This coil is indicated for use in conjunction with 1.5T and 3.0T GE Healthcare Magnetic Resonance Scanner systems to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description

The MC 1504G-16R (1.5T) and MC 3004G-16R (3.0T) Head Coils are multi-channel receive only coils consisting of 16 RF elements. Each RF element has active and passive blocking networks, and integrated preamplifiers. The MC 1504G-16R RF elements are tuned to 'H at 1.5T (63.9 MHz), while the MC 3004G-16R RF elements are tuned to 'H at 3.0T (127.8 MHz). The coil housing is constructed out of a rigid plastic with an opening for patient viewing and comfort; the head support/base is included with each coil assembly.

AI/ML Overview

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and testing:

This document primarily describes the substantial equivalence of a new head coil (MC 1504G-16R and MC 3004G-16R) to existing predicate devices. The focus is on demonstrating that the new device performs similarly to or better than the predicates, rather than establishing acceptance criteria against a specific, quantitative performance threshold for a diagnostic outcome. Therefore, the information provided isn't in the typical format of acceptance criteria for an AI/CADe device where metrics like sensitivity, specificity, or AUC are assessed against predefined targets.

However, based on the text, we can infer the performance comparisons made.

1. Table of Acceptance Criteria and the Reported Device Performance

Parameter/Criteria	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1	Testing conducted in accordance with IEC 60601-1; compliance implied.
Mechanical Safety	Compliance with IEC 60601-1	Testing conducted in accordance with IEC 60601-1; compliance implied.
Functional Performance (Electrical Bench)	Proper assembly, function, and tuning to established specifications (unspecified)	Electrical bench measurements performed to ensure proper assembly, function, and tuning to established specifications.
Performance (Phantom - Signal-to-Noise Ratio (SNR))	Equivalent or improved SNR compared to predicate device	Comparative SNR measurements based on NEMA MS-1 performed. (Implied: results were favorable for substantial equivalence). "The use of additional elements may increase coil sensitivity and reduce data acquisition time."
Image Quality (Volunteer Scans)	Equivalence in resulting image quality to predicate device	Volunteer scans performed; images reviewed in blind fashion by registered technologists to demonstrate equivalence in resulting image quality.
System Compatibility	Compatible with 1.5T and 3.0T Magnetic Resonance Scanner systems	All system testing conducted using 1.5T and 3.0T MR Scanner systems running standard clinical applications.

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

Sample Size (Test Set): Not explicitly stated numbers.
- Volunteer Scans: "Volunteer scans were performed." The number of volunteers is not specified.
- Phantoms: "Performance evaluations (phantoms) were completed." The number of phantoms is not specified.
Data Provenance: Not specified, but generally, such studies for medical device clearance are conducted internally or at partnering institutions within the country of the manufacturer. The study is prospective in nature, involving new scans/tests specifically for this evaluation.

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

Number of Experts: Not explicitly stated, but "registered technologists in magnetic resonance" were used. This implies more than one.
Qualifications of Experts: "Registered technologists in magnetic resonance." No specific experience level (e.g., years of experience) is provided. Their role was to assess "equivalence in resulting image quality," meaning they were evaluating the technical quality of the images rather than making clinical diagnoses.

4. Adjudication Method for the Test Set

Adjudication Method: "Scan images were then reviewed in blind fashion by registered technologists in magnetic resonance." No specific adjudication method (e.g., 2+1, 3+1) is mentioned beyond the blind review. This suggests a qualitative assessment rather than a structured consensus process.

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 MRMC study was done. This device is a hardware component (MRI head coil), not an AI/CADe system designed to assist human readers. Therefore, there's no mention of human reader improvement with AI assistance.

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

Not applicable. This is a hardware device (MRI coil), not an algorithm or AI system. Its performance is evaluated through physical and imaging characteristics.

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

For image quality evaluation, the "ground truth" was essentially the subjective assessment of "equivalence in resulting image quality" by "registered technologists in magnetic resonance" when comparing images from the proposed device to images from predicate devices. This can be considered a comparative expert assessment of image quality.
For physical performance, the "ground truth" was established by engineering specifications and industry standards (e.g., IEC 60601-1 for safety, NEMA MS-1 for SNR measurements).

8. The Sample Size for the Training Set

Not applicable / No specific training set. As a physical hardware device, there isn't a "training set" in the machine learning sense. The device design and specifications are based on engineering principles and knowledge, not data-driven training.

