The intended use of the Noras OR head coil 1.5 T 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 1.5T 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 OR Head Coil 1.5T 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 1.5T, 63.6 MHz. Each coil is connected to the MAGNETOM system by a separate cable. Use of the OR Head Coil 1.5T requires the Siemens OR Head Holder.

AI/ML Overview

This submission is for a medical device (OR Head Coil 1.5T) and not a diagnostic algorithm. Therefore, many of the requested criteria, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), sample size for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth definitions, are not applicable in the context of device clearance for an MRI head coil.

The regulatory approval for this device (K060758) is based on substantial equivalence to a predicate device, not on meeting specific quantifiable performance metrics for an AI algorithm.

However, I can extract the relevant information regarding the device itself and its safety and effectiveness considerations from the provided text.

Here's a breakdown of the relevant information:

Acceptance Criteria and Device Performance (in the context of a medical device submission)

Criterion	Reported Device Performance/Compliance
Substantial Equivalence	The Noras OR Head Coil 1.5T is deemed substantially equivalent to the predicate device, "MRI Devices Corporation (now Invivo Corporation) High Resolution Head Coil - Model HRH-63-8" (K013159, cleared October 16, 2001). This is the primary "acceptance criterion" for 510(k) clearance.
Intended Use	The device's intended use matches the predicate device for MR examination. It is intended for MR examination of the human brain just before, during, and at the end of brain surgery in the operating room. It can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI. When used with 1.5T MAGNETOM Systems, it produces transverse, sagittal, coronal, and oblique images of head internal structures. These images, when interpreted by a trained physician, provide useful diagnostic information.
General Safety and Effectiveness Concerns (Standards Compliance)	The OR Head Coil 1.5T will conform to: FDA recognized NEMA Standards for the measurement of performance and safety parameters.IEC standards for safety issues with Magnetic Resonance Imaging Devices, specifically IEC 60601-2-33: 2002.NEMA tests were performed on Software platform syngo MR2004A, and the Common Risk Analysis for syngo MR2006A (same functionality) was included. The NEMA tests on the Symphony are deemed applicable to all MAGNETOM 1.5T systems. Performance is considered safe and effective when used with currently available MAGNETOM 1.5T systems.
Technological Characteristics	The device is an 8-channel phased array coil, divided into a bottom and top array of 4 channels each. Each channel is tuned to the Larmor frequency of the 1H spin in a 1.5T magnetic field (63.6 MHz). Each coil connects to the MAGNETOM system via a separate cable. It requires the Siemens OR Head Holder. These characteristics are considered "substantially equivalent" to those of the predicate device, despite the predicate being limited to use outside the operating room.

Study Details (as inferable from the document, though not a typical "study" for an AI algorithm)

Sample Size used for the test set and the data provenance: Not applicable. This is a device clearance for hardware. NEMA tests involve standardized phantoms and equipment, not patient data in the sense of a clinical trial for an algorithm. The "test set" here refers to the device itself being tested for compliance with engineering standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for device hardware testing. Ground truth (e.g., accurate measurements) for NEMA standards compliance is established by the test procedures themselves.
Adjudication method for the test set: Not applicable. Compliance with NEMA and IEC standards is determined by achieving defined measured values.
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 is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (head coil).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the NEMA and IEC standards, the "ground truth" is adherence to predefined technical specifications and safety limits for electromagnetic fields, image uniformity, signal-to-noise ratio, etc. These are engineering and physics-based measurements.
The sample size for the training set: Not applicable. This is not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the word "NORAS" in large, bold, black letters. The letters are slightly slanted to the right. There is a black line underneath the word, and the bottom of the image is cut off.

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510(k) Summary

OR Head Coil 1.5T

MAY - 5 2006

Date of Summary Preparation: March 15, 2006

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

General Information 1.
- Importer/Distributor Name and Address Siemens Medical Solutions, Inc. 51 Valley Stream Parkway Malvern, PA 19355

Establishment Registration Number 2240869

Manufacturing Site Name and Address Noras Röntgen- und Medizintechnik GmbH Leibnizstrasse 4 97204 Höchberg Germany

Establishment Registration Number Establishment Registration 3004929307

Owner/Operator 9071737

Contact Person 2.

Judy Campbell Siemens Medical Solutions, Inc. 51 Valley Stream Parkway, E-50 Malvern, PA 19355 Telephone: (610) 448-4918 (610) 448-1787 Fax: Email Address: judith.campbell@siemens.com

CONFIDENTIAL

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Trade Name: Common Name: Classification Name: Classification Panel: CFR Number: Device Class: Product Code:

OR Head Coil 1. OR Head Coil 1.5 Magnetic Resonance Diagnostic Device Radiology 21 CFR § 892.1000 ============================================================================================================================================================================== 90MOS

4. Device Description

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Use of the OR Head Coil 1.5T requires the Siemens OR Head Holder. The pictures below show the complete set.

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Traditional 510(k) Noras Rontgen- Und Medizintechnik GmbH OR Head Coil 1.5T March 16, 2006

CONFIDENTIAL

000 05

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The intended use of the Noras OR Head Coil ST 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 and Siemens believe that, within the meaning of the Safe Medical Devices Act of 1990, the 8-channel phased array OR head coil 1.5T for the Magnetom Systems is substantially equivalent to the following coil:

Coil Name	Pemarket Notification	Clearance Date
MRI DevicesCorporation (NowKnown as InvivoCorporation)High Resolution HeadCoil -Model HRH-63-8	K013159	October 16, 2001

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 both coils are substantially equivalent.

General Safety and Effectiveness Concerns 8.

The OR Head Coil 1.5T 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 1.5T systems.

The NEMA Tests can be found in Appendix C. The NEMA Tests were done on Software platform syngo MR2004A. 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 the Symphony are applicable to all MAGNETOM 1.5T systems.

Traditional 510(k) Noras Rontgen- Und Medizintechnik GmbH OR Head Coil 1.5T March 16, 2006

CONFIDENTIAL

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Conclusion as to Substantial Equivalence 9.

Noras and Siemens believe that, within the definition of the Safe Medical Devices Act of 1990, the Noras 8-channel phased array OR head coil 1.5T is substantially equivalent to the predicate device listed above.

Auebert Wares

Hubert Noras President

March 16, 2006

Traditional 510(k) Noras Rontgen- Und Medizintechnik GmbH OR Head Coil 1.5T March 16, 2006

CONFIDENTIAL

000 07

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY - 5 2006

Ms. Judith Campbell Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, E-50 MALVERN PA 19355

Re: K060758

Trade/Device Name: Noras OR Head Coil 1.5 T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 16, 2006 Received: March 21, 2006

Dear Ms. Campbell:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation prumber at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

Noras OR Head Coil 1.5 T

Indications for Use:

Used in the 1.5T 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-CONT NUE ON ANOTHER PAGE OF 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	K060258
Page	of

Traditional 510(k)

Noras Rontgen- Und Medizintechnik GmbH

CONFIDENTIAL
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March 16, 200€

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.