Who is the manufacturer of IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)?

Imris, Inc. filed the 510(k) submission for IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) (K113748).

What is the FDA product code for IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)?

HBL. It is classified under 21 CFR 882.4460 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)?

IMRIS Head Fixation Device (HFD100) (K103493); MAYFIELD® MR/X-Ray Skull Clamp (K081401); DORO® Radiolucent/MRI Compatible Cranial stabilization (K063494).

Who can help prepare an FDA 510(k) submission like IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

K113748 · Imris, Inc. · HBL · Mar 23, 2012 · Neurology

Device Facts

Record ID	K113748
Device Name	IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
Applicant	Imris, Inc.
Product Code	HBL · Neurology
Decision Date	Mar 23, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4460
Device Class	Class 2

Intended Use

The IMRIS MR/X-ray Head Fixation Device System is an MR safe mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The MR/X-ray HFD is indicated for use during utilization of imaging modalities such as intraoperative MRI, CT imaging, and C-Arm X-ray angiography.

Device Story

Mechanical support system for rigid cranial stabilization during surgery; immobilizes head in prone, supine, or lateral positions. Comprises table adaptor, linkage system, and 3-pin skull clamp. Used in operating rooms or angiography suites; operated by surgical staff. Compatible with intraoperative MRI, CT, and C-Arm X-ray imaging. Provides stable positioning to facilitate surgical access and imaging; benefits patient by maintaining precise alignment during complex neurosurgical procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included usability, workflow, loading, third-party accessory compatibility, MRI compatibility (artifacts and heating), radiolucency, and reliability.

Technological Characteristics

Materials: PEEK, Teflon, Cast Acrylic. 3-pin skull clamp design. Mechanical support system; MR safe. Supports 20kg load; 80lb pin force. Two-pin mounting mechanism for IMRIS OR/Angio tables. Sterile pins sourced from Integra LifeSciences.

Indications for Use

Indicated for patients undergoing head, neck, or spine surgery requiring rigid cranial stabilization. Used during intraoperative MRI, CT imaging, and C-Arm X-ray angiography. No specific age or gender contraindications listed.

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

IMRIS Head Fixation Device (HFD100) (K103493)
MAYFIELD® MR/X-Ray Skull Clamp (K081401)
DORO® Radiolucent/MRI Compatible Cranial stabilization (K063494)

