The MAYFIELD® Infinity XR2 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 skeletal fixation is necessary.

In addition, the clamp is indicated for use during utilization of imaging modalities such as intra-operative CT imaging, C-Arm x-ray, digital subtraction techniques, and MR imaging.

Device Description

The MAYFIELD Infinity Skull Clamp is a cranial stabilization device, designed to provide rigid skeletal fixation. The MAYFIELD® Infinity XR2 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 skeletal fixation is necessary.

The MA YFIELD Infinity XR2 Skull Clamp has not been modified since its clearance to market by United States Food and Drug Administration (FDA) on April 20, 2009 under K090506.

The proposed MAYFIELD Infinity XR2 Skull Clamp is identical in every way to the currently marketed MAYFIELD Infinity XR2 Skull Clamp except for revised labeling which includes information regarding the safe use of this device when used in an MR environment and updated cleaning/decontamination instructions.

AI/ML Overview

Below is an analysis of the provided 510(k) summary for the MAYFIELD® Infinity XR2 Skull Clamp. This device is a traditional medical device (a skull clamp), not an AI/ML powered device, so many of the requested categories related to AI performance, ground truth, and training sets are not applicable or cannot be extracted from this document type.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary is for a traditional medical device (skull clamp), not an AI/ML-powered device. Therefore, the "acceptance criteria" discussed are typically related to mechanical performance, materials, and safety, especially in an MR environment, rather than metrics like accuracy, sensitivity, or specificity common in AI/ML performance.

Acceptance Criteria (Bench Testing)	Reported Device Performance
No attraction to magnet in 1.5T MR environment	Passed (no attraction)
No attraction to magnet in 3T MR environment	Passed (no attraction)

Note: The document states that the device is "identical in every way to the currently marketed MAYFIELD Infinity XR2 Skull Clamp except for revised labeling which includes information regarding the safe use of this device when used in an MR environment and updated cleaning/decontamination instructions." This implies that the core mechanical performance (load range, fixation strength, etc.) was previously established for the predicate device (K090506) and is assumed to be met here due to identical design. The new testing focuses specifically on MR safety.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated in terms of number of devices or number of tests for the MR environment testing. Typically, for bench testing like this, a sufficient number of samples (e.g., 3-5) would be tested to demonstrate reproducibility.
Data Provenance: The testing was "bench testing" performed by the manufacturer, Integra LifeSciences Corporation. There is no information on country of origin of data as it's not patient-derived data, and it is prospective in the sense that it was conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for magnetic attraction in an MR environment is established by physical measurement using established ASTM standards (ASTM F2052), not by expert consensus or interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is objective bench testing against a standard, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/ML device that assists human readers with interpretation. It is a physical device (skull clamp).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

For the MR environment testing, the ground truth was based on objective physical measurements and adherence to the requirements of the ASTM F2052 standard ("Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment").

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a physical medical device, not an AI/ML algorithm.

Summary

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Integra LifeSciences Corporation - Traditional 510(k) MAYFIELD® Infinity XR2 Skull Clamp

510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

807.92(a)(1) - Submitter Information
Name	Integra LifeSciences Corporation
Address	311 Enterprise DrivePlainsboro, NJ 08536 USA
Phone number	609-936-5526
Fax number	609-275-9445
Establishment Registration Number	3003418325
Name of contact person	Aakash Jain
Date prepared	February, 12 2012
Manufacturing Site Information
Name	Integra LifeSciences Corporation
Address	4900 Charlemar Drive, Bldg. ACincinnati, OH 45227
Establishment Registration Number	3004608878
807.92(a)(2) - Name of device
Trade or proprietary name	MAYFIELD® Infinity XR2 Skull Clamp
Classification name	Holder, Head, Neurosurgical (Skull Clamp)
Common or usual name	Neurosurgical head holder (skull clamp)
Classification panel	Neurology
Product Code(s)	HBL
Regulation Number	882.4460
Device Class	Class II
807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed
	MAYFIELD® Infinity XR2 Skull Clamp (K090506)
807.92(a)(4) - Device description

The MA YFIELD Infinity XR2 Skull Clamp has not been modified since its clearance to market by United States Food and Drug Administration (FDA) on April 20, 2009 under K090506.

