(147 days)
Unknown
The summary mentions "computer reconstruction" and "CaLM Reconstruction" which could potentially involve AI/ML, but there is no explicit mention of AI, ML, or related terms like deep learning or neural networks. The description of performance studies focuses on noise reduction and image quality, which can be achieved through various image processing techniques, not exclusively AI/ML.
No
The device is described as a diagnostic imaging system that gathers information to assist in evaluation, detection, diagnosis, therapeutic planning, and outcome assessment, but does not provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the information gathered by the device "can assist in the evaluation, detection, diagnosis, therapeutic planning and therapeutic outcome assessment of (but not limited to) cancer, cardiovascular disease and brain dysfunction." The term "diagnosis" clearly indicates it is a diagnostic device.
No
The device description clearly states it is a "large bore, TOF, PET-CT system" and describes physical components like a gantry aperture and detector, indicating it is a hardware device with integrated 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 (like blood, urine, tissue). This device is an in vivo imaging system that scans the patient's body directly.
- The intended use and device description clearly state it images the distribution of radiopharmaceuticals in the patient body and produces cross-sectional images of the body. This is a direct interaction with the patient, not an analysis of a sample outside the body.
- The device description focuses on the hardware and its capabilities for acquiring images of the patient.
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 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.
Product codes
KPS, JAK
Device Description
Celesteion, PCA-9000A/3, V6.5, 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, V6.5 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)
Bench testing utilizing phantoms were conducted and it was determined that use of CaLM Reconstruction resulted in images with reduced noise while preserving detail and contrast. Representative clinical images were acquired to demonstrate that the subject device is capable of obtaining multi-phase, PET ECG gated data and that the new feature performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
November 16, 2018
Canon Medical Systems Corporation % Orlando Tadeo Sr. Manager, Regulatory Affairs 2441 Michelle Drive TUSTIN CA 92780
Re: K181646
Trade/Device Name: Celesteion, PCA-9000A/3, V6.5 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: October 17, 2018 Received: October 18, 2018
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 mav, 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 avare 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hol 2. Nils
for Robert A. 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
K 181646
510(k) Number (if known)
Device Name
Celesteion, PCA-9000A/3, v6.5
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)
ك 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
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 21, 2018
6. TRADE NAME(S):
Celesteion, PCA-9000A/3, V6.5
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
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 | Marketed
by | Regulation
Number | Regulation
Name | Product
Code | 510(k)
Number | Clearance
Date |
|-------------------------------------|------------------------------------|----------------------|----------------------------------------------|-----------------|------------------|-------------------|
| Celesteion,
PCA-9000A/3,
v6.4 | Canon
Medical
Systems
USA | 21 CFR
892.1200 | Emission
Computed
Tomography
System | KPS | K170490 | June 1, 2017 |
12. REASON FOR SUBMISSION:
Modification to existing device
13. DEVICE DESCRIPTION:
Celesteion, PCA-9000A/3, V6.5, 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, V6.5 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.
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,
5
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:
Celesteion, PCA-9000A/3, V6.5, is substantially equivalent to Celesteion, PCA-9000A/3, V6.4, which received premarket clearance under K170490 and is marketed by Canon Medical Systems USA. The Celesteion, PCA-9000A/3, V6.5, incorporates modifications to the cleared device including a modification to the existing respiratory gating system to improve workflow, implementation of a new PET ECG gating system, and two new features, Variable Bed Time (vBT) and Clear Adaptive Low-Noise Method (CaLM) Reconstruction. 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 device:
| Item | Celesteion, PCA-9000A/3, V6.5 | Celesteion, PCA-9000A/3, V6.4 |
|---|---|---|
| 510(k) Number | This submission | K170490 |
| Variable bed time (vBT) | Available | N/A |
| CaLM (Clear adaptive Low-noise | ||
| Method Reconstruction) | Available | N/A |
| PET Respiratory Gating System | ||
| (NKRS-001A) | Available | |
| -Workflow Improvement | Available | |
| PET ECG gating | ||
| (NHEG-001A) | Available | N/A |
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.
6
Bench testing utilizing phantoms were conducted and it was determined that use of CaLM Reconstruction resulted in images with reduced noise while preserving detail and contrast. Representative clinical images were acquired to demonstrate that the subject device is capable of obtaining multi-phase, PET ECG gated data and that the new feature performs as intended.
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.
18. CONCLUSION
Celesteion, PCA-9000A/3, V6.5, 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.