HEAD FIATION DEVICE (HFD 100)

K103493 · Imris, Inc. · HBL · Mar 11, 2011 · Neurology

Device Facts

• Record ID: K103493
• Device Name: HEAD FIATION DEVICE (HFD 100)
• Applicant: Imris, Inc.
• Product Code: HBL · Neurology
• Decision Date: Mar 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4460
• Device Class: Class 2

Intended Use

The IMRIS Head Fixation Device System is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

Device Story

HFD100 is a mechanical 3-point rigid cranial fixation system; consists of table adapter, linkage system, skull clamp, and skull pins. Used in OR or angiography rooms to immobilize patient head/neck during surgery; supports prone, supine, or lateral positioning. Provides rigid skeletal fixation while maintaining MR compatibility to minimize imaging artifacts. Operated by surgical staff. Output is physical stabilization of the patient's skull; enables surgeon to perform procedures with stable anatomy and intraoperative imaging access. Benefits include secure patient positioning and compatibility with intraoperative MR/CT imaging environments.

Clinical Evidence

Bench testing only. Testing included loading tests, MR image artifact assessment, MR heating tests, cleaning/labeling verification, marking durability, flammability, and usability/workflow validation. Biocompatibility of pins verified via predicate (K072208).

Technological Characteristics

3-pin skull clamp; titanium and composite materials; 80lb pin force; 20kg support load. MR compatible. Mechanical mounting to OR/Angio tables. Sterilization/biocompatibility per ISO 10993-1:2003.

Indications for Use

Indicated for patients undergoing head, neck, or spine surgery requiring rigid cranial stabilization. Used for immobilization in prone, supine, or lateral positions during surgical procedures, including those utilizing intraoperative 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® MR/X-Ray Skull Clamp (K081401)
• MAYFIELD® Disposable and Reusable Titanium Skull Pins (K072208)
• DORO® Radiolucent/MRI Compatible Cranial stabilization (K063494)

Submission Summary (Full Text)

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K103493

### 510(k) SUMMARY FOR HFD100

(As required by 21 CFR 807.92)

#### 1. GENERAL INFORMATION

IMBIS

| Establishment: | IMRIS Inc. | | | MAR 11 2011 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------|--|--|-------------|
| Address: | 100-1370 Sony Place<br>Winnipeg, Manitoba<br>Canada, R3T 1N5 | | | |
| Registration Number: | 3003807210 | | | |
| Contact Person: | Mr. Sanjay Shah<br>QA and Regulatory Engineer<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] | | | |
| Date of Summary<br>Preparation: | February 1, 2011 | | | |
| Device Name / Trade name | Head Fixation Device (HFD100) | | | |
| Classification Name: | Neurosurgical head holder (skull clamp) | | | |
| Classification Panel: | Radiology | | | |
| Classification (CFR section): | 21 CFR 882.4460 | | | |
| Class: | Class II | | | |
| Product Code: | HBL | | | |

#### 2. PREDICATE DEVICES

The HFD100 system is substantially equivalent to the following predicate medical devices.

| NAME OF THE DEVICE | 510(K)<br>NUMBER | DATE OF<br>CLEARANCE | MANUFACTURER |
|-----------------------------------------------------------|------------------|----------------------|-------------------------------------|
| MAYFIELD® MR/X-Ray Skull<br>Clamp | K081401 | Oct 8, 2008 | Integra LifeSciences<br>corporation |
| MAYFIELD® Disposable and<br>Reusable Titanium Skull Pins | K072208 | Sep 7, 2007 | Integra LifeSciences<br>corporation |
| DORO® Radiolucent/MRI<br>Compatible Cranial stabilization | K063494 | May 21, 2007 | Pro med instruments<br>GmbH |

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3. DEVICE DESCRIPTION

IMRIS

The IMRIS Head Fixation Device System (HFD100) is an MR compatible mechanical support system intended to be used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

The HFD100 and its accessories are designed to immobilize the head during surgical procedures and support the patient in the prone, supine or lateral positions. The HFD100 system can be use with either the operating room table or the angiography room table. The IMRIS HFD100 consists of the Table Adapter, Linkage System. Skull Clamp and Skull Pins. The linkage system is used to mount the Skull Clamp (including 3 skull pins) to the table Adaptor is used to mount HFD100 on the table. The 3-point rigid cranial fixation device, skull clamp, provides multifunctional options for cranial stabilization and provides maximum immobilization of the patient's skull during the procedure. The HFD100 provides rigid skeletal fixation within the optimal imaging envelope during intraoperative procedure with minimal artifacts in the acquired images.

