-The Whole Body (including head, abdomen, breast, 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
MR Angiography/MR Vascular Imaging -

Device Description

The Extra Large Body coil is an enlarged version of the current OPART™ Large Body Coil. This coil is an optional coil which was developed to allow positioning of larger sized patients in the OPART™ system. The Extra Large Body coil can be used as a standalone coil, or in conjunction with the T-spine surface coil (cleared with OPART™ system K962933). Signal is received in QD mode when used in conjunction with the T-spine surface coil.
The Extra Large Body Coil is constructed with the same materials that are currently in use for the released coil set for OPART™.

AI/ML Overview

This document describes the design and regulatory approval of an "Extra Large Body Coil" for an MRI system, the OPART™. The information provided primarily focuses on establishing the device's substantial equivalence to a previously cleared device, rather than a clinical study evaluating its performance against specific acceptance criteria in a medical context.

Based on the provided text, there is no clinical study that explicitly defines and proves the device meets specific performance acceptance criteria in the way typically expected for a diagnostic AI/medical device. Instead, the submission focuses on substantial equivalence for a physical component (the coil) of an MRI system.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for algorithms or diagnostic performance metrics (e.g., sensitivity, specificity, AUC) is not applicable here because this is a hardware accessory submission based on substantial equivalence. The "performance" being evaluated is related to physical and safety parameters of the MRI coil.

Acceptance Criteria (Benchmarking/Safety/Physical)	Reported Device Performance (Extra Large Body Coil)
Safety Parameters:
Maximum static field strength	0.35 Tesla
Rate of change of magnetic field	19 T/second
Maximum radio frequency power deposition (SAR)	<0.4 Watt/kg
Acoustic noise levels (maximum)	98.4 dB (A)
Imaging Performance Parameters:
Head Specification volume	10 cm dsv
Body Specification volume	20 cm dsv
Material composition	Same materials as currently in use for the released coil set for OPART™
Intended Use	Imaging of Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels), Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging (with no new indications from predicate)

Note: The "acceptance criteria" here are implicitly the existing standards and performance characteristics of the predicate device (the current Large Body Coil cleared with K962933) and general MRI safety standards. The new coil is presented as meeting these same criteria or being within acceptable limits.

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

Test Set Description: The "test set" in this context refers to the data used to demonstrate the functionality of the new Extra Large Body Coil. This is not a clinical study test set in the sense of a patient cohort for diagnostic algorithm validation.
Data Provenance: The document mentions "Sample phantom images and clinical images are presented from the Extra Large Body coil (Appendix 5 & 6)."
- Sample Size: Not explicitly stated. The term "sample" implies a limited number of instances rather than a statistically powered clinical trial.
- Provenance: The location (country of origin) of these phantom and clinical images is not specified.
- Retrospective/Prospective: Not specified. Given it's a 510(k) for a hardware accessory, it's likely these images were collected as part of the engineering and verification process, which could be considered a form of prospective data collection for this purpose, but not a large-scale clinical trial.

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

Not applicable. The "ground truth" for a hardware component like an MRI coil typically relates to its physical performance (e.g., signal-to-noise ratio, image uniformity, mechanical integrity) which is measured objectively using phantoms and engineering tests, and clinical image quality (which would be reviewed by radiologists). The submission does not detail an expert review process for image quality beyond a general statement that "clinical images are presented." There is no indication of a formal ground-truth establishment process by a panel of experts for diagnostic accuracy in this submission.

4. Adjudication Method for the Test Set

Not applicable. As a hardware submission focused on substantial equivalence and safety, there is no mention of an adjudication method for a test set in the context of diagnostic performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is typically used for evaluating the performance of diagnostic algorithms or imaging techniques, often comparing human reader performance with and without AI assistance. This submission is for a physical MRI coil, and such a study is not relevant to its regulatory approval process described here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is a hardware component. The concept of an "algorithm only" or "human-in-the-loop" study does not apply.

7. Type of Ground Truth Used

In this context, the "ground truth" is primarily derived from:
- Engineering Specifications: Testing the coil against predefined physical and electromagnetic parameters (e.g., static field strength, SAR, acoustic noise levels, specification volumes).
- Phantom Imaging: Objective measurements of image quality (e.g., signal-to-noise, uniformity) using standardized phantoms.
- Clinical Image Appearance: Subjective assessment of image quality and diagnostic utility from "clinical images" (though the criteria and expert review process are not detailed in this summary).
There's no mention of pathology, long-term outcomes data, or expert consensus in the diagnostic sense being used for ground truth in this specific submission.

8. Sample Size for the Training Set

Not applicable. This submission is for a hardware component, not an AI/ML algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided text.

Summary

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K99/057

510(k) Premarket Notification

SUMMARY OF SAFETY AND EFFECTIVENESS

1. DEVICE NAME:	Magnetic Resonance Diagnostic Device Accessory
Model Number:	MRT-600
Trade/Proprietary Name:	OPART™
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:	same as above
5. DATE OF SUBMISSION:	March 29, 1999
6. DEVICE DESCRIPTION:	The Extra Large Body coil is an enlarged version of the current OPART™ Large Body Coil. This coil is an optional coil which was developed to allow positioning of larger sized patients in the OPART™ system. The Extra Large Body coil can be used as a standalone coil, or in conjunction with the T-spine surface coil (cleared with OPART™ system K962933). Signal is received in QD mode when used in conjunction with the T-spine surface coil.The Extra Large Body Coil is constructed with the same materials that are currently in use for the released coil set for OPART™.
7. 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)
8. IMAGING PERFORMANCE PARAMETERS:
Specification volume:
Head:	10cm dsv
Body:	20cm dsv

Sample phantom images and clinical images are presented from the Extra Large Body coil (Appendix 5 & 6).

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INTENDED USE 9.

Anatomical regions: Head, body, extremity, spine, neck, TMJ, breast, and heart Hydrogen Nuclei excited: Diagnostic imaging of the human body (including head, abdomen, Diagnostic use: breast, heart, pelvis, spine, blood vessels, limbs, and extremities), fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.

10. EQUIVALENCY INFORMATION:

Toshiba America MRI, Inc., believes that the Extra Large Body Coil option for OPART™ system is substantially equivalent to the current Large Body Coil which was cleared with the OPART™ diagnostic resonance system 510(k) number K962933.

This optional coil does not introduce any new indications for use from those cleared in the Premarket Notification for OPART™ diagnostic resonance system 510(k) number K962933.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ken Nehmer Quality Engineer Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, California 94080

2 U

RE:

K991057 Body Coil for OPART (Model MRT-600) Dated: March 29, 1999 Received: March 30, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS

Dar 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 redassified 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 (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 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 requirement 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,
Dan Letizia

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

Image /page/2/Picture/14 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wings, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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510(k) Number (if known):

K991057

Device Name:

: 上一

Extra Large Body Coil for OPART™ (MRT-600) ___________________________________________________________________________________________________________________________________

Indications for Use:

Imaging of:

-The Whole Body (including head, abdomen, breast, 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
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)

Prescription Use	X	Over-The-Counter Use
(Per 21 CFR§801.109)		(Optional Format 1-2-96)
	(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT,
510(k) Number	K991057
and Radiological Devices

CONFIDENTIAL

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.