(14 days)
Imaging of:
- The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging. ]
- . Fluid Visualization
- . 2D / 3D Imaging
- MR Angiography / MR Vascular Imaging .
- Blood Oxygenation Level Dependent (BOLD) imaging .
- Perfusion / Diffusion Imaging .
- Proton Spectroscopy .
The EXCELART Vantage Atlas is a 1.5 tesla Magnetic Resonance Imaging (MRI) System. The Atlas has a 1.4 m short magnet (55 cm field of view) and includes Toshiba's Pianissimo™ technology (scan noise reduction technology). The wide bore has a 655 mm opening.
There are two models in the EXCELART Vantage Atlas line as follows:
• EXCELART Vantage Atlas-Z Model No. MRT-1503/S3
• EXCELART Vantage Atlas-X Model No. MRT-1503/S3
The EXCELART Vantage Atlas MRI System is comparable to the EXCELART Vantage ZGV MRI System (K060003, cleared January 18, 2006) with the following modifications:
- . 16 Channel phased array system control
- . CPU performance of the computer system has been enhanced
- The longitudinal movement of the patient couch has been increased
- . Additional table top coil ports
- . Additional RF coils – Atlas SPEEDER Head, Atlas SPEEDER Spine, and Atlas SPEEDER Body)
- SAR limit is 4 W/kg for whole body in conformance with IEC 60601-2-33 (2002)
The provided 510(k) summary for the EXCELART Vantage Atlas MRI system (K063361) indicates that this device is a modification of a previously cleared device, the EXCELART Vantage ZGV MRI System (K060003). Therefore, the submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with specific acceptance criteria and detailed performance metrics comparing it to a ground truth.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not contain explicit acceptance criteria in the form of quantitative performance targets (e.g., sensitivity, specificity, accuracy, or image quality metrics) against a specific ground truth. Instead, the acceptance is based on demonstrating that the modified device maintains the safety and imaging performance of its predicate device, subject to specific hardware and software changes.
The "performance" is implicitly demonstrated through the declaration that "No changes from the previous submission, K060003" for both "IMAGING PERFORMANCE PARAMETERS" and "INTENDED USE." This means the device is expected to perform at least comparably to the predicate device, which would have had its own performance established during its clearance.
Therefore, a table cannot be directly constructed for acceptance criteria and reported device performance for this specific 510(k) in the way one might for a software algorithm with diagnostic outputs.
The primary change that might be considered an "acceptance criterion" related to safety is:
| Acceptance Criterion (Safety) | Reported Device Performance (K063361) |
|---|---|
| Maximum SAR (Whole Body, 1st operating mode, IEC 60601-2-33 (2002)) | 4 W/kg (This is an increase from the predicate's 3 W/kg, but still within safety standards) |
| Other Safety Parameters (Static Field Strength, Acoustic Noise, dB/dt, Emergency Shutdown, Biocompatibility) | Same as predicate device (EXCELART Vantage ZGV) |
| Imaging Performance Parameters | Same as predicate device (EXCELART Vantage ZGV) |
| Intended Use | Same as predicate device (EXCELART Vantage ZGV) |
2. Sample size used for the test set and the data provenance
The document does not describe a specific test set in terms of patient data or images used to evaluate the new device's imaging performance. The substantial equivalence argument relies on the inherent design and engineering principles, stating "No changes from the previous submission, K060003" for imaging performance. This implies that if any testing was done beyond engineering verification, it would have been at the component or system level, not necessarily on a distinct patient image dataset with a ground truth.
Given the nature of the submission (hardware/software modifications to an existing MRI system), rigorous clinical image-based testing on a test set with human readers is not explicitly detailed. The provenance of such data, if it existed, is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no specific clinical test set for performance evaluation is described, there is no mention of experts establishing ground truth for such a set within this document.
4. Adjudication method for the test set
Since no specific clinical test set for performance evaluation is described, no adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done or reported in this 510(k) submission. This is consistent with the device being a hardware/software update to an MRI system itself, rather than an AI-driven image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done or reported. The device is an MRI system, not an independent algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the nature of the submission (modifications to an existing MRI machine), the concept of "ground truth" in the diagnostic performance sense is not applicable to this document's scope. The "truth" being established is that the modified system retains the safety and imaging capabilities of the predicate device, which would likely have been verified through engineering tests, phantom studies, and potentially limited clinical scans, rather than large-scale diagnostic accuracy studies.
8. The sample size for the training set
No training set is mentioned or applicable for this device. This is a hardware/software update to a medical imaging device, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
In summary, this 510(k) submission is for modifications to a previously cleared MRI system. The "acceptance criteria" and "proof" of meeting them primarily revolve around demonstrating that the changes (increased channel count, CPU enhancement, new coils, increased SAR limit) do not negatively impact the established safety and performance of the predicate device, or that any changes remain within acceptable regulatory limits (e.g., increased SAR is still compliant with IEC standards). There is no indication of a new clinical performance study with a test set, experts, or ground truth establishment as would be typical for a novel diagnostic device or AI algorithm.
