MAYFIELD SKULL CLAMP

K120633 · Integra LifeSciences Corporation · HBL · May 24, 2012 · Neurology

Device Facts

• Record ID: K120633
• Device Name: MAYFIELD SKULL CLAMP
• Applicant: Integra LifeSciences Corporation
• Product Code: HBL · Neurology
• Decision Date: May 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4460
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Mayfield® 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 skull fixation is necessary.

Device Story

MAYFIELD Skull Clamp is a cranial stabilization device providing rigid skeletal fixation. Device features 2-pin rocker arm allowing 360° rotation under full impingement force; integral force gauge in torque screw for monitoring skull pin force; adjustable ratchet arm for various head sizes; side-acting pawls for clamp release. Used in operating rooms or diagnostic/intra-operative suites by neurosurgeons. Device does not contact patient directly; separate MAYFIELD Skull Pins provide patient contact. Healthcare providers use device to secure head/neck position during surgery, facilitating surgical access and stability. Benefits include precise, stable cranial positioning during complex neurosurgical procedures.

Clinical Evidence

Bench testing only. Testing included force gauge accuracy, static load (160 lb), load loss, transient/static torque, vertical shear, skull pin compatibility, manual cleaning validation, low-level/thermal disinfection validation, and repeated decontamination/autoclave cycle testing. No clinical data required.

Technological Characteristics

Materials: PEEK/glass fiber composite, Radel R, Teflon, Hastelloy, stainless steel, silicone. Mechanical sensing via integral force gauge. Dimensions: 4-9 inch adjustment range. Non-radiolucent. Manual operation. Sterilization: Autoclave (134°C).

Indications for Use

Indicated for patients requiring rigid skeletal fixation during open/percutaneous craniotomies and spinal surgery. Not recommended for children under 5 years of age.

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 Infinity XR2 Skull Clamp (K090506)

Submission Summary (Full Text)

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K120633

## 510(k) SUMMARY

MAY 2 4 2012

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 Drive<br>Plainsboro, NJ 08536 USA |
| Phone number | 609-936-5583 |
| Fax number | 609-275-9445 |
| Establishment Registration<br>Number | 3003418325 |
| Name of contact person | Lindsay Mignone |
| Date prepared | February 29, 2012 |
| Manufacturing Site Information | |
| Name | Integra LifeSciences Corporation |
| Address | 4900 Charlemar Drive, Bldg. A<br>Cincinnati, OH 45227 |
| Establishment Registration<br>Number | 3004608878 |
| 807.92(a)(2) - Name of device | |
| Trade or proprietary name | MAYFIELD® 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 MAYFIELD Skull Clamp is a cranial stabilization<br>device, designed to provide rigid skeletal fixation. |
| | The MAYFIELD Skull Clamp supports a 2-pin rocker arm,<br>which allows for 360° rotation under full impingement<br>force. The device has the means for skull pin force |

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・・

determination via an integral force gauge in the torque
screw opposite the rocker arm. The device is equipped
with an adjustable ratchet arm to allow the surgeon to
adjust the clamp for various head sizes. The ratchet arm is
released by side-acting pawls, which facilitate the removal
of the clamp from the patient.

The MAYFIELD Skull Clamp is available in three
configurations, including the base configuration,
A-3059. The A-3059 C clamp is equipped with a child
rocker assembly, and is suitable for patients with smaller
head sizes. The A-3059 S clamp is equipped with an
adjustment knob at the base of the clamp, which allows
the user to limit free play between the clamp base and
ratchet extension.

The MAYFIELD Skull Clamp does not directly contact the
patient. The MAYFIELD Skull Pins used with the skull
clamp are the components which contact the patient. The
skull pins are supplied separately and are not the subject
of this 510(k).

