The Philips CT Big Bore 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. These systems are indicated for head and whole body X-ray Computed Tomography applications in oncology, vascular and cardiology, for 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 CT Big Bore is available in three system configurations, the Oncology configuration the Radiology (Base) configuration, and the new Sliding Gantry configuration.

The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips CT Big Bore 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 detector array, fixed to the Rotor frame
1. Patient Support (Couch) supports the patient in a stationary position while the gantry moves in and out on a carriage.
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 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.

The Sliding Gantry Configuration provides the following features.

. The patient table is stationary during the scan.
. Patient is located on the stationary table.
To perform imaging, CT gantry rides on a carriage and moves over the patient.

AI/ML Overview

The Philips CT Big Bore Sliding Gantry Configuration is a Computed Tomography X-Ray System. The device has undergone non-clinical testing to demonstrate its substantial equivalence to the primary predicate device, Philips CT Big Bore (K171850).

1. Acceptance Criteria and Reported Device Performance

CT Performance Metric	Acceptance Criteria (from predicate Philips CT Big Bore)	Reported Device Performance (Philips CT Big Bore Sliding Gantry Configuration)
MTF	Not explicitly stated, implied to be identical to predicate	Cut-off: High Mode 16±2lp/cm; Standard Mode: 13±2 lp/cm
CTDIvol	Not explicitly stated, implied to be identical to predicate	Head: 10.61mGy/100mAs±25%; Body: 5.92mGy/100mAs±25% at 120kV
CT number accuracy	Not explicitly stated, implied to be identical to predicate	Water: 0±4HU
Noise	Not explicitly stated, implied to be identical to predicate	0.27% ± 0.04% at 120 kV, 250 mAs, 12 mm slice thickness, UA filter
Slice Thickness	Not explicitly stated, implied to be identical to predicate	0.5mm - 1.5mm at nominal 0.75mm; 1.0mm - 2.0mm at nominal 1.5mm

The document states that the validation test plan was executed as planned and acceptance criteria were met for each requirement. The "Values and ranges measured on phantoms" for the Philips CT Big Bore Sliding Gantry Configuration implies these were the performance metrics observed and deemed acceptable.

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

The testing involved phantom studies for basic CT performance tests. The document does not specify an exact "sample size" in terms of number of phantoms or scans. The data provenance is through bench testing of the device against international and FDA recognized consensus standards and FDA regulations and guidance documents. This is a non-clinical study.

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

This information is not applicable as the study was non-clinical bench testing using phantoms, not a study involving human experts establishing ground truth for diagnostic imaging.

4. Adjudication method for the test set

Not applicable as no human adjudication was performed; the study involved objective measurements of physical phantom properties.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "The proposed Philips CT Big Bore Sliding Gantry Configuration did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."

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

The device is a Computed Tomography X-Ray System, not an AI algorithm. The performance evaluation was of the system itself (hardware and embedded software) in producing images based on defined physical metrics. Therefore, this can be considered a "standalone" evaluation of the system's technical performance.

7. The type of ground truth used

The ground truth was based on objective physical measurements from phantoms as per established CT performance testing standards. For example, for CT number accuracy, the ground truth for water is 0 HU.

8. The sample size for the training set

Not applicable. This device is a CT imaging system and not an AI algorithm that typically requires a training set. The performance evaluation was based on non-clinical verification and validation testing against engineering requirements and established standards.

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

Not applicable. As stated above, this device is a CT imaging system and does not involve a training set that requires ground truth establishment in the context of machine learning.

