The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.57/3T is, in conjunction with a Magnetic Resonance Scanner, intra-operative MR imaging during an open-skull neurosurgery.

The OR Head Holder LUCY is used for safe securing the patient's head during a surgical intervention at the head. It is possible to make an intraoperative assessment during the intervention to determine its progress. In the MR area the Head Coils enable the diagnostic imaging. Using Computed Tomography or C-arm Fluoroscopy, it is mandatory to remove the Head Coils and the device serves as a skull clamp only.

Device Description

The OR Head Holder LUCY can be used for intra-operative MR Imaging, CT Imaging and C-arm Imaging. In use with the NORAS OR Head Coils 1.5T or 3T, the OR Head Holder LUCY can be applied for intra operative MR imaging during an open skull neurosurgery at human patients.

The NORAS OR Head Holder LUCY is used for safe fixation of the patient's head during neurosurgical procedures on the patient's skull with planning and resection aid for MRI, CT and C-arm Imaging.

One additional feature of the OR Head Holder LUCY is the ability of height adjustment providing an ideal patient positioning in 70 cm MRI (Siemens Magnetom Aera and Skyra and Philips Ingenia 1.5T/3T, Ingenia Ambition 1.5T and Ingenia Elition 3.0T) and in CT- Scanners. Furthermore, the whole set up can be moved parallel to the bore direction (in Z- direction).

The configuration allows comfortable positioning of the patient in prone, lateral or supine position on the transfer board and allows an exact adjustment of the Head Holder during the positioning of the patient´s head. The system supports awake craniotomy.

Mechanical, the model of the Head Holder allows a slight movement of both posts of the three-point fixation at the Arc with a stable geometry, which minimizes unwanted movements. The patients head will be fixed by three skull pins.

AI/ML Overview

The provided text is a 510(k) summary for the NORAS OR Head Holder LUCY with HeadCoilSet. This document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a performance study with acceptance criteria in the manner typically seen for AI/ML devices or diagnostic tools.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text. The document details non-clinical bench testing to demonstrate that "technological changes do not raise any new issues of safety or effectiveness over the predicate," implying a focus on engineering validation rather than clinical performance metrics against specific acceptance thresholds for diagnostic accuracy.

The closest information available pertains to the general safety and effectiveness concerns and non-clinical tests.

Here's what can be extracted and what cannot:

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

Cannot be fully provided as requested for diagnostic/performance metrics. The document states that "Testing and analysis have been conducted to show that the verification, validation, and safety requirements have been met per the FDA as established standards." It also mentions adherence to NEMA Standards and DIN EN standards (DIN EN 60601-2-33:2017) for safety parameters related to MRI devices. However, specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) are not listed, nor are numerical results for such performance. The reported "performance" focuses on mechanical and electrical safety, and compatibility with MRI scanners.

Acceptance Criterion (Inferred from text)	Reported Device Performance (Inferred from text)
Compliance with NEMA Standards	Met
Compliance with DIN EN 60601-2-33:2017 (Safety for MRI devices)	Met
Risk mitigation per DIN EN ISO 14971:2013	Risks controlled via measures in development, testing, and product labeling
No new issues of safety or effectiveness compared to predicates	Achieved through non-clinical bench testing
Compatibility with specified MR systems (Siemens 1.5T/3T, Philips 1.5T/3T)	Confirmed through testing

2. Sample size used for the test set and the data provenance:

Cannot be provided. The document describes "non-clinical bench testing" and "testing and analysis" but does not specify sample sizes or types of data (e.g., patient images). It does not mention clinical test sets or data provenance (country of origin, retrospective/prospective) in the context of device performance evaluation. The "data" refers to engineering test results, not clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Cannot be provided. Since this is a non-AI/ML device primarily focused on mechanical and electrical safety and physical compatibility, there is no mention of "experts" establishing a "ground truth" for a test set in the diagnostic sense. The expertise involved would be in engineering and regulatory compliance.

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

Not applicable/Cannot be provided. This concept is relevant for studies involving human readers and complex diagnostic interpretations, which is not the type of study described for this device.

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:

Not applicable/Not done. This device is a medical accessory (head holder and coil set) for MRI, not an AI/ML diagnostic tool. Therefore, MRMC studies and human-in-the-loop performance metrics are not relevant or described.

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

Not applicable/Not done. This is not an algorithm or AI device.

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

Not applicable. For this device, "ground truth" would relate to the physical and electrical properties meeting specified engineering tolerances and safety standards. It does not involve clinical diagnostic ground truth like pathology or outcomes data.

8. The sample size for the training set:

Not applicable/Cannot be provided. This device is not an AI/ML model that requires a training set of data.

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

Not applicable/Cannot be provided. As above, no training set information is present.

