Celesteion, PCA-9000A/3

{0}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/2 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, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 1, 2017 Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780 Re: K170490 Trade/Device Name: Celesteion, PCA-9000A/3, v6.4 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK Dated: April 28, 2017 Received: May 1, 2017 Dear Mr. Tadeo: 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 {1}------------------------------------------------ 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. 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/ResourcesforYou/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, Michael D. '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) #### K170490 Device Name Celesteion, PCA-9000A/3, v6.4 #### Indications for Use (Describe) The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT component produces crosssectional images of the body by computer reconstruction of x-ray transmission data. The PET component images the distribution of PET radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT images. This device is to be used by a trained health care professional to gather metabolic and functional information from the distribution of the radiopharmaceutical in the body for the assessment of metabolic and physiologic functions. This information can assist in the evaluation, detection, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) cancer, cardiovascular disease and brain dysfunction. Additionally, this device can be operated independently as a whole body multi-slice CT scanner. Type of Use (Select one or both, as applicable) اك Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Toshiba Medical. The logo is in red and consists of two words, "TOSHIBA" on top and "MEDICAL" on the bottom. The words are in a bold, sans-serif font. The logo is simple and clean, and the red color makes it stand out. ### 510(k) SUMMARY #### SUBMITTER'S NAME: 1. Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550 #### 2. OFFICIAL CORRESPONDENT: Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance # 3. ESTABLISHMENT REGISTRATION: 9614698 ### 4. CONTACT PERSON: Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459 #### 5. Date Prepared: April 28, 2017 # 6. TRADE NAME(S): Celesteion, PCA-9000A/3, V6.4 ### 7. COMMON NAME: System, Emission Computed Tomography #### 8. DEVICE CLASSIFICATION: Class II (21 CFR §892.1200, Emission Computed Tomography System) ### 9. PRODUCT CODE / DESCRIPTION: 90KPS / Emission Computed Tomography System {4}------------------------------------------------ ### 10. PERFORMANCE STANDARD: This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020] #### 11. PREDICATE DEVICE: | Product | Marketed<br>by | Regulation<br>Number | Regulation<br>Name | Product<br>Code | 510(k)<br>Number | Clearance<br>Date | |----------------------------|------------------------------------------|----------------------|----------------------------------------------|-----------------|------------------|-------------------| | Celesteion,<br>PCA-9000A/2 | Toshiba<br>America<br>Medical<br>Systems | 21 CFR<br>892.1200 | Emission<br>Computed<br>Tomography<br>System | KPS | K140651 | June 11, 2014 | #### 12. REASON FOR SUBMISSION: Modification to existing device ### 13. DEVICE DESCRIPTION: Celesteion, PCA-9000A/3, V6.4, is a large bore, TOF, PET-CT system, which combines a high-end CT system with a high-throughput PET system. The high-end CT system is a multi-slice helical CT scanner with a gantry aperture of 900 mm and a maximum scanning field of 700 mm. The highthroughput PET system has a time of flight (TOF) detector with temporal resolution of 450 ps. Celesteion, PCA-9000A/3, V6.4, is intended to acquire PET images of any desired region of the whole body and CT images of the same region (to be used for attenuation correction or image fusion), to detect the location of positron emitting radiopharmaceuticals in the body with the obtained images. This device is used to gather the metabolic and functional information from the distribution of radiopharmaceuticals in the body for the assessment of metabolic and physiologic functions. This information can assist research, diagnosis, therapeutic planning, and therapeutic outcome assessment. This device can also function independently as a whole body multi-slice CT scanner. ### 14. INDICATIONS FOR USE: The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and Xray Computed Tomography (CT) systems. The CT component produces cross- sectional images of the body by computer reconstruction of x-ray transmission data. The PET component images the distribution of PET radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT images. This device is to be used by a trained health care professional to gather metabolic and functional information from the distribution of the radiopharmaceutical in the body for the assessment of metabolic and physiologic functions. This information can assist in