(141 days)
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.
The Philips CT Big Bore is currently available in two system configurations, the Oncology configuration and the Radiology (Base) 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:
- 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 - Patient Support (Couch) carries the patient in and out through the Gantry bore synchronized with the scan
- 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.
This document describes the Philips CT Big Bore, a Computed Tomography X-Ray System. The submission focuses on demonstrating substantial equivalence to a predicate device rather than a standalone clinical efficacy study with acceptance criteria in the typical sense of a diagnostic AI product. Therefore, much of the requested information regarding clinical studies and expert review for ground truth is not directly applicable in the same way.
However, based on the provided text, we can infer and extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are framed in terms of achieving similar or improved performance compared to the predicate device and meeting established industry standards for CT systems. The reported device performance is primarily a comparison to the predicate device's specifications and measurements on phantoms.
| Metric | Acceptance Criteria (Implicit: Similar to/Better than Predicate & Standards) | Reported Device Performance (Philips CT Big Bore / Tested Values) |
|---|---|---|
| Design/Fundamental Scientific Technology | ||
| Application | Head/Body (Identical to Predicate) | Head/Body |
| Scan Regime | Continuous Rotation (Identical to Predicate) | Continuous Rotation |
| No. of Slices | Up to 40 (Predicate) | 16/32 (with optional WARP/DAS for 32 slices) |
| Scan Modes | Surview, Axial Scan, Helical Scan (Identical to Predicate) | Surview, Axial Scan, Helical Scan |
| Minimum Scan Time | 0.42 sec for 360° rotation (Identical to Predicate) | 0.42 sec for 360° rotation |
| Image (Spatial) Resolution | 15 lp/cm max. (Predicate) | 16 lp/cm (±2 lp/cm) |
| Image Noise, Body, STD Res. | 10.7 at 16.25 mGy (Predicate) | 10.7 |
| Image Matrix | Up to 1024 x 1024 (Identical to Predicate) | Up to 1024 x 1024 |
| Display | 1024 x 1280 (Identical to Predicate) | 1024 x 1280 |
| Host Infrastructure | Windows XP (Predicate) | Windows 7 (Essentially the same, Windows based) |
| CIRS Infrastructure | PC/NT computer based on Intel processor & custom Multiprocessor Array (Predicate) | Windows Vista & custom Multiprocessor Array (Identical, Windows based) |
| Communication | Compliance with DICOM (Identical to Predicate) | Compliance with DICOM |
| Dose Reporting and Management | No (Predicate) | Compliance with MITA XR25 and XR29 |
| Generator and Tube Power | 60 kW (Predicate) | 80 kW (Software limited to 60kW) |
| mA Range | 30-500mA (Predicate) | 20-665mA (Software limited to 500mA) |
| kV Settings | 80, 120, 140 (Predicate) | 80, 100, 120, 140 |
| Focal Spot | Dynamic Focal Spot (Identical to Predicate) | Dynamic Focal Spot in X axis |
| Tube Type | MRC 800 (Predicate) | MRC Ice Tube (880) (Identical tube technology) |
| Detectors Type | 2.4 or 4 cm NanoPanel detector (Predicate) | 2.4 cm NanoPanel (Revision, slightly better performance stated) |
| Scan Field of View | Up to 600 mm (Identical to Predicate) | Up to 600 mm |
| Detector Type | Single layer ceramic scintillator plus photodiode array (Identical to Predicate) | Single layer ceramic scintillator plus photodiode array |
| Gantry Tilt | $\pm 30^0$ (Identical to Predicate) | $\pm 30^0$ |
| Gantry Rotation Speed | 143 RPM (Identical to Predicate) | 143 RPM |
| Bore Size | 850 mm (Identical to Predicate) | 850 mm |
| Low dose CT lung cancer screening | Yes (Predicate) | Yes (Configuration with Brilliance Big Bore cited in K153444) |
| Communication between injector and scanner | SAS (Spiral Auto Start) (Predicate) | SAS and SyncRight |
| DoseRight / Dose Management | Yes (K012238) (Predicate) | Yes and iDose4 |
| Dose Modulation | D-DOM and Z-DOM (Predicate) | D-DOM (Angular DOM) and Z-DOM FDOM, 3D-DOM |
| Cone Beam Reconstruction Algorithm - COBRA | Yes (Identical to Predicate) | Yes |
| Axial 2D Reconstruction | Yes (Identical to Predicate) | Yes |
| Lung Nodule Assessment | Yes (K023785) (Identical to Predicate) | Yes |
| ECG Signal Handling | Yes (Identical to Predicate) | Yes |
| Cardiac Reconstruction | Yes (Identical to Predicate) | Yes |
| Bolus Tracking | Yes (K02005) (Identical to Predicate) | Yes |