Related Devices

K191740 — DORO LUCENT® iXI and iMRI Headrest System · Pro Med Instruments GmbH · Feb 21, 2020
K141950 — HFD100 ROCKER ARM ACCESSORY · Imris, Inc. · Sep 4, 2014
K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) · Pro Med Instruments GmbH · Apr 24, 2024
K063494 — DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS · Pro-Med Instruments GmbH · May 21, 2007
K191979 — DORO QR3 XTom Headholder System · Pro Med Instruments GmbH · Oct 22, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ IMRIS 510(k) Summary for MR/X-ray HFD # 510(k) SUMMARY FOR MR/X-ray HFD MAR 2 3 2012 KII37 (As required by 21 CFR 807.92) #### 1. GENERAL INFORMATION IMRIS Inc. Address: Establishment: Registration Number: Contact Person: 3003807210 Mr. Sanjay Shah QA and Regulatory Engineer Email: sshah@imris.com Phone: 1-204-480-7070 Fax: 1-204-480-7071 100-1370 Sony Place Winnipeg, Manitoba Canada, R3T 1N5 | Date of Summary Preparation: | March 6, 2012 | |-------------------------------|-----------------------------------------| | Device Name / Trade name | IMRIS MR/X-ray Head Fixation Device | | Classification Name: | Neurosurgical head holder (skull clamp) | | Classification Panel: | Neurology | | Classification (CFR section): | 21 CFR 882.4460 | | Class: | Class II | | Product Code: | HBL | # 2. PREDICATE DEVICES The MR/X-ray HFD system is substantially equivalent to the following predicate medical devices. | NAME OF THE DEVICE | 510(K) NUMBER | DATE OF CLEARANCE | MANUFACTURER | |-----------------------------------------------------------|------------------|----------------------|-------------------------------------| | IMRIS Head Fixation Device (HFD100) | K103493 | Nov 29, 2010 | IMRIS Inc. | | MAYFIELD® MR/X-Ray Skull Clamp | K081401 | Oct 8, 2008 | Integra LifeSciences corporation | | DORO® Radiolucent/MRI Compatible Cranial stabilization | K063494 | May 21, 2007 | Pro med instruments GmbH | {1}------------------------------------------------ #### 3. DEVICE DESCRIPTION The IMRIS MR/X-ray Head Fixation Device System (HFD) is an MR safe mechanical support system intended to be used in head, neck and spine surgery when rigid fixation is recruined for cranial stabilization. The IMRIS MR/X-ray HFD has been designed for use with intra-perative MR imaging, Xray Fluoroscopy and CT imaging modality. The IMRIS MR/X-ray HFD and its accessories are designed to immobilize the head during surgical procedures and support patient in the prone, supine or lateral positions. The IMRIS MR/A Province ട് പ്രേം കേ ray HFD system can be used with either the operating room table or the angigraphy room table. The table adaptor is used to mount IMRIS MR/X-ray HFD on the table. The linkage system is used to mont the Skull Clamp to the table Adapter. The skull clamp (including 3 skull pins) is used to hold head and neck in a particular position during surgical procedures. ### 4. INDICATION FOR USE The IMRIS MR/X-ray Head Fixation Device System is an MR safe mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The MRXray HFD is indicated for use during utilization of imaging modalities such as intraoperativer. MI, CT imaging, and C-Arm X-ray angiography. | | 5. COMPARISON TO PREDICATE DEVICES | | |--|------------------------------------|--| |--|------------------------------------|--| | Manufacturer | Integra LifeSciences Corporation | Pro med instruments GmbH | IMRIS Inc. | IMRIS Inc. | | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | FDA 510(k) # | K081401 | K063494 | K103493 | Subject Device | | | Trade/Device Name | MAYFIELD® MR/X-Ray Skull Clamp | DORO® Radiolucent/MRI Compatible Cranial Stabilization and Halo Systems and accessories | HFD100 | MR/X-RAY HFD | | | Product Code | HBL | HBL | HBL | HBL | | | FDA Classification | 21 CFR 882.4460 | 21 CFR 882.4460 | 21 CFR 882.4460 | 21 CFR 882.4460 | | | Indication for use | The MAYFIELD® MR/X- Ray 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 fixation is necessary. In addition, the clamp is indicated for use during utilization of imaging modalities such as intraoperative CT and MR imaging, C-Arm X- ray, and digital subtraction techniques. | The Radiolucent MRI Compatible Skull Clamp Headrest System with Skull Pins The DORO® Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins are components of a mechanical support system which is used in head and neck surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative CT or MR Imaging is used. The Radiolucent / MRI Compatible Horseshoe Headrest System The DORO® | 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. | The IMRIS MR/X- ray Head Fixation Device System is an MR safe mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The MR/X-ray HFD is indicated for use during utilization of imaging modalities such as intraoperative MRI, CT imaging, and C- Arm X-ray angiography. | | | | | Radiolucent / MRI Compatible Horseshoe Headrest System are components of a mechanical support system which is used in head and neck surgery when non- invasive head support is required and when intra-operative CT or MR Imaging is used. | | | | | CHARACTERIS TIC | Integra LifeSciences Corporation MAYFIELD® MR/X-Ray Skull Clamp (K081401) | Pro med instruments GmbH DORO® Radiolucent/MRI Compatible Cranial Stabilization and Halo Systems and accessories (K063494) | IMRIS Inc. IMRIS HFD100 (K103493) | IMRIS Inc. IMRIS MR/X- RAY HFD (Current submission) | COMPARISION | | Skull Clamp | 3-Pin Skull. clamp | 3-Pin Skull clamp | 3-Pin Skull clamp | 3-Pin Skull