(58 days)
Not Found
No
The document describes a standard MRI system and does not mention AI, ML, or related terms in the device description, intended use, or performance studies.
No
The device is described as a diagnostic imaging modality that produces images for diagnosis, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Vantage Titan 3T systems are "indicated for use as a diagnostic imaging modality" and that the images produced "yield information that can be useful in diagnosis."
No
The device description explicitly states it is a "3 Tesla Magnetic Resonance Imaging (MRI) System," which is a hardware device. The summary describes the system's capabilities in acquiring and displaying images, which are functions of the hardware.
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: The Vantage Titan 3T system is a Magnetic Resonance Imaging (MRI) system. It produces images of the internal structures of the body by using magnetic fields and radio waves. This is an in vivo (within the living body) imaging modality, not an in vitro test.
- Intended Use: The intended use clearly states it's a "diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body." This describes an imaging process, not a test performed on a sample outside the body.
- Device Description: The description confirms it's an MRI system, which is an imaging device.
Therefore, the Vantage Titan 3T system falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
- Proton density (PD) (also called hydrogen density)
- Spin-lattice relaxation time (T1)
- Spin-spin relaxation time (T2)
- Flow dynamics ●
- Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K143008. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
head or body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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 both phantom and representative clinical images were obtained to demonstrate the subject device is capable of reducing metal related artifacts on MR images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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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 and 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 % Mr. Orlando Tadeo Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780
June 26, 2019
Re: K191128
Trade/Device Name: Vantage Titan 3T, MRT-3010/A5, V2.50 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: April 26, 2019 Received: April 29, 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
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191128
Device Name Vantage Titan 3T, MRT-3010/A5, V2.50
Indications for Use (Describe)
Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
- ·Proton density (PD) (also called hydrogen density)
- ·Spin-lattice relaxation time (T1)
- ·Spin-spin relaxation time (T2)
- ·Flow dynamics
- ·Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
| 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 OMB number."
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Image /page/3/Picture/0 description: The image contains the logo for Canon Medical Systems USA, Inc. The word "Canon" is written in red, with the rest of the text in black. The text is left-aligned and appears to be a company logo.
Made For life
K191128
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92
1. CLASSIFICATION and DEVICE NAME
| Classification Name: | Magnetic Resonance Diagnostic Device |
|---|---|
| Regulation Number: | 90-LNH (Per 21 CFR § 892.1000) |
| Trade Proprietary Name: | Vantage Titan 3T |
| Model Number: | MRT-3010/A5, V2.50 |
2. SUBMITTER'S NAME
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
3. OFFICIAL CORRESPONDENT
Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance Canon Medical Systems Corporation
4. CONTACT PERSON, U.S. AGENT and ADDRESS
Contact Person
Janine F. Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7853 Fax: (714) 730-1310 E-mail: jfreyes@us.medical.canon
Official Correspondent/U.S. Agent
Paul Biggins Senior Director, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-7808 Fax: (714) 730-1310 E-mail: pbiggins@us.medical.canon
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EDICAL SYSTEMS USA, INC.
Made For life
-
- MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
-
- ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED April 26, 2019
-
- DEVICE NAME Vantage Titan 3T, MRT-3010/A5, V2.50
-
- TRADE NAME
Vantage Titan 3T, MRT-3010/A5, V2.50
10. CLASSIFICATION NAME
Magnetic Resonance Diagnostic Device (MRDD)
11. CLASSIFICATION PANEL
Radiology
12. DEVICE CLASSIFICATION
Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)
13. PRODUCT CODE
90-LNH
14. PREDICATE DEVICE
Predicate Device (system): Vantage Titan 3T, MRT-3010/A5, V2.50
| System | Subject | Predicate Device |
|---|---|---|
| Vantage Titan 3T, MRT-3010/A5, V2.50 | Vantage Titan 3T, MRT-3010/A5, V2.50 | |
| Marketed By | Canon Medical Systems USA, Inc. | Canon Medical Systems USA, Inc. |
| 510(k) Number | This Submission | K143008 |
| Clearance Date | April 9th, 2015 |
15. REASON FOR SUBMISSION
Modification of a cleared device
16. SUBMISSION TYPE
Traditional 510(k) Premarket Notification
2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968 https://us.medical.canon
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CAL SYSTEMS USA, INC.
