PHILIPS IQON SPECTRAL CT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element below them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Philips Medical Systems (Cleveland), Inc. % Ms. Catherine M. Connell Regulatory Affairs Specialist 595 Miner Road CLEVELAND OH 44143 November 21, 2014 Re: K133674 Trade/Device Name: Philips IOon Spectral CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 23, 2014 Received: October 24, 2014 Dear Ms. Connell: 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. {1}------------------------------------------------ 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, Robert A Ochs for Janine M. Morris 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) K133674 Device Name Philips IQon Spectral CT ### Indications for Use (Describe) The Philips IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment parts, and accessories. The IQon Spectral CT system acquires one CT dataset – composed of data from a higher-energy detected x-ray spectrum and a lower- energy detected x-ray spectramay be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The background is white, which makes the blue letters stand out. #### Section 5: 510(k) Summary [As required by 21 CFR 807.92(c)] | Applicant's Name:<br>Address: | Philips Medical Systems (Cleveland), Inc.<br>595 Miner Road<br>Cleveland, OH 44143<br>USA | |-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Telephone number: | +1 440 483 3000 | | Contact Person:<br>Title:<br>Address: | Catherine M. Connell<br>Regulatory Affairs Specialist<br>595 Miner Road<br>Cleveland, OH 44143<br>USA | | Telephone number:<br>Fax number:<br>E-mail: | +1 440 483 5581<br>+1 440 483 4918<br>catherine.connell@philips.com | | 510(k) Summary<br>Date of Preparation: | 23-October-2014 | | Device Trade Name: | Philips IQon Spectral CT | | Common or Usual Name: | Computed tomography x-ray system | | Classification<br>Name:<br>Regulation:<br>Class:<br>Product Code:<br>Panel: | Computed tomography x-ray system<br>21 CFR 892.1750<br>II<br>JAK<br>Radiology | | Predicate devices | Philips Brilliance iCT (K131773) | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters against a white background. The font is sans-serif and the letters are evenly spaced. The overall impression is clean and modern, reflecting the brand's identity. The color contrast makes the word stand out. The Philips IQon Spectral CT is a whole-body computed Device Description: tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories. The Philips IQon Spectral CT includes the detector array previously described in K131773 "Modified Brilliance iCT". > The IQon Spectral CT consists of three main components – a scanner system that includes a rotating gantry, a movable patient couch, and an operator console for control and image reconstruction; a Spectral Reconstruction System; and a Spectral CT Viewer. On the gantry, the main active components are the x-ray high voltage (HV) power supply, the x-ray tube, and the detection system. > In addition to the above components and the software operating them, the system includes workstation hardware and software for data acquisition; and image 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters against a white background. The font is sans-serif and the letters are evenly spaced. The overall impression is clean and modern, reflecting the brand's identity. The color contrast makes the word stand out. The Philips IQon Spectral CT is a Computed Tomography X-Ray Intended Use: System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. > The IQon Spectral CT system acquires one CT dataset – composed of data from a higher-energy detected x-ray spectrum and a lowerenergy detected x-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. > This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill the majority of the frame. The background is plain white, which makes the blue letters stand out. Substantial Equivalence: The Philips IQon Spectral CT has an intended use and technology that are similar to the predicate device. > As described above, the Philips IQon Spectral CT includes the hardware configuration previously described in K131773 "Modified Brilliance iCT", updated system software, a Spectral Reconstruction System; and a Spectral CT Viewer application. The IQon Spectral CT system is able to generate conventional (combined) CT images (equivalent to a CT image series from a non-spectral detector CT system) as described in K131773. The scanner software has been updated to a more recent version of software that provides for an easier user workflow (iPatient). To address the addition of spectral CT imaging capability, a reference device has been identified. Because both devices are able to acquire two CT spectra, each is able to perform various types of spectral analysis, such as: - Monoenergetic images - . Materials Basis/Density Pairs, such as - o 1/ H20 - o I / Ca - o Ca / Uric Acid - I Effective Atomic Number - 트 Material Separation/Differentiation - I Attenuation Curves - Density Measurements/Visualization - Reduction of Beam Hardening - Reduction of Calcium Blooming The Summaries of Non-Clinical Testing and Clinical Testing, presented below, provide a brief outline of the testing data that has been presented to demonstrate substantial equivalence. {7}------------------------------------------------ Image /page/7/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. | Summary of Non-Clinical<br>Testing: | The following tests demonstrated that the IQon Spectral CT system<br>continues to conform to IEC 61223-3-5:2004:<br>CT Number, Uniformity, Noise and Tomographic Section<br>Thickness Measurements CTDI Dose Measurements Air Dose Measurements Spatial Resolution Measurements Low Contrast Detectability Measurements Acceptance and Constancy Test Performance testing demonstrates following spectral capabilities: Monoenergetic Images - keV and HU stability Monoenergetic Images – CT linearity at 70 keV Iodine Quantification and Water-No-Iodine Iodine Map Imaging Calcium-No-Iodine images, and Iodine-No-Calcium images Calcium-No-Uric-Acid images, and Uric-Acid-No-Calcium<br>images Virtual Non-Contrast (VNC) images Effective Atomic Number Beam Harding Artifact Reduction | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of Clinical<br>Testing: | Clinical images were collected and analyzed, to ensure that images<br>constructed by the IQon Spectral CT system meet user needs. This<br>evaluation demonstrated that spectral images were useful for the<br>visualization and analysis of anatomical and pathological<br>structures. | | Conclusion: | Philips Medical Systems (Cleveland), Inc. believes that, based<br>on the information provided in this submission, the Philips IQon<br>Spectral CT is substantially equivalent to its predicate devices<br>without raising any new safety and/or effectiveness concerns. |