Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical aspects of a head fixation device and does not mention any AI or ML components or functionalities.

Therapeutic

No.
The device is described as a mechanical support system for rigid fixation and immobilization during surgical procedures, not as providing a therapeutic effect.

Diagnostic

No

The device description indicates it is a mechanical support system for immobilizing the head during surgery for cranial stabilization, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components like a Table Adapter, Linkage System, Skull Clamp, and Skull Pins, indicating it is a mechanical system, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
Device Function: The IMRIS Head Fixation Device System is a mechanical support system used to immobilize the head, neck, and spine during surgical procedures. It provides rigid fixation for cranial stabilization.
Lack of Specimen Analysis: The device does not interact with or analyze any biological specimens from the patient. Its function is purely mechanical support and stabilization.

Therefore, the IMRIS Head Fixation Device System falls under the category of a surgical instrument or medical device used for physical support and stabilization, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

HBL

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MR imaging

Anatomical Site

head, neck and spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K081401, K072208, K063494

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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
Winnipeg, Manitoba
Canada, R3T 1N5
Registration Number:	3003807210
Contact Person:	Mr. Sanjay Shah
QA and Regulatory Engineer
Email: sshah@imris.com
Phone: 1-204-480-7070
Fax: 1-204-480-7071
Date of Summary
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)
NUMBER | DATE OF
CLEARANCE | MANUFACTURER |
|-----------------------------------------------------------|------------------|----------------------|-------------------------------------|
| MAYFIELD® MR/X-Ray Skull
Clamp | K081401 | Oct 8, 2008 | Integra LifeSciences
corporation |
| MAYFIELD® Disposable and
Reusable Titanium Skull Pins | K072208 | Sep 7, 2007 | Integra LifeSciences
corporation |
| DORO® Radiolucent/MRI
Compatible Cranial stabilization | K063494 | May 21, 2007 | Pro med instruments
GmbH |

1

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

2

IMRIS

510(k) Summary for HFD100

| 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 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. | 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®
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. | 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. |

-----------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

3

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

| CHARACTERISTIC | Integra LifeSciences
Corporation
MAYFIELD® MR/X-Ray
Skull Clamp (K081401)
and
MAYFIELD® Disposable
and Reusable Titanium
Skull (K072208) | Pro med
instruments GmbH
DORO®
Radiolucent/MRI
Compatible Cranial
Stabilization and
Halo Systems and
accessories
(K063494) | IMRIS Inc.
HFD100 | COMPARISION |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Skull Clamp | 3-Pin Skull clamp | 3-Pin Skull clamp | 3-Pin Skull clamp | Same |
| MRI system
Compatibility | MRI compatible | MRI compatible | MRI compatible | Same |
| Material | Composite materials | NOVOTEX
laminated fabric
with phenolic resin
(GRP) colored with
BASANTOL black
X82 liquid and
POM (Delrin),
PEEK and
Polyurethan. | Titanium and
Composite
materials | 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 | Different |
| Support load | 20kg | 12.5kg | 20kg | Same
(same as
MAYFIELD®
skull clamp) |
| Pin force | 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 | Same |
| Sterile Pins | Titanium
MAYFIELD® Disposable
and Reusable Titanium
Skull Pins
(K072208) | DORO®
Radiolucent
Disposable Single-
Use Skull Pins
or Titanium X-ray
and MRI
compatible. | Titanium
Exactly the same
as Integra
LifeSciences
Corporation Pins | Same
(same as
Integra
LifeSciences
Corporation
Pins) |
| CHARACTERISTIC | Integra LifeSciences
Corporation
MAYFIELD® MR/X-Ray
Skull Clamp (K081401)
and
MAYFIELD® Disposable
and Reusable Titanium
Skull (K072208) | Pro med
instruments GmbH
DORO®
Radiolucent/MRI
Compatible Cranial
Stabilization and
Halo Systems and
accessories
(K063494) | IMRIS Inc.
HFD100 | COMPARISION |
| | Titanium Disposable Child
Skull Pin A1119 | | Titanium
Disposable Child
Skull Pin A1119 | Same |
| | Titanium Disposable Adult
Skull Pin A1120 | | Titanium
Disposable Adult
Skull Pin A1120 | Same |
| | Adult Skull Pin, Titanium
A1121 | | Adult Skull Pin,
Titanium A1121 | Same |
| | Child Skull Pin, Titanium
A1122 | | Child Skull Pin,
Titanium A1122 | Same |

4

IMRIS

510(k) Summary for HFD100

:

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

5

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.

6

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.

7

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 (800) 638-2041 or (301) 796-7100 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

8

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.

-------------------------------------------------	---	--------	-----------------------------------------------------

(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