(164 days)
Not Found
Yes
The document explicitly mentions "deep learning artificial neural network methods" and the "AiCE algorithm" which is described as employing these methods to improve image quality and reduce noise in PET images.
No
The device is described as a "diagnostic imaging system" used to "gather metabolic and functional information" for "evaluation, detection, localization, diagnosis, staging, follow-up, therapeutic planning and therapeutic outcome assessment" of diseases. It does not actively treat or mitigate disease.
Yes
The "Intended Use" section explicitly states that the device can assist in the "diagnosis" of various diseases and disorders. Additionally, the “Device Description” states that the device is used to assist “research, detection, localization, evaluation, diagnosis, staging, follow-up of diseases and disorders”.
No
The device description clearly states it is a combined PET and CT system, which are hardware components. While it includes software (AiCE-i for PET) for image processing, the device itself is a physical imaging system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples outside the body. The definition of an IVD involves examining specimens such as blood, urine, or tissue in a laboratory setting.
- This device is an in vivo diagnostic imaging system. It directly images the distribution of radiopharmaceuticals within the patient's body to gather information about metabolic and physiologic functions. This process happens inside the living patient.
The device's function is to acquire and process images generated from within the patient, not to analyze samples taken from the patient. Therefore, it falls under the category of medical imaging devices, not IVDs.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
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 radiopharmacenticals 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 function 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.
AiCE-i for PET is intended to improve image quality and reduce image noise for FDG whole body data by employing deep learning artificial neural network methods which can explore the statistical properties of PET data. The AiCE algorithm can be applied to improve image quality and denoising of PET images.
Product codes (comma separated list FDA assigned to the subject device)
KPS, JAK
Device Description
Cartesion Prime (PCD-1000A) V10.8 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 scan field of view (FOV) of 700 mm. The high-throughput 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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April 23, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K203314
Trade/Device Name: Cartesion Prime (PCD-1000A/3) V10.8 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: March 23, 2021 Received: March 24, 2021
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) K203314
Device Name Cartesion Prime (PCD-1000A/3) V10.8
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 radiopharmacenticals 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 function 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.
AiCE-i for PET is intended to improve image quality and reduce image noise for FDG whole body data by employing deep learning artificial neural network methods which can explore the statistical properties of PET data. The AiCE algorithm can be applied to improve image quality and denoising of PET images.
| 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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AL SYSTEMS USA, INC.
Made For life
510(k) SUMMARY
1. SUBMITTER'S NAME:
Fumiaki Teshima Senior Manager, Quality Assurance Department Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
2. ESTABLISHMENT REGISTRATION: 9614698
3. OFFICIAL CORRESPONDENT/CONTACT PERSON:
Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459
4. Date Prepared:
November 6, 2020
5. TRADE NAME(S):
Cartesion Prime (PCD-1000A/3) V10.8
6. COMMON NAME:
System, X-ray, Computed Tomography System, Emission Computed Tomography
7. DEVICE CLASSIFICATION:
Class II (per 21 CFR 892.1750, Computed Tomography X-ray System and 21 CFR §892.1200, Emission Computed Tomography System)
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8. PRODUCT CODE / DESCRIPTION:
90JAK / Computed Tomography X-Ray System 90KPS / Emission Computed Tomography System
9. PERFORMANCE STANDARD:
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]
10. PREDICATE DEVICE:
| Product | Marketed
by | Regulation
Number | Regulation
Name | Product
Code | 510(k)
Number | Clearance Date |
|--------------------------------------|------------------------------------|----------------------|----------------------------------------------|-----------------|------------------|------------------|
| Cartesion Prime,
PCD-1000A, V10.7 | Canon
Medical
Systems
USA | 21 CFR
892.1200 | Emission
Computed
Tomography
System | KPS | K202349 | October 15, 2020 |
11. REASON FOR SUBMISSION:
Modification of a cleared device
12. DEVICE DESCRIPTION:
Cartesion Prime (PCD-1000A) V10.8 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 scan field of view (FOV) of 700 mm. The high-throughput PET system has a digital PET detector utilizing SiPM sensors with temporal resolution of