(81 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 Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynavic Scan and Cine Imaging.] - -Fluid Visualization - ・ 2D/3D Imaging - MR Angiography/MR Vascular Imaging -
Versions 2 (V2) software is a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images.
The provided text is a summary of a 510(k) Premarket Notification for a software upgrade (Versions 2 (V2) software) for an existing Magnetic Resonance Diagnostic Device Accessory, the OPART™ (MRT-600). The submission focuses on demonstrating substantial equivalence to the previously cleared OPART™ system (K962933) and does not detail a study or specific acceptance criteria for a new device's performance.
Instead, the document asserts that the modifications and new sequences in V2 software do not "raise new questions of safety or efficacy" and do not introduce "any new indications for use." This type of submission relies on the established safety and efficacy of the predicate device, rather than requiring new performance studies with detailed acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study proving device performance cannot be extracted from the provided text because such a study was not performed or described. The submission's core argument is that the changes are minor and do not necessitate new performance data.
However, I can extract information related to the device and its intended use:
Device Information from the document:
- 1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as this is a software upgrade claiming substantial equivalence. The "acceptance criteria" here implicitly refer to maintaining the performance and safety profiles of the predicate device (OPART™ K962933).
- Reported Device Performance: The document provides "Imaging Performance Parameters" for the system, not specifically for the V2 software upgrade's new features. This suggests these are the general capabilities of the MR system.
| Parameter | Specification |
|---|---|
| Safety Parameters | |
| Maximum static field strength | 0.35 Tesla |
| Rate of change of magnetic field | 19T/second |
| Maximum radio frequency power deposition (SAR) | <0.4 Watt/kg |
| Acoustic noise levels (maximum) | 98.4 dB(A) |
| Imaging Performance Parameters | |
| Specification volume (Head) | 10cm dsv |
| Specification volume (Body) | 20cm dsv |
| Intended Use | |
| Anatomical regions | Head, body, extremity, spine, neck, TMJ, breast, and heart |
| Nuclei excited | Hydrogen |
| Diagnostic use | Diagnostic imaging of the human body (including head, abdomen, breast, heart, pelvis, spine, blood vessels, limbs, and extremities), fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy. |
-
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. The submission states "Sample phantom images and clinical images are presented for new sequences" but does not detail a formal test set, sample size, or data provenance. This aligns with a substantial equivalence claim for a software upgrade.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth establishment for a test set is not described.
-
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods for a test set are not described.
-
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. This device is a software upgrade for an MRI system, not an AI-assisted diagnostic tool.
-
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is an MRI system software upgrade, not an algorithm being tested for standalone performance. "Sample phantom images and clinical images" were presented, which would be an algorithm-only output, but no formal standalone study is described.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. No specific ground truth methodology is detailed for the "sample clinical images."
-
8. The sample size for the training set:
- Not applicable/Not provided. As this is not an AI/machine learning submission, there is no mention of a training set.
-
9. How the ground truth for the training set was established:
- Not applicable/Not provided. No training set is mentioned.
{0}------------------------------------------------
510(k) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS
2636923
Bruce Clark
-
- DEVICE NAME: Model Number: Trade/Proprietary Name:
Magnetic Resonance Diagnostic Device Accessory MRT-600 OPART™
- DEVICE NAME: Model Number: Trade/Proprietary Name:
ESTABLISHMENT REGISTRATION: 2.
- U.S. AGENT NAME AND ADDRESS: 3.
CONTACT PERSON:
MANUFACTURING SITE: 4.
-
- DATE OF SUBMISSION:
- DEVICE DESCRIPTION: (650)872-2722 ext. 6068
280 Utah Avenue
Toshiba America MRI, Inc.
Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080
South San Francisco, CA 94080
April 20, 1998
Versions 2 (V2) software is a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images.
0.35 Tesla
7.
SAFETY PARAMETERS: Maximum static field strength:
Rate of change of magnetic field: 19T/second Maximum radio frequency power deposition (SAR): <0.4 Watt/kg Acoustic noise levels (maximum): 98.4 dB (A)
| 8. | IMAGING PERFORMANCE PARAMETERS: | |||
|---|---|---|---|---|
| Specification volume: | Head: | 10cm dsv | ||
| Body: | 20cm dsv |
Sample phantom images and clinical images are presented for new sequences.
9. INTENDED USE
Anatomical regions: Head, body, extremity, spine, neck, TMJ, breast, and heart Nuclei excited: Hydrogen Diagnostic use: Diagnostic imaging of the human body (including head, abdomen, breast, heart, pelvis, spine, blood vessels, limbs, and extremities), fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.
{1}------------------------------------------------
EQUIVALENCY INFORMATION: 10.
:
Toshiba America MRI, Inc., believes that the Versions 2 (V2) software upgrade for OPART™ system is substantially equivalent to the software which was cleared with the initial OPART™ system (K962933). The modifications added to the Versions 2 (V2) software do not raise new questions of safety or efficacy. This software does not introduce any new indications for use from those cleared in the Premarket Notification for OPART™ diagnostic resonance system 510(k) number K962933.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUI 1 1998
Bruce Clark Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco. CA 94080 Re:
Version 2 Software Upgrade for OPART™ MRI System Dated: April 23, 1998 Received: April 24, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Clark:
We have reviewed your Section 510%) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendoments, or to devices that have been reclassified in accordance with the provisions of the Federal. Food, Drug, and Cosmenc Act (Act). 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 proctice, labeling, against misbranding and adulteration.
If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic OS inspections the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,
This letter will allow you to begin marketing your device as described in your S10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed prodicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page __ 1___ of ______________________________________________________________________________________________________________________________________________________________
| 510(k) Number (if known): | R98 1475 |
|---|---|
| Device Name: | OPART TM (MRT-600) Versions 2 Software Upgrade |
| Indications for Use: | (unchaged from initial OPART TM system K962933) |
| 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 Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynavic Scan and Cine Imaging.]
- -Fluid Visualization
- ・ 2D/3D Imaging
- MR Angiography/MR Vascular Imaging -
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K981475 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR§801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
(Optional Format 1-2-96)CONFIDENTIAL
§ 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.