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K06336/
510(k) Premarket No Excelart Vantage™ Atlas Z, Atlas X
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
NOV 2 1 2006
| 1. Device Name | Magnetic Resonance Diagnostic Device Accessor | |
|---|---|---|
| Model Name: | MRT 1503/S5, MRT-1503/S3 | |
| Trade/Proprietary Name | EXCELART Vantage Atlas-Z, Atlas-X | |
| 2. Establishment Registration No.: | 2020563 | |
| 3. U.S Agent Name and Address: | Toshiba America Medical Systems, Inc. | |
| 2441 Michelle Drive | ||
| Tustin, CA 92780 | ||
| Contact Person: | Paul Biggins | |
| (714) 730-5000 | ||
| 4. Manufacturing Site: | Toshiba Corporation | |
| Medical Systems Company | ||
| 1385 Shimoishigami | ||
| Otawara-shi, Tochigi 32408550, Japan | ||
| 5. Date of Submission: | November 1, 2006 |
6. DEVICE DESCRIPTION
The EXCELART Vantage Atlas is a 1.5 tesla Magnetic Resonance Imaging (MRI) System. The Atlas has a 1.4 m short magnet (55 cm field of view) and includes Toshiba's Pianissimo™ technology (scan noise reduction technology). The wide bore has a 655 mm opening.
There are two models in the EXCELART Vantage Atlas line as follows:
| • EXCELART Vantage Atlas-Z | Model No. MRT-1503/S3 |
|---|---|
| • EXCELART Vantage Atlas-X | Model No. MRT-1503/S3 |
The EXCELART Vantage Atlas MRI System is comparable to the EXCELART Vantage ZGV MRI System (K060003, cleared January 18, 2006) with the following modifications:
- . 16 Channel phased array system control
- . CPU performance of the computer system has been enhanced
- The longitudinal movement of the patient couch has been increased
- . Additional table top coil ports
- . Additional RF coils – Atlas SPEEDER Head, Atlas SPEEDER Spine, and Atlas SPEEDER Body)
- SAR limit is 4 W/kg for whole body in conformance with IEC 60601-2-33 (2002)
{1}------------------------------------------------
6.1. Summary Of Major Hardware Changes
- a. Maximum supported phased array channel has been increased from 8 to 16.
- b. CPU performance of computer system has been enhanced.
- c. Patient couch longitudinal movement has been increased.
- d. Table top coil ports have been added.
- e. Atlas SPEEDER Head and Atlas SPEEDER Spine and Atlas SPEEDER Body are added to the available coil list.
6.2. Summary Of Major Software Changes
- a. 16 channel phased array system control.
- b. New CPU correspondence.
- c. New patient couch control.
- d. New RF coil control.
- e. SAR limitation control.
7. SAFETY PARAMETERS
| Current EXCELART Vantage™ZGV (No changes from theprevious submission, K060003 ) | New EXCELARTVantageAtlas-Z/Atlas-X | |
|---|---|---|
| a. Static Field Strength: | 1.5 T | Same |
| b. Peak and A-weighted AcousticNoise: | 110 dB (A-weighted) | Same |
| c. Operational Modes: | 1st operating mode for dB/dt andSAR | Same |
| i. Safety Parameter Display: | SAR, dB/dt | Same |
| ii. Operating mode accessrequirements: | Allows access to 1st level operatingmode | Same |
| d. Maximum SAR | 3W/kg for whole body (1stoperating mode specified in IEC60601-2-33 (2002)) | 4W/kg for whole body(1st operating modespecified in IEC60601-2-33 (2002)) |
| e. Maximum dB/dt and GradientCoil Dimensions: | <1st operating mode specified inIEC 60601-2-33 (2002)692 x 893 x 1405(unit: mm) | Same |
| f. Potential Emergency Conditionsand Means Provided forShutdown: | Shut down by Emergency RampDown Unit for collision hazard byferromagnetic objects | Same |
| g. Biocompatibility of Materials: | Not applicable | Same |
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8. IMAGING PERFORMANCE PARAMETERS
No changes from the previous submission, K060003 .
9. INTENDED USE
No changes from the previous submission, K060003 .
10. EQUIVALENCY INFORMATION
Toshiba Medical Systems Corporation believes that the new EXCELART Vantage Atlas-Z and Atlas-X (model MRT-1503/S3, MRT-1503/S3) Magnetic Resonance Imaging (MRI) system are substantially equivalent to the current EXCELART Vantage™ ZGV (model MRT-1503/PS) (K060003 ) cleared on January 18, 2006.
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Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN..." arranged around the left side of the circle. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers. The image is black and white and appears to be a scan or photocopy, given the slightly rough texture and uneven contrast.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NOV 2 1 2006
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 26th Street NW BUFFALO MN 55313
Re: K063361
Trade/Device Name: EXCELART Vantage Atlas Model MRT-1503 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 4, 2006 Received: November 7, 2006
Dear Mr. Job:
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 Cometic 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006". The letters "FDA" are prominently displayed in the center of the logo. Three stars are located below the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
{4}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso or has made a determination that your device complies with other requirements of the Act that . Federal statutes and regulations administered by other Federal agencies. You must or uny with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms teter notification. The FDA finding of substantial equivalence of your device to a legally premiered predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 1
Indications for Use
510(k) Number (if known):
Device Name: EXCELART Vantage Atlas-Z, EXCELART Vantage Altas-X
Indications for Use:
Imaging of:
- The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging. ]
- . Fluid Visualization
- . 2D / 3D Imaging
- MR Angiography / MR Vascular Imaging .
- Blood Oxygenation Level Dependent (BOLD) imaging .
- Perfusion / Diffusion Imaging .
- Proton Spectroscopy .
Prescription Use (Part 21 CFR 801Subpart D)
OR
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sion-Off Division of Reproductive, Ab and Radiological Devices 5 10lk) Number _
§ 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.