The Gantry has an aperture of 700mm and consists of the following internal units:
a. Stator a fixed mechanical frame that carries hardware and software.
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. The generator has a power rating of 100kW with optional 120kW.
d. Data Measurement System (DMS) a detectors array, fixed to the rotor frame. The DMS provides 8cm of coverage (4cm for the iCT SP configuration) and up to 256 slices (128 slices for the iCT SP configuration).The gantry offers 0.3 second rotation time (with optional 0.27s rotation).
Patient Table (aka Couch or Support) carries the patient in and out through the Gantry bore synchronized with the scan. There are three available patient supports:
a. Standard Table provides maximum scannable range of 1750mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 450 lbs.(204kg)
b. Bariatric Table provides maximum scannable range of 1750mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 650 lbs.(295kg)
c. Extended Table provides maximum scannable range of 2100mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 450 lbs.(204kg)
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.
Monitors
Software features to view and analyze images.

AI/ML Overview

This document is a 510(k) premarket notification for the Philips iCT CT System, which is a Computed Tomography X-Ray System. The document details the device's indications for use, description, and a comparison with a predicate device (Philips Brilliance Volume) to establish substantial equivalence.

Based on the provided text, the Philips iCT CT System is a Computed Tomography (CT) X-Ray System. The document outlines that the system is intended to produce images of the head and body by computer reconstruction of x-ray transmission data. It also explicitly states its indication for "low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer."

Regarding acceptance criteria and the study proving the device meets these criteria:

The document focuses on demonstrating substantial equivalence to a predicate device (Philips Brilliance Volume) rather than presenting a performance study with explicit acceptance criteria for a novel AI/ML-driven diagnostic device. This means the 510(k) submission primarily relies on comparing the design, technology, and specified performance parameters of the new device to an already legally marketed device, and showing that any differences do not raise new questions of safety or effectiveness.

Therefore, many of the requested elements for an AI/ML diagnostic device study (like sample size for test sets, expert adjudication, MRMC studies, standalone performance with specific metrics like sensitivity/specificity, or ground truth establishment for novel findings) are not detailed or applicable in the traditional sense for this 510(k) submission. This submission is for hardware (CT scanner) with associated software for image reconstruction, not primarily a sophisticated AI/ML diagnostic algorithm operating on those images for making clinical decisions beyond image acquisition and display.

Here's an attempt to address the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) for a CT system demonstrating substantial equivalence, the "acceptance criteria" are implicitly met by showing that the proposed device's characteristics are either identical to or comparable to the predicate device, and any changes do not adversely affect safety or effectiveness. The document presents a comparative table, not a table of specific numerical performance acceptance criteria for a diagnostic algorithm.