Summary

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August 3, 2018

Philips Medical Systems (Cleveland) Inc. % Michael Chilbert, Ph.D., P.E. Regulatory Affairs Engineer 595 Miner Road CLEVELAND OH 44143

Re: K181797

Trade/Device Name: Philips CT Big Bore Sliding Gantry Configuration Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 22, 2018 Received: July 5, 2018

Dear Dr. Chilbert:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Hole 2. Nils

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) K181797

Device Name

Philips CT Big Bore Sliding Gantry Configuration

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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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:	Michael Chilbert, Ph.D., P.E.Regulatory Affairs Engineer595 Miner RoadCleveland, OH44143 USA
Telephone number:E-mail:	+1 440 869-4576michael.chilbert@philips.com
510(k) Summary Date ofPreparation:	15-June-2018
Device Trade Name:	Philips CT Big Bore Sliding Gantry Configuration
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	K171850 - Phillips CT Big Bore
ClassificationName:Regulation:Class:Product Code:Panel:	Computed Tomography X-ray system21 CFR 892.1750IIJAKRadiology

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Indications for Use

The Philips CT Big Bore Sliding Gantry Configuration 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. These systems are indicated for head and whole body X-ray Computed Tomography applications in oncology, vascular and cardiology, for 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 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.

Intended Use:

The Philips CT Big Bore Sliding Gantry Configuration is a Computed Tomography X-Ray System intended to produce images of the head and body to be used for diagnostic imaging in radiology and in oncology as part of treatment preparation and radiation therapy planning. These systems are indicated for head and whole body X-ray Computed Tomography applications in patients of all ages and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*.

Device Description:

The Philips CT Big Bore is available in three system configurations, the Oncology configuration the Radiology (Base) configuration, and the new Sliding Gantry configuration.

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 detector array, fixed to the Rotor frame
1. Patient Support (Couch) supports the patient in a stationary position while the gantry moves in and out on a carriage.
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

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The Sliding Gantry Configuration provides the following features.

. The patient table is stationary during the scan.
. Patient is located on the stationary table.
To perform imaging, CT gantry rides on a carriage and moves over the patient.

Substantial Equivalence:

Primary Predicate Device: Phillips CT Big Bore Manufacturer: Philips Medical Systems (Cleveland), Inc. Predicate Device k#: K171850

The design, intended use and technology provided with the proposed Philips CT Big Bore Sliding Gantry Configuration is identical to the predicate device, Phillips CT Big Bore, and therefore is considered substantially equivalent.

Table 5-2: Substantial Equivalence ComparisonComparison of the primary predicate device, Phillips CT Big Bore (K171850)versus the proposed Philips CT Big Bore Sliding Gantry Configuration
Feature	Philips CT BigBore	ProposedPhilips CTBig Bore SlidingGantry Configuration	Comments
Gantry (Stator,Rotor, X-Ray Tubeand Generator,Data MeasurementSystem)	No change	No change	Identical
Software	No change	No change	Identical
Patient Support	Couch slideshorizontally, Gantryis stationary	Couch is stationary inthe horizontal axis,Gantry slideshorizontally	See table 10.1 for details. Thisoperational change does notintroduce new hazards and has noeffect on the safety or effectivenessof the device.
Console	No change	No change	Identical
EnvironmentalRequirements	No change	No change	Identical
Table 5-2: Substantial Equivalence ComparisonComparison of the primary predicate device, Phillips CT Big Bore (K171850)versus the proposed Philips CT Big Bore Sliding Gantry Configuration
Feature	Philips CT BigBore	ProposedPhilips CTBig Bore SlidingGantry Configuration	Comments
HorizontalMovements,minimumincrements	No change	No change	identical
Horizontal positionprecision planning	No change	No change	identical
Horizontal positionrepeatability	No change	No change	identical
Horizontal speed	Maximum Speed =185 mm/secMinimum Speed =0.5 mm/sec	Maximum Speed = 150mm/secMinimum Speed = 1mm/sec	Clinical scans on Big Bore scanneruse speeds in the range of 1mm/secto 60mm/sec, thus there is no impactto these differences.
Horizontal (Linear)movement whenemergency stop isactuated	No change	No change	Identical
Horizontalobstructiondetection	Couch stopshorizontal motionwhen obstructed.	Gantry stops horizontalmotion when obstructed.	The operational change does notintroduce new hazards.
Collision envelope	25 mm gaprequirement is met.Operator ismonitoring motion ofcouch in relation tothe gantry.	25 mm gap requirementis met. Operator ismonitoring the motion ofthe sliding gantry inrelation to the stationarycouch.	The operator is instructed to observethe patient position while performingthe scan, as in the case of thepredicate device. This operationalchange does not introduce newhazards.
Couch VerticalMovements	Controlled by CT(Gantry)	Patient support isprovided by a third partycouch, which operatesindependently.	This operational change does notintroduce new hazards and has noeffect on the safety or effectivenessof the device.

