MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020

K053045 · Integra LifeSciences Corporation · HBL · Nov 21, 2005 · Neurology

Device Facts

• Record ID: K053045
• Device Name: MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
• Applicant: Integra LifeSciences Corporation
• Product Code: HBL · Neurology
• Decision Date: Nov 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4460
• Device Class: Class 2

Intended Use

The MAYFIELD® Radiolucent Skull Pins A-2020 are intended for use with a skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative CT or MR imaging is used. The MAYFIELD® Radiolucent Skull Pins A-2020 are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative CT or MR imaging of the patient is used.

Device Story

Single-use skull pins used with Mayfield® Skull Clamps; provide rigid skeletal fixation for patient head and neck positioning during neurosurgical procedures. Designed for compatibility with intra-operative CT or MR imaging. Installed in sets of three (two in rocker arm, one opposite) into skull clamp. Operated by surgeons in OR setting. Benefits include stable head fixation while maintaining imaging compatibility.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-use radiolucent skull pins; mechanical fixation device; non-powered; dimensions/materials not specified beyond radiolucent classification.

Indications for Use

Indicated for patients undergoing open or percutaneous craniotomies and spinal surgeries requiring rigid skeletal fixation during procedures involving intra-operative CT or MR imaging.

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 Pins (K021604)

Submission Summary (Full Text)

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Confidential

Integra LifeSciences Corporation Special 510(k): Device Modification Mayfield® Radiolucent Skull Pins

KOSZOUS

## Mayfield® Radiolucent Skull Pins 510(k) Summary

#### Submitter's name and address:

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

Contact person and telephone number:

Donna R. Wallace Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 (609) 936- 2397

Date prepared: October 20, 2005

#### Name of device:

| Proprietary Name: | Mayfield® Radiolucent Skull Pins |
|----------------------|----------------------------------|
| Common Name: | Skull Pins |
| Classification Name: | Neurological Head Holder |

## Substantial Equivalence:

The Mayfield® Radiolucent Skull Pins are substantially equivalent in function and intended use to the unmodified Mayfield® Radiolucent Skull Pins which have been cleared to market under Premarket Notification 510(k) K021604.

#### Indications Use:

The Mayfield® Radiolucent Skull Pins are intended for use with a skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative CT or MR imaging is used.

The Mayfield® Radiolucent Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and vhen Intra-Operative CT or MR imaging of the patient is used.

### Device Description:

The Mayfield® Radiolucent Skull Pins are single use devices which are used with Mayfield® Skull Clamps for approaches that require rigid skeletal fixation. In preparation for surgery three Radiolucent Skull Pins are installed in a Mayfield® Skull Clamp. Two Radiolucent Skull Pins are inserted in the Rocker Arm side of the Clamp and a single Radiolucent Skull Pins is inserted on the opposite side. The Mayfield® Radiolucent Skull Pins may be used in surgical procedures when rigid fixation is desired and Intra-Operative CT or MR imaging is used.

## Conclusion:

The modified Mayfield® Radiolucent Skull Pins is substantially equivalent to the unmodified Mayfield® Radiolucent Skull Pins. The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not reise new issues of safety and effectiveness.

E-001

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

NOV 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Donna R. Wallace, RAC Director Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K053045

Trade/Device Name: MAYFIELD® Radiolucent Skull Pins Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: October 27, 2005 Received: October 31, 2005

Dear Ms. Wallace:

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.

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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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Barbara Bucheld
for

Mark N. Melkerson 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

KOS3CHS 510(k) Number (if known):

Device Name: MAYFIELD® Radiolucent Skull Pins

Indications For Use:

The MAYFIELD® Radiolucent Skull Pins A-2020 are intended for use with a skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative CT or MR imaging is used.

The MAYFIELD® Radiolucent Skull Pins A-2020 are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative CT or MR imaging of the patient is used.

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)

Barbara BuellMD

Division of General, Restorative, and Neurological Devices

**510(k) Number** K053045 Page 1 of 1

D-001