The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray 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, staging, restaging, follow-up, therapeutic planning and therapeutic outcome assessment of (but not limited to) oncological, cardiovascular, neurological diseases and disorders. Additionally, this device can be operated independently as a whole body multi-slice CT scanner.

Device Description

Cartesion Prime, PCD-1000A, V10.7 system combines a high-end CT and a high-throughput PET designed to acquire CT, PET and fusion images. The high-end CT system is a multi-slice helical CT scanner with a gantry aperture of 780 mm and a maximum scanning field of 700 mm. The highthroughput PET system has a digital PET detector utilizing SIPM sensors with temporal resolution of <280 ps. Cartesion Prime, PCD-1000A, V10.7 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, detection, localization, diagnosis, staging, restaging, follow-up of diseases and disorders, as well as their therapeutic planning, and therapeutic outcome assessment. This device can also function independently as a whole body multi-slice CT scanner.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes performance improvements and successful testing against standards. However, key performance indicators and improvements mentioned can be synthesized into a pseudo-acceptance table based on comparisons to the predicate device and improved image quality.

Acceptance Criteria (Implied)	Reported Device Performance (Cartesion Prime, PCD-1000A, V10.7)
PET System Performance
Count rate peak NECR (Net Equivalent Count Rate)	> 160 kcps
Count rate peak true	> 600 kcps
Variable bed time (vBT)	Available
Image quality with CaLM (Clear adaptive Low-noise Method Reconstruction)	Improved Signal-to-Noise Ratio, reduced noise, preserved detail and contrast
Image quality with Point Spread Function (PSF) correction	Better contrast, reduced noise, improved spatial resolution
Image quality with PET Respiratory Gating	Improved image quality, allowed acquisition of multiple phase data sets
Image quality with PET Cardiac Gating	Improved image quality, allowed acquisition of multiple phase data sets
Safety and Regulatory Compliance
Compliance with Quality System Regulations (21 CFR § 820 & ISO 13485)	Conformance
Compliance with applicable IEC, NEMA, and FDA radiation safety standards	Conformance
Software documentation level of concern	Moderate Level of Concern (per FDA guidance)
Cybersecurity compliance	Per FDA cybersecurity premarket guidance

Sample Size Used for the Test Set and Data Provenance:

The document does not specify a patient sample size for the test set. The testing described primarily involves "bench testing." It mentions improvements in image quality (Signal-to-Noise Ratio, noise, contrast, spatial resolution) with various features and functionalities. The data provenance is not explicitly stated as patient data from a specific country or as retrospective/prospective. The description suggests testing was conducted on phantoms or simulated data suitable for bench testing, rather than human subjects.

Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

The document does not mention the use of experts to establish ground truth for a test set. This is consistent with the nature of the described "bench testing," which would typically involve objective measurements against known physical standards or simulated conditions, rather than expert interpretation of medical images.

Adjudication Method for the Test Set:

No adjudication method is mentioned, as expert interpretation and ground truth establishment (as typically understood in clinical studies) are not described for the test set.

Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided information. The submission focuses on device modifications and performance improvements validated through bench testing, rather than human reader performance studies.

Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The testing described appears to be a standalone (algorithm only without human-in-the-loop performance) study, specifically focusing on the technical performance characteristics of the device and its included software features. The document highlights improvements in image quality metrics (SNR, noise, contrast, spatial resolution) directly attributable to the device's algorithms and hardware, without involving human interpretation of the output.

Type of Ground Truth Used:

The type of ground truth used appears to be based on objective physical measurements and established imaging science principles relevant to the technical specifications of a PET/CT system. For example, "Signal-to-Noise Ratio," "noise," "contrast," and "spatial resolution" are quantifiable metrics. The improvements observed with CaLM, PSF correction, and gating are against an implicit baseline or ideal performance under controlled bench testing conditions, rather than against clinical outcomes, pathology, or expert consensus on patient cases.

Sample Size for the Training Set:

The document does not provide any information regarding a training set size. This indicates that the validation performed for this submission was not based on machine learning model training and evaluation using labeled datasets in the traditional sense, but rather on direct performance testing of the device's imaging capabilities and software features.

How Ground Truth for the Training Set Was Established:

As no training set is mentioned, the method for establishing its ground truth is not applicable in this context.

