(60 days)
No
The summary describes a standard PET/CT imaging system and its technical specifications. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies.
No
The device is described as a diagnostic imaging system that gathers metabolic and functional information to assist in evaluation, detection, diagnosis, therapeutic planning, and therapeutic outcome assessment, but does not provide any therapeutic intervention itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can assist in the evaluation, detection, diagnosis, therapeutic planning and therapeutic outcome assessment".
No
The device description explicitly details hardware components (CT and PET systems, gantry, detector, sensors) and performance studies include hardware-related metrics (spatial resolution, sensitivity, NECR, energy/timing resolution).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: This device is an imaging system (PET/CT) that acquires images of the patient's body using radiopharmaceuticals and X-rays. It does not analyze samples taken from the body.
- Intended Use: The intended use describes gathering metabolic and functional information from the distribution of radiopharmaceuticals in the patient body and producing images. This is an in vivo (within the living organism) diagnostic process, not in vitro.
Therefore, this device falls under the category of medical imaging devices, not 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
KPS, JAK
Device Description
Cartesion Prime, PCD-1000A, 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 high-throughput PET system has a digital PET detector utilizing SiPM sensors with temporal resolution of 280 ps. Cartesion Prime, PCD-1000A 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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET), X-ray Computed Tomography (CT)
Anatomical Site
Whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained health care professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. PET image quality metrics were performed which validated that the subject device met established specifications for spatial resolution, sensitivity, NECR, energy/timing resolution and PET/CT alignment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Spatial resolution, sensitivity, NECR, energy/timing resolution
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Canon Medical Systems Corporation % Orlando Tadeo, Jr. Senior Manager, Regulatory Affairs Canon Medical Systems USA
August 13, 2019
Re: K191582
2441 Michelle Drive TUSTIN CA 92780
Trade/Device Name: Cartesion Prime, PCD-1000A Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: June 13, 2019 Received: June 14, 2019
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)
Device Name
Cartesion Prime, PCD-1000A
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, 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) | |
|---|---|
| [Z] Prescription Use (Part 21 CFR 801 Subpart D) | D Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
-
- SUBMITTER'S NAME: Canon Medical Systems 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
2. OFFICIAL CORRESPONDENT: Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
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:
June 12, 2019
6. TRADE NAME(S):
Cartesion Prime, PCD-1000A
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 |
|-----------------------------------------------------------------------|-------------------------------------|----------------------|----------------------------------------------|-----------------|------------------|-------------------|
| Celesteion,
PCA-9000A/3,
v6.5
Primary
Predicate
Device | Canon
Medical
Systems
USA | 21 CFR
892.1200 | Emission
Computed
Tomography
System | KPS | K181646 | November 16, 2018 |
| Discovery MI
Reference
Device | GE
Medical
Systems,
L.L.C. | 21 CFR
892.1200 | Emission
Computed
Tomography
System | KPS | K161574 | August 11, 2016 |
| Aquilion
Prime SP, TSX-
303B/1, v8.4
Reference
Device | Canon
Medical
Systems
USA | 21 CFR
892.1200 | 21 CFR
892.1750 | JAK | K172188 | October 6, 2017 |
12. REASON FOR SUBMISSION:
New medical device
13. DEVICE DESCRIPTION:
Cartesion Prime, PCD-1000A, 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 high-throughput PET system has a digital PET detector utilizing SiPM sensors with temporal resolution of 280 ps. Cartesion Prime, PCD-1000A 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 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.
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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.
15. SUBSTANTIAL EQUIVALENCE:
Cartesion Prime, PCD-1000A, is substantially equivalent to the primary predicate device, Celesteion, PCA-9000A/3, V6.5, which received premarket clearance under K181646 and is marketed by Canon Medical Systems USA. Both systems have the same indications for use and intended use. Cartesion Prime, PCD-1000A, implements all of the software features previously cleared with the Celesteion, PCA-9000A/3, V6.5 under K181646. One difference between these devices is that the Cartesion Prime, PCD-1000A, PET detector incorporates digital silicone photomultiplier sensors versus the analog, photomultiplier tubes utilized in the PET detector of the primary predicate device. The digital sensors in the subject device are substantially equivalent to those previously cleared with the reference device, Discovery MI, K161574. Another difference is the CT portion used with the subject device is substantially equivalent to the reference device Aquilion Prime SP, K172188. The imaging chain including but not limited to the X-ray tube, detector and data acquisition system of the CT portion is identical to that of the Aquilion Prime SP; however the subject device includes an upgraded computer system with Windows 10. See below for a brief comparison of the technological characteristics between the subject device, primary predicate device and reference devices.
| Item | Cartesion Prime
PCD-1000A | Celesteion
PCA-9000A/3,V6.5 | Discovery MI | Aquilion Prime SP |
|--------------------------------|------------------------------|--------------------------------|----------------------------|-------------------|
| 510(k) Number | This submission | K181646 | K161574 | K172188 |
| PET Specifications | | | | |
| Sensitivity (cps/kBq) | >13 | ≥3.6 | 13.5 | |
| Count rate maximum NECR | >130 kcps
@