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Integra LifeSciences Corporation – Traditional 510(k) MAYFIELD® Infinity XR2 Skull Clamp

510(k) Summary
807.92(a)(5) Intended use of the device
Indications for use	The MAYFIELD® Infinity XR2 Skull Clamp is placed onthe patient's skull to hold their head and neck securely in aparticular position when rigid fixation is desired. Theclamp is indicated for use in open and percutaneouscraniotomies as well as spinal surgery when rigid skeletalfixation is necessary.
	In addition, the clamp is indicated for use during utilizationof imaging modalities such as intra-operative CT imaging,C-Arm x-ray, digital subtraction techniques, and MRimaging.

807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate

Characteristics	MAYFIELD Infinity XR2Skull Clamp	Predicate: MAYFIELDInfinity XR2 Skull Clamp(K090506)
Shape	Curved uprights	Same
Adjustment for varioushead sizes	Ratchet arm is adjustable	Same
Load Range	0-80 lbs	Same
80 lb force applicator	Yes	Same
Three point fixation	Yes	Same
Rocker Arm
2 pin	Yes	Same
360° rotation under fullimpingement force	Yes	Same
Removable	Yes	Same
Secured using theswivel lock knob	Yes	Same
Child Rocker Arm	Yes (Interchangeable ChildRocker Arm Accessory)	Same
Hinged base plate	Yes	Same
Clamp Release	Plunger	Same
Multiple pawls	Yes	Same
510(k) Summary
Characteristics	MAYFIELD Infinity XR2Skull Clamp	Predicate: MAYFIELDInfinity XR2 Skull Clamp(K090506)
Target Patient Population	Not recommended for childrenunder 5 years of age	Same
Materials	PEEK / Carbon fibercompositeRadel R (Polyphenylsulphone)TeflonHastelloyNylonTitanium 6ALV4Polyamide-imideViton	Same
Cleaning/Decontamination	Intended to be used non-sterile.Intended to be cleaned by userbetween uses.	Same
	pH range 3-11 and hightemperature	Neutral pH and hightemperature
	Can be autoclavedDisinfection: Pre cycle vacuumat 2psia then steam disinfect at132°C to 135°C for 3 minutesDecontamination: Immersionin each solution for 1 hour thenautoclave at 134°C for 18minutes to 1 hour	Can be autoclavedDisinfection: Pre cyclevacuum at 2psia then steamdisinfect at 132°C to 135°Cfor 3 minutes
Where Used	Used in the operating room ofthe hospital.Also used in the diagnostic andor the intra-operative operatingsuite.	Same
Pins	Uses existing MAYFIELDSkull pins	Same
Accessories	Interchangeable Child rockerarm, Metal-free conversionaccessory, Removable forceapplicator	Same

Page 2 of 4

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Integra LifeSciences Corporation - Traditional 510(k) MAYFIELD® Infinity XR2 Skull Clamp

of composition to the currently ma identical to the currently marketed device, all performance testing relating to the performance of the predicate device remains unchanged.

Additional bench testing was performed to determine the safe use conditions for this

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Integra LifeSciences Corporation - Traditional 510(k) MAYFIELD® Infinity XR2 Skull Clamp

510(k) Summary

product in an MR environment.

No attraction to the magnet in either 1.5T or 3T ASTM F2052

807.92(b)(3) CONCLUSIONS DRAWN FROM NON-CLINICAL DATA

Testing demonstrated that the MAYFIELD Infinity XR2 Skull Clamp can be used in an MR Environment . . . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 23,2013

Integra Lifesciences Corporation c/o Ms. Janet Kay Director, Regulatory Affairs 22 Terry Avenue Burlington, MA 01803

Re: K130389

Trade/Device Name: Mayfield® Infinity XR2 Skull Clamp Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: Class II Product Code: HBL Dated: February 12, 2013 Received: February 15, 2013

Dear Ms. Kay:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address:

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to:

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address:

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K130389

Device Name: Mayfield® Infinity XR2 Skull Clamp

Indications For Use:

In addition, the clamp is indicated for use during utilization of imaging modalities such as intra-operative CT imaging, C-Arm x-ray, digital subtraction techniques, and MR imaging.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang -S

(Division Sign Off)
Division of Neurological and Physical
Medicine Devices (DNPMD)

510(k) Number : K130389

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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).