#### 4. INDICATION FOR USE

The IMRIS Head Fixation Device System is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

#### 5. COMPARISION TO PREDICATE DEVICES

| Manufacturer | Integra LifeSciences<br>Corporation | Integra<br>LifeSciences<br>Corporation | Pro med<br>instruments GmbH | IMRIS Inc. |
|-----------------------|-------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------|
| FDA 510(k) # | K081401 | K072208 | K063494 | Subject Device<br>(K103493) |
| Trade/Device<br>Name | MAYFIELD® MR/X-Ray<br>Skull Clamp | MAYFIELD®<br>Disposable and<br>Reusable Titanium<br>Skull Pins | DORO®<br>Radiolucent/MRI<br>Compatible Cranial<br>Stabilization and<br>Halo Systems and<br>accessories | HFD100 |
| Product Code | HBL | HBL | HBL | HBL |
| FDA<br>Classification | 21 CFR 882.4460 | 21 CFR 882.4460 | 21 CFR 882.4460 | 21 CFR 882.4460 |

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## IMRIS

#### 510(k) Summary for HFD100

| Indication for<br>use | The MAYFIELD® MR/X-<br>Ray Skull clamp is<br>placed on the patient's<br>skull to hold their head<br>and neck securely in a<br>particular position when<br>rigid fixation is desired.<br>The clamp is indicated<br>for use in open and<br>percutaneous<br>craniotomies as well as<br>spinal surgery when rigid<br>fixation is necessary. In<br>addition, the clamp is<br>indicated for use during<br>utilization of imaging<br>modalities such as<br>intraoperative CT and<br>MR imaging, C-Arm X-<br>ray, and digital<br>subtraction techniques. | The MAYFIELD®<br>Disposable and<br>Reusable Titanium<br>Skull Pins are<br>intended for use with<br>a MAYFIELD skull<br>clamp that is placed<br>on the patient's skull<br>to hold their head<br>and neck in a<br>particular position<br>during surgical<br>procedures when<br>rigid skeletal fixation<br>is desired and Intra-<br>Operative MR<br>imaging is used.<br>The MAYFIELD®<br>Disposable and<br>Reusable Titanium<br>Skull Pins are<br>indicated for use in<br>open and<br>percutaneous<br>craniotomies and<br>spinal surgeries<br>when rigid skeletal<br>fixation is<br>necessary and when<br>Intra-Operative MR<br>imaging of the patient<br>is used. | The Radiolucent<br>MRI Compatible<br>Skull Clamp<br>Headrest System<br>with Skull Pins<br>The DORO®<br>Radiolucent / MRI<br>Compatible Skull<br>Clamp Headrest<br>System with Skull<br>Pins are components<br>of a mechanical<br>support system<br>which is used in head<br>and neck surgery<br>when rigid skeletal<br>fixation is required for<br>cranial stabilization<br>and when intra-<br>operative CT or MR<br>Imaging is used.<br>The Radiolucent /<br>MRI Compatible<br>Horseshoe<br>Headrest System<br>The DORO®<br>Radiolucent / MRI<br>Compatible<br>Horseshoe Headrest<br>System are<br>components<br>of a mechanical<br>support system<br>which is used in head<br>and neck surgery<br>when non-invasive<br>head support is<br>required and when<br>intra-operative CT or<br>MR Imaging is used. | The IMRIS Head<br>Fixation Device<br>System is an MR<br>compatible<br>mechanical support<br>system which is used<br>in head, neck and<br>spine surgery when<br>rigid fixation is<br>required for cranial<br>stabilization. |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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#### 6. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE: (807.92 (A) (6))

