Philips iCT CT System

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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. 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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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K162838 Device Name Philips iCT CT System #### Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | <span></span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black" stroke-width="2"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span></span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Image /page/3/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white. ## 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 Road<br>Cleveland, OH 44143 USA | | Contact Person: | Christine Anderson | | Title: | Regulatory Affairs Specialist | | Address: | 595 Miner Road<br>Cleveland, OH 44143 USA | | Telephone number: | +1 440 483-7732 | | Fax number: | +1 440 483-4918 | | E-mail: | Christine.anderson@philips.com | | 510(k) Summary Date<br>of Preparation: | 07-Mar-2017 | | Device Trade Name: | Philips iCT CT System | | Common or Usual<br>Name: | 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 | {4}------------------------------------------------ Philips Medical Systems (Cleveland) Inc. Image /page/4/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white. ## 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. 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: - 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). {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white. - 2. 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) - 3. 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. - 4. Monitors - 5. 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 –<br>Components/specifications | Predicate: Brilliance<br>Volume<br>(K060937) | Proposed: Philips<br>iCT | Comments | |------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The "Brilliance<br>Volume" is a<br>Computed<br>Tomography X-Ray<br>System intended to<br>produce cross-<br>sectional images of<br>the body by computer<br>reconstruction of x-ray<br>transmission data<br>taken at different | The iCT is a Computed<br>Tomography X-Ray<br>System intended to<br>produce images of the<br>head and body by<br>computer<br>reconstruction of x-ray<br>transmission data<br>taken at different<br>angles and planes.<br>These devices may | Indications for Use<br>updated for<br>proposed iCT to<br>add reference to<br>patients of all ages<br>and low dose CT<br>lung cancer<br>screening<br>(K153444). The<br>predicate CT was<br>also indicated for | | Characteristics –<br>Components/specifications | Predicate: Brilliance<br>Volume<br>(K060937) | Proposed: Philips<br>iCT | Comments | | | angles and planes.<br>This device may<br>include signal analysis<br>and display<br>equipment, patient,<br>and equipment<br>supports, components<br>and accessories. | include signal analysis<br>and display equipment,<br>patient and equipment<br>supports, components<br>and accessories. The<br>iCT is indicated for<br>head, whole body,<br>cardiac and vascular<br>X-ray Computed<br>Tomography<br>applications in patients<br>of all ages. | patient of all ages,<br>but it was not<br>specifically stated<br>in the indications. | | | | These scanners are<br>intended to be used for<br>diagnostic imaging and<br>for low dose CT lung<br>cancer screening for<br>the early detection of<br>lung nodules that may<br>represent cancer*.<br>The screening must be<br>performed within the<br>established inclusion<br>criteria of programs /<br>protocols that have<br>been approved and<br>published by either a<br>governmental body or<br>professional medical<br>society. | | | | | *Please refer to clinical<br>literature, including the<br>results of the National<br>Lung Screening Trial<br>(N Engl J Med 2011;<br>365:395-409) and<br>subsequent literature,<br>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)<br>Axial | Helical<br>Axial | | | Gantry | | | | | Gantry Aperture (Bore) size | 700 mm | 700 mm | No change | | Characteristics –<br>Components/specifications | Predicate: Brilliance<br>Volume<br>(K060937) | Proposed: Philips<br>iCT | Comments | | Gantry tilt | ±30° | 0° | The iCT Gantry<br>does not have the<br>tilt feature. This<br>change does not<br>affect safety or<br>effectiveness. | | 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,<br>0.5, 0.75, 1.0, 1.5<br>seconds for full 360°<br>scans; 0.2 for partial<br>angle 240°<br>scans.(Optional - 0.27<br>seconds for full 360°<br>scans; 0.18 seconds<br>for partial angle 240°<br>scans) | 0.3, 0.33, 0.375, 0.4,<br>0.5, 0.75, 1.0, 1.5<br>seconds for full 360°<br>scans; 0.2 for partial<br>angle 240°<br>scans.