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), Dynamic Scan and Cine Imaging.] -Fluid Visualization -2D/3D Imaging Additional indications for v3.1, v3.2, & v3.3 (only) - MR Angiography/MR Vascular Imaging - Additional indication for v3.2 & v3.3 (only) - Water/Fat Imaging - Additional indication for v3.3 {only} Perfusion/Diffusion Imaging -

Device Description

Versions v3.0/v3.1/v3.2/v3.3 software are a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images. The four versions have the same base software features with certain additional features available in each subsequent version (see Comparison Table, Appendix B, for detailed description). A brief description follows: - v3.0: Based on v2.5 (K990260) with MR Angio and FASE sequences removed - v3.1: Based on v2.5 (K990260) - v3.2: Based on v2.6 (K990260) - v3.3: Based on v2.6 (K990260) with addition of Perfusion/Diffusion imaging

AI/ML Overview

This 510(k) premarket notification describes an upgrade to an existing Magnetic Resonance Diagnostic Device, the OPART™ (Model MRT-600), to software versions v3.0, v3.1, v3.2, and v3.3, along with optional hardware items. The core of this submission is to demonstrate substantial equivalence to previously cleared versions and to justify new functionalities and increased safety parameters.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on safety parameters and imaging performance. The "acceptance criteria" appear to be specified maximums for safety and a general "specification volume" for imaging. The "reported device performance" is essentially that the device operates within these stated limits and produces sample images.

Parameter	Acceptance Criteria	Reported Device Performance
Maximum static magnetic field strength	Specified (0.35 Tesla)	0.35 Tesla (inherent to the device model)
Rate of change of magnetic field	Specified (19 T/second)	19 T/second (inherent to the device model)
Maximum radio frequency power deposition (SAR)	< 1.5 Watt/kg	< 1.5 Watt/kg (increase from <0.4 W/kg for previous versions)
Acoustic noise levels (maximum)	98.4 dB (A)	98.4 dB (A) (inherent to the device model)
Specification volume (Head)	10cm dsv	Sample phantom images and clinical images presented (Appendix K & L)
Specification volume (Body)	20cm dsv	Sample phantom images and clinical images presented (Appendix K & L)
New Software Functionality	Equivalent to predicate devices & perform as intended	Sample phantom images and clinical images presented (Appendix K & L)
Optional Hardware Items	Equivalent to predicate devices	Demonstrated equivalence to cleared predicate devices

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Sample phantom images and clinical images are presented for new sequences (see Appendices K & L)."

Sample Size: Not explicitly stated as a number of patients or images. The term "sample" suggests a limited number, likely a qualitative representation rather than a statistically powered quantitative study.
Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from Toshiba America MRI, Inc., headquartered in South San Francisco, CA, which might imply U.S. data, but this is not confirmed.
Retrospective or Prospective: Not explicitly stated. Given the context of a 510(k) for software upgrades, it's possible that both retrospective clinical images (to showcase existing capabilities with new software) and prospective images (to demonstrate new sequences) were used, but the document does not specify.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The submission focuses on technical specifications, safety, and substantial equivalence to predicate devices, not on the diagnostic performance validation by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. As there's no mention of expert review or diagnostic accuracy studies, an adjudication method is not applicable to the reported data.

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

An MRMC comparative effectiveness study was not performed. This submission is for an upgrade to an MRI device's software and optional hardware, not for an AI-powered diagnostic tool. Therefore, there's no "AI assistance" component or improvement effect size to report.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone algorithm performance study was not described. The device is an MRI diagnostic system, which inherently requires human operation and interpretation. The "software functionality" refers to image acquisition and reconstruction, not autonomous diagnostic algorithms.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not describe the establishment of ground truth in the context of diagnostic accuracy. The "ground truth" for this submission appears to be:

