(89 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 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 Diffusion Imaging The EPI Plus optional package adds the following to the above indications: Perfusion Imaging
This submission consists of a new Magnetic Resonance Imaging system which is based primarily on the cleared EXCELARTTM (K990620) with the following new functions added to the standard system. • Pianissimo: Gradient acoustic reduction system • QD Whole Body coil • QD Head coil • QD C/T/L Spine Array coil • 18.1" LCD flat screen monitor • Increase of SAR limit from <1.0 Watts/Kg to < 1.5 Watts/Kg The following optional features are introduced in this submission. • Flexible Body Array coil • Shoulder Array coil • Storage Plus Package which includes: * 8 GByte hard disk drive * memory increase of 256 MBytes • EPI Plus Package (see Appendix 15) which includes: * extending Diffusion function * adding Perfusion function • Super FASE Plus Package (see Appendix 19) which includes: * ECG - Preparation * Fresh Blood Imaging (FBI) * Swap Phase Encode Extended Data acquisition (SPEED) * Composite MIP · MRA Plus Package (see Appendix 23) which includes: * Visual Preparation * Moving Bed * 3D Centric scan * Sequential Target MIP Display (STAMD)
This document is a 510(k) Premarket Notification for a Magnetic Resonance Diagnostic Device Accessory (MRI system), specifically the EXCELART™ with Pianissimo. The submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel AI algorithm or diagnostic tool.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable or not explicitly detailed in this type of submission for this kind of device. The focus here is on the safety and performance characteristics of the MRI system itself and its accessories.
Here's a breakdown based on the provided text, indicating what information is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
For an MRI system, performance is generally evaluated against safety parameters and imaging capabilities rather than diagnostic accuracy metrics. The document specifies safety parameters and imaging volumes.
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Safety Parameters | ||
| Maximum static field strength | - (Implied to meet predicate's 1.5T) | 1.5T |
| Rate of change of magnetic field | - (Implied to meet predicate's ~19.5 T/sec.) | 19.35 T/sec. (Pianissimo) vs 19.5 T/sec (EXCELART™) |
| Maximum radio frequency power (SAR) | <1.5 W/kg (increased from <1.0 W/kg for previous EXCELART™) | <1.5 W/kg |
| Acoustic noise levels (maximum) | - (Implied improvement over predicate, though no specific numerical acceptance criterion is stated, the Pianissimo system is designed for reduction) | 86.0 dB (Pianissimo) vs 110.8 dB (EXCELART™) |
| Imaging Performance Parameters | ||
| Head Specification Volume | 16cm dsv (same as previously cleared EXCELART™ K990620) | 16cm dsv |
| Body Specification Volume | 28cm dsv (same as previously cleared EXCELART™ K990620) | 28cm dsv |
| Coil Equivalence | Demonstrated substantial equivalence to existing cleared RF coils and software packages | EXCELART™ QD Whole Body equivalent to MRT-150A QD Whole Body (K922798)EXCELART™ C/T/L Spine Array equivalent to VISART QD Spine Array (K965068)EXCELART™ QD Head equivalent to VISART QD Head (K961092)EXCELART™ Flex Body equivalent to VISART GP Flex (K965068)EXCELART™ Shoulder Array equivalent to MRT-150A Shoulder (K942609)Optional software packages (EPI Plus, SuperFASE Plus, MRA Plus) based on previously cleared V4 software (K983110). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it's not a study on a diagnostic algorithm's performance on a dataset of patient images. The "test set" for an MRI system's technical specifications typically involves phantom measurements and engineering tests. The acoustic noise data was measured in accordance with NEMA guidelines, indicating a standardized testing methodology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This filing is about the technical specifications and safety of an MRI device and its accessories, not a diagnostic algorithm requiring ground truth established by medical experts on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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
Not applicable. This device is an MRI system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an MRI hardware and associated software update, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device would be its physical and electronic measurements (e.g., magnetic field strength, RF power, acoustic noise levels, imaging volume specifications) which are verified through engineering tests and NEMA standards, not clinical "ground truth" on patient diagnoses.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI algorithm in the context of diagnostic interpretation that would involve a training set of images.
9. How the ground truth for the training set was established
Not applicable. See point 8.
In summary of the study that proves the device meets the acceptance criteria:
The study proving the device meets its acceptance criteria is implicitly the engineering and performance testing conducted by the manufacturer (Toshiba Corporation) for the MRI system and its components. This includes:
- Physical measurements for safety parameters like static field strength, rate of change of magnetic field, and radio frequency power (SAR).
- Acoustic noise measurements conducted in accordance with NEMA guidelines (National Electrical Manufacturers Association), which are standard procedures for evaluating MRI system noise. The reported 86.0 dB for the Pianissimo system versus 110.8 dB for the standard EXCELART™ demonstrates an improvement in acoustic performance.
- Verification of imaging performance parameters such as head and body specification volumes (16cm dsv and 28cm dsv, respectively), which are stated to be the same as previously cleared systems, implying continued adherence to established performance benchmarks.
- Demonstration of "substantial equivalence" for new coils and software packages to previously cleared devices (e.g., K990620 for EXCELART™, K922798, K965068, K961092, K942609 for various coils, and K983110 for software V4). This is the primary method of "proof" for a 510(k) submission: showing the new device is as safe and effective as a legally marketed predicate device.