clamp | Same | | MRI system Compatibility | MRI compatible | MRI compatible | MRI compatible | MRI safe | Same | | Used with Imaging Modality | Intraoperative CT and MR imaging, C-Arm X-ray, and digital subtraction | Intra-operative CT or MR | Intraoperative MRI | Intraoperative MRI, CT imaging, and C- Arm X-ray angiography. | Same as Integra and Pro med | | Material | Composite materials | NOVOTEX laminated fabric with phenolic resin (GRP) colored with BASANTOL black X82 liquid and POM (Delrin), PEEK and Polyurethan | Titanium, Teflon coated fiberglass phenolic composites and Acetol (POM) | PEEK, Teflon, Cast Acrylic | Different | | Mounting | Two pin mounting mechanism On Standard OR Table | Two pin mounting mechanism On Standard OR Table | Two pin mounting mechanism On IMRIS design OR table or Angio table | Two pin mounting mechanism On IMRIS design OR table or Angio table | Same as HFD100 | | Support load | 20kg | 12.5kg | 20kg | 20kg | Same | | Pin force | 80lb | 80lb | 80lb | 80lb | Same | | Application | General neurosurgical procedures Intra-operative neurosurgical procedures | General neurosurgical procedures Intra-operative neurosurgical procedures | General neurosurgical procedures Intra-operative neurosurgical procedures | General neurosurgical procedures Intra-operative neurosurgical procedures | General neurosurgical procedures Intra-operative neurosurgical procedures | | CHARACTERIS TIC | Integra LifeSciences Corporation MAYFIELD® MR/X-Ray Skull Clamp (K081401) | Pro med instruments GmbH DORO® Radiolucent/MRI Compatible Cranial Stabilization and Halo Systems | IMRIS Inc. IMRIS HFD100 (K103493) | IMRIS Inc. IMRIS MR/X- RAY HFD (Current submission) | COMPARISION | | | | and accessories (K063494) | | | | | Sterile Pins | MAYFIELD@ Radiolucent Skull Pins A- 2020 | DORO® Radiolucent Disposable Single-Use Skull Pins of Yttried | | MAYFIELD@ Radiolucent Skull Pins A- 2020 | Same (Exactly the same as Integra LifeSciences Corporation Pins) | | | (FDA 510(k) # K021604) | Zirconium or Titanium are X-ray and MRI compatible. MR- Safe | | | | | | MAYFIELD® Titanium Disposable Child Skull Pin A1119 | | MAYFIELD® Titanium Disposable Child Skull Pin A1119 | MAYFIELD® Titanium Disposable Child Skull Pin A1119 | | | | (FDA 510(k) # K072208) | | | | | | | MAYFIELD® Titanium Disposable Adult Skull Pin A1120 | | MAYFIELD® Titanium Disposable Adult Skull Pin A1120 | MAYFIELD® Titanium Disposable Adult Skull Pin A1120 | | | | (FDA 510(k) # K072208) | | | | | | | MAYFIELD® Adult Skull Pin, Titanium A1121 | | MAYFIELD® Adult Skull Pin, Titanium A1121 | MAYFIELD® Adult Skull Pin, Titanium A1121 | | | | (FDA 510(k) # K072208) | | | | | | | MAYFIELD® Child Skull Pin, Titanium A1122 | | MAYFIELD® Child Skull Pin, Titanium A1122 | MAYFIELD® Child Skull Pin, Titanium A1122 | | | | (FDA 510(k) # K072208) | | | | | {2}------------------------------------------------ # IMRIS # 510(k) Summary for MR/X-ray HFD {3}------------------------------------------------ #### 6. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE: (807.92 (A) (6)) {4}------------------------------------------------ IMRIS . 510(k) Summary for MR/X-ray HFD KIIST . {5}------------------------------------------------ K113748 ## 7. SUMMARY OF NON-CLINICAL DATA #### Biocompatibility of Pins: The skull pins used in the MR/X-ray HFD are invasive. The biocompatibility of pins has been verified by Integra LifeSciences Corporation in K021604 and 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 MR/X-ray HFD system passed the following tests and meets product specifications. The tests include Usability requirements and workflow, Loading test, Third party accessories compatibility test, MRI compatibility test (MR image artifacts test, MR heating test), Radiolucency and Reliability test. #### 8. CONCLUSION 0 The MR/X-ray HFD has the same intended use and indications for use as the predicate devices. Performance data demonstrate safety and effectiveness of the MR/X-ray HFD with the new characteristics. The IMRIS MR/X-ray HFD 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, IMRIS HFD100, Integra LifeSciences MAYFIELD® MR/X-Ray Skull Clamp and Pro med instruments DORO® Radiolucent/MRI Compatible Cranial stabilization. {6}------------------------------------------------ Image /page/6/Picture/0 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 eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Mr. Sanjay Shah QA and Regulatory Engineer IMRIS Inc. 100-1370 Sony Place R3T 1N5 WINIPEG, MANITOBA CANADA MAR 2 3 2012 Re: K113748 Trade/Device Name: IMRIS MR/X-ray Head Fixation Device Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: March 14, 2012 Received: March 15, 2012 #### 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR). Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of {7}------------------------------------------------ #### Page 2 medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): K113748 Device Name: IMRIS MR/X-ray Head Fixation Device Indications for Use: The IMRIS MR/X-ray Head Fixation Device System is an MR safe mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The MR/X-ray HFD is indicated for use during utilization of imaging modalities such as intraoperative MRI, CT imaging, and C-Arm X-ray angiography. 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 In Vitro Diagnostic Devices (OIVD) ***_****_*. (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number K113748 IMRIS 510(k) Premarket Notification IMRIS MR/X-ray HFD Page 1 of 1