Technical Specifications: Measured values for safety parameters (e.g., SAR, acoustic noise).
Image Quality: Qualitative assessment based on "sample phantom images and clinical images" (Appendices K & L) to demonstrate that the new sequences produce recognizable and potentially diagnostically useful images, implicitly compared to expected image quality from existing MRI systems.
Substantial Equivalence: The primary "ground truth" for the entire submission is the demonstration that the modified device is as safe and effective as predicate devices, which implies the predicate devices already met certain performance standards.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The software described (v3.0/v3.1/v3.2/v3.3) facilitates image acquisition and reconstruction, and adds new imaging sequences. It is not an AI/ML algorithm that would require a "training set" in the conventional sense of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable, as there is no "training set" for an AI/ML algorithm mentioned in this submission.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily an analysis demonstrating substantial equivalence to previously cleared predicate devices (K990260, K981475, K983110, K962933, K962138, K946244/A1, K933018/S1).

Specific evidence includes:

Technical Specifications Compliance: The document lists safety parameters (static field strength, rate of change of magnetic field, SAR, acoustic noise) and states that the device operates within these specified limits. The increase in SAR limit from <0.4 W/kg to <1.5 W/kg is specifically justified in Appendix J, indicating a technical evaluation was performed to ensure safety at this higher limit.
Qualitative Image Review: "Sample phantom images and clinical images are presented for new sequences (see Appendices K & L)." This implicitly demonstrates that the device, with its new software features, can acquire and reconstruct images that are visually acceptable and consistent with traditional MRI output for diagnostic purposes. This is a qualitative assessment rather than a quantitative diagnostic accuracy study.
Functional Equivalence: The new software functionalities (e.g., multi-phase/multi-slice for cardiac gating, dual-channel RF coil array, Perfusion/Diffusion imaging) and optional hardware items are described and asserted to be substantially equivalent to capabilities already cleared in other predicate devices.

In essence, the "study" is a compilation of engineering specifications, safety analyses, and qualitative imaging demonstrations, all framed within the context of showing that the upgraded device maintains its safety and effectiveness characteristics, and that new features are comparable to those found in already approved devices. There are no detailed clinical trials or diagnostic performance studies described in this summary to "prove" meeting acceptance criteria in a statistical sense for diagnostic accuracy.

Summary

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510(k) Premarket Notification

K993574

SUMMARY OF SAFETY AND EFFECTIVENESS

DEVICE NAME: Magnetic Resonance Diagnostic Device Accessory 1. MRT-600 Model Number: Trade/Proprietary Name: OPART™ including: OPART™/Prodiga, (v3.0 & manual bed) OPART™/Potenza (v3.2 & motorized bed) OPART™/Paragon (v3.3, motorized bed, & array electronics) 2636923 2. ESTABLISHMENT REGISTRATION: 3. U.S. AGENT NAME AND ADDRESS: Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080 CONTACT PERSON: Ken Nehmer (650)872-2722 ext. 6083 4. MANUFACTURING SITE: Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080 DATE OF SUBMISSION: October 19, 1999 5. 6. DEVICE DESCRIPTION: Versions v3.0/v3.1/v3.2/v3.3 software are a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images. The four versions have the same base software features with certain additional features available in each subsequent version (see
Comparison Table, Appendix B, for detailed description). A brief description follows:
v3.0: Based on v2.5 (K990260) with MR Angio and FASE sequences removed
v3.1: Based on v2.5 (K990260)
v3.2: Based on v2.6 (K990260)
v3.3: Based on v2.6 (K990260) with addition of Perfusion/Diffusion imaging

A brief summary of the new software functionality is described below:

6.1 DESCRIPTION OF NEW SOFTWARE FUNCTIONALITY (v3.0/v3.1/v3.2/v3.3) এ.

Increase in software limit of SAR from <0.4Watt/kg to < 1.5Watt/kg
B. Multi-phase/Multi-slice for cardiac gating

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Peripheral gating (optional) software support C.
Flouro monitor with pointing device (optional) software support D.
Dual-channel RF coil array (optional) software support E.