| Calcium Scoring | Yes (Identical to Predicate) | Yes |
| Heartbeat Calcium Scoring (HBCS) | Yes (Identical to Predicate) | Yes |
| Virtual Colonoscopy | Yes (Identical to Predicate) | Yes |
| Pediatric Applications Support | Yes (Identical to Predicate) | Yes |
| Remote Workstation Option | Yes - MxView - later renamed Extended Brilliance Workstation (Predicate) | Yes - IntelliSpace Portal (K162025) |
| Volume Rendering | Yes (Identical to Predicate) | Yes |
| Liver Perfusion | Yes (Identical to Predicate) | Yes |
| Dental Planning | Yes (Identical to Predicate) | Yes |
| Functional CT | Yes (Identical to Predicate) | Yes |
| Stent Planning | Yes (Identical to Predicate) | Yes |
| Retrospective Tagging | Yes (Identical to Predicate) | Yes |
| Prospective Cardiac Gating | Yes (Identical to Predicate) | Yes |
| CT Performance Metrics (Phantoms) | ||
| MTF | Cut-off: High Mode 16±2lp/cm; Standard Mode: 13±2 lp/cm (Measured) | |
| CTDIvol (Head) | 10.61mGy/100mAs±25% at 120kV (Measured) | |
| CTDIvol (Body) | 5.92mGy/100mAs±25% at 120kV (Measured) | |
| CT number accuracy (Water) | 0±4HU (Measured) | |
| Noise | 0.27% ± 0.04% at 120 kV, 250 mAs, 12 mm slice thickness, UA filter (Measured) | |
| Slice Thickness (Nominal 0.75mm) | 0.5mm - 1.5mm (Measured) | |
| Slice Thickness (Nominal 1.5mm) | 1.0mm - 2.0mm (Measured) |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of an AI/algorithm-driven diagnostic study. Instead, it refers to "bench testing included basic CT performance tests on phantoms" and "Sample clinical images were provided with this submission, which were reviewed and evaluated by radiologists."
- Sample Size for Test Set: Not specified for clinical images. For bench testing, it refers to "phantoms."
- Data Provenance: Not specified for the "sample clinical images." Given the context of a 510(k) for a hardware device, it's highly likely these were internal and possibly from a variety of sources. It's not stated whether they were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: "radiologists" (plural, but exact number not specified).
- Qualifications of Experts: Only "radiologists" are mentioned. No details on years of experience or subspecialty.
4. Adjudication Method for Test Set
- Adjudication Method: Not specified. The document states, "All images were evaluated to have good image quality," suggesting a qualitative assessment rather than a structured adjudication process for a specific diagnostic task.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a typical MRMC comparative effectiveness study was not performed as described. This submission is for a CT scanner itself, not an AI-assisted interpretation tool where human readers' performance with and without AI would be compared.
- Effect Size of Human Readers with AI vs. without AI: Not applicable, as this was not an AI-assistance study.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, this was not a standalone algorithm performance study. The submission is for a complete CT imaging system. The performance metrics reported are for the overall system, not an isolated algorithm. The document mentions "optional software algorithm called WARP or DAS" for increasing slice count, and features like "iDose4" (an extension of DoseRight) and "FDOM, 3D-DOM" for dose modulation, but their standalone performance is not detailed in terms of a clinical study.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "sample clinical images," the ground truth seems to be expert opinion / qualitative assessment by radiologists that the image quality was "good." For the technical performance parameters (MTF, CTDIvol, CT number accuracy, Noise, Slice Thickness), the ground truth was derived from physical phantom measurements against established technical specifications.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document describes a CT scanner (hardware and embedded software), not a machine learning model that would have a separate "training set" in the conventional sense. The "training" for the system's development would be through engineering design, iterative testing, and adherence to established physical and software engineering principles.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. (See point 8). The development of the CT system likely involved extensive engineering design, simulations, and validation against known physical principles and performance targets, which are fundamentally different from establishing ground truth for a machine learning training set.
