(48 days)
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 Head Fixation Device System (HFD100) Rocker Arm Accessory is an MR compatible mechanical support system intended to use 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 patient in the prone, supine or lateral positions. The HFD100 system is comprised of the table adapter, linkage system, one or two rocker arm skull clamps, and skull pins. The HFD100 system can be used with either the operating room table or the angiography room table. The table adaptor is used to mount HFD100 on the table. The linkage system is used to mount the Skull Clamp (including 3 or 4 skull pins) to the table Adapter.
The Skull Clamp requires the use of three (3) or four (4) Skull Pins. IMRIS is using MAYFIELD® Disposable and Reusable Titanium Skull Pins manufactured by Integra LifeSciences Corporation and cleared by FDA K072208. The MAYFIELD® Disposable and Reusable Titanium Skull Pins are used in surgical procedures when rigid fixation is desired and Intra-Operative MR imaging is used.
IMRIS 3-pin and 4-pin HFD100 attached to the OR table assembly is part of the IMRISneuro system. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. The HFD100 can be used individually or with the IMRIS Flexible Intra-operative Head Coils and third party accessories, such as retractor systems and navigation mounts. The HFD100 provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images.
The IMRISneuro 1.5T/3T Systems (Neuro III-SV) are traditional MRI units that have been suspended on an overhead rail system to facilitate intra-operative, interventional and diagnostic use. The main components of the IMRISneuro systems are the MRI system, the magnet mover system, the OR Table assembly, the Intra-operative Coil and the Head Fixation Device. The IMRISneuro intraoperative imaging systems are tools for radiologists and surgeons, used to acquire images for diagnosis and surgical planning and monitoring during surgery. When images are requested by the surgeon, the magnet is brought into the operating room or Angiography room moving on a pair of overhead rails. The patient remains stationary throughout the procedure and the magnet moves into the room and over the patient for imaging. The magnet can be moved into and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. The surgeon has access to updated MR images in the surgical field, but does not have to change the surgery would typically be performed. Obtaining images intra-operatively allows surgeons to verify the absence of surgical complications before releasing the patient from the operating room.
The provided text describes a 510(k) premarket notification for a medical device, the IMRIS Head Fixation Device (HFD100) Rocker Arm Accessory. This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to a previously cleared predicate device.
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state specific quantitative acceptance criteria (e.g., "withstanding X N of force," "maintaining Y mm of displacement"). Instead, the main "acceptance criterion" for this 510(k) submission is that the HFD100 Rocker Arm Accessory, which enables a 4-pin configuration, maintains the performance and safety equivalency of the previously cleared 3-pin HFD100 system.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Maintain performance and safety of the predicate 3-pin HFD100 system | "HFD100 Rocker Arm Accessory performance has been evaluated in verification and validation to ensure the 4-pin configuration maintains the performance of the 3-pin HFD100 system components." "These differences have been identified and assessed in risk management and verification and validation testing." |
| MR compatibility | "The IMRIS HFD100 and its accessories are designed to immobilize the head during surgical procedures and support patient in the prone, supine or lateral positions." "The HFD100 Rocker Arm Accessory is also an MR compatible mechanical support system..." |
| Rigid fixation for cranial stabilization | "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 HFD100 provides rigid skeletal fixation..." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in terms of patients or independent cases. The "study" mentioned is described as "verification and validation testing." For a mechanical device like this, verification and validation typically involve engineering tests on the device itself, rather than clinical data from a "test set" of patients.
- Sample Size: Not applicable in the context of clinical data. It would refer to the number of devices or components tested, which is not specified.
- Data Provenance: Not applicable in the context of clinical data (e.g., country of origin, retrospective/prospective). The data would be from engineering tests conducted by IMRIS.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device and submission. The ground truth for a mechanical fixation device's performance would be established through engineering specifications, standards adherence (though none are referenced in this submission), and physical testing, not expert clinical consensus on images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a "test set" in the context of clinical data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is typically done for diagnostic imaging or AI algorithms where human interpretation is involved. This submission is for a mechanical fixation device, not an imaging or AI interpretation product.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is not an algorithm or AI product.
7. Type of Ground Truth Used
The "ground truth" for this device's performance would be based on engineering specifications, physical measurements, and mechanical testing results (e.g., stability under load, material properties, MRI compatibility through phantom testing). The document does not detail these specific technical ground truths but implies they were met through "verification and validation testing."
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2014
IMRIS, INC. Ms. Karissa Holcomb Regulatory Affairs Specialist 5101 Shady Oak Rd Minnetonka, MN 55343
Re: K141950 Trade/Device Name: HFD100 Rocker Arm Accessory Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: Class II Product Code: HBL Dated: July 17, 2014 Received: July 18, 2014
Dear Ms. Holcomb:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141950
Device Name
Head Fixation Device (HFD100) Rocker Arm Accessory
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| @Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos E. Pena -S
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510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.
| Submitter: | IMRIS, Inc. |
|---|---|
| 5101 Shady Oak Road | |
| Minnetonka, MN 55343 | |
| Establishment Registration Number: 3010326005 | |
| Contact Person: | Karissa Holcomb BS, MS |
| Regulatory Affairs Specialist | |
| Telephone: | 763.203.6411 |
| Fax: | 866.992.3224 |
| Email: | kholcomb@imris.com |
| Alternate Contact Person: | Daniel Biank, JD, MEng, PE, RAC |
| VP, Regulatory Affairs, Quality, & IT | |
| Telephone: | 763.203.6310 |
| Fax: | 866.992.3224 |
| Email: | dbiank@imris.com |
| Date Prepared: | July 17, 2014 |
| Device Name | |
| Trade Name: | Head Fixation Device (HFD100) Rocker Arm Accessory |
| Common Name: | Neurosurgical Head Holder (Skull Clamp) |
| Classification Name: | Neurosurgical head holder (skull clamp) |
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Predicate Devices:
| 510(k) | DecisionDate | Device Name | Manufacturer |
|---|---|---|---|
| K103493 | Mar. 03,2011 | Head Fixation Device (HFD100) | IMRIS, Inc. |
Device Description:
The IMRIS Head Fixation Device System (HFD100) Rocker Arm Accessory is an MR compatible mechanical support system intended to use 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 patient in the prone, supine or lateral positions. The HFD100 system is comprised of the table adapter, linkage system, one or two rocker arm skull clamps, and skull pins. The HFD100 system can be used with either the operating room table or the angiography room table. The table adaptor is used to mount HFD100 on the table. The linkage system is used to mount the Skull Clamp (including 3 or 4 skull pins) to the table Adapter. Please refer to Figure 1 for overview of the HFD100 and HFD100 Rocker Arm Accessory systems.
Image /page/4/Figure/7 description: The image shows a medical device with different components labeled. The components include a table adaptor, linkage system, skull clamp and subcomponents, and a 4-pin configuration. The image shows the different parts of the medical device and how they are connected.
Figure 1 IMRIS HFD100 and HFD100 Rocker Arm Accessory
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IMRIS (
The Skull Clamp requires the use of three (3) or four (4) Skull Pins. IMRIS is using MAYFIELD® Disposable and Reusable Titanium Skull Pins manufactured by Integra LifeSciences Corporation and cleared by FDA K072208. The MAYFIELD® Disposable and Reusable Titanium Skull Pins are used in surgical procedures when rigid fixation is desired and Intra-Operative MR imaging is used. IMRIS and Integra