Removal of Functionality for v3.0 only

Removal of MR Angiography sequences A.
в. Removal of FASE sequences

Additional Functionality for v3.1, v3.2, & v3.3 only

Multi-slice 2D PS MRA A.
B. Gated Angio support

Additional Functionality for v3.3 only

FSE Enhancement-1mm thickness, shorter ΔTE, dual contrast A.
B. 3 point Dixon FE3D Water/Fat
C. Diffusion imaging
D. Perfusion imaging

OPTIONAL HARDWARE ITEMS

Extremity Array coil A.
B. Fluoro Monitor & Pointing Device
C. Peripheral Pulse Gating
D. Motorized Bed

7. SAFETY PARAMETERS:

Maximum static field strength:	0.35 Tesla
Rate of change of magnetic field:	19T/second
Maximum radio frequency power deposition (SAR):	< 1.5 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 (see Appendices K & L).

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, 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), Dynamic Scan and Cine Imaging.] Fluid Visualization and 2D/3D Imaging.
	MR angiography/MR Vascular Imaging (v3.1, v3.2, & v3.3 only)
	Water/Fat imaging (v3.2 & v3.3 only)
	Perfusion/Diffusion imaging (v3.3 only)

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10. EQUIVALENCY INFORMATION

Toshiba America MRI, Inc., believes that the versions v3.0/v3.1/v3.2/v3.3 software upgrades for OPART™ system is substantially equivalent to the software which was cleared with versions v2.5/v2.6 (K990260). Data pertaining to the increase in the SAR limit from < 0.4 Watt/kg to < 1.5 Watt/kg is discussed in Appendix J. MR Angiography has been removed from the indications for use for v3.0 software only. Versions v3.1, v3.2, and v3.3 software includes MR angiography in their indications for use. Version v3.2 and v3.3 includes Water/Fat imaging to their indications for use which was cleared in v2.1 software (K981475). Version v3.3 adds Diffusion/Perfusion imaging to the indications for use statement and is substantially equivalent to v4.0 software for FLEXART/VISART (K983110). The Extremity Array coil is substantially equivalent to the currently cleared OPART™ Extremity coil (K962933). The Fluoro monitor and pointing device is substantially equivalent to the currently cleared OPART™ Fluoro monitor (K962933). The Peripheral Pulse gating unit is substantially equivalent to the VISART/FLEXART Peripheral Pulse gating described in K983110 and K962138. The Motorized Bed is substantially equivalent to the ACCESS™ Compass Bed (K946244/A1) and the FLEXART Bed (K933018/S1).

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Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in bold black font. The words are stacked on top of each other. The words are centered in the image.

Image /page/3/Picture/16 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

JAN 18 2000

Ken Nehmer Quality Engineer Toshiba America, Inc. 280 Utah Avenue South San Francisco, CA 94080 RE:

K993574 OPART™ (Model MRT-600) including: OPART™ /Prodiga, OPART™/Potenza and OPART™/Paragon Dated: October 18, 1999 Received: October 21, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH/90 MOS

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 (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 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 assumplions. 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 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 1 of 1

, '

510(k) Number (if known):

K993574

Device Name: v3.0/v3.1/v3.2/v3.3 Software and Optional Hardware Upgrade OPART™ (MRT-600)

Indications for Use:

lmaging 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), Dynamic Scan and Cine Imaging.]
-Fluid Visualization
-2D/3D Imaging

Additional indications for v3.1, v3.2, & v3.3 (only)

MR Angiography/MR Vascular Imaging -
Additional indication for v3.2 & v3.3 (only)
Water/Fat Imaging -
Additional indication for v3.3 {only}

Perfusion/Diffusion Imaging -

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ー

Prescription Use(Per 21 CFR§801.109)	X
OR
Over-The-Counter Use
	(Optional Format 1-2-96)

mont b
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices510(k) Number K943574

Regulation Number and Section

§ 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.