The MAYFIELD® Disposable and Reusable Titanium Skull Pins are intended for use with a MAYFIELD skull clamp that is placed on the patient's skull to held their bead and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative MR imaging is used.

The MAYFIELD® Disposable and Reusable Titanium Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skouled fir ation is necessary and when Intra-Operative MR imaging of the patient is used.

Device Description

The MAYFIELD® Disposable and Reusable Titanium Skull Pins are available in two sizes, Adult and Child which are used with MAYFIELD® Skull Clamps that are applied to the patient's skull to hold their head and neck in a particular position during surgical procedures where rigid skeletal fixation is desired and intra-operative MR imaging is used.

In preparation for surgery three Titanium Skull Pins are installed in a MAYFIELD® Skull Clamp. Two Titanium Skull Pins are inserted in the Rocker Arm side of the Clamp and a single Titanium Skull Pin is inserted on the opposite side.

The MAYFIELD® Disposable and Reusable Titanium Skull Pins will be used during open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative MR imaging of the patient is used.

AI/ML Overview

This document is a 510(k) summary for MAYFIELD® Disposable and Reusable Titanium Skull Pins. It does not describe a study that uses acceptance criteria and device performance in the way typically associated with AI/ML device submissions. Instead, this is a premarket notification for a traditional medical device, demonstrating substantial equivalence to previously cleared devices.

Therefore, many of the requested fields are not applicable (N/A) in this context. The document focuses on demonstrating that the new device is as safe and effective as existing legally marketed predicate devices, primarily by comparing their intended use, technology, and materials.

Here's a breakdown of the requested information based on the provided text, indicating "N/A" where the information is not present or not relevant to this type of submission:

1. A table of acceptance criteria and the reported device performance

Since this is a submission for a traditional mechanical medical device based on substantial equivalence, specific quantitative acceptance criteria and performance metrics in the style of an AI/ML device study are not provided. The "performance" is implicitly demonstrated through comparison to predicate devices and the absence of new safety/effectiveness issues.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Material Composition: Titanium material suitability for intended use, especially with Intra-Operative MR imaging.	The device is made of Titanium, similar to the MAYFIELD® Radiolucent Disposable Skull Pins (K071458) and DORO® Titanium Pins (K063494), which are also used with Intra-Operative MR imaging. This implies suitable material properties for the intended use and MR compatibility inherent to Titanium. The submission states, "The MAYFIELD® Disposable and Reusable Titanium Skull Pins as the MAYFIELD® Radiolucent Disposable Skull Pins (K071458) and the DORO Titanium Pins (K063494) may be used in surgical procedures when Intra-Operative MR imaging of the patient is used."
Functionality/Intended Use: Ability to hold the patient's head and neck in a particular position during surgical procedures needing rigid skeletal fixation.	"The MAYFIELD® Disposable and Reusable Titanium Skull Pins like the predicate devices are used in a skull clamp that is placed on the patient's head to hold the patient's head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired." The device is available in Adult and Child sizes, used with MAYFIELD® Skull Clamps. This indicates it performs the same function as predicates.
Clinical Application: Suitability for open and percutaneous craniotomies and spinal surgeries.	"The MAYFIELD® Disposable and Reusable Titanium Skull Pins like the predicate devices may be used in open and percutaneous craniatories and spinal surgeries when rigid skeletal fixation is necessary."
Safety and Effectiveness: Does not raise new issues of safety and effectiveness compared to predicate devices.	The conclusion explicitly states: "The MAYFIELD® Disposable and Reusable Titanium Skull Pins are similar to the predicate devices in the intended use, the fundamental scientific technology of the device, and does not raise new issues of safety and effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable (N/A). This submission is based on substantial equivalence to existing devices, not on a clinical trial with a "test set" in the context of AI/ML performance evaluation.
Data provenance: Not applicable (N/A). No specific patient data or clinical study data is presented in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable (N/A). Ground truth generation for a test set is not part of this type of submission. The safety and effectiveness are established by demonstrating comparability to predicate devices, which are assumed to be safe and effective based on their established use.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable (N/A). No test set requiring adjudication is described.

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 (N/A). This is not an AI/ML device, and no MRMC study was conducted or described.

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

Not applicable (N/A). This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable (N/A). The concept of "ground truth" as used in AI/ML performance studies is not relevant here. The "truth" is established by the known safety and effectiveness of the existing predicate devices.

8. The sample size for the training set

Not applicable (N/A). There is no "training set" as this is not an AI/ML device.

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

Not applicable (N/A). There is no "training set" or ground truth establishment in this context.

Summary

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MAYFIELD® Disposable and Reusable Titanium Skull Pins

510(k) Summary 1072208

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 (609) 936- 6850

Date prepared:

August 7, 2007

Name of device:

Trade Name:	MAYFIELD® Disposable and Reusable Titanium Skull Pins
Common Name:	Skull Pins
Classification Name:	Neurological head holder (Skull Clamp)
Regulation Number:	21 CFR 882.4460
Product Code:	HBL

Substantial Equivalence:

The MAYFIELD® Disposable and Reusable Titanium Skull Pins are substantially equivalent in function and intended use to the MAYFIELD® Disposable Steel Skull Pins (K932860), MAYFIELD® Reusable Steel Skull Pins (pre-amendment), MAYFIELD® Radiolucent Disposable Skull Pins (K071458) and DORO Titanium Pins (K063494).

The MAYFIELD® Disposable and Reusable Titanium Skull Pins like the predicate devices are used in a skull clamp that is placed on the patient's head to hold the patient's head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired. The MAYFIELD® Disposable and Reusable Titanium Skull Pins like the predicate devices may be used in open and percutaneous craniatories and spinal surgeries when rigid skeletal fixation is necessary.

The MAYFIELD® Disposable and Reusable Titanium Skull Pins as the MAYFIELD® Radiolucent Disposable Skull Pins (K071458) and the DORO Titanium Pins (K063494) may be used in surgical procedures when Intra-Operative MR imaging of the patient is used.

SEP - 7 2007

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Indications Use:

The MAYFIELD® Disposable and Reusable Titanium Skull Pins are intended for use with a MAYFIELD 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 MR imaging is used.

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

Device Description:

Conclusion:

The MAYFIELD® Disposable and Reusable Titanium Skull Pins are substantially equivalent to the MAYFIELD® Disposable Steel Skull Pins (K932860), MAYFIELD® Reusable Steel Skull Pins (pre-amendment), MAYFIELD® Radiolucent Disposable Skull Pins (K071458) and DORO® Skull Pins (K063494). The MAYFIELD® Disposable and Reusable Titanium Skull Pins are similar to the predicate devices in the intended use, the fundamental scientific technology of the device, and does not raise new issues of safety and effectiveness.

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Image /page/2/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 heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Integra LifeSciences corpration % Helder A. Sousa Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, New Jersey 08536

2007

Re: K072208

Trade/Device Name: MAYFIELD® Disposable and Reusable Titanium Skull Pins Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: August 7, 2007 Received: August 8, 2007

Dear Helder 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.

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Page 2 - Helder 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, permitte 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) 633-241 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

for Pete

Mark N. Melkerson
Director

DEP D.RS gof
9/7/07

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): K072208

MAYFIELD® Disposable and Reusable Titanium Skull Pins Device Name: Indications For Use:

Prescription Use (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 of General, Restarativest 1 and Neurological Devices

510(k) Number K072207

C - 1 of 1

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).