Philips Spectral CT Applications

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a symbol consisting of three stylized human profiles facing to the right, connected by a flowing, ribbon-like shape. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 7, 2015 Philips Medical Systems Nederland B.V. % Ms. Susan Ouick Regulatory Affairs Specialist Philips Medical Systems (Cleveland) Inc. 595 Miner Road CLEVELAND OH 44143 Re: K150665 Trade/Device Name: Philips Spectral CT Applications Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, LLZ Dated: July 28, 2015 Received: July 29, 2015 Dear Ms. Quick: 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). 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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'Hara For Robert Ochs, Ph.D. Acting 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) K150665 Device Name Philips Spectral CT Applications #### Indications for Use (Describe) The Philips Spectral CT Applications support viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. The Spectral CT Applications provide 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. The Spectral enhanced Advanced Vessel Analysis (SAVA) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of contrast-enhanced vessels. The Spectral enhanced Comprehensive Cardiac Analysis (SCCA) application is intended to assist clinicians in viewing and evaluating cardiovascular CT images. The Spectral enhanced Tumor Tracking (sTT) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of tumors." | 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 style="font-size:16px;">☐</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 text stand out. | Section 5: | 510(k) Summary<br>[As required by 21 CFR 807.92(c)] | | | |-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--|--| | Applicant's Name:<br>Address: | Philips Medical Systems Nederland B.V.<br>Veenpluis 4-6<br>5684 PC Best<br>The Netherlands | | | | Contact Person:<br>Title:<br>Address: | Susan Quick<br>Regulatory Affairs Specialist<br>595 Miner Road<br>Cleveland, OH 44143<br>USA | | | | Telephone<br>number: | +1 440 483-2291 | | | | Fax number:<br>E-mail: | +1 440 483-4918<br>Susan.quick@philips.com | | | | 510(k) Summary<br>Date of<br>Preparation: | 05-March-2015 | | | | Device Trade Name: | Spectral CT Applications | | | | Common or Usual<br>Name: | Computed Tomography X-ray System (CT System) | | | | Classification<br>Name:<br>Regulation:<br>Class:<br>Product Code:<br>Panel: | Computed Tomography X-ray System<br>21 CFR 892.1750<br>ll<br>JAK, LLZ<br>Radiology | | | | Predicate devices | IQon Spectral CT (K133674)<br>EBW NM 2.0 (K111336)<br>Brilliance iCT (K060937) | | | {4}------------------------------------------------ Image /page/4/Picture/0 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. Device Description: The Spectral CT Applications package introduces a set of three SW clinical applications: spectral enhanced Comprehensive Cardiac Analysis (sCCA), spectral enhanced Advanced Vessel Analysis (sAVA), and spectral enhanced Tumor Tracking (sTT). Each application provides tools that assist a trained personal in visualization and analysis of anatomical and pathological structures. > The sCCA application is targeted to assist the user in analysis and diagnostic of Cardiac Cases, as contrast enhanced and ECG triggered scans. The application input is a cardiac case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the coronary tree and chambers. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the coronary vessel & findings along it. The sAVA application is targeted to assist the user in analysis and diagnostic of CT Angiography cases, as contrast enhanced and whole body CT-angiography scans. The application input is a CT Angiography case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the vessel of interest. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the vessels & findings along it. The sTT application is targeted to assist the user in analysis of tumors, as contrast enhanced, soft tissue oriented, and whole body scans. The application input is a tumor suspected contrast enhanced case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the tumor of interest. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the tumor. {5}------------------------------------------------ Image /page/5/Picture/0 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. - The Philips Spectral CT Applications support viewing and analysis of Intended Use: images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. The Spectral CT Applications provide 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. The Spectral enhanced Advanced Vessel Analysis (sAVA) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of contrast-enhanced vessels. The Spectral enhanced Comprehensive Cardiac Analysis (sCCA) application is intended to assist clinicians in viewing and evaluating cardiovascular CT images. The Spectral enhanced Tumor Tracking (sTT) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of tumors. {6}------------------------------------------------ Image /page/6/Picture/0 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 plain white. Substantial Philips has identified one Primary and two Reference predicate devices Equivalence: for the Spectral CT Applications. > The Primary predicate, Spectral CT viewer (part of Philips IQon Spectral CT), addresses the enhanced visualization and analysis capabilities of spectral images derived by the spectral data. The Reference predicates address functionality of the baseline applications AVA, CCA, and TT. #### Table 5-1 Primary Predicate | Device trade name | 510(k) number | Product code | |-----------------------------------------------------|---------------|--------------| | Philips IQon<br>Spectral CT<br>(Spectral CT Viewer) | K133674 | JAK | #### Table 5-2 Reference Predicates | Spectral CT<br>Applications | Reference<br>Predicate | 510(k)<br>number | Product code | |-----------------------------|---------------------------------------------------|------------------|--------------| | sAVA | AVA from Brilliance<br>iCT (Brilliance<br>Volume) | K060937 | JAK | | sCCA | CCA from Brilliance<br>iCT (Brilliance<br>Volume) | K060937 | JAK | | sTT | TT from EBW NM<br>2.0 | K111336 | LLZ | ### Intended Use and Indications for Use Discussion The proposed intended uses of the Spectral CT Applications are combining indications coming from their primary and reference predicates. Similar to the reference predicates (CCA, AVA: K133674, K060937; TT: K111336), the Spectral CT Applications assist clinicians in viewing and evaluating CT images of Cardiac, Angiography, and Tumor related cases. The differences between the intended use of the Reference predicates and the proposed Spectral CT applications is that