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

Not applicable. See point 8.

Summary

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MAR 2 9 2011

KII0691

r '/3

510(k) Summary (As required by section 21 CFR 807.92(c))

Contact:	MR Instruments, Inc.Joshua J. HolwellChief Operating OfficerTelephone: 952-746-1435 x326 / Fax: 952-746-1437Email: jholwell@mrinstruments.com
Date Prepared:	February 7, 2011
Product Trade Name:	MC 1504G-16R, 1.5T, 16-Channel Head CoilMC 3004G-16R, 3.0T, 16-Channel Head Coil
Common/Usual Name:	Head Coil / Brain Coil
Classification Name:	Magnetic Resonance Diagnostic Device, Class II(21 CFR 892.1000, Product Code MOS)
Predicate Device:	HRH-63-8, 1.5T, 8-Channel Head Array,MRI Devices (K013159)
	HRH-127-8, 3.0T, 8-Channel Head Array,MRI Devices (K022372)
Manufacturer:	MR Instruments, Inc.5610 Rowland Road, Suite 145Minnetonka, MN 55343

Establishment Registration: 3003852428

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Device Description:

Statement of Intended Use:

This coil is indicated for use in conjunction with a Magnetic Resonance Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician vield information that may assist in diagnosis.

Summary of Technological Characteristics in Comparison to the Predicate Device:

The MC 1504G-16R (1.5T) and MC 3004G-16R (3.0T) Head Coils are substantially equivalent to the MRI Devices HRH-63-8, 1.5T (K013159) and HRH-127-8, 3.0T (K022372) Head Arrays, respectively.

The proposed and predicate devices are both multi-channel RF receive only head coils that utilize phased array technology. Additionally, both the proposed and predicate devices are designed to work in conjunction with a Magnetic Resonance Scanner, and have similar size, shape and construction.

The primary difference between the proposed and predicate devices is that the predicate utilizes an 8 element phased array RF structure as opposed to a 16 element phased array RF structure. The use of additional elements may increase coil sensitivity and reduce data acquisition time.

Summary of Non-Clinical Testing:

Design verification and validation testing was performed to ensure that the coil design specifications and customer requirements were met.

Electrical bench measurements were performed to ensure proper assembly, function and tuning to established specifications.

Electrical/mechanical device safety and system safety (phantoms) testing were conducted in accordance with IEC 60601-1.

Performance evaluations (phantoms) were completed using the proposed and predicate devices with comparative signal-to-noise (SNR) measurements based on NEMA MS-1.

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Volunteer scans were performed with the proposed and predicate devices to acquire paired images using routine clinical scan sequences. Scan images were then reviewed in blind fashion by registered technologists in magnetic resonance to demonstrate equivalence in resulting image quality.

All system testing was conducted using 1.5T and 3.0T Magnetic Resonance Scanner systems running standard clinical applications.

Summary of Clinical Testing:

No additional clinical evaluations of the head coil devices for this use have been conducted.

Conclusions:

The MC 1504G-16R (1.5T) and MC 3004G-16R (3.0T) Head Coils are substantially equivalent to the MRI Devices HRH-63-8, 1.5T (K013159) and HRH-127-8, 3.0T (K022372) Head Arrays, respectively.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

MR Instruments, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313

MAR 2 9 2011

Re: K110591

Trade/Device Name: MR Instruments, Inc., MC 1504G-16R, 1.5T, 16 Channel Head Coil; MC 3004G-16R, 3.0T, 16 Channel Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 16, 2011 Received: March 17, 2011

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address . http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __

Device Name:

MR Instruments, Inc. MC 1504G-16R, 1.5T, 16-Channel Head Coil MC 3004G-16R, 16-Channel Head Coil
MC 3004G-16R, 3.0T, 16-Channel Head Coil

Indications for Use:

This coil is indicated for use in conjunction with 1.5T and 3.0T GE Healthcare Magnetic
interpreted for use in conjunction with 1.5T and 3.0T spectre of the free Resonal and Scated for tse in conjunction with 1.5T and 3.0T GE Healthcare Magnetic
Resonance Scanner systems to produce images and/or spectra of the head, that when the submit wanner bystems to produce images and/or spectra of the head.
interpreted by a trained physician yield information that may assist in diagnosis.

Prescription Use _ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices Evaluation (OIVD)

Mung S. Patil

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_ રી જિલ્લા

Page 1 of 1

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.