The MAYFIELD Skull Clamp is intended to be used non-
sterile. It can be autoclaved and cleaned using detergents
ranging from a pH of 3 to a pH of 11 as part of the cleaning
and decontamination process.

| 807.92(a)(5) Intended use of the device | |
|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The MAYFIELD 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. |
| 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate | |

| | MAYFIELD Skull Clamp | Predicate MAYFIELD Infinity XR2 Skull Clamp (K090506) |
|-----------------------------------|---------------------------|-------------------------------------------------------|
| Design | | |
| Shape | Parallelogram | Curved uprights |
| Adjustment for various head sizes | Ratchet arm is adjustable | Same |
| Load Range | 0-80 lbs | Same |
| 80 lb force applicator | Yes | Same |
| Three point fixation | Yes | Same |

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# Integra LifeSciences Corporation
Premarket Notification Traditional 510(k)
MAYFIELD Skull Clamp

| | MAYFIELD Skull Clamp | Predicate MAYFIELD Infinity<br>XR2 Skull Clamp (K090506) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Rocker Arm<br>2 pin | Yes | Same |
| 360° rotation under full<br>impingement force | Yes | Same |
| Removable | No | Yes |
| Secured using the<br>swivel lock knob | Yes | Same |
| Child Rocker Arm | Yes (Catalog No. A-3059 C<br>only) | Yes (Interchangeable Child<br>Rocker Arm Accessory) |
| Hinged base plate | No | Yes |
| Clamp Release | Side acting pawls | Plunger |
| Adjustment knob | Yes (Catalog No. A-3059 S<br>only) | No |
| Multiple pawls | Yes | Same |
| Target Patient<br>Population | Not recommended for children<br>under 5 years of age | Same |
| Materials | PEEK / Glass fiber composite<br>Radel R (Polyphenylsulphone)<br>Teflon<br>Hastelloy<br>Stainless Steel<br>Silicone | PEEK / Carbon fiber<br>composite<br>Radel R (Polyphenylsulphone)<br>Teflon<br>Hastelloy<br>Nylon<br>Titanium 6ALV4<br>Polyamide-imide<br>Viton |
| Cleaning/<br>Decontamination | Intended to be used non-<br>sterile. Intended to be cleaned<br>by user between uses.<br>pH range 3-11 and high temps<br>Can be autoclaved<br>Disinfection: Pre cycle vacuum<br>at 2psia then steam disinfect at<br>132°C to 134°C for 4 minutes<br>Decontamination: Immersion in<br>bleach solution for 1 hour then<br>autoclave at 134°C for 18<br>minutes to 1 hour | Same<br>Neutral pH - high temp<br>Same<br>Disinfection: Pre cycle<br>vacuum at 2psia then steam<br>disinfect at 132°C to 135°C for<br>3 minutes |
| Imaging Modality | Non-radiolucent | Radiolucent |
| | MAYFIELD Skull Clamp | Predicate MAYFIELD Infinity XR2 Skull Clamp (K090506) |
| Where Used | Used in the operating room of the hospital.<br>Also used in the diagnostic and or the intra-operative operating suite. | Same |
| Pins | Uses existing MAYFIELD Skull pins | Same |
| Accessories | None | Interchangeable Child rocker arm, Metal-free conversion accessory, Removable force applicator |
| 807.92(b)(1-2) NONCLINICAL TESTS SUBMITTED | | |
| Test | Result | |
| Skull Clamp Gauge Characteristics –<br>Establishes the characteristics of the integral force gauge on the skull clamp | Pass – The skull clamp was capable of indicating impingement force in increments of 20 lbs up to 80 lbs, and was accurate to within the ± 4 lb limit at each force graduation. | |
| Skull Clamp Range – Determines the physical limits of the skull clamp adjustment | Pass – The clamp provided a range of positions from 4 inches through 9 inches. | |
| Skull Clamp Static Load – Verifies the ability of the skull clamp to sustain an 80lb load to a 2x factor of safety | Pass – The clamp supported 160 lb for no less than 24 hours without mechanical failure. | |
| Skull Clamp Load Loss – Verifies the ability of the skull clamp to maintain a user defined load in use | Pass – The clamp provided a static clamping force of 80 lbs for 24 hours without a loss of loading greater than 5%. | |
| Skull Clamp Transient Torque – Verifies the ability of the skull clamp to resist transient torque while in use | Pass – The swivel locking mechanism was capable of withstanding a dynamic torque of 20 lb/ft for 30 seconds without mechanical failure. | |
