The intended use of the Noras OR Head Holder is the fixation of the human skull just before, during and at the end of the intervention in the operating room. The head holder enables prone, supine and lateral patient positioning.

The Noras OR Head Coil 1.5T(K060758) can be adopted to the OR Head Holder in conjunction with a Siemens Magnetom System 1.5T to provide MR images before, during and at the end of the intervention. The head holder can be adjusted from adult use down to use for a new born child.

The intended use of the Noras OR Head Holder, in conjunction with a Magnetic Resonance Scanner, is to stabilize patient's head during neurosurgical procedures,

Used in conjunction with Siemens MAGNETOM Systems and the Noras OR Head Coil, it is indication with Olemens MAGNE I OM Systems and

Special Accessories are available for use with the head holder for awake cranic and becomes are available for use with the head holder for aw craniotomies, pediatric patients and minimally invasive interventions.

Device Description

The OR Head Holder is a fixation unit for the human head before, during and after an intervention at the human brain. The head holder will come with two versions of table adapters, depending on the OR table top used.

The Noras Part Numbers are: SI7000 for use with the Symphony, and Sonata Table top and the Miyabi transport system; and Part Number SI7300 for use with the table top for Espree or TIM Trio.

The OR Head Holder is a fixation unit for the human skull. It can be mounted on the Symphony/Sonata/Espree/Trio table top or the Miyabi Shell.

The OR Head holder provides the possibility to adopt the 1.5T Noras OR Head Coil and in conjunction with a 1.5T Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of brain surgery in the operating room.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "OR Head Holder" device by Siemens Medical Solutions USA, Inc. The purpose of this submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

However, the submission does not include an acceptance criteria table, a study explicitly designed to show the device meets specific performance criteria with reported device performance metrics, or information about AI assistance. The document focuses on showing substantial equivalence to an existing device through comparison of intended use and technological characteristics, rather than reporting on a new performance study with acceptance criteria.

Therefore, many of the requested details cannot be extracted from this document as they are not present in a 510(k) submission for this type of medical device where substantial equivalence is the primary pathway.

Here's a breakdown of what can and cannot be answered based on the provided text:

Acceptance Criteria and Device Performance Study Information:

Information Requested	Details from Document
1. Table of acceptance criteria and the reported device performance	NOT APPLICABLE/NOT PROVIDED. The 510(k) submission for this device (an OR Head Holder) focuses on substantial equivalence to a predicate device, not on specific performance acceptance criteria or a clinical study with reported performance metrics. The submission asserts the device is "substantially equivalent" to an existing device (SIEMENS Neurosurgical OR Head Holder, Catalog #7548204, K012495) because both are designed to fix a human skull in the OR environment and work in an MR magnetic field.
2. Sample size used for the test set and the data provenance	NOT APPLICABLE/NOT PROVIDED. No test set or associated data provenance (country of origin, retrospective/prospective) is described. The submission relies on a comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and their qualifications	NOT APPLICABLE/NOT PROVIDED. No test set or ground truth establishment by experts is detailed in this type of 510(k) submission for this device.
4. Adjudication method for the test set	NOT APPLICABLE/NOT PROVIDED. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done - Effect size of human readers improvement with AI vs without AI assistance	NOT APPLICABLE/NOT PROVIDED. The device is an "OR Head Holder," a physical fixation unit. It does not involve AI or human reader interpretation, so an MRMC study related to AI assistance is irrelevant and was not performed.
6. If a standalone (algorithm only without human-in-the-loop performance) was done	NOT APPLICABLE/NOT PROVIDED. The device is a physical head holder; there is no "algorithm only" performance to evaluate.
7. The type of ground truth used	NOT APPLICABLE/NOT PROVIDED. As no performance study with a test set is described, there is no mention of ground truth types (e.g., expert consensus, pathology, outcomes data). The basis for clearance is substantial equivalence to a predicate device's established safety and effectiveness.
8. The sample size for the training set	NOT APPLICABLE/NOT PROVIDED. This device is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no concept of a "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established	NOT APPLICABLE/NOT PROVIDED. As there is no training set for an algorithm, there is no ground truth establishment for a training set. The safety and effectiveness of the device are implied by its substantial equivalence to a predicate device, which would have undergone its own clearance/approval process based on its design, materials, and intended use as a physical medical device for fixation during neurosurgical procedures and MR imaging compatibility.

Summary regarding the 510(k) Submission:

The 510(k) submission for the Noras OR Head Holder sought to demonstrate substantial equivalence to an existing cleared device, the SIEMENS Neurosurgical OR Head Holder (K012495). The core argument for substantial equivalence is that both devices:

Are designed to fix a human skull in an operating room (OR) environment.
Are designed to work directly in the magnetic field of an MR scanner.
Have the same intended use: fixation of the human skull before, during, and at the end of intervention in the operating room, enabling prone, supine, and lateral patient positioning.

This type of submission relies on comparing the new device's technological characteristics and intended use to a predicate device, rather than providing new clinical study data with specific acceptance criteria and performance metrics.