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Summary of Non-Clinical Testing:

This 510(k) premarket notification contains technical documentation, which demonstrates that the proposed Philips CT Big Bore Sliding Gantry Configuration is substantially equivalent to the primary predicate device, Phillips CT Big Bore in terms of safety and effectiveness. Testing was performed on the proposed Philips CT Big Bore Sliding Gantry Configuration according to the following international and FDA recognized consensus standards and FDA requlations and quidance documents:

. ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: Ed 3 2007-03, 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 2.1:2013-04 Medical electrical equipment -- Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic Xray equipment
IEC 60601-1-6: Ed 3.1 2013-10 Medical electrical equipment -- Part 1-6: General . requirements for basic safety and essential performance - Collateral standard: Usability
. IEC 60601-2-44:Ed 3.1 2012 Medical electrical equipment -- Part 2-44: Particular requirements for the safety of X-rav equipment
. ANSI AAMI IEC 62304:2006 First Edition Medical device software -- Software life cycle processes
IEC 62366 Ed 1.0 2015-02 Medical devices -- Part 1: Application of usability ● engineering to medical devices
ISO 14971 Medical devices Application of risk management to medical devices (Ed. . 2.0, 2007-03-01)
. 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).
. Pediatric Information for X-ray Imaging Device Premarket Notifications - Guidance for Industry and Food and Drug Administration Staff
Code of Federal Requlations Title 21, Subchapter J Radiological Health .

Bench testing included basic CT performance tests on phantoms, safety tests and software tests for functional and non-functional attributes of the proposed Philips CT Big Bore Sliding Gantry Configuration.

CT Performance Metric	Values and ranges measured on phantoms
MTF	Cut-off: High Mode 16±2lp/cm; Standard Mode: 13±2 lp/cm
CTDIvol	Head: 10.61mGy/100mAs±25%; Body: 5.92mGy/100mAs±25%at 120kV
CT number accuracy	Water: 0±4HU
Noise	0.27% ± 0.04% at 120 kV, 250 mAs, 12 mm slice thickness, UAfilter
Slice Thickness	0.5mm - 1.5mm at nominal 0.75mm; 1.0mm - 2.0mm at nominal1.5mm

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The completed verification test protocols cover the main system level 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. The detailed results are provided in the Full System Verification Test Report.

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

The validation testing includes clinical validation and serviceability validation. The clinical validation covered requirements related to clinical workflows and features. The serviceability validation is planned to cover requirements related to installation, servicing and troubleshooting of the systems, which will be performed at system installation.

The validation test plan was executed as planned and acceptance criteria met for each requirement. All deviations found were analyzed based on the defect management process and are being dispositioned per process.

Conclusion: All verification and validation tests were executed according to the Philips Big Bore Sliding Gantry Configuration System Design Verification and Validation Plans, All deviations found were analyzed based on the defect management process and are being dispositioned per process. No unacceptable deviation exist.

Summary of Clinical Performance Testing

The proposed Philips CT Big Bore Sliding Gantry Configuration did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing.

Conclusion:

The test results demonstrate that the proposed Philips CT Big Bore Sliding Gantry Configuration meets the acceptance criteria and is adequate for its intended use. Additionally, the risk management activities show that all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable.

Based on the supporting data provided in this Special 510(k) submission, the proposed Philips CT Big Bore Sliding Gantry Configuration is considered substantially equivalent to the primary predicate device, Philips CT Big Bore in terms of safety and effectiveness. There are no significant differences that may raise new issues of safety or effectiveness. Bench tests and user validation have been performed to demonstrate that the proposed Philips CT Big Bore Sliding Gantry Configuration is as safe and effective as the predicate Philips CT Big Bore, 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.