(93 days)
No
The description focuses on the mechanical aspects of head fixation and compatibility with imaging modalities. There is no mention of AI/ML algorithms for image analysis, diagnosis, or any other function.
No.
The device is a mechanical support system used for cranial stabilization during surgery; it does not treat or cure any medical condition.
No
This device is a mechanical support system designed for cranial stabilization during surgery, not for diagnosing medical conditions. It uses imaging modalities but does not interpret or analyze them to make a diagnosis.
No
The device description explicitly details physical components like a mechanical support system, table adaptor, linkage system, and skull clamp with pins, indicating it is a hardware device, not software-only.
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 MR/X-ray Head Fixation Device System is a mechanical support system used to immobilize the head, neck, and spine during surgical procedures and imaging. It is a physical device that interacts with the patient's body externally to provide stability.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens. Its function is purely mechanical support and compatibility with imaging modalities.
Therefore, the device falls under the category of a surgical support or positioning device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HBL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intraoperative MRI, CT imaging, and C-Arm X-ray angiography
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)
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.
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.
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.
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
§ 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).
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
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
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