Summary

{0}------------------------------------------------

October 15, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Canon Medical Systems Corporation % Orlando Tadeo Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive TUSTIN CA 90630

Re: K202349

Trade/Device Name: Cartesion Prime, PCD-1000A, V10.7 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK Dated: August 17, 2020 Received: August 18, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K202349

Device Name

Cartesion Prime, PCD-1000A, V10.7

Indications for Use (Describe)

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, staging, restaging, follow-up, therapeutic planning and therapeutic outcome assessment of (but not limited to) oncological, cardiovascular, neurological diseases and disorders . Additionally, this device can be operated independently as a whole body multi-slice CT scanner.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 0MB number."

{3}------------------------------------------------

Made For life

510(k) SUMMARY

1. SUBMITTER'S NAME: Canon Medical Systems

1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

2. OFFICIAL CORRESPONDENT:

Fumiaki Teshima Senior Manager, Quality Assurance Department

3. ESTABLISHMENT REGISTRATION: 9614698

4. CONTACT PERSON:

Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459

5. Date Prepared:

August 17, 2020

6. TRADE NAME(S):

Cartesion Prime, PCD-1000A, V10.7

7. COMMON NAME:

System, X-ray, Computed Tomography System, Emission Computed Tomography

8. DEVICE CLASSIFICATION:

Class II (per 21 CFR 892.1750, Computed Tomography X-ray System and 21 CFR §892.1200, Emission Computed Tomography System)

PHONE: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780

K202349

{4}------------------------------------------------

9. PRODUCT CODE / DESCRIPTION:

90JAK / Computed Tomography X-Ray System 90KPS / Emission Computed Tomography System

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	Marketedby	RegulationNumber	RegulationName	ProductCode	510(k)Number	Clearance Date
Cartesion Prime,PCD-1000A PrimaryPredicate Device	CanonMedicalSystemsUSA	21 CFR892.1200	EmissionComputedTomographySystem	KPS	K191582	August 13, 2019
Celesteion, PCA-9000A/3, v6.5Reference PredicateDevice	CanonMedicalSystemsUSA	21 CFR892.1200	EmissionComputedTomographySystem	KPS	K181646	November 16, 2018

12. REASON FOR SUBMISSION:

Modification of a cleared device

13. DEVICE DESCRIPTION:

{5}------------------------------------------------

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, localization, diagnosis, staging, follow-up, therapeutic planning and therapeutic outcome assessment of (but not limited to) oncological, cardiovascular, neurological diseases and disorders. Additionally, this device can be operated independently as a whole body multi-slice CT scanner.

15. SUBSTANTIAL EQUIVALENCE:

Cartesion Prime, PCD-1000A, V10.7, is substantially equivalent to the primary predicate device, Cartesion Prime, PCD-1000A, which received premarket clearance under K191582 and is marketed by Canon Medical Systems USA. Both systems have the same indications for use and intended use. The Cartesion Prime, PCD-1000A, V10.7, incorporates modifications to the cleared device including implementation of a respiratory gating system and cardiac gating. 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 Cartesion Prime remain unchanged from the cleared device. See below for a brief comparison of the technological characteristics between the subject and the predicate device:

Item	Cartesion Prime, PCD-1000A,V10.7	Cartesion Prime, PCD-1000A
510(k) Number	This submission	K191582
Count rate peak NECR	> 160 kcps	> 130 kcps@<12 kBq/ml
Count rate peak true	> 600 kcps	> 300 kcps@<12 kBq/ml
Variable bed time (vBT)	Available	Available
CaLM (Clear adaptive Low-noiseMethod Reconstruction)	Available	Available

Previously cleared software option being implemented to the modified device:

PET Respiratory Gating System (NKRS-001A)	Previously cleared under K181646
PET Cardiac Gating (NHEG-001A)	Previously cleared under K181646

{6}------------------------------------------------

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, IEC60601-1-2, IEC60601-1-6, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, IEC61675-1, NEMA XR-25, NEMA XR-26, NEMA XR-29 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. Additional bench testing was conducted and it was determined that use of CaLM Reconstruction resulted in images with improved Signal-to-Noise Ratio, and reduced noise while preserving detail and contrast, Point Spread Function (PSF) correction resulted in images with better contrast, reduced noise and improved spatial resolution, and that using PET Respiratory and Cardiac Gating improved image quality and allowed for the acquisition of multiple phase data sets.

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. Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 2, 2014, 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.

This 510(k) submission was prepared based upon the FDA Guidance for Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems.

18. CONCLUSION

Cartesion Prime, PCD-1000A, V10.7, 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.

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.