Summary

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KO71179

JUN 1 8 2007

510(k) Summary OR Head Holder

Date of Summary Preparation: April 20, 2007

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 Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, E-50 Malvern, PA 19355

Establishment Registration Number 2240869

Manufacturing Site Name and Address Noras Röntgen- und Medizintechnik GmbH Leibnizstrasse 4 97204 Höchbera 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 Fax: (610) 448-1787 Email Address: judith.campbell@siemens.com

Page 4

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Device Name and Classification 3.

Trade Name:	OR Head Holder
Common Name:	OR Head Holder
Classification Name:	Magnetic Resonance Diagnostic Device
Classification Panel:	Neurology
CFR Number:	21 CFR § 882.446
Device Class:	II
Product Code:	HBL

4. Device Description

The Noras Part Numbers are: SI7000 for use with the Symphony, and Sonata Table top and the Miyabi transport system; and Part Number SI7300 for use with the table top for Espree or TIM Trio.

Image /page/1/Picture/5 description: In the image, there is a close-up of a metal object. The object has a flat, rectangular piece on the left side, and a more complex structure on the right side. The object appears to be a mechanical part, possibly from a machine or engine.

The picture on the left shows the OR Head holder SI7000 with the rectangular base plate (left) to fix the head holder to the OR table top or Miyabi shell.

On the right there is the C-Arc visible with the screws to fix the skull.

Image /page/1/Picture/8 description: This image shows a black and white photo of what appears to be a medical device attached to a person's head. The device is circular and has several metal arms extending from it. The person's head is visible inside the device, and their face is obscured. The image is grainy and has a low resolution.

Image /page/1/Picture/9 description: In the image, a machine is shown with a large circular component on the right side. A long, horizontal arm extends from the left towards the center of the machine. There are some smaller components attached to the arm. The image is in black and white and has a grainy texture.

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Traditional 510(k) Siemens Medical Solutions USA, Inc. OR Head Holder

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The pictures above show the OR Head holder SI7000 (right mounted on the table top for Magnetom Sonata and Symphony, left mounted on the Miyabi transport system with optional OR Head Coil and reflectors for navigation system.

Image /page/2/Picture/1 description: The image shows a close-up of a piece of machinery. The machinery is made of metal and has a variety of different parts. There are two circular holes in the middle of the machinery. The machinery appears to be old and well-used.

The picture on the left shows the OR Head holder SI7300 and the OR table top for Siemens Magnetom Espree and Tim Trio. The big base plate with the lower part of the hemisphere joint is implemented into the OR table top.

The pictures below show the OR Head holder SI7300 mounted on the OR table top for Siemens Magnetom Espree or Tim Trio. (left prone and supine position, right lateral patient position)

Image /page/2/Picture/4 description: The image contains two black and white photos. The photo on the left shows a close up of a piece of machinery. The photo on the right shows a person standing next to a piece of machinery.

The head holder always remains the same, but the package differs only in the table connection.

Traditional 510(k) Siemens Medical Solutions USA, Inc. OR Head Holder

Page 6

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5. Intended Use

6. Substantial Equivalence

Noras and Siemens believe that, within the meaning of the Safe Medical Devices Act of 1990, the OR Head Holder for Magnetom Systems is substantially equivalent to the following Neurosurgical OR Head Holder:

Device Name	Premarket Notification	Clearance Date
SIEMENS NeurosurgicalOR Head HolderCatalog #7548204	K012495	October 31, 2001

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

Both Neurosurgical OR Head Holders are designed to fix a human skull in the OR environment. Both units have been designed to work directly in the magnetic field of an MR.

8. General Safety and Effectiveness Concerns

Device Description

The OR Head Holder is a fixation unit for the human skull. It can be mounted on the Symphony/Sonata/Espree/Trio table top or the Miyabi Shell.

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9. Conclusion as to Substantial Equivalence

Noras and Siemens believe that, within the definition of the Safe Medical Device Act of 1990, the Noras OR head holder SI7000 or SI7300 is substantially equivalent to the predicate device listed above Both systems are used to stabilize the head of the patient during the entire neurosurgical procedure in the OR environment.

Hubert Noras President

April 20, 2007

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Traditional 510(k) Siemens Medical Solutions USA. Inc. OR Head Holder

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

March 30, 2014

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

Re: K071179 Trade/Device Name: Noras OR Head Holder Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS, HBL Dated: April 24, 2007 Received: April 27, 2007

Dear Ms. Campbell:

This letter corrects our substantially equivalent letter of June 13, 2007.

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

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Page 2 - Ms. Campbell

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

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

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Indications for Use

510(k) Number (if known):

Device Name:

Noras OR Head Holder

Indications for Use:

The intended use of the Noras OR Head Holder, in conjunction with a Magnetic and and a a a a a collect of the Noras OR Head Holder, in conjunction with a Magnetic
Resonance Scanner, is to stabilize patient's head during neurosurgical procedures,

Used in conjunction with Siemens MAGNETOM Systems and the Noras OR Head Coil, it is indication with Olemens MAGNE I OM Systems and

Special Accessories are available for use with the head holder for awake cranic and becomes are available for use with the head holder for aw
craniotomies, pediatric patients and minimally invasive interventions.

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

OF NOT WRITE BELOW THIS OF NEEDED) 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	KM11179
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Page 2Traditional 510(k) Siemens Medical Solutions USA, Inc. OR Head Holder

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.