| Skull Clamp Static Torque – Verifies the ability of the skull clamp to resist applied torque while in use | Pass – The swivel locking mechanism was capable of withstanding a static torque of 10 lb/ft for 24 hours without slippage or mechanical failure. | |
| Skull Clamp Vertical Shear – Verifies the ability of the skull clamp to support an applied vertical load | Pass- The loading mechanism was capable of withstanding a vertical shear loading of at least 100 lbs at 80 lbs pin loading. | |
| Skull Pin Compatibility - Verifies compatibility of the skull clamp with MAYFIELD Skull Pins and Base Units. | Pass – The skull clamp demonstrated compatibility with MAYFIELD Skull Pins and the A3100 series of MAYFIELD Base Units. | |
| Manual Cleaning Validation - Validates the effectiveness of the manual cleaning process on the skull clamp | Pass – The skull clamp demonstrated a protein level < 6.4 µg/cm² and hemoglobin < 2.2 µg/cm² following the manual cleaning process | |
| Low Level Disinfection Validation –<br>Validates the effectiveness of the low level<br>disinfection process on the skull clamp | Pass – The skull clamp demonstrated a 6 log10<br>reduction or better for S. aureus, E. coli, K.<br>pneumoniae and P. aeruginosa following the<br>low level disinfection process. | |
| Thermal Disinfection Validation –<br>Validates the effectiveness of the thermal<br>disinfection process on the skull clamp | Pass – The skull clamp demonstrated a 6 log10<br>reduction or better for S. aureus, E. coli, K.<br>pneumoniae and P. aeruginosa following the<br>thermal disinfection process. | |
| WHO Performance Test – Verifies the<br>ability of the skull clamp to withstand<br>repeated cycles of the WHO (World Health<br>Organization) recommended guidelines for<br>decontamination without mechanical failure | Pass – The skull clamp was capable of<br>withstanding 15 cycles of the WHO<br>decontamination process without mechanical<br>failure. | |
| Autoclave Preconditioning Test –<br>Verifies the ability of the skull clamp to<br>withstand repeated autoclave cycles<br>without mechanical failure | Pass – The skull clamp was capable of<br>withstanding 15 autoclave cycles of 134°C for<br>60 minutes, and passed all mechanical testing<br>following autoclave preconditioning. | |
| Shipping Verification Test – Verifies that<br>the packaging for the skull clamp is<br>capable of protecting the device during<br>transit to ISTA Procedure 2A standards | Pass – The packaging for the skull clamp was<br>not breached during the ship test. The skull<br>clamp remained undamaged and passed all<br>function checks during inspection. | |
| Biocompatibility | No component contacts the patient; therefore,<br>no biocompatibility studies are required | |

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

Testing confirmed that the performance of the MAYFIELD Skull Clamp meets the product specifications of the device. .

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Integra Life Sciences Corporation c/o Ms. Lindsay Mignone Regulatory Affairs Associate 311 Enterprise Dr. Plainsboro. NJ 08536

MAY 2 4 2012

Re: K120633

Trade/Device Name: Mayfield A-3059, A-3059C, A-3059S Skull Clamp Regulation Number: 21 CFR 882.4460 Regulation Name: Neurological Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: February 29, 2012 Received: March 1, 2012

Dear Ms. Mignone:

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.

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## Page 2 - Ms. Lindsay Mignone

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D.

Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): K | 20 43 3

Device Name:__Mayfield A-3059, A-3059C, A-3059S Skull Clamp

Indications for Use:

The Mayfield® 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 skull fixation is necessary.

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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

JOE HUTTER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K120633