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November 9, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
Philips Medical Systems (Cleveland) Inc. Michael Chilbert Regulatory Affairs Engineer 595 Miner Road Cleveland, Ohio 44143
Re: K171850
Trade/Device Name: Philips CT Big Bore Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: October 10, 2017 Received: October 12, 2017
Dear Mr. Michael Chilbert:
We have reviewed vour 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 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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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.
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,
Robert Oaks
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) K171850
Device Name Philips CT Big Bore
Indications for Use (Describe)
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.
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 CT Big Bore 510(k) Submission
Section 5
510(k) Summary
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[As required by 21 CFR 807.92(c)] Applicant's Name: Philips Medical Systems (Cleveland), Inc. Address: 595 Miner Road Cleveland, OH 44143 USA Contact Person: Michael Chilbert, Ph.D., P.E. Title: Regulatory Affairs Engineer Address: 595 Miner Road Cleveland, OH 44143 USA Telephone number: +1 440 483-3284 Fax number: +1 440 483-4918 E-mail: michael.chilbert@philips.com 510(k) Summary Date of Preparation: 19-June-2017 Device Trade Name: Philips CT Big Bore Common or Usual Name: Computed Tomography X-ray system Classification Name: Computed Tomography X-ray system Regulation: 21 CFR 892.1750 Class: = Product Code: JAK Panel: Radiology Primary Predicate device K033357 - AcQSim Multislice CT Scanner Classification Name: Computed Tomography X-ray system Regulation: 21 CFR 892.1750 Class: = Product Code: JAK Panel: Radiology
510(k) Summary of Safety and Effectiveness
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Indications for Use
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 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 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.
Intended Use:
The Philips CT Big Bore 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 currently available in two system configurations, the Oncology configuration and the Radiology (Base) 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:
-
- 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
-
- Patient Support (Couch) carries the patient in and out through the Gantry bore synchronized with the scan
-
- 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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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.
Substantial Equivalence:
Primary Predicate Device: AcQSim Multislice CT Scanner Manufacturer: Philips Medical Systems (Cleveland), Inc. Predicate Device k#: K033357
The design, intended use and technology provided with the proposed Philips CT Big Bore is identical to the predicate device, AcQSim Multislice CT Scanner, and therefore is considered substantially equivalent.
| Table 5-2: Substantial Equivalence ComparisonComparison of the primary predicate device, AcQSim Multislice CT Scanner (K033357)versus the proposed Philips CT Big Bore | |||
|---|---|---|---|
| AcQSimMultislice CTScanner | ProposedPhilips CTBig Bore | Comments | |
| Design/Fundamental Scientific Technology | |||
| Application | Head/Body | Head/Body | Identical |
| Scan Regime | Continuous Rotation | ContinuousRotation | Identical |
| No. of Slices | Up to 40 | 16/32 | Both the predicate and proposed CTsystems currently use a 24 mm widedetector providing 16 slices/channels.The proposed Philips CT Big Bore canincrease the number of images to 32from the 16 channels of data using anoptional software algorithm called WARPor DAS. This is available on IngenuityCT, K160743 |
| Scan Modes | SurviewAxial ScanHelical Scan | SurviewAxial ScanHelical Scan | Identical |
| Minimum ScanTime | 0.42 sec for 360°rotation | 0.42 sec for 360°rotation | Identical |
| Image (Spatial)Resolution | 15 lp/cm max. | 16 lp/cm (±2 lp/cm). | Identical |