Characteristic – Components/Specifications	Predicate: Brilliance Volume (K060937) Reported Performance	Proposed: Philips iCT Reported Performance	Comments / "Acceptance Met" Justification
Indications for Use	Standard diagnostic imaging.	Diagnostic imaging, plus low dose CT lung cancer screening for early detection of lung nodules.	Modified to add lung cancer screening, with reference to clinical literature for evidence. This is a functional expansion, implicitly accepted by stating safety/effectiveness is maintained.
Gantry Aperture (Bore) size	700 mm	700 mm	No change; meets predicate's spec.
Gantry tilt	±30°	0°	The iCT Gantry does not have the tilt feature. This change does not affect safety or effectiveness. (Implicitly "accepted" because it's deemed not to compromise safety/effectiveness).
Rotation times	0.3, 0.33, 0.375, 0.4, 0.5, 0.75, 1.0, 1.5 seconds for full 360° scans; 0.2 for partial angle 240° scans. (Optional - 0.27 seconds for full 360° scans; 0.18 seconds for partial angle 240° scans)	Identical to predicate.	No change; meets predicate's spec.
Patient Table Scan Range	1600 mm	Standard: 1750 mm; Bariatric: 1750 mm; Long: 2100 mm	Increased scannable range. Stated to "not affect safety or effectiveness." (Implicitly "accepted" as an improvement without new risks).
Table Z-position accuracy	+/- 0.25 mm	Standard: +/- 0.25 mm; Bariatric: +/- 0.25 mm; Long: +/- 0.25 mm	No change; meets predicate's spec.
Table longitudinal speed	0.5 – 143 mm/sec	Standard: 0.5 - 185 mm/sec; Bariatric: 0.5 - 185 mm/sec; Long: 0.5 – 185 mm/sec	Slight increase in longitudinal speed. Stated to "not affect safety or effectiveness." (Implicitly "accepted").
Table maximum load capacity	Standard: 450 lbs. (204kg); Bariatric: 650 lbs. (405kg)	Standard: 450 lbs. (204kg); Bariatric: 650 lbs. (405kg); Long: 450 lbs. (204kg)	No change (for existing tables). Addition of "Long" table with same load for its type. Meets predicate's specs.
Generator power rating	100kW (120kW optional)	100kW (120kW optional)	No change; meets predicate's spec.
kVp settings	80, 100, 120, 140	80, 100, 120, 140	No change; meets predicate's spec.
mA range (step size)	10-830 (1mA steps), optional 10-1,000	10-830 (1mA steps), optional 10-1,000	No change; meets predicate's spec.
Focal spot size	small 0.6 x 0.7; large 1.1 x 1.2	small 0.6 x 0.7; large 1.1 x 1.2	No change; meets predicate's spec.
Anode effective heat capacity	30 MHU	30 MHU	No change; meets predicate's spec.
X-Ray power supply	High-Frequency up to 120 kW, 10-1000 mA, 80-140 kV	High-Frequency up to 120 kW, 10-1000 mA, 80-140 kV	No change; meets predicate's spec.
Detectors	NanoPanel: Ceramic scintillator + Photodiode 86016 elements - up to 128 slices simultaneously	iCT - same, but now with 256 slices; iCT SP - 43008 photodiode elements for 128 slices	Material is the same as predicate. Slice increase is possible with X-ray tube function (implicitly "accepted" as an enhancement not affecting safety).
Maximum Slices	128	iCT configuration: 256; iCT SP configuration: 128	Slice increase is possible with the capability of the x-ray tube function. (Implicitly "accepted").
Scan field	500 mm maximum	50 - 500 mm continuous; 25 - 250mm ultra-high resolution (UHR)	Same, with added UHR. (Implicitly "accepted" as an enhancement).
Console computer	PC/XP computer based on Intel processors and custom Multiprocessor Array	Windows 7 based on Intel processors and customer Multiprocessor Array.	Change to Windows 7 based operating system does not affect safety or effectiveness. (Implicitly "accepted").
Image matrix	512x512, 768x768, 1024x1024	512x512, 768x768, 1024x1024	No change; meets predicate's spec.

2. Sample size used for the test set and the data provenance:

The document mentions "Design Verification planning and testing was conducted at the sub-system and at the system level." It also states "Design validation of user needs and intended use was conducted via simulated use testing with production equivalent Philips iCT CT Systems."

Test Set Sample Size: Not specified in terms of patient data or clinical cases for diagnostic performance. The document refers to "system and sub-system level verification" and "simulated use testing." This suggests engineering and functional testing rather than a large-scale clinical performance study on a specific number of patient scans.
Data Provenance: Not specified. Given it's a Philips product for a global market, the data provenance for engineering/simulated testing is likely internal R&D, not necessarily specific patient data sets from particular countries. "Retrospective or prospective" is not applicable in the context of hardware/software functional testing described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This 510(k) is not for an AI/ML diagnostic algorithm that requires expert-established ground truth on clinical images for its performance evaluation. The "ground truth" for a CT system's performance in this context would be its physical specifications, image quality metrics (like spatial resolution, contrast resolution, noise), and safety parameters (radiation dose). These are typically verified against engineering specifications, phantoms, and regulatory standards, not clinical ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical image or diagnostic performance adjudication is described.

5. 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:

Not applicable. This submission is for a CT hardware system, not an AI-assisted diagnostic tool that integrates with human readers. The "low dose CT lung cancer screening" indication refers to the capability of the scanner, and refers to existing clinical literature (National Lung Screening Trial) as evidence for the efficacy of low-dose CT screening in general, not specific AI augmentation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable for a diagnostic algorithm. The device, the Philips iCT CT System, is the standalone imaging system for image acquisition and reconstruction. Its performance is evaluated against engineering specifications and industry standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's technical performance (e.g., image quality, scan range, rotation times) would be established by:

Engineering specifications: The designed parameters of the CT system components.
Physical phantoms: Standardized objects used to measure image quality characteristics (e.g., spatial resolution, contrast-to-noise ratio, slice thickness accuracy).
Calibration procedures: Ensuring the system's measurements are accurate.
Compliance with international standards: (e.g., IEC 60601 series for medical electrical equipment safety and performance).

