(174 days)
Imaging of:
- The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities). [Application terms include MRCP (MR Cholangiopancreatography), 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
This submission consists of a software upgrade to the MRT-50GP/E2 (FLEXARTTM), MRT-50GP/H2 (FLEXARTTM/Hyper), MRT-150/F1 (VISARTTM), MRT-150/F2 (VISARTTM/Hyper)
Here's an analysis of the provided 510(k) summary relating to acceptance criteria and the study conducted:
Disclaimer: The provided document (K983110) is a 510(k) Premarket Notification summary from 1998 for a software upgrade to existing Magnetic Resonance Diagnostic Devices (FLEXART™ and VISART™). It focuses on demonstrating substantial equivalence to previously cleared devices. It primarily discusses safety parameters and imaging performance specifications rather than a typical clinical study with acceptance criteria for a new AI/CAD device.
This document predates widespread AI in medical imaging and the standard AI/CAD study structure. Therefore, many of the requested fields (like sample size for test/training sets, ground truth establishment methods, MRMC studies, effect sizes, and standalone performance) are not directly addressed in the provided text as they pertain to a different type of device evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the document, the "acceptance criteria" are more akin to specifications that the software upgrade maintains, and the "reported device performance" indicates that these specifications are met or comparable to the predicate devices.
| Parameter/Criteria | Acceptance Criteria (V3.5 s/w) | Reported Device Performance (V4.0 s/w) | Outcome/Met? |
|---|---|---|---|
| Safety Parameters | |||
| Maximum static field strength (FLEXART™) | 0.5 T | 0.5 T | Met |
| Maximum static field strength (VISART™) | 1.5 T | 1.5 T | Met |
| Rate of change of magnetic field (FLEXART™) | 11 T/sec. | 11 T/sec. | Met |
| Rate of change of magnetic field (FLEXART™/Hyper) | 13.3 T/sec. | 13.3 T/sec. | Met |
| Rate of change of magnetic field (VISART™) | 13.3 T/sec. | 13.3 T/sec. | Met |
| Rate of change of magnetic field (VISART™/Hyper) | 19.5 T/sec. | 19.5 T/sec. | Met |
| Maximum RF power deposition (FLEXART™) | <0.4 W/kg | <0.4 W/kg | Met |
| Maximum RF power deposition (VISART™) | <1.0 W/kg | <1.0 W/kg | Met |
| Acoustic noise levels (FLEXART™) | 100.2 dB(A) | 100.2 dB(A) | Met |
| Acoustic noise levels (FLEXART™/Hyper) | 98.5 dB(A) | 98.5 dB(A) | Met |
| Acoustic noise levels (VISART™) | 105.3 dB | 105.3 dB | Met |
| Acoustic noise levels (VISART™/Hyper) | 105.1 dB | 105.1 dB | Met |
| Imaging Performance Parameters | |||
| Specification volume: Head | 16cm dsv | 16cm dsv | Met |
| Specification volume: Body | 28cm dsv | 28cm dsv | Met |
| Functionality: New sequences (e.g., cardiac tagging, Cine imaging) | Not explicitly listed as "acceptance criteria" but included as new features | "Sample clinical images are presented for new sequences" and substantial equivalence claimed. | Implied Met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an algorithmic performance evaluation. The evaluation primarily relies on:
- Engineering specifications and measurements: For safety and imaging performance parameters (e.g., static field strength, SAR, acoustic noise, specification volume).
- Demonstration of "Sample clinical images": For new sequences. The number of images or patients is not specified.
- Comparison to predicate devices: The core of a 510(k) submission is to show substantial equivalence.
Data Provenance: Not explicitly stated, however, the manufacturing site is "Toshiba Corporation, Japan". The context suggests data would likely be from internal testing and validation, potentially clinical data from relevant medical sites if "sample clinical images" implies actual patient scans. It is retrospective in the sense that it's comparing against existing cleared versions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The evaluation focuses on engineering specifications and "sample clinical images" which are presented, but details on expert review or ground truth establishment are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the type of submission (software upgrade, substantial equivalence), a formal adjudication process for a clinical test set is not explicitly mentioned as being part of the presented summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported or described in the provided document. The submission is a 510(k) for a software upgrade, demonstrating substantial equivalence, not a comparative effectiveness study comparing human readers with and without AI assistance.