(Optional - 0.27<br>seconds for full 360°<br>scans; 0.18 seconds<br>for partial angle 240°<br>scans) | No change | | | Patient Support/Couch/Table | | | | Patient Supports | Standard<br>Bariatric | Standard<br>Bariatric<br>Extended (aka Long) | The predicate<br>device released<br>with two table<br>options. The long,<br>or extended, table<br>was added to the<br>CT System. The<br>extended table<br>allows for run off<br>studies and does<br>not affect safety or<br>effectiveness. | | Patient table scan range | 1600 mm | Standard: 1750 mm<br>Bariatric: 1750 mm<br>Long: 2100 mm | The scannable<br>range increased<br>for the standard<br>and bariatric<br>patient supports. It<br>does not affect<br>safety or<br>effectiveness. | | Table Z-position accuracy | +/- 0.25 mm | Standard: +/- 0.25 mm<br>Bariatric: +/- 0.25 mm<br>Long: +/- 0.25 mm | No change | | Table longitudinal speed | 0.5 – 143 mm/sec | Standard: 0.5 - 185<br>mm/sec<br>Bariatric: 0.5 - 185<br>mm/sec<br>Long: 0.5 – 185<br>mm/sec | Slight increase in<br>longitudinal speed.<br>lt does not affect<br>safety or<br>effectiveness | | Characteristics –<br>Components/specifications | Predicate: Brilliance<br>Volume<br>(K060937) | Proposed: Philips<br>ICT | Comments | | Table maximum load capacity | Standard: 450 lbs.<br>(204kg)<br>Bariatric: 650 lbs.<br>(405kg) | Standard: 450 lbs.<br>(204kg)<br>Bariatric: 650 lbs.<br>(405kg)<br>Long: 450 lbs. (204kg) | No change | | Generator power rating | 100kW (120kW<br>optional) | 100kW (120kW<br>optional) | No change | | kVp settings | 80, 100, 120, 140 | 80, 100, 120, 140 | No change | | mA range (step size) | 10-830 (1mA steps),<br>optional 10-1,000) | 10-830 (1mA steps),<br>optional 10-1,000) | No change | | Focal spot size | small 0.6 x 0.7; large<br>1.1 x 1.2 | small 0.6 x 0.7; large<br>1.1 x 1.2 | No change | | Anode effective heat capacity | 30 MHU | 30 MHU | No change | | X-Ray tube, max. applied<br>power | Dynamic Focal Spot in<br>X and Z (2), up to<br>120kW, (8) | Dynamic Focal Spot in<br>X and Z (2), up to<br>120kW, (8) | No change | | X-Ray power supply | High-Frequency<br>up to 120 kW, 10-1000<br>mA, 80-140 kV | High-Frequency<br>up to 120 kW, 10-1000<br>mA, 80-140 kV | No change | | Detectors | NanoPanel: Ceramic<br>scintillator+<br>Photodiode 86016<br>elements - up to 128<br>slices simultaneously | iCT - same, but now<br>with 256 slices<br>iCT SP - 43008<br>photodiode elements<br>for 128 slices | The material is the<br>same as the<br>predicate. | | Slices | Brilliance Volume: 128 | iCT configuration: 256<br>iCT SP configuration:<br>128 | Slice increase is<br>possible with the<br>capability of the x-<br>ray tube function. | | Coverage | Brilliance Volume: 8<br>cm | iCT configuration: 8 cm<br>iCT SP configuration: 4<br>cm | The iCT SP<br>configuration has a<br>4 cm detector. It<br>does not affect<br>safety or<br>effectiveness as<br>compared to the<br>predicate. | | Collimations available | 128 x 0.625 mm<br>64 x 0.625 mm<br>32 x 1.25 mm<br>16 x 2.5 mm<br>2 x 0.5 mm | iCT configuration:<br>128 x 0.625 mm<br>112 x 0.625 mm<br>96 x 0.625 mm<br>64 x 0.625 mm<br>32 x 0.625 mm<br>20 x 0.625 mm<br>16 x 0.625 mm<br>8 x 0.625 mm<br>4 x 0.625 mm<br>2 x 0.625 mm | The collimations<br>identified for the<br>proposed iCT and<br>iCT SP are<br>clarifications of the<br>available<br>collimations and<br>needed by the<br>user. | | Characteristics -<br>Components/specifications | Predicate: Brilliance<br>Volume<br>(K060937) | Proposed: Philips<br>iCT | Comments | | | | 64 x 1.25 mm<br>32 x 1.25 mm<br>iCT SP configuration:<br>64 x 0.625 mm<br>32 x 0.625 mm<br>20 x 0.625 mm<br>16 x 0.625 mm<br>8 x 0.625 mm<br>4 x 0.625 mm<br>2 x 0.625 mm<br>64 x 1.25 mm<br>32 x 1.25 mm | | | Slice Thickness | Helical mode 0.67 –<br>7.5 mm<br>Axial mode 0.5 – 12<br>mm<br>Axial or helical? 0.5,<br>0.625, 1.25, 2.5mm<br>and various<br>combinations up to<br>4x10mm | Helical mode 0.67mm<br>– 10 mm<br>Axial mode 0.625 mm<br>– 10 mm | The slice<br>thicknesses<br>provided are<br>clarifications of the<br>original<br>specifications. | | Scan field | 500 mm maximum | 50 -500 mm<br>continuous<br>25 - 250mm ultra-high<br>resolution (UHR) | These are the<br>same. The ultra-<br>high resolution was<br>not identified in the<br>predicate 510(k) | | Console computer (Common Host) and Common Image Reconstruction System (CIRS) | | | | | Computer and CIRS<br>(Common Image<br>Reconstruction System) | PC/XP computer<br>based on Intel<br>processors and<br>custom Multiprocessor<br>Array | Windows 7 based on<br>Intel processors and<br>customer<br>Multiprocessor Array. | The change to a<br>Windows 7 based<br>operating system<br>does not affect<br>safety or<br>effectiveness. | | Image matrix | 5122, 7682, 10242 | 5122, 7682, 10242 | No change | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is plain white, which makes the blue letters stand out. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The color of the text is blue. The background is white, providing a clear contrast that makes the brand name easily visible. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is plain white, which makes the blue letters stand out. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. ## 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. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. 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 {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. 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.