The intended use of the Noras OR Head Coil 3T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).

Used in the 3T MAGNETOM Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.

When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Device Description

The Noras OR Head Coil 3T is an 8-channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. Each-channel is tuned to the Larmor frequency of the 1H spin in a magnetic field of 3T, 123.2 MHz. Each coil is connected to the MAGNETOM system by a separate cable.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the Noras OR Head Coil 3T, which is an MRI coil. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device.

Therefore, many of the requested details, such as specific acceptance criteria, detailed device performance metrics, sample sizes for test and training sets, and information about expert-established ground truth, are not available in the provided text.

Here is an analysis based on the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and conformity to general safety and performance standards, rather than proving performance against specific acceptance criteria.

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

This information is not provided as there is no mention of a clinical test set or data from human subjects for performance evaluation specific to this device. The assessment relies on conformity to NEMA and IEC standards, which are likely tested with phantoms or in controlled laboratory environments.

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

This information is not provided as there is no mention of a test set with expert-established ground truth in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a test set requiring adjudication.

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

This information is not applicable/provided. The device is an MRI head coil, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This information is not applicable/provided. The device is an MRI head coil, not an algorithm. Performance assessment is based on its physical and electrical characteristics and ability to produce images, not on standalone algorithm performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not provided as there is no specific "ground truth" mentioned in the context of a clinical performance study for this device. The document emphasizes conformity to recognized standards (NEMA, IEC) for performance and safety parameters. These standards often rely on objective physical measurements using phantoms rather than clinical "ground truth" from patients.

8. The Sample Size for the Training Set

This information is not provided as there is no mention of a "training set" in the context of the device's development or evaluation. As an MRI coil, it does not involve machine learning algorithms that would typically require a training set.

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

This information is not provided and is not applicable, as there is no mention of a training set.

Based on the provided document, the study demonstrating that the device meets (implicitly, rather than explicitly stated acceptance criteria) is the conformity to recognized standards and substantial equivalence to a predicate device.

Acceptance Criteria (Implied):
- Conformity to FDA recognized NEMA Standards for the measurement of performance and safety parameters.
- Conformity to IEC standards for safety issues with Magnetic Resonance Imaging Devices, specifically IEC 60601-2-33:2002.
- Substantial equivalence to predicate devices (Noras OR Head Coil 1.5T and MRI Devices Corporation High Resolution Head Coil Model HRH-63-8) in terms of intended use, technological characteristics, and safety/effectiveness.
Study That Proves the Device Meets the Implied Acceptance Criteria:
- "The NEMA Tests were done on software platform version VB15A." (Page 3) This statement indicates that specific tests outlined by NEMA (National Electrical Manufacturers Association) standards were performed. These tests would evaluate various performance characteristics of the MRI coil, such as signal-to-noise ratio, uniformity, spatial resolution, etc.
- Conformity Statements: The document explicitly states, "The Noras OR Head Coil 3T will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33:2002." (Page 3). This serves as the primary evidence provided for meeting safety and performance expectations through adherence to established industry standards.
- Substantial Equivalence Argument: The core of the 510(k) submission is the argument that the Noras OR Head Coil 3T is "substantially equivalent" to predicate devices (Noras OR Head Coil 1.5T and MRI Devices Corporation High Resolution Head Coil Model HRH-63-8). This implies that its performance and safety are comparable to devices already cleared for market.

In summary, the document does not contain details of a specific clinical study with explicit acceptance criteria and performance results for the Noras OR Head Coil 3T. Instead, it relies on demonstrating compliance with recognized industry standards (NEMA, IEC) and establishing substantial equivalence to previously cleared devices to prove its safety and effectiveness.