For the lung cancer screening indication, the document refers to "clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature." This means the ground truth for the clinical utility of low-dose CT screening, in general, is based on outcomes data from large clinical trials. The device's "acceptance" for this indication is based on its capability to perform scans at low dose within established protocols, implying it meets the technical requirements to participate in such screening programs.

8. The sample size for the training set:

Not applicable. This is not for a machine learning model that requires a "training set" of clinical data in the typical sense.

9. How the ground truth for the training set was established:

Not applicable. No machine learning training set is described.

In summary: This 510(k) document is a regulatory submission for a general-purpose CT scanner. Its "acceptance criteria" and "proof" primarily revolve around demonstrating that its technical specifications, design, and functionality are substantially equivalent to a previously cleared predicate device, and that any modifications (like extended scan range, increased slices, or removal of gantry tilt) do not compromise safety or effectiveness. The inclusion of "low dose CT lung cancer screening" as an indication relies on the device's ability to perform scans compatible with established clinical guidelines, rather than presenting novel AI performance data for nodule detection or characterization.

Summary

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

April 7, 2017

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

Re: K162838

Trade/Device Name: Philips iCT CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 7, 2017 Received: March 9, 2017

Dear Ms. Anderson:

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. O'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) K162838

Device Name Philips iCT CT System

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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Philips Medical Systems (Cleveland) Inc.

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510(k) Summary of Safety and Effectiveness [As required by 21 CFR 807.92(c)]

Applicant's Name:	Philips Medical Systems (Cleveland), Inc.
Address:	595 Miner RoadCleveland, OH 44143 USA
Contact Person:	Christine Anderson
Title:	Regulatory Affairs Specialist
Address:	595 Miner RoadCleveland, OH 44143 USA
Telephone number:	+1 440 483-7732
Fax number:	+1 440 483-4918
E-mail:	Christine.anderson@philips.com
510(k) Summary Dateof Preparation:	07-Mar-2017
Device Trade Name:	Philips iCT CT System
Common or UsualName:	Computed Tomography X-Ray System
	Classification
Name:	Computed Tomography X-Ray System
Regulation:	21 CFR 892.1750
Class:	II
Product Code:	JAK
Panel:	Radiology
Predicate Device:	K060937 – Philips Brilliance Volume

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Philips Medical Systems (Cleveland) Inc.

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Indications for Use:

The Philips iCT CT System 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 iCT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

*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 main system modules and functionalities are:

1. Gantry. The Gantry has an aperture of 700mm and consists of the following internal units:
- a. Stator a fixed mechanical frame that carries hardware and software.
- 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. The generator has a power rating of 100kW with optional 120kW.
- d. Data Measurement System (DMS) a detectors array, fixed to the rotor frame. The DMS provides 8cm of coverage (4cm for the iCT SP configuration) and up to 256 slices (128 slices for the iCT SP configuration).The gantry offers 0.3 second rotation time (with optional 0.27s rotation).

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1. Patient Table (aka Couch or Support) carries the patient in and out through the Gantry bore synchronized with the scan. There are three available patient supports:
- a. Standard Table provides maximum scannable range of 1750mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 450 lbs.(204kg)
- b. Bariatric Table provides maximum scannable range of 1750mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 650 lbs.(295kg)
- c. Extended Table provides maximum scannable range of 2100mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 450 lbs.(204kg)
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.
1. Monitors
1. Software features to view and analyze images.

Substantial Equivalence:

Philips is citing substantial equivalence of the Philips iCT CT System to the Philips Brilliance Volume. The regulatory citations for the Brilliance Volume are listed below: Predicate Device: Brilliance Volume Predicate 510(k): K060937 Regulation: 21 CFR 892.1750 Class: II Product Code: JAK Panel: Radiology Manufacturer: Philips Medical Systems (Cleveland), Inc.

The design, intended use and technology provided with the proposed Philips iCT CT System is equivalent to the currently marketed predicate.