6. If a Standalone Performance Study Was Done
A standalone performance study in the context of evaluating an algorithm only without human-in-the-loop performance was not described or reported. This submission concerns a software upgrade to an MRI device, not an AI or CAD algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission primarily consists of:
- Engineering measurements and specifications: For safety and scanner performance parameters (e.g., measured static field strength, SAR, acoustic noise, image volume).
- Clinical observation/demonstration: "Sample clinical images" are presented to show the functionality and quality of new sequences. The specific type of "ground truth" for these images (e.g., pathology, clinical follow-up) is not specified.
8. The Sample Size for the Training Set
The concept of a "training set" in the context of machine learning is not applicable to this document. This submission does not describe an AI or machine learning device that requires a training set. It's a software upgrade to an existing MRI system.
9. How the Ground Truth for the Training Set Was Established
As stated in point 8, the concept of a "training set" is not applicable to this submission.
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K98 3110
510(k) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | DEVICE NAME:Model Number: | Magnetic Resonance Diagnostic Device AccessoryMRT-50GP /E2 (FLEXARTTM), /H2 (FLEXARTTM/Hyper)MRT-150 /F1 (VISARTTM), /F2 (VISARTTM/Hyper) | ||
|---|---|---|---|---|
| Trade/Proprietary Name: | FLEXARTTM, FLEXARTTM/Hyper, VISARTTM,VISARTTM/Hyper | |||
| 2. | ESTABLISHMENT REGISTRATION: | 2636923 | ||
| 3. | U.S. AGENT NAME AND ADDRESS: | Toshiba America MRI, Inc.280 Utah AvenueSouth San Francisco, CA 94080 | ||
| CONTACT PERSON: | Ken Nehmer(650)872-2722 ext. 6083 | |||
| 4. | MANUFACTURING SITE: | Toshiba Corporation1385 ShimoisigamiOtawara-shi, Tochigi-KenJapan 324 | ||
| 5. | DATE OF SUBMISSION: | September 1, 1998 | ||
| 6. | DEVICE DESCRIPTION: | This submission consists of a software upgrade to the MRT-50GP/E2 (FLEXARTTM), MRT-50GP/H2 (FLEXARTTM/Hyper),MRT-150/F1 (VISARTTM), MRT-150/F2 (VISARTTM/Hyper) | ||
| 7. | SAFETY PARAMETERS:Maximum static field strength: | FLEXARTTM &FLEXARTTM/Hyper | V3.5 s/w0.5 T | V4.0 s/w0.5 T |
| VISARTTM &VISARTTM/Hyper | 1.5T | 1.5T | ||
| Rate of change of magnetic field: | FLEXARTTMFLEXARTTM/Hyper | 11 T/sec.13.3 T/sec. | 11 T/sec.13.3 T/sec. | |
| VISARTTMVISARTTM/Hyper | 13.3 T/sec.19.5 T/sec. | 13.3 T/sec.19.5 T/sec. | ||
| Maximum radio frequency powerdeposition (SAR): | V3.5 s/w | V4.0 s/w | ||
| FLEXART™ &FLEXART™/Hyper | <0.4 W/kg | <0.4 W/kg | ||
| VISART™ &VISART™/Hyper | <1.0 W/kg | <1.0 W/kg | ||
| Acoustic noise levels (maximum): | ||||
| FLEXART™ | 100.2 dB(A) | 100.2 dB(A) | ||
| FLEXART™/Hyper | 98.5 dB(A) | 98.5 dB(A) | ||
| VISART™ | 105.3 dB | 105.3 dB | ||
| VISART™/Hyper | 105.1 dB | 105.1 dB |
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Acoustic noise data was measured in accordance with NEMA guidelines. The user is cautioned to have the patient wear acoustic noise protection during scanning.