Summary

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K091546
page 1 of 4

510(k) Summary

JUN 2 4 2009

Noras OR Head Coil 3T

Date of Summary Preparation: April 30, 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

1. General Information

Importer/Distributor Name and Address Noras MRI products GmbH Leibnizstr.4 97204 Hoechberg / Germany

ERN: 3004929307 Owner/Operator Number: 9071737

Manufacturing Site Name and Address Noras MRI products GmbH Leibnizstr.4 97204 Hoechberg / Germany

ERN: 3004929307 Owner/Operator Number: 9071737

2. Contact Person

Zahed Sedighiani Regulatory Affairs Manager Noras MRI products GmbH Leibnizstr.4 97204 Hoechberg Germany Tel: (+49) 931 / 29927-17 Fax: (+49) 931 / 29927-20 zahed.sedighiani@noras.de

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K091546
Page 2 of 4

Device Name and Classification 3.

Trade Name: OR Head Coil 3T Common Name: OR Head Coil 3T Classification Name: Magnetic Resonance Diagnostic Device Classification Panel: Radiology 21 CFR § 892.1000 CFR Number: Device Class: Product Code: 90MOS

Device Description 4.

Image /page/1/Picture/5 description: The image shows two headbands with wires and connectors. The headbands are curved and appear to be made of a dark material. Each headband has a wire that extends from it, terminating in a connector. The connectors are rectangular and have multiple pins or contacts. The background is black, which makes the headbands and connectors stand out.

Use of the Noras OR Head Coil 3T requires the Noras OR Head Holder (K071179 April 30, 2007). The pictures below show the complete set.

Image /page/1/Figure/7 description: The image contains two separate pictures. The picture on the left shows a complex mechanical device with multiple components and wires. The picture on the right shows a similar mechanical device, but with a different configuration and a visible arrow at the bottom.

Special 510(k) Noras MRI products GmbH OR Head Coil 3T April 30, 2009

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K091546
Page 3 of 4

5. Intended Use

The intended use of the Noras OR Head Coil 3T is the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. It can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI.

6. Substantial Equivalence

Noras MRI products GmbH believes that, within the meaning of the Safe Medical Devices Act of 1990, the 8-channel phased array Noras OR Head Coil 3T for the Magnetom Systems is substantially equivalent to the following coil:

Predicate Device Name andManufacturer	510(k)Number	Clearance Date	ProductCode	ComparableProperties
Noras OR Head Coil 1,5T	K060758	March 21, 2006	90MOS	Proton imaging
MRI Devices Corporation (nowknown as Invivo Corporation)High Resolution Head CoilModel HRH-63-8	K013159	October 16, 2001	90MOS	High ResolutionHead ImagingfMRI

Summary of Technological Characteristics of the Principal Device as 7. Compared with the predicate Device

Although the MRI Devices High Resolution Head Coil is limited for use outside the operating room, we believe that all top coils are substantially equivalent.

General Safety and Effectiveness Concerns 8.

The Noras OR Head Coil 3T will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33:2002, This will assure that the performance of this device can be considered safe and effective when used with the currently available MAGNETOM 3T systems Trio a Tim and Verio.

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The NEMA Tests can be found in Appendix C. The NEMA Tests were done on software platform version VB15A. We have included the Common Risk Analysis for syngo MR2006A, which is the same functionality as syngo platform MR 2004A. We believe the NEMA tests on Trio a Tim are applicable to Verio system.

Conclusion as to Substantial Equivalence 9.

Noras MRI products GmbH believes that, within the definition of the Safe Medical Devices Act of 1990, the 8-channel phased array Noras OR Head Coil 3T is substantially equivalent to the predicate device listed above.

Hubert Noras

Hubert Noras
President

1. 09
  April 30, 2009

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DEPARTMENT OF HEALTH & HUMAN SERVICES ... . .

_Public Health Service .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 24 2009

Mr. Zahed Sedighiani Regulatory Affairs Manager Noras MRI Products GmbH Leibnizstr. 4. Hoechberg 97204 GERMANY .

Re: K091546

Trade/Device Name: Noras OR Head Coil 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 30, 2009 Received: May 27, 2009

Dear Mr. Sedighiani:

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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Iarina M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Ko f 15 yc

Device Name: Noras OR Head Coil 3T

Indications for Use:

Used in the 3T MAGNETOM Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.

When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR	Over-The-Counter Use (21 CFR 801 Subpart C)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices

510(k) Number	K091546
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Special 510(k) Noras MRI products GmbH OR Head Coil 3T April 30, 2009

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.