the evaluation, detection, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) cancer, cardiovascular disease and brain dysfunction. Additionally, this device can be operated independently as a whole body multi-slice CT scanner. {5}------------------------------------------------ ### 15. SUBSTANTIAL EQUIVALENCE: Celesteion, PCA-9000A/3, V6.4, is substantially equivalent to Celesteion, PCA-9000A/2, which received premarket clearance under K140651 and is marketed by Toshiba America Medical Systems. The Celesteion, PCA-9000A/3, V6.4, incorporates modifications to the cleared device including implementation of the PUREVision CT detector previously cleared under K150003, implementation of SEMAR, a previously cleared metal artifact reduction software application, a PET respiratory gating system, improvements to PET image visualization using Point Spread Function (PSF) correction and introduction of SUBEFIIght, new marketing terminology for existing device features, in device labeling. These changes do not affect the safety or efficacy of the cleared device, as demonstrated in performance testing. The method of operation and manufacturing process for the Celesteion remain unchanged from the cleared device. See below for a brief comparison of the technological characteristics between the subject and the predicate devices: | Item | Celesteion, PCA-9000A/3, V6.4 | Celesteion, PCA-9000A/2 | |--------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------| | 510(k) Number | This submission | K140651 | | PET Specifications | | | | Scan | 3D PET acquisition with CT acquisition for attenuation correction | 3D PET acquisition with CT acquisition for attenuation correction | | Sensitivity (cps/kBq) | ≥3.6 | ≥3.6 | | Count rate maximum NECR | 61±10 kcps | 61±10 kcps | | System energy resolution | ≤ 13.7% | ≤ 13.7% | | System timing resolution | ≤ 450 ps | ≤ 450 ps | | Scatter fraction (%) | ≤ 42.7 | ≤ 42.7 | | Spatial Resolution FWHM at 1cm | ≤ 5.1 | ≤ 5.1 | | PET Detector | | | | PUREVision Detector | Yes<br>(Improved sensitivity of detector<br>and standard deviation of noise) | No | | Transaxial FOV | Up to 70 cm | Up to 70 cm | | Axial FOV | 19.6 cm | 19.6 cm | | SURE FLIGHT | Standard | N/A | | CT Specifications | | | | CT Detection System | 16 row<br>Solid State Detector | 16 row<br>Solid State Detector | | Output capacity | 72 kW (max) | 72 kW (max) | | X-ray Tube Voltage | 80, 100, 120 and 135 kV | 80, 100, 120 and 135 kV | | X-ray Tube Current | 10 mA to 600 mA | 10 mA to 600 mA | | X-ray Tube Heat Capacity | 7.5 MHU | 7.5 MHU | | X-ray Tube cooling rate | 1,386 kHU/min (max)<br>1,008kHU/min (actual) | 1,386 kHU/min (max)<br>1,008kHU/min (actual) | {6}------------------------------------------------ | Item | Celesteion, PCA-9000A/3,<br>V6.4 | Celesteion, PCA-9000A/2 | |-------------------------------------------|--------------------------------------------------|--------------------------------------------------| | Focal Spot Size (IEC) | 0.09mm x 0.8mm (small)<br>1.6mm x 1.4 mm (large) | 0.09mm x 0.8mm (small)<br>1.6mm x 1.4 mm (large) | | PUREVision CT Detector | Available | N/A | | New Features | | | | PET Respiratory Gating System | Available | N/A | | Point Spread Function (PSF)<br>Correction | Available | N/A | Previously cleared software option being implemented to the modified device: | SEMAR (Helical) | Previously cleared under K142465 | |-----------------|----------------------------------| |-----------------|----------------------------------| ## 16. SAFETY: The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the following standards IEC60601-1-2, IEC60601-1-2, IEC60601-1-6, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25, NEMA XR-26 and NEMA NU-2. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020. # 17. TESTING Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrates that the established specifications for the device have been met. The modified system utilizes the "985ViSION CT Detector that was previously 510(k) cleared under K150003. Image quality metrics studies concluded that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio and noise properties. Additional bench testing was conducted to support PSF claims including improved contrast recovery, sharper point source in air, more uniform point size across the field of view, ringing artifact reduction, SUV increase and reduced reconstruction time. Testing of the subject device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) and the National Electrical Manufacturers Association (NEMA) for Medical Devices, CT and PET Systems. Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Additionally, testing of the subject device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems. {7}------------------------------------------------ #### 18. CONCLUSION Celesteion, PCA-9000A/3, V6.4, performs in a manner that is similar to and is intended for the same use as the predicate device, as indicated in product labeling. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate device.