NORAS OR HEAD HOLDER

K071179 · Siemens Medical Solutions USA, Inc. · MOS · Jun 13, 2007 · Radiology

Device Facts

• Record ID: K071179
• Device Name: NORAS OR HEAD HOLDER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MOS · Radiology
• Decision Date: Jun 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Mechanical fixation unit for human skull; used in operating room during neurosurgical procedures. Device provides stable patient positioning (prone, supine, lateral) for brain surgery. Integrates with Siemens MAGNETOM 1.5T MR scanners via optional Noras OR Head Coil to facilitate intraoperative MR imaging. Operated by neurosurgeons/OR staff. Device consists of adjustable head holder with table-specific adapters (SI7000 for Symphony/Sonata/Miyabi; SI7300 for Espree/TIM Trio). Provides stable platform for surgical intervention; enables imaging before, during, and after surgery. Benefits include precise head stabilization and continuous MR imaging capability without moving patient from OR table.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Mechanical skull fixation unit; MR-compatible materials. Adjustable form factor for patients ranging from newborns to adults. Includes table-specific adapters for Siemens Magnetom systems. Standalone mechanical device; no energy source or software algorithms.

Indications for Use

Indicated for stabilization of the human skull during neurosurgical procedures in the operating room. Suitable for adult and pediatric patients, including newborns. Supports prone, supine, and lateral positioning. Used in conjunction with Siemens MAGNETOM systems and Noras OR Head Coil for MR imaging. Accessories available for awake craniotomies and minimally invasive interventions.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• SIEMENS Neurosurgical OR Head Holder Catalog #7548204 (K012495)

Reference Devices

• Noras OR Head Coil 1.5T (K060758)

Submission Summary (Full Text)

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

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: [phone] Fax: [phone] Email Address: [e-mail]

Page 4

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

- 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 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.

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.

Page 5

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

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

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

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

# 5. Intended Use

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.

### 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 Neurosurgical<br>OR Head Holder<br>Catalog #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.

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.

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

# 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

Page 8

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

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

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

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

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 [phone] or [phone] 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 [phone] or [phone] 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

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

# 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) | <span style="text-decoration: overline;">✓</span> |
|----------------------------------------------|---------------------------------------------------|
| | AND/OR |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="text-decoration: underline;"></span> |

*Division Sign-Off*

Division of Reproductive, Abdominal, and Radiological Devices

| 510(k) Number | <span style="text-decoration: underline;"><i>KM11179</i></span> |
|---------------|-----------------------------------------------------------------|
|---------------|-----------------------------------------------------------------|

Page _ of _
Page 2Traditional 510(k) Siemens Medical Solutions USA, Inc. OR Head Holder

CONFIDENTIAL

3