Characteristics –Components/specifications	Predicate: BrillianceVolume(K060937)	Proposed: PhilipsiCT	Comments
Indications for Use	The "BrillianceVolume" is aComputedTomography X-RaySystem intended toproduce cross-sectional images ofthe body by computerreconstruction of x-raytransmission datataken at different	The iCT is a ComputedTomography X-RaySystem intended toproduce images of thehead and body bycomputerreconstruction of x-raytransmission datataken at differentangles and planes.These devices may	Indications for Useupdated forproposed iCT toadd reference topatients of all agesand low dose CTlung cancerscreening(K153444). Thepredicate CT wasalso indicated for
Characteristics –Components/specifications	Predicate: BrillianceVolume(K060937)	Proposed: PhilipsiCT	Comments
	angles and planes.This device mayinclude signal analysisand displayequipment, patient,and equipmentsupports, componentsand accessories.	include signal analysisand display equipment,patient and equipmentsupports, componentsand accessories. TheiCT is indicated forhead, whole body,cardiac and vascularX-ray ComputedTomographyapplications in patientsof all ages.	patient of all ages,but it was notspecifically statedin the indications.
		These scanners areintended to be used fordiagnostic imaging andfor low dose CT lungcancer screening forthe early detection oflung nodules that mayrepresent cancer*.The screening must beperformed within theestablished inclusioncriteria of programs /protocols that havebeen approved andpublished by either agovernmental body orprofessional medicalsociety.
		*Please refer to clinicalliterature, including theresults of the NationalLung Screening Trial(N Engl J Med 2011;365:395-409) andsubsequent literature,for further information.
Design/Fundamental Scientific Technology
Application	Head/Body	Head/Body	No change
Scan regime	Continuous Rotation	Continuous Rotation	No change
Scan Modes	Surview	Surview	No change
	Spiral (helical)Axial	HelicalAxial
Gantry
Gantry Aperture (Bore) size	700 mm	700 mm	No change
Characteristics –Components/specifications	Predicate: BrillianceVolume(K060937)	Proposed: PhilipsiCT	Comments
Gantry tilt	±30°	0°	The iCT Gantrydoes not have thetilt feature. Thischange does notaffect safety oreffectiveness.
Focus-isocenter distance	570 mm	570 mm	No change
Focus-detector distance	1040mm	1040mm	No change
Rotation times	0.3, 0.33, 0.375, 0.4,0.5, 0.75, 1.0, 1.5seconds for full 360°scans; 0.2 for partialangle 240°scans.(Optional - 0.27seconds for full 360°scans; 0.18 secondsfor partial angle 240°scans)	0.3, 0.33, 0.375, 0.4,0.5, 0.75, 1.0, 1.5seconds for full 360°scans; 0.2 for partialangle 240°scans.(Optional - 0.27seconds for full 360°scans; 0.18 secondsfor partial angle 240°scans)	No change
	Patient Support/Couch/Table
Patient Supports	StandardBariatric	StandardBariatricExtended (aka Long)	The predicatedevice releasedwith two tableoptions. The long,or extended, tablewas added to theCT System. Theextended tableallows for run offstudies and doesnot affect safety oreffectiveness.
Patient table scan range	1600 mm	Standard: 1750 mmBariatric: 1750 mmLong: 2100 mm	The scannablerange increasedfor the standardand bariatricpatient supports. Itdoes not affectsafety oreffectiveness.
Table Z-position accuracy	+/- 0.25 mm	Standard: +/- 0.25 mmBariatric: +/- 0.25 mmLong: +/- 0.25 mm	No change
Table longitudinal speed	0.5 – 143 mm/sec	Standard: 0.5 - 185mm/secBariatric: 0.5 - 185mm/secLong: 0.5 – 185mm/sec	Slight increase inlongitudinal speed.lt does not affectsafety oreffectiveness
Characteristics –Components/specifications	Predicate: BrillianceVolume(K060937)	Proposed: PhilipsICT	Comments
Table maximum load capacity	Standard: 450 lbs.(204kg)Bariatric: 650 lbs.(405kg)	Standard: 450 lbs.(204kg)Bariatric: 650 lbs.(405kg)Long: 450 lbs. (204kg)	No change
Generator power rating	100kW (120kWoptional)	100kW (120kWoptional)	No change
kVp settings	80, 100, 120, 140	80, 100, 120, 140	No change
mA range (step size)	10-830 (1mA steps),optional 10-1,000)	10-830 (1mA steps),optional 10-1,000)	No change
Focal spot size	small 0.6 x 0.7; large1.1 x 1.2	small 0.6 x 0.7; large1.1 x 1.2	No change
Anode effective heat capacity	30 MHU	30 MHU	No change
X-Ray tube, max. appliedpower	Dynamic Focal Spot inX and Z (2), up to120kW, (8)	Dynamic Focal Spot inX and Z (2), up to120kW, (8)	No change
X-Ray power supply	High-Frequencyup to 120 kW, 10-1000mA, 80-140 kV	High-Frequencyup to 120 kW, 10-1000mA, 80-140 kV	No change
Detectors	NanoPanel: Ceramicscintillator+Photodiode 86016elements - up to 128slices simultaneously	iCT - same, but nowwith 256 slicesiCT SP - 43008photodiode elementsfor 128 slices	The material is thesame as thepredicate.
Slices	Brilliance Volume: 128	iCT configuration: 256iCT SP configuration:128	Slice increase ispossible with thecapability of the x-ray tube function.
Coverage	Brilliance Volume: 8cm	iCT configuration: 8 cmiCT SP configuration: 4cm	The iCT SPconfiguration has a4 cm detector. Itdoes not affectsafety oreffectiveness ascompared to thepredicate.
Collimations available	128 x 0.625 mm64 x 0.625 mm32 x 1.25 mm16 x 2.5 mm2 x 0.5 mm	iCT configuration:128 x 0.625 mm112 x 0.625 mm96 x 0.625 mm64 x 0.625 mm32 x 0.625 mm20 x 0.625 mm16 x 0.625 mm8 x 0.625 mm4 x 0.625 mm2 x 0.625 mm	The collimationsidentified for theproposed iCT andiCT SP areclarifications of theavailablecollimations andneeded by theuser.
Characteristics -Components/specifications	Predicate: BrillianceVolume(K060937)	Proposed: PhilipsiCT	Comments
		64 x 1.25 mm32 x 1.25 mmiCT SP configuration:64 x 0.625 mm32 x 0.625 mm20 x 0.625 mm16 x 0.625 mm8 x 0.625 mm4 x 0.625 mm2 x 0.625 mm64 x 1.25 mm32 x 1.25 mm
Slice Thickness	Helical mode 0.67 –7.5 mmAxial mode 0.5 – 12mmAxial or helical? 0.5,0.625, 1.25, 2.5mmand variouscombinations up to4x10mm	Helical mode 0.67mm– 10 mmAxial mode 0.625 mm– 10 mm	The slicethicknessesprovided areclarifications of theoriginalspecifications.
Scan field	500 mm maximum	50 -500 mmcontinuous25 - 250mm ultra-highresolution (UHR)	These are thesame. The ultra-high resolution wasnot identified in thepredicate 510(k)
Console computer (Common Host) and Common Image Reconstruction System (CIRS)
Computer and CIRS(Common ImageReconstruction System)	PC/XP computerbased on Intelprocessors andcustom MultiprocessorArray	Windows 7 based onIntel processors andcustomerMultiprocessor Array.	The change to aWindows 7 basedoperating systemdoes not affectsafety oreffectiveness.
Image matrix	5122, 7682, 10242	5122, 7682, 10242	No change

