The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for use with the MR system MAGNETOM Aera / Skyra and the Combi-Dockable-Table together with Trumpf OR Tables TrueSystem 7500 (EU/US Version) and as well as together with Maquet OR Tables Magnus (EU/US Version) and Alpha Maquet Plus (EU/US Version).

For Philips:

The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery.

The NORAS OR Head Holder is used for safely securing the patient's head during the intervention.

The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for Philips MR system Ingenia 1.5T/3T in combination with Maquet Transfer Board together with Maquet OR table.

Device Description

The NORAS OR Head Holder and the NORAS OR Head Coil 1.5T / 3.0T combine the functions of a head holder for neurosurgical interventions and an MR receiving coil for intra-operative surgery.

The NORAS OR Head Holder without the NORAS OR Head Coil 1.5T / 3.0T can be used for stabilizing the patient's head. It can also be used in combination with the body coil.

The Head Frame of the NORAS OR Head Holder allows adjustment to heads varying in size. For optimal access to the area of intervention, the Head Frame can be swiveled and rotated.

AI/ML Overview

The provided document pertains to the 510(k) premarket notification for the NORAS OR Head Holder Flexibility. The device is a "Magnetic Resonance Diagnostic Device" and is intended for use in intra-operative MR imaging during open-skull neurosurgery, primarily for safely securing the patient's head.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) that a diagnostic device would typically have, nor does it report specific performance values for the device in such a format. This is because the NORAS OR Head Holder Flexibility is primarily a support and positioning device for MR imaging, rather than an active diagnostic algorithm.

Instead, the acceptance criteria are implicitly related to:

Safety and Mechanical Integrity: Ensuring the device can safely secure a patient's head and function properly within an MR environment without posing new risks.
Compatibility: Ensuring it works as intended with specified MR systems and operating tables.
Substantial Equivalence: Demonstrating that it is as safe and effective as a legally marketed predicate device.

Here's an interpretation of the implied acceptance criteria and the device's reported performance based on the provided text:

Acceptance Criteria (Implied)	Reported Device Performance (Summary of Evidence)
Mechanical Safety and Integrity (e.g., ability to securely hold a patient's head, structural soundness in the OR/MR environment)	"According to our internal evaluations as well the external tests done by VDE the new components such as Z-joint meet the requirements of IEC 60601-1 3.ed (clause 9.8) and do not adversely affect the safety of the design."
Electrical Safety and Electromagnetic Compatibility (EMC) (relevant for MR environment)	"The NORAS OR Head Holder Flexibility combined with the NORAS OR Head Coil 1.5T / 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."
Functional Compatibility with specific MR systems & OR tables	The device is suitable for use with:Siemens: MR system MAGNETOM Aera / Skyra, Combi-Dockable-Table, Trumpf OR Tables TrueSystem 7500, Maquet OR Tables Magnus, Alpha Maquet Plus.Philips: MR system Ingenia 1.5T/3T, Maquet Transfer Board, Maquet OR table.
Substantial Equivalence (to a predicate device regarding safety and effectiveness)	Manufacturer believes the device is substantially equivalent to the predicate device: NORAS OR Head Holder (K071179). The new device includes "only some minor mechanical changes which contribute to more flexibility in patient positioning" compared to the predicate, and these changes "do not adversely affect the safety of the design." Its comparable property to the predicate is "Fixation of the patient's head."
Intended Use (ability to perform the specified function)	"The NORAS OR Head Holder is used for safely securing the patient's head during the intervention." (This is the core function, and the device is presented as meeting this function through its design and safety testing).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "sample size" in terms of patient data or a "test set" in the context of diagnostic algorithm validation. The testing described is primarily focused on engineering and safety standards conformance for the device's mechanical and electrical properties.

The testing involves "external tests done by VDE" and "internal evaluations" concerning mechanical aspects (e.g., Z-joint meeting IEC 60601-1 clause 9.8).
Conformance to NEMA and IEC 60601-2-33:2002 standards is stated for safety and performance in an MR environment.

These types of tests are typically conducted in a laboratory or engineering testing facility setting rather than with a "test set" of patient data. Therefore, concepts like data provenance (country of origin, retrospective/prospective) are not applicable in the usual sense for this type of device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this device. As explained above, the device is a piece of hardware for patient positioning, not an AI/diagnostic algorithm that requires ground truth established by medical experts on patient data. The "ground truth" here is adherence to engineering and safety standards, verified by testing bodies and internal evaluations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to this device, as there is no "test set" of medical images or patient data requiring expert 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 to this device. An MRMC study is relevant for evaluating the impact of an AI-powered diagnostic tool on human reader performance, which the NORAS OR Head Holder Flexibility is not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable to this device. It is a hardware device, not a standalone AI algorithm. It acts as a component within a human-in-the-loop imaging workflow (neurosurgeon, MR technologist, radiologist, etc.).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically used in diagnostic algorithm validation (e.g., pathology, clinical outcomes) is not applicable here. The "ground truth" for this device's acceptance is its conformance to established international and FDA-recognized engineering and medical device safety standards (e.g., IEC 60601-1, IEC 60601-2-33, NEMA standards). The truth is established by meeting these pre-defined technical and safety requirements through testing.

8. The sample size for the training set

This information is not applicable to this device. There is no AI algorithm being trained, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable to this device, as there is no training set or AI algorithm involved.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that appears to represent three human profiles in a row.

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

August 6, 2014

NORAS MRI Products GmbH % Mr. Zahed Sedighiani Quality and Regulatory Management Leibnizstrasse 4 Hoechberg D-97204 GERMANY

Re: K133506

Trade/Device Name: NORAS OR Head Holder "Flexibility" Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS, HBL Dated: June 25, 2014 Received: June 27, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133506

Device Name

NORAS OR Head Holder Flexibility 114464

Indications for Use (Describe)

For Siemens:

The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.57 / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery.