| CHARACTERISTIC | Integra LifeSciences<br>Corporation<br>MAYFIELD® MR/X-Ray<br>Skull Clamp (K081401)<br>and<br>MAYFIELD® Disposable<br>and Reusable Titanium<br>Skull (K072208) | Pro med<br>instruments GmbH<br>DORO®<br>Radiolucent/MRI<br>Compatible Cranial<br>Stabilization and<br>Halo Systems and<br>accessories<br>(K063494) | IMRIS Inc.<br>HFD100 | COMPARISION |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Skull Clamp | 3-Pin Skull clamp | 3-Pin Skull clamp | 3-Pin Skull clamp | Same |
| MRI system<br>Compatibility | MRI compatible | MRI compatible | MRI compatible | Same |
| Material | Composite materials | NOVOTEX<br>laminated fabric<br>with phenolic resin<br>(GRP) colored with<br>BASANTOL black<br>X82 liquid and<br>POM (Delrin),<br>PEEK and<br>Polyurethan. | Titanium and<br>Composite<br>materials | Different |
| Mounting | Two pin mounting<br>mechanism On Standard<br>OR Table | Two pin mounting<br>mechanism On<br>Standard OR Table | Two pin mounting<br>mechanism On<br>IMRIS design OR<br>table or Angio<br>table | Different |
| Support load | 20kg | 12.5kg | 20kg | Same<br>(same as<br>MAYFIELD®<br>skull clamp) |
| Pin force | 80lb | 80lb | 80lb | Same |
| Application | • General neurosurgical<br>procedures<br>• Intra-operative<br>neurosurgical<br>procedures | • General<br>neurosurgical<br>procedures<br>• Intra-operative<br>neurosurgical<br>procedures | • General<br>neurosurgical<br>procedures<br>• Intra-<br>operative<br>neurosurgical<br>procedures | Same |
| Sterile Pins | Titanium<br>MAYFIELD® Disposable<br>and Reusable Titanium<br>Skull Pins<br>(K072208) | DORO®<br>Radiolucent<br>Disposable Single-<br>Use Skull Pins<br>or Titanium X-ray<br>and MRI<br>compatible. | Titanium<br>Exactly the same<br>as Integra<br>LifeSciences<br>Corporation Pins | Same<br>(same as<br>Integra<br>LifeSciences<br>Corporation<br>Pins) |
| CHARACTERISTIC | Integra LifeSciences<br>Corporation<br>MAYFIELD® MR/X-Ray<br>Skull Clamp (K081401)<br>and<br>MAYFIELD® Disposable<br>and Reusable Titanium<br>Skull (K072208) | Pro med<br>instruments GmbH<br>DORO®<br>Radiolucent/MRI<br>Compatible Cranial<br>Stabilization and<br>Halo Systems and<br>accessories<br>(K063494) | IMRIS Inc.<br>HFD100 | COMPARISION |
| | Titanium Disposable Child<br>Skull Pin A1119 | | Titanium<br>Disposable Child<br>Skull Pin A1119 | Same |
| | Titanium Disposable Adult<br>Skull Pin A1120 | | Titanium<br>Disposable Adult<br>Skull Pin A1120 | Same |
| | Adult Skull Pin, Titanium<br>A1121 | | Adult Skull Pin,<br>Titanium A1121 | Same |
| | Child Skull Pin, Titanium<br>A1122 | | Child Skull Pin,<br>Titanium A1122 | Same |

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# IMRIS

510(k) Summary for HFD100

:

:

:

1 - 1 - 1 - 1 - 1 - 1 -

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#### 7. SUMMARY OF NON-CLINICAL DATA

#### Biocompatibility of Pins:

The skull pins used in the HFD100 are invasive. The skull pins meet ISO 10993-1:2003 (Biological Evaluation of medical devices) and relevant ISO 10993 series standards. The biocompatibility of pins has been verified by Integra LifeSciences Corporation in K072208.

There is no change made by IMRIS. Pins initially included are provided by Integra Life Sciences with their labeling. IMRIS does not relabel the pins. Pins are purchased from Integra LifeSciences Corporation directly.

#### Design Verification and Validation Test (Bench Testing)

The HFD100 system passed the following tests and meets product specifications.

- t Loading test
- . MR image artifacts test
- . MR heating test
- . Cleaning, marking and labeling requirements
- Marking durability .
- Flammability requirement .
- . Usability requirements and workflow

#### 8. CONCLUSION

The HFD100 has the same intended use and indications for use as the predicate devices. Performance data demonstrate safety and effectiveness of the HFD100 with the new characteristics.

The IMRIS HFD100 verification/validation results and performance/safety standard results show that the device is safe and effective and substantially equivalent to the currently available predicate devices, Integra LifeSciences MAYFIELD® MR/X-Ray Skull Clamp and Pro med instruments DORO® Radiolucent/MRI Compatible Cranial stabilization.

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Image /page/6/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 facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

IMRIS, Inc. c/o Mr. Sanjay Shah QA and Regulatory Engineer 100-1370 Sony Place Winipeg. Manitoba Canada, R3T 1N5

MAR 1 1 201

Re: K103493

Trade/Device Name: Head Fixation Device (HFD 100) Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: February 1, 2011 Received: February 2, 2011

Dear Mr. Shah:

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. 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 - Mr. Sanjay Shah

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.lda.gov/AboutFDA/CentersOffices/CDRHOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

MB. Eydelhus. MD

Malvilia B. 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 Statement

510(k) Number (if known):

K103493

---

Device Name:

Head Fixation Device (HFD100)

#### Indications For Use:

The IMRIS Head Fixation Device System is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(Part 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)

CG

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

| 510(k) Number | K103493 |
|---------------|---------|
|---------------|---------|

IMRIS 510(k) Premarket Notification HFD100

November 24, 2010