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Summary of Non-Clinical Testing:

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 Requirement Specifications (SSRSs) and the system level verification is conducted against the System Requirement Specification (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.

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Testing was performed on the proposed Philips iCT CT System according to the following international and FDA recognized consensus standards and FDA quidance documents:

IEC 60601-1:2005+A1:2012 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 44: Particular requirements for the safety of X-ray equipment
IEC 62304:2006 First edition medical device software - Software life cycle processes
. IEC 62366:2014 ED1.1 Medical devices -- Part 1: Application of usability engineering to medical devices
ISO 14971:2007 Medical devices Application of risk management to medical . devices

Design validation of user needs and intended use was conducted via simulated use testing with production equivalent Philips iCT CT Systems. Validation testing included clinical workflow validation, service validation, and manufacturing validation.

Conclusion: Traceability from requirements to test results confirmed, for both design verification and design validation, that design requirements were met. The Philips iCT CT System meets system design requirements and user needs and intended use.

Summary of Clinical Testing:

The proposed Philips iCT System did not require any external clinical site testing. 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.

Conclusion:

It is the conclusion of Philips that the proposed Philips iCT CT System is substantially equivalent to the predicate, Brilliance Volume. There are no significant differences that raise new issues of safety or effectiveness. The proposed Philips iCT CT and the

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predicate produce images of the head and body by computer reconstruction of x-ray transmission data. As provided in the table above, design and fundamental technology, and subsystems such as the patient supports, generator, x-ray tube and detector of the proposed iCT CT System are either identical to the predicate or have minor changes that do not affect safety and effectiveness. Verification and validation testing, risk management activities and conformance to international standards demonstrate the safety and effectiveness of the proposed Philips iCT CT System. The comparison of the proposed Philips iCT CT System in regards to design and technology as well as successful completion of verification, validation and risk management activities demonstrate that the proposed Philips iCT CT System is as safe and effective as the predicate device.

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.