The document does not detail specific study protocols, raw data, or results from these tests beyond the summary values provided in the table. The FDA's clearance (K993803) indicates that these submissions were deemed sufficient to demonstrate substantial equivalence for marketing.
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993803
510(k) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | DEVICE NAME:Model Number:Trade/Proprietary Name: | Magnetic Resonance Diagnostic Device AccessoryMRT-1500 /P2EXCELARTTM with Pianissimo | 7. SAFETY PARAMETERS: | EXCELART™ | EXCELART™w/Pianissimo |
|---|---|---|---|---|---|
| 2. | ESTABLISHMENT REGISTRATION: | 2636923 | Maximum static field strength: | 1.5T | 1.5T |
| 3. | U.S. AGENT NAME AND ADDRESS: | Toshiba America MRI, Inc.280 Utah AvenueSouth San Francisco, CA 94080 | Rate of change of magnetic field: | 19.5 T/sec. | 19.35 T/sec. |
| CONTACT PERSON: | Ken Nehmer(650)872-2722 ext. 6083 | Maximum radio frequency power | <1.0 W/kg | <1.5 W/kg | |
| 4. | MANUFACTURING SITE: | Toshiba Corporation1385 ShimoisigamiOtawara-shi, Tochigi-KenJapan 324 | Acoustic noise levels (maximum): | 110.8 dB | 86.0 dB |
| 5. | DATE OF SUBMISSION: | November 8, 1999 | |||
| 6. | DEVICE DESCRIPTION: | This submission consists of a new Magnetic ResonanceImaging system which is based primarily on the clearedEXCELARTTM (K990620) with the following new functionsadded to the standard system.• Pianissimo: Gradient acoustic reduction system• QD Whole Body coil• QD Head coil• QD C/T/L Spine Array coil• 18.1" LCD flat screen monitor• Increase of SAR limit from <1.0 Watts/Kg to < 1.5Watts/Kg | |||
| The following optional features are introduced in thissubmission.• Flexible Body Array coil• Shoulder Array coil• Storage Plus Package which includes:* 8 GByte hard disk drive* memory increase of 256 MBytes• EPI Plus Package (see Appendix 15) which includes:* extending Diffusion function* adding Perfusion function• Super FASE Plus Package (see Appendix 19) whichincludes:* ECG - Preparation* Fresh Blood Imaging (FBI)* Swap Phase Encode Extended Data acquisition |
- (SPEED)
- Composite MIP
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· MRA Plus Package (see Appendix 23) which includes:
-
- Visual Preparation
-
- Moving Bed
-
3D Centric scan
-
Sequential Target MIP Display (STAMD)
Acoustic noise data was measured in accordance with NEMA guidelines.
IMAGING PERFORMANCE PARAMETERS: 8.
| Specification volume: Head: | EXCELART™16cm dsv* |
|---|---|
| Body: | 28cm dsv* |
* Same as previously cleared with initial EXCELART™ system (K990620).
9. INTENDED USE
Anatomical regions: Head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities
Nuclei excited: Hvdrogen
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, Blood Oxygenation Level Dependent (BOLD) Imaging, Diffusion Imaging, [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, 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 EXCELART™ with Pianissimo Magnetic Resonance Imaging (MRI) system is substantially equivalent to the EXCELART™ Magnetic Resonance System (K990620) cleared on May 14, 1999.
The new coils introduced are substantially equivalent to existing cleared RF coils as compared in the following table:
| New coil | Substantially equivalent to: |
|---|---|
| EXCELART™ QD Whole Body | MRT-150A QD Whole Body(K922798) |
| EXCELART™ C/T/L Spine Array | VISART QD Spine Array(K965068) |
| EXCELART™ QD Head | VISART QD Head (K961092) |
| EXCELART™ Flex Body | VISART GP Flex (K965068) |
| EXCELART™ Shoulder Array | MRT-150A Shoulder(K942609) |
The optional software packages (EPI Plus, SuperFASE Plus, MRA Plus) used for the EXCELART™ MRI system are based on the same software that was previously cleared as V4 (K983110).
The VISART/Ex MRI system (more powerful gradient system) described in the common Operation Manual located in Appendix 27 (pages S-4 and 6-41 through 6-45) is not part of this submission and will not be made available for sale in the United States of America.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like strokes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 2000
Ken Nehmer Manager Regulatory Affairs/Quality Systems Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080
Re: K993803 Pianissimo and Other Options for Excelart MRI System Dated: November 8, 1999 Received: November 9, 1999 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 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 (Ad). 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 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 conceming 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 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 finding of substantial equivalence of your device to 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 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/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):
Device Name:
EXCELART™ with Pianissimo and options
Indications for Use:
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 Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.]
Nº13893
Fluid Visualization
2D/3D Imaging
MR Angiography/MR Vascular Imaging
Blood Oxygenation Level Dependent (BOLD) Imaging
Diffusion Imaging
The EPI Plus optional package adds the following to the above indications: Perfusion Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use(Per 21 CFR§801.109) | ✓ OR Over-The-Counter Use ______ |
|---|---|
| (Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K993803 |
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.