IMAGING PERFORMANCE PARAMETERS: 8.
| Specification volume: Head: | FLEXART™ &VISART™ † | V3.5 s/w | V4.0 s/w |
|---|---|---|---|
| 16cm dsv | 16cm dsv | ||
| Body: | FLEXART™ &VISART™ † | 28cm dsv | 28cm dsv |
t = specifications for both standard and hyper versions
Sample clinical images are presented for new sequences.
9. INTENDED USE
| Anatomical regions: Head, body, extremity, spine, neck, TMJ, and heart | |
|---|---|
| Nuclei excited: | Hydrogen |
| Diagnostic use: | Diagnostic imaging of the whole body (including head, abdomen, breast, |
| heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities), | |
| fluid visualization, 2D and 3D imaging, MR angiography/MR Vascular Imaging | |
| and MR fluoroscopy. [Application terms include MRCP (MR | |
| Cholangiopancreatography), MR Urography, MR Myelography, SAS (Surface | |
| Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac Tagging.] |
10. EQUIVALENCY INFORMATION:
Toshiba America MRI, Inc. (TAMI), believes that the Version 4.0 software upgrade for the FLEXART™ and VISART™ systems is substantially equivalent to the software version 3.5 for FLEXART™ (K970573) which was cleared on 7/21/97 and VISART™ (K965068) which was cleared on 7/15/97. TAMI believes that the introduction of cardiac tagging in V4.0 is substantially equivalent to Cardiac Tagging Techniques (K973799) which was cleared on 1/2/98, and CINE Imaging which was cleared with version 3.1 for FLEXART™ (K962138) on 12/23/96. The modifications added to the Version 4.0 software do not raise new questions of safety or efficacy.
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Image /page/2/Picture/1 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 three abstract shapes that resemble birds in flight. The shapes are arranged in a diagonal line, with the largest shape at the top and the smallest shape at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 25 1999
Ken Nehmer Quality Engineer Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080 Re:
K983110 Software Version 4.0 for Flexart and Visart Dated: December 17, 1998 . Received: December 21, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Nehmer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have vie nave reviewed your occain oroly nealisations for uses stated in the encosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the manical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls r cocial rood, Drag, and e comers controls provisions of the Act include requirements for annual registration, listing of provisions of the Act. "The general ce, 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 if your device to such additional controls. Existing major regulations affecting your device can be found in the Code of be subject o battractional controlly equivalent determination assumes compliance with r occurrent Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for the Gallers Good management (21 CFR Part 820) and that, through periodic QS inspections, the Food and Mculan Donoral rogalerity such assumptions. Failure to comply with the GMP regulation may result in Drug Action. In addition, FDA may publish further announcements concerning your device in the Eederal regarding about. In addition - 27 has your premarket notification submission does not affect any obligation you might have under sections 531 through 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 510(k) premarket notification. The FDA I his reter will and you to bogin markeding your os a legally marketed 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 and additionally 809.10 for in if you doon opeonices), 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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _________________________________________________________________________________________________________________________________________________________________________
| "
510(k) Number (if known):
K983110 ______________________________________________________________________________________________________________________________________________________________________
Device Name:
Version 4,0 Software Upgrade (FLEXART™ & VISART™)
Indications for Use:
Imaging of:
-
The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, The Whole Doug (inoluding noad, are ities). [Application terms include MRCP (MR spirie, blood vessels , linios and oxientition ("Myelography, MR Fluoroscopy, SAS Onolanglopanoroatography); manic Scan, Cine Imaging, and Cardiac tagging.]
-
Fluid Visualization -
-
2D/3D Imaging •
-
MR Angiography/MR Vascular Imaging "
-
Blood Oxygenation Level Dependent (BOLD) 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 | K983110 |
| Prescription Use (Per 21 CFR§801.109) | |
|---|---|
| --------------------------------------- | -- |
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.