the Spectral CT applications introduce capabilities of viewing and analysis of CT images of Cardiac, Angiography, and Tumor related cases at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. The Spectral CT Applications provide for the quantification and graphical display of attenuation, material density, and effective atomic number which is not available with the reference predicates. {7}------------------------------------------------ Image /page/7/Picture/0 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, providing a strong contrast that makes the word stand out. # Technological Characteristics The proposed Spectral CT Applications (sAVA, sCCA, and sTT) are based on Spectral CT Viewer (K133674) as the Primary predicate, while incorporating basic tools, like: measurements, Display modes (2D, 3D) and layouts, etc. and enhanced visualization and analysis capabilities that are derived from utilization of spectral data. These enhanced visualization and analysis capabilities include spectral plots, keV slider, and Spectral Magic Glass. The proposed Spectral CT Applications (sAVA, sCCA, and sTT) are based on the baseline applications mentioned above as the reference predicates while sharing the characteristics of those baseline applications, mainly: - Both AVA and sAVA support whole body CT Angiography (CTA) scans and assist clinicians in viewing and evaluating CT images, for the inspection of contrast-enhanced vessels. - Both CCA and sCCA support cardiac CT scans and assist clinicians ● in viewing and evaluating cardiovascular CT images. - Both TT and sTT support whole body CT scans and assist clinicians in viewing and evaluating CT images, for the inspection of tumors. - The Spectral CT Applications (sAVA, sCCA, and sTT) incorporate in the high level - the same workflow stages and functionalities as the reference predicate baseline CT Applications; and in more details, allow to generate presets and layouts and provide measurement tools, segmentation tools, and summary tables similar to the reference predicate baseline CT Applications. The difference between the Primary predicate and the Spectral CT applications is the customized workflow and summary tables that are tailored to meet the specific case of interest. The differences between the Spectral CT applications and the baseline CT Application reference predicates is in the enhanced visualization and analysis capabilities that are derived from utilization of spectral data. {8}------------------------------------------------ Image /page/8/Picture/0 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, providing a strong contrast that makes the word stand out. # Table 5-3: Main functionalities and characteristics of Predicates vs. Spectral CT Applications | Features | Proposed Spectral CT Applications | Primary Predicate (K133674) | Reference Predicate (K060937, and K111336) | |---------------------------------------------------------------------------------------|--------------------------------------------------------|-----------------------------|--------------------------------------------| | SW Clinical application | Yes | Yes | Yes | | Incorporate workflow stages | Yes | Yes | Yes | | Supports conventional images | Yes | Yes | Yes | | Supports spectral images, including: SBI,<br>Material Density Pairs, MonoE | Yes | Yes | No | | DICOM compliant | Yes | Yes | Yes | | Supports Axial (2D) and volumetric (3D)<br>visualization modes | Yes | Yes | Yes | | Provides presets and layouts for conventional<br>images | Yes | Yes | Yes | | Provides presets and layout for spectral<br>images | Yes | Yes | No | | Provides measurement tools: average, STD,<br>length, area, volume, and spectral plots | Yes | Yes | Yes | | Provides measurement tools: spectral plots | Yes | Yes | No | | Provides segmentation tools: clipping, inject,<br>delete | Yes | Yes | Yes | | Provides segmentation tools: bone/skull<br>removal, couch removal | Yes – in<br>Spectral<br>Enhanced<br>AVA<br>application | No | Yes – in<br>AVA<br>application | | Provides segmentation tools: coronary &<br>chambers | Yes – in<br>Spectral<br>Enhanced<br>CCA<br>application | No | Yes – in<br>CCA<br>application | | Provides summary tables | Yes | No | Yes | | Generates "on-the fly" datasets | Yes | Yes | No | | Provides keV slider | Yes | Yes | No | | Provides spectral magic glass | Yes | Yes | No | Premarket Notification [510(k)] Submission Philips Medical Systems Spectral CT Applications Philips Medical Systems The Spectral CT Applications are similar to the applications a Spectral CT Applications The Spectral CT Applications are Similar to the Spectral CT the applications Spectral CT Applications incorporated in the cleared predicate devices. The Spectra {9}------------------------------------------------ Image /page/9/Picture/0 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. The word is horizontally oriented and centered. Summary of Non-Spectral CT applications have been verified through SW verification Clinical Testing: process. In which covered Functionality, risk mitigations, and IFU. The Verification was using datasets that were generated by the Philips IQon Spectral CT system (K133674) and Verification testing specs to methodically cover functionality as described in the requirement specification documents. The verification indicated that SW requirements were met and IFU contains appropriate clarification on functionality and warnings. The conclusions are summarized in the Verification report. Summary of Clinical Spectral CT applications have been validated to show that intended uses Testing: of the spectral CT applications are met. Validation stage was using clinical datasets derived from Philips IQon Spectral CT system (K133674) and the SW version that successfully passed verification process. The intended uses of each application were evaluated by Philips Internal certified radiologists that represented a typical user. The evaluators were questioned against each of the intended uses and provided score to describe their level of satisfaction. The validation indicated that intended uses and defined user needs were met, hence: sCCA and sAVA applications allow visualization, manipulation and analysis of spectral data and that sTT application assist clinicians in viewing and evaluating CT images for the inspection of tumors. Conclusion: Philips Medical Systems believes that the Spectral CT Applications are similar to the applications that are incorporated in the predicate devices. There are no significant differences that may raise new issues of safety or effectiveness. Bench tests have been performed to demonstrate that the Spectral CT Applications are as safe and effective as the applications that are incorporated in the predicate devices, without raising any new safety and/or effectiveness concerns.