MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104

K050319 · Integra Lifesciences Corp. · HBL · Mar 31, 2005 · Neurology

Device Facts

• Record ID: K050319
• Device Name: MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
• Applicant: Integra Lifesciences Corp.
• Product Code: HBL · Neurology
• Decision Date: Mar 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4460
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mayfield® MR/CT 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 us 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

Mayfield® MR/CT Skull Clamp provides rigid skeletal fixation for neurosurgical procedures; enables patient positioning in prone or supine orientations. Device features swiveling rocker arm with 360° rotation; allows surgeon to adjust fixation pin placement to avoid critical skull areas; rotation possible under full skeletal force for easier final positioning. Lean body design improves operative site exposure. Used in OR settings by surgeons; supports intraoperative imaging including CT, MR, and digital subtraction angiography. Benefits include secure head/neck stabilization and compatibility with diagnostic imaging modalities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Neurological head holder; mechanical skull clamp; swiveling rocker arm with 360° rotation; lean body design for improved surgical access; radiolucent materials for compatibility with CT/MR imaging.

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® Radiolucent Skull Clamp (K050319)

Submission Summary (Full Text)

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Confidential

111

## Mayfield® MR/CT Skull Clamp

510(k) Summary K050319

# Submitter's name and address:

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

### Contact person and telephone number:

Charles E. Dinkler II Director New Product Development [phone]

## Date prepared: March 22, 2005

#### Name of device:

| Proprietary Name: | Mayfield® MR/CT Skull Clamp |
|----------------------|-----------------------------|
| Common Name: | Head Holder or Skull Clamp |
| Classification Name: | Neurological Head Holder |

## Substantial Equivalence:

The Mayfield® MR/CT Skull Clamp is substantially equivalent to the Mayfield® Radiolucent Skull Clamp,

#### Indications Use:

The Mayfield® MR/CT 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 us 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/CT Skull Clamp is designed to provide rigid skeletal fixation for proccdures involving all imaging modalities, intra-operative MR, CT and digital subtraction angiography. The Skull Clamp is designed for patient positioning in the prone or supine positions. The design of the Skull Clamp allows the surgeon more freedom in positioning the fixation pins. Avoidance 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, making final positioning after pin impingement easier. The lean body design of the Mayfield® MR/CT Skull Clamp also allows for greater exposure to the operative site.

#### Conclusion:

The Mayficld® MR/CT Skull Clamp is substantially equivalent to the commercially marketed predicate device and does not raise new issues of safety and effectiveness.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized design of three overlapping shapes that resemble an abstract representation of a human figure.

Public Health Service

MAR 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Charles E. Dinkler II Director New Product Development Integra LifeSciences Corporation 4900 Charlemar Drive, Building A Cincinnati, Ohio 45227

Re: K050319

R650517
Trade/Device Name: Mayfield MR/CT Skull Clamp Regulation Number: 21 CFR 882.4460 Regulation Name: Neurological head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: March 3, 2005 Received: March 4, 2005

Dear Mr. Dinkler:

We have reviewed your Section 510(k) premarket notification of intent to market the individiation We have reviewed your Section >10(x) premainted in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices markets in interstate for use stated in the encry mancede province of the Medical Device Americal resident, brug commerce prof to May 20, 1776, the enaounter with the provisions of the Federal Food. Drue.
devices that have been reclassified in accordance with the provisions of the UMA devices that have been reclassified in acceraanse of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require applic the general controls provisions of the Act. The You may, merelore, manel the Act include requirements for annual registration. Iisting of general controls provisions of the free mers.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Spccial Controls) or class III (PMA). it If your device is classified (See aborb) this. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations in may be subject to suell additional controller interest of the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peachard Concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not nean Please be advised that 1197 s issuates of were complies with other requirements of the Act that 117A has made a determinations administered by other Federal agencies. You must or any Federal statutes and regulations and adding, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), adomig (21 OFR Part 820), and if applicable, the clectronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Charles E. Dinkler II

This letter will allow you to begin marketing your device as described in your Section 510(k) This ledel will anow you to cegm mailing of substantial equivalence of your device to a legally premaince hotheadon: The PDA mianing of ecation 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 If you desire specific acries is = 3 % = 0 1 5. Also, please note the regulation entitled. Contact the Office of Compullier and (21 CFR Part 807.97). You may obtain of Snall other general informational 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,

Stupt Rlurdu

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): KOSO319

Device Name: Mayfield MR/CT Skull Clamp

Indications For Use:

The Mayfield MR/CT 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-Am 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)

Ayet Murdus

(Division Division of General, Restorative, and Neurological Devices

**510(k) Number** K050319

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