| Image Noise, Body,STD Res., 16.25mGy | 10.7 | 10.7 | 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 | Essentially the same, Windows basedcomputer running iPatient systemsoftware, does not affect safety andeffectiveness |
| Table 5-2: Substantial Equivalence Comparison | |||
| Comparison of the primary predicate device, AcQSim Multislice CT Scanner (K033357) | |||
| versus the proposed Philips CT Big Bore | |||
| AcQSimMultislice CTScanner | ProposedPhilips CTBig Bore | Comments | |
| CIRS Infrastructure | PC/NT computerbased on Intelprocessor & customMultiprocessor Array | Windows Vista &customMultiprocessorArray | Identical, Windows based computer |
| Communication | Compliance withDICOM | Compliance withDICOM | Identical |
| Dose Reportingand Management | No | Compliance withMITA | MITA XR25 and XR29 compliance iscurrently available on Philips CT BigBore systems and the predicate systemswith v3.6 software or higher, does notaffect safety and effectiveness |
| XR25 and XR29 | |||
| Generator and Tube | |||
| Power (kW Output) | 60 kW | 80 kW(Software limited to60kW) | Generator is FDA class I, 510(k) exempt,no change in functionality, physically thesame. This change does not affect safetyand effectiveness. |
| mA Range | 30-500mA | 20-665mA(Software limited to500mA) | The impact of increasing the tube poweris an extended mA range, difference inrange does not affect safety andeffectiveness. |
| kV Settings | 80, 120, 140 | 80, 100, 120, 140 | Provides another setting that may beuseful in standard scanning, does notaffect safety and effectiveness |
| Focal Spot | Dynamic Focal Spot | Dynamic FocalSpot in X axis | Identical |
| Tube Type | MRC 800 | MRC Ice Tube(880) | Identical tube technology, the two tubesshare the same anode, cathode, bearing,anode drive, and electrical interfaces, butdiffer in housing, does not affect safetyand effectiveness |
| Detectors | |||
| Slice Thicknesses | 0.5, 0.625, 1.25,2.5mm and variouscombinations up to4x10mm | Helical: 0.67mm –5mmAxial: 0.625mm –12.5mm | Identical, slice thickness, does not affectsafety and effectiveness. |
| Table 5-2: Substantial Equivalence ComparisonComparison of the primary predicate device, AcQSim Multislice CT Scanner (K033357)versus the proposed Philips CT Big Bore | |||
| AcQSimMultislice CTScanner | ProposedPhilips CTBig Bore | Comments | |
| Type | 2.4 or 4 cmNanoPanel detector | 2.4 cm NanoPanel | The detector for the Philips CT Big Boreis a revision of the detector that wasused in the predicate, both detectorshave the same design specifications butthe detector used in the Philips CT BigBore shows slightly better performance.Marketing may use the "Elite"nomenclature in the detector name. Thischange does not affect safety andeffectiveness. |
| Scan Field of View | Up to 600 mm | Up to 600 mm | Identical |
| Detector Type | Single layer ceramicscintillator plusphotodiode array | Single layerceramic scintillatorplus photodiodearray | Identical |
| Gantry | |||
| Gantry Tilt | $\pm 30^0$ | $\pm 30^0$ | Identical |
| Gantry RotationSpeed | 143 RPM | 143 RPM | Identical |
| Bore Size | 850 mm | 850 mm | Identical |
| Clinical Features | |||
| Low dose CT lungcancer screening | Yes | Yes | The proposed Philips CT Big Bore hasthe same configuration with the BrillianceBig Bore cited in K153444 and belongsto the family of a series of CT devicescleared in K153444. |
| Communicationbetween injectorand scanner | SAS (Spiral AutoStart) | SAS and SyncRight | SyncRight is used in conjunction with theSAS to improve clinical workflow ofcontrast enhanced scanning.The functionality of the injector will notbe altered by SyncRight; only starting theinjector and, if necessary stopping of theinjector as well as entering injectionparameters is available from the scannerconsole.This modification does not affect thesafety or effectiveness of the device. |
| DoseRight /Dose Management(K012238) | Yes | Yes and iDose4 | DoseRight was cleared under K012238,iDose is an extension of the existingfeature DoseRight, and both provide thesame basic function (low dosescanning). This feature does not affectthe safety or effectiveness of the device. |
| Table 5-2: Substantial Equivalence ComparisonComparison of the primary predicate device, AcQSim Multislice CT Scanner (K033357)versus the proposed Philips CT Big Bore | |||
