MAYFIELD MR/X-RAY SKULL CLAMP

K081401 · Integra Lifesciences Corp. · HBL · Oct 8, 2008 · Neurology

Device Facts

• Record ID: K081401
• Device Name: MAYFIELD MR/X-RAY SKULL CLAMP
• Applicant: Integra Lifesciences Corp.
• Product Code: HBL · Neurology
• Decision Date: Oct 8, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4460
• Device Class: Class 2

Intended Use

The MAYFIELD® MR/X-Ray Skull clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. In addition, the clamp is indicated for use during utilization of imaging modalities such as intraoperative CT and MR imaging, C-Arm X-ray, and digital subtraction techniques.

Device Story

Mechanical skull clamp providing rigid skeletal fixation; used for patient positioning in prone or supine orientations during neurosurgical procedures. Device requires three skull pins for attachment. Features a swiveling rocker arm capable of 360° rotation, even under full skeletal force, to avoid critical skull areas. Used in OR settings by surgeons; facilitates intraoperative imaging (MR, CT, X-ray). Benefits include stable head positioning and compatibility with diagnostic imaging modalities.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical neurosurgical head holder; utilizes three skull pins for fixation. Features a swiveling rocker arm with 360° rotation capability. Designed for compatibility with MR, CT, and X-ray imaging environments.

Indications for Use

Indicated for patients requiring rigid head and neck fixation during open or percutaneous craniotomies, spinal surgery, and procedures involving intraoperative CT, MR imaging, C-Arm X-ray, or digital subtraction techniques.

Regulatory Classification

Identification

A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.

Predicate Devices

• MAYFIELD® MR/CT Skull Clamp (K050319)

Submission Summary (Full Text)

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

## MAYFIELD® MR/X-Ray Skull Clamp 510(k) Summary K081401

### Submitter's name and address:

Integra LifeSciences Corporation 4900 Charlemar Drive, Building A Cincinnati, Ohio 45227 USA

#### Contact person and telephone number:

Helder A. Sousa Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 [phone]

Date prepared: May 16, 2008

#### Name of device:

| Proprietary Name: | MAYFIELD® MR/X-Ray Skull Clamp |
|----------------------|--------------------------------|
| Common Name: | Skull Clamp |
| Classification Name: | Neurological Head Holder |

#### Substantial Equivalence:

The MAYFIELD® MR/X-Ray Skull Clamp is substantially equivalent in function and intended use to the unmodified MAYFIELD® MR/CT Skull Clamp which has been cleared to market under Premarket Notification 510(k) K050319.

#### Indications Use:

The MAYFIELD® MR/X-Ray Skull clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. In addition, the clamp is indicated for use during utilization of imaging modalities such as intraoperative CT and MR imaging, C-Arm X-ray, and digital subtraction techniques.

#### Device Description:

The MAYFIELD® MR/X-Ray Skull Clamp is designed to provide rigid skeletal fixation for procedures involving imaging modalities, such as intra-operative MR, CT, and digital subtraction angiography. The Skull Clamp is designed for patient positioning in the prone or supine positions. The Skull Clamp requires the use of three (3) each Skull Pins. A voidance of critical areas of the skull is made possible by a swiveling rocker arm which rotates 360°. In addition, the swiveling rocker arm can rotate 360° under full skeletal force.

#### Conclusion:

The modified MAYFIELD® MR/X-Ray Skull Clamp is substantially equivalent to the unmodified MAYFIELD® MR/CT Skull Clamp (K050319). The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

OCT 0 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Integra LifeSciences Corporation % Helda A. Sousa Regulatory Affairs Project Manager 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K081401

Trade/Device Name: MA YFIELD® MR/X-Ray Skull Clamp Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: September 5, 2008 Received: September 8, 2008

Dear Helda A. Sousa:

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. Iisting 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 (PMA), 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.

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.

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

## Page 2 - Helda A. Sousa

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours.

Mark H. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

K081401 510(k) Number (if known):

Device Name: MAYFIELD® MR/X-Ray Skull Clamp

Indications For Use:

The MA YFIELD® MR/X-Ray Skull clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. In addition, the clamp is indicated for use during utilization of imaging modalities such as intraoperative CT and MR imaging, C-Arm X-ray, and digital subtraction techniques.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for mkm

(Division Sign-C Division of General, Restorative, and Neurological Devices

510(k) Number K081401

Page 1 of 1

B-001