The NORAS OR Head Holder is used for safely securing the patient's head during the intervention.

For Philips:

The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery.

The NORAS OR Head Holder is used for safely securing the patient's head during the intervention.

The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for Philips MR system Ingenia 1.5T/3T in combination with Maguet Transfer Board together with Maquet OR table.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Michael D'Hara

FORM FDA 3881 (1/14)

SC Publishing Services (301) 443-6740

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

003_Summary.docx

Image /page/4/Picture/1 description: The image shows the logo for NORAS MRI products. The word "NORAS" is in bold, blue letters, with a horizontal line underneath. To the right of the word "NORAS" is a graphic of a heartbeat line, and the words "MRI products" are stacked on top of each other to the right of the heartbeat line.

510(k) Summary

NORAS OR Head Holder Flexibility

Date of Summary Preparation: March 28, 2014

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

003 Summary.docx

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for NORAS. The logo is in blue and white. The word "NORAS" is in large, bold letters, and to the right of it is a heartbeat line with the words "MRI products" below it.

2. Contact Person

Zahed Sedighiani MSc. Medical Engineering Quality Assurance & International Licensing NORAS MRI products GmbH Leibnizstr.4 97204 Hoechberg Germany Tel: (+49) 931 / 29927-17 Fax: (+49) 931 / 29927-20 zahed.sedighiani@noras.de

Device Name and Classification 3.

Trade Name:	NORAS OR Head Holder Flexibility
Common Name:	NORAS OR Head Holder Flexibility
Classification Name:	Magnetic Resonance Diagnostic Device
Classification Panel:	Radiology
CFR Number:	21 CFR § 892.1000
Device Class:	II
Product Code:	MOS, HBL

{6}------------------------------------------------

Device Description 4.

The NORAS OR Head Holder and the NORAS OR Head Coil 1.5T / 3.0T combine the functions of a head holder for neurosurgical interventions and an MR receiving coil for intra-operative surgery.

The NORAS OR Head Holder without the NORAS OR Head Coil 1.5T / 3.0T can be used for stabilizing the patient's head. It can also be used in combination with the body coil.

The Head Frame of the NORAS OR Head Holder allows adjustment to heads varying in size. For optimal access to the area of intervention, the Head Frame can be swiveled and rotated.

Image /page/6/Picture/6 description: The image shows a complex mechanical device, possibly a prototype or a component of a larger machine. It features a combination of curved pipes, flat plates, and cylindrical elements, all connected in an intricate arrangement. The device appears to be made of metal, with a light-colored finish. The background is a plain, light gray, which helps to isolate the device and highlight its details.

Image /page/6/Picture/7 description: The image shows a complex mechanical apparatus, possibly a component of a larger machine or a specialized tool. It features a series of interconnected metal frames, gears, and adjustable parts, suggesting a high degree of precision and functionality. The device is mounted on a base, allowing for stability and controlled movement. The overall design indicates it may be used for manufacturing, scientific research, or engineering applications.

Image /page/6/Picture/8 description: The image shows a medical device, possibly an MRI machine or a component of one. The top part of the image shows a person lying on a table, positioned within a large, circular device. The bottom part of the image shows a close-up of a similar circular device, which appears to be a coil or part of the imaging system, mounted on a platform.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for NORAS MRI products. The logo is in blue and white. The word "NORAS" is in large, bold letters. To the right of the word "NORAS" is a line that resembles a heart rate monitor. The words "MRI products" are stacked on top of each other to the right of the line.

5. Indications for Use

For Siemens:

The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery.

The NORAS OR Head Holder is used for safely securing the patient's head during the intervention.

For Philips:

The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery.

The NORAS OR Head Holder is used for safely securing the patient's head during the intervention.

6. Substantial Equivalence

NORAS MRI products GmbH believes that, within the meaning of the Safe Medical Devices Act of 1990, the NORAS OR Head Holder Flexibility is substantially equivalent to the following OR Head Holder:

PredicateDevice NameandManufacturer	510(k)Number	ClearanceDate	ProductCode	ComparableProperties
NORAS OR HeadHolder	K071179	April 27-2007	MOS, HBL	Fixation of thepatient's head

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for NORAS MRI products. The logo features the word "NORAS" in bold, blue letters, with a horizontal line extending from the right side of the word. The line then forms a heartbeat-like waveform, with the words "MRI products" stacked vertically to the right of the waveform. The logo is set against a white background, with a blue shape on the left side.

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

In comparison to the existing OR head holders, the OR Head Holder Flexibility PN: 114464 includes only some minor mechanical changes which contribute to more flexibility in patient positioning. According to our internal evaluations as well the external tests done by VDE the new components such as Z-joint meet the requirements of IEC 60601-1 3.ed (clause 9.8) and do not adversely affect the safety of the design.

8. General Safety and Effectiveness Concerns

The NORAS OR Head Holder Flexibility combined with the NORAS OR Head Coil 1.5T / 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 Siemens MAGNETOM Aera/Skyra 1.5T/3T as well as Philips Ingenia 1.5T/3T systems.

Conclusion as to Substantial Equivalence 9.

NORAS MRI products GmbH believes that, within the definition of the Safe Medical Devices Act of 1990, the NORAS OR Head Holder Flexibility is substantially equivalent to the predicate device listed above.

Zahed Sedighiani Quality and Requlatory Affairs Manager June 25, 2014

{9}------------------------------------------------

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.