Summary

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March 3, 2022

Image /page/0/Picture/1 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

NORAS MRI products GmbH % Ms. Patricia Kirchner Quality & Regulatory Affairs Leibnizstr. 4 Hoechberg, Bavaria 97204 GERMANY

Re: K211658

Trade/Device Name: OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS, HBL Dated: January 10, 2022 Received: January 12, 2022

Dear Ms. Kirchner:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211658

Device Name

OR Head Holder LUCY with HeadCoilSet Siemens 1.5 T; OR Head Holder LUCY with HeadCoilSet Siemens 3T; OR Head Holder LUCY with HeadCoilSet Philips 1.5T; OR Head Holder LUCY with HeadCoilSet Philips 3T;

Indications for Use (Describe)

The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.57/3T is, in conjunction with a Magnetic Resonance Scanner, intra-operative MR imaging during an open-skull neurosurgery.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for NORAS MRI products. The logo features the word "NORAS" in bold, blue letters, with a horizontal line underneath. To the right of "NORAS" is a stylized image of a heartbeat line in black, with the words "MRI products" in smaller, blue letters underneath the heartbeat line. The background is white.

510(k) Summary

K211658

As required by section 807.92(c)

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 Date Prepared: March, 01 2021 Manufacturer: NORAS MRI products GmbH Leibnizstr. 4 97204 Hoechberg / Germany Registration Number: 3004929307 Owner/Operator Number: 9071737 Contact Person: Manuel Noras CEO NORAS MRI products GmbH Leibnizstr. 4 97204 Hoechberg / Germany Tel.: (+49) 931 29927 - 29 Fax: (+49) 931 29927 – 20 E-Mail: Manuel.Noras@noras.de Device Name: OR Head Holder LUCY with HeadCoilSet Siemens 1.5 T OR Head Holder LUCY with HeadCoilSet Siemens 3T OR Head Holder LUCY with HeadCoilSet Philips 1.5T OR Head Holder LUCY with HeadCoilSet Philips 3T

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Image /page/4/Picture/0 description: The image shows the logo for NORAS MRI products. The logo has the word "NORAS" in bold, blue letters on the left side of the image. To the right of the word "NORAS" is a thin line that resembles a heartbeat. To the right of the heartbeat line are the words "MRI products" in smaller, blue letters.

Trade Name:	OR Head Holder LUCY with HeadCoilSet Siemens 1.5 T (Ref. 119734)OR Head Holder LUCY with HeadCoilSet Siemens 3T (Ref. 119736)OR Head Holder LUCY with HeadCoilSet Philips 1.5T (Ref. 120281)OR Head Holder LUCY with HeadCoilSet Philips 3T (Ref. 120282)
Common Name:	OR Head Holder LUCY with HeadCoilSet Siemens 1.5 TOR Head Holder LUCY with HeadCoilSet Siemens 3TOR Head Holder LUCY with HeadCoilSet Philips 1.5TOR Head Holder LUCY with HeadCoilSet Philips 3T
Classification Panel:	Radiology
Regulation Number:	21 CFR § 892.1000
Device Class:	II
Product Code:	MOS, HBL

2. Safety and Effectiveness information supporting substantial equivalence

Device Description

The NORAS OR Head Holder LUCY is used for safe fixation of the patient's head during neurosurgical procedures on the patient's skull with planning and resection aid for MRI, CT and C-arm Imaging.

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Image /page/5/Picture/0 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 "S". To the right of the line, there is a stylized image of a heartbeat, followed by the words "MRI products" in smaller, blue letters. The background is white.

Image /page/5/Picture/1 description: The image shows two different views of a medical device used for brain surgery. The device is white and gold and has a curved shape. The first view shows the device without a head in it, and the second view shows the device with a head in it. The device appears to be used to hold the head in place during surgery.

Image: Head Holder Set up with coils and fixed patient

Indications for use

The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scanner, intra-operative MR imaging during an open-skull neurosurgery.

The OR Head Holder LUCY is used for safe securing the patient's head during a surgical intervention at the head. It is possible to make an intraoperative assessment during the intervention to determine its progress. In the MR area the Head Coils enable the diagnostic imaging. Using Computed Tomography or Carm Fluoroscopy, it is mandatory to remove the Head Coils and the device serves as a skull clamp only.

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Image /page/6/Picture/0 description: The image shows the logo for NORAS MRI products. The logo features the word "NORAS" in a bold, blue font, with a horizontal line extending from underneath the word. To the right of the line, there is a stylized waveform graphic, also in blue, followed by the words "MRI products" in a smaller, black font. The overall design is clean and professional, suggesting a company that specializes in MRI-related products.

