(58 days)
No
The summary describes standard image reconstruction and processing techniques for PET/CT systems (computer reconstruction, attenuation correction, image fusion, PSF correction, gating) but does not mention AI or ML. The performance studies focus on traditional image quality metrics and reconstruction methods.
No
The device is described as a diagnostic imaging system that gathers information for evaluation, detection, diagnosis, staging, and therapeutic planning/outcome assessment, but it does not directly treat or cure any conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device can assist in the "evaluation, detection, diagnosis, staging, restaging, follow-up, therapeutic planning and therapeutic outcome assessment" of various diseases. Furthermore, the "Device Description" also mentions its use for "research, detection, localization, diagnosis, staging, restaging, follow-up of diseases and disorders". These are all diagnostic functions.
No
The device description explicitly states it is a system that combines hardware components (PET and CT scanners) to acquire images. While it includes software for image reconstruction and processing, it is not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. The device described is an imaging system that acquires data from within the patient's body (in vivo) using PET and CT technologies.
- The intended use and device description clearly state that it images the distribution of radiopharmaceuticals in the patient body and produces cross-sectional images of the body. This is characteristic of in vivo imaging devices, not IVDs.
- The device is used to gather metabolic and functional information from the distribution of the radiopharmaceutical in the body. This further reinforces its in vivo nature.
Therefore, this device falls under the category of medical imaging systems rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KPS, JAK
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
§ 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.
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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
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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
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Indications for Use
510(k) Number (if known) K202349
Device Name
Cartesion Prime, PCD-1000A, V10.7
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 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.
| 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)
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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
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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 | Marketed
by | Regulation
Number | Regulation
Name | Product
Code | 510(k)
Number | Clearance Date |
|--------------------------------------------------------------------|------------------------------------|----------------------|----------------------------------------------|-----------------|------------------|-------------------|
| Cartesion Prime,
PCD-1000A Primary
Predicate Device | Canon
Medical
Systems
USA | 21 CFR
892.1200 | Emission
Computed
Tomography
System | KPS | K191582 | August 13, 2019 |
| Celesteion, PCA-
9000A/3, v6.5
Reference Predicate
Device | Canon
Medical
Systems
USA | 21 CFR
892.1200 | Emission
Computed
Tomography
System | KPS | K181646 | November 16, 2018 |
12. REASON FOR SUBMISSION:
Modification of a cleared device
13. 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 160 kcps | > 130 kcps@ 600 kcps | > 300 kcps@