The MAYFIELD® Radiolucent Disposable 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 lutra-Operative CT or MR imaging is used.

The MAYFIELD® Radiolucent Disposable Skull Pins 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 Description

The Mayfield® Radiolucent Disposable 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 Disposable Skull Pins may be used in surgical procedures when rigid fixation is desired and Intra-Operative CT or MR imaging is used.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "Mayfield® Radiolucent Disposable Skull Pins." It is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device in function and intended use.	The Mayfield® Radiolucent Disposable Skull Pins are substantially equivalent in function and intended use to the unmodified Mayfield® Radiolucent Skull Pins (K021604 and K050345). The modifications do not affect the intended use, fundamental scientific technology, or raise new safety/effectiveness issues.

2. Sample size used for the test set and the data provenance:

Sample size: Not applicable. This submission relies on substantial equivalence to predicate devices, not new performance testing with a specific test set.
Data provenance: Not applicable. The submission refers to prior 510(k) clearances.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new clinical or performance study involving human experts to establish ground truth was conducted or reported in this 510(k) summary.

4. Adjudication method for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a mechanical skull pin, not an AI-based diagnostic or assistive technology for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used:

Not applicable. The basis for clearance is substantial equivalence (to previously cleared devices), not a new ground truth established for a novel device performance claim.

8. The sample size for the training set:

Not applicable. No machine learning training set is relevant for this device.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Mayfield® Radiolucent Disposable Skull Pins 510(k) Summary K071458

JUN 1 3 2007

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: May 9, 2007

Name of device:

Proprietary Name:	Mayfield® Radiolucent Disposable Skull Pin
Common Name:	Skull Pins
Classification Name:	Neurological Head Holder

Substantial Equivalence:

The Mayfield® Radiolucent Disposable 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 and K050345.

Indications Use:

The Mayfield® Radiolucent Disposable 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 Disposable Skull Pins 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 Description:

Conclusion:

The modified Mayfield® Radiolucent Disposable 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 raise new issues of safety and effectiveness.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three overlapping, curved lines forming its body and wings. The logo is surrounded by text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUN 1 8 2007

Re: K071458

Trade/Device Name: MAYFIELD® Radiolucent Disposable Skull Pin Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: May 24, 2007 Received: May 29, 2007

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, listing 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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Page 2 - Ms. Donna R. Wallace, RAC

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .

Sincerely yours,

Mark N. Melkerson
Director

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): K071458

Device Name: MAYFIELD® Radiolucent Disposable Skull Pin

Indications For Use:

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)

(Division Sign-Off) (Division Sign of General, Restorative, and Neurological Devices

510(k) Number

Page 1 of 1

B-001

Regulation Number and Section

§ 882.4460 Neurosurgical head holder (skull clamp).

(a)
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.(b)
Classification. Class II (performance standards).