Substantial Equivalence

NORAS MRI products GmbH believes that, within the meaning of the Safe Medical Device Act of 1990, the OR Head Holder LUCY with Head Coil Set 1.5T/3T is substantially equivalent to the following Devices:

Predicate DeviceName andManufacturer	510(k)Number	ClearanceDate	ProductCode	ComparableProperties
NORAS OR HeadHolder FlexibilityNORAS MRIproducts GmbH	K133506	August 6,2014	MOS; HBL	Fixation of thepatient's head
MAYFIELD@ InfinityXR2 Skull ClampIntegra LifeSciencesCorporation	K130389	April 23, 2013	HBL	Fixation of thepatient's headand neck

Summary of Technological Characteristics of the Principal Device as

Compared with the Predicate Device

The OR Head Holder LUCY bears many similarities to its predicates, the NORAS OR Head Holder Flexibility and the MAYFIELD@ Infinity XR2 Skull Clamp. The OR Head Holder LUCY has the same indication for use as the predicate devices. All of them, the subject and the two predicate devices, are used for the fixation of the patient's head.

The NORAS OR Head Coil Set 1.5T and 3T can be used with both NORAS Head Holders, Flexibility and LUCY. The Coils were already registered with the FDA under the Premarket Submission Number K060758/K091546 and Listing Number E646984/D093265 by NORAS MRI Products GmbH.

The subject device offers the following improvements and minor differences over the predicate device "NORAS OR Head Holder Flexibility".

-The subject device can be used in Computed Tomography or C-arm Fluoroscopy
-The Subject device has other dimensional specifications. It is 330 mm less wide and deeper than the predicate device.
The subject device is made of different materials than the predicate device. -
-The subject device have a fixation only by three skull pins.

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Image /page/7/Picture/0 description: The image shows the logo for NORAS MRI products. The logo features the word "NORAS" in bold, blue letters, with the letters slightly overlapping each other. To the right of "NORAS" is a thin, blue line that resembles a heartbeat waveform. Below the waveform, the words "MRI products" are written in a smaller, sans-serif font, also in blue.

The subject device offers the following minor differences over the predicate device "Mayfield Infinity XR2 Skull Clamp"

-The subject device is made of different materials than the predicate device.
The subject device uses NORAS or Brainlab Pins, Mayfield Infinity XR2 Skull -Clamp uses only Mayfield Pins.
-The range of the force indicator of the subject device is higher (0-500N) than of the predicate device (0-356N).
-The subject device uses slightly different cleaning, disinfection and sterilization procedures.

General Safety and Effectiveness Concerns

The OR Head Holder LUCY 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 DIN EN standards for safety issues with the Magnetic Resonance Imaging Devices (DIN EN 60601-2-33:2017). This will assure that the performance of this device can be considered safe and effective when used with the currently available Siemens Magnetom Aera 1.5T & Skyra 3T and Philips Ingenia 1.5T/3T. Ingenia Ambition 1.5T and Ingenia Elition 3.0T systems.

Risk management is ensured via a risk analysis in compliance with DIN EN ISO 14971:2013 to identify and provide mitigation to potential hazards in a risk analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in development, testing and product labeling. To minimize risks, NORAS adhere to recognized and established industry practices and standards to minimize safety and performance risks. Furthermore, the operators and end users of the device are doctors or trained staff and responsible for other hospital procedures.

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

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Image /page/8/Picture/0 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. To the right of the line, there is a stylized image of a heartbeat, with the words "MRI products" in smaller, blue letters below it. The background of the logo is white.

Non-clinical Tests

Testing and analysis have been conducted to show that the verification, validation, and safety requirements have been met per the FDA as established standards. Risk Management is ensured via a risk analysis in compliance with DIN EN ISO 14971:2013 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. NORAS adhere to recognized and established industry standards, such as the DIN EN ISO 60601-1 series, to minimize electrical and mechanical hazards.

Non-clinical bench testing was conducted to support the intended use and to confirm that technological changes do not raise any new issues of safety or effectiveness over the predicate.

Conclusion as to Substantial Equivalence

The subject device, OR Head Holder LUCY, is optimized for MRI, CT and C-arm supported surgery, just like the Mayfield Infinity XR2 Skull Clamp. While the other predicate device, NORAS OR Head Holder Flexibility, is optimized for its usefulness in interventional surgery applications. All three devices are Head Holders and the fundamental attributes of the subject device and the predicate devices are the same.

The conclusions from the non-clinical data suggest that the subject device has the same fundamental technological characteristics with respect to the predicate device and exhibits an equivalent safety and performance profile as that of the predicate device.

Following, NORAS MRI products GmbH believes, that the OR Head Holder LUCY with HeadCoilSet Siemens 1.5T/3T and HeadCoilSet Philips 1.5T/3T does not raise new questions of safety or effectiveness and, therefore, is substantially equivalent to the predicate devices listed above.

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.