| AcQSimMultislice CTScanner | ProposedPhilips CTBig Bore | Comments | |
| Dose Modulation(part of DoseRight,above) | D-DOM and Z-DOM | D-DOM (AngularDOM) and Z-DOMFDOM, 3D-DOM | Dose Modulation function modulates thetube current based on patient bodysymmetry change. FDOM incorporatesthe features of Z-DOM and D-DOM anddoes not introduce new hazards, but onlysupports a mode which combinesangular and longitudinal modulation. Thisfeature does not affect the safety oreffectiveness of the device. |
| Cone BeamReconstructionAlgorithm - COBRA | Yes | Yes | Identical |
| Axial 2DReconstruction | Yes | Yes | Identical |
| Lung NoduleAssessment(K023785) | Yes | Yes | Identical |
| ECG SignalHandling | Yes | Yes | Identical |
| CardiacReconstruction | Yes | Yes | Identical |
| Bolus Tracking(K02005) | Yes | Yes | Identical |
| Calcium Scoring | Yes | Yes | Identical |
| Heartbeat CalciumScoring (HBCS) | Yes | Yes | Identical |
| VirtualColonoscopy | Yes | Yes | Identical |
| PediatricApplicationsSupport | Yes | Yes | Identical |
| RemoteWorkstation Option | Yes - MxView -later renamedExtended BrillianceWorkstation | Yes - IntelliSpacePortal (K162025) | Change of name, no effect on the safetyor effectiveness of the device. |
| Volume Rendering | Yes | Yes | Identical |
| Liver Perfusion | Yes | Yes | Identical |
| Dental Planning | Yes | Yes | Identical |
| Functional CT | Yes | Yes | Identical |
| Stent Planning | Yes | Yes | Identical |
| RetrospectiveTagging | Yes | Yes | Identical |
| ProspectiveCardiac Gating | Yes | Yes | Identical |
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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 is substantially equivalent to the primary predicate device, AcQSim Multislice CT Scanner in terms of safety and effectiveness. Testing was performed on the proposed Philips CT Big Bore according to the following international and FDA recognized consensus standards and FDA regulations and 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 Xray 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).
- . Code of Federal Regulations 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 system.
| 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, UA filter |
| Slice Thickness | 0.5mm - 1.5mm at nominal 0.75mm; 1.0mm - 2.0mm at nominal 1.5mm |
The completed test protocols cover the main system level software and hardware 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.
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Conclusion: All verification tests were executed according to the System Verification Plan. There were no deviations to the System Verification Plan. All executed tests passed the specified requirements.
The completed test plan identified the tasks, deliverables, methodology, requirements and the resources for validation of the intended use and meets customer needs.
Summary of Clinical Testing:
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 systems. 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.
Conclusion: The validation test plan was executed as planned and acceptance criteria met for each requirement. All defects were managed and closed. All validation tests of this Premarketing Notification [510(k)] submission demonstrates the safety and effectiveness of the Philips CT Big Bore in its performance as a CT system. The results of this validation testing are available in the Final Validation Report.
Sample clinical images were provided with this submission, which were reviewed and evaluated by radiologists. All images were evaluated to have good image quality.
The proposed Philips CT Big Bore has the same configuration as the Brilliance Big Bore cited in K153444, therefore the Philips CT Big Bore is cleared for low dose CT lung cancer screening.
The proposed Philips CT Big Bore can be used as defined in its clinical workflow and intended use.
Conclusion:
Philips believes that the proposed Philips CT Big Bore is substantially equivalent to the predicate device, AcQSim Multislice CT Scanner. 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 is as safe and effective as the predicate device, AcQSim Multislice CT Scanner, without raising any new safety and/or effectiveness concerns.
§ 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.