Made For life
17. DEVICE DESCRIPTION
The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K143008. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
18. SUMMARY OF CHANGE(S)
This submission is to report the following software functionalities have been added:
- mART: Metal Artifact Reduction Technique ●
- mART+: Metal Artifact Reduction Technique with the addition of View Angle Tilting (VAT) ●
19. SAFETY PARAMETERS
| Item | Subject Device:
Vantage Titan 3T,
MRT-3010/A5, V2.50 | Predicate Device:
Vantage Titan 3T,
MRT-3010/A5, V2.50 | Notes |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------|
| Static field strength | 3T | 3T | Same |
| Operational Modes | Normal and 1st Operating Mode | Normal and 1st Operating Mode | Same |
| i. Safety parameter display | SAR, dB/dt | SAR, dB/dt | Same |
| ii. Operating mode access
requirements | Allows screen access to 1st level
operating mode | Allows screen access to 1st level
operating mode | Same |
| Maximum SAR | 4W/kg for whole body (1st operating
mode specified in IEC 60601-2-33:
2010 +A1:2013) | 4W/kg for whole body (1st operating
mode specified in IEC 60601-2-33:
2010 +A1:2013) | Same |
| Maximum dB/dt | 1st operating mode specified in IEC
60601-2-33: 2010 +A1:2013 | 1st operating mode specified in IEC
60601-2-33: 2010 +A1:2013 | Same |
| Potential emergency
condition and means
provided for shutdown | Shutdown by Emergency Ramp Down
Unit for collision hazard for
ferromagnetic objects | Shutdown by Emergency Ramp
Down Unit for collision hazard for
ferromagnetic objects | Same |
20. IMAGING PERFORMANCE PARAMETERS
No change from the previous predicate submission, K143008.
21. INDICATIONS FOR USE
Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
6
DICAL SYSTEMS USA, INC.
Made For life
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
- Proton density (PD) (also called hydrogen density)
- Spin-lattice relaxation time (T1)
- Spin-spin relaxation time (T2)
- Flow dynamics ●
- Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
22. SUMMARY OF DESIGN CONTROL ACTIVITIES
Design controls for the software functionalities were conducted under K143008. The functionalities in this submission are embedded in software version 2.5. There are no new design control activities to report as part of this device modification.
23. SAFETY
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards.
This device is based upon the same technologies, materials and software as the predicate device. Risk activities were conducted in concurrence with established medical device development standards and guidance. Additionally, testing was done in accordance with applicable recognized consensus standards published by the International Electrotechnical Commission (IEC) for medical devices and the National Electrical Manufacturers Association (NEMA):
LIST OF APPLICABLE STANDARDS
- IEC60601-1 (2005), Amd.1 (2012) ●
- IEC60601-1-2 (2007)
- IEC60601-1-8 (2006), Amd.1 (2012)
- IEC60601-2-33 (2010), Amd.1 (2013) ●
- IEC60825-1 (2007) ●
- IEC62304 (2006)
- IEC62366 (2007), Amd.1 (2014)
- NEMA MS 1 (2008) ●
- NEMA MS 2 (2008)
- NEMA MS 3 (2008)
- NEMA MS 4 (2010) ●
- NEMA MS 5 (2010)
24. TESTING
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, was included in K143008.
PHONE: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780 https://us.medical.canon
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Made For life
Bench testing utilizing both phantom and representative clinical images were obtained to demonstrate the subject device is capable of reducing metal related artifacts on MR images.
25. SUBSTANTIAL EQUIVALENCE
Canon Medical Systems Corporation believes that the Vantage Titan 3T, MRT-3010/A5, V2.50 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device, Vantage Titan 3T, MRT-3010/A5, V2.50, referenced in this submission. Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Titan 3T, MRT-3010/A5, V2.50 are substantially equivalent to the previously cleared predicate device.
26. CONCLUSION
The implementation of mART and mART+ on the Vantage Titan 3T, MRT-3010/A5, V2.5 software do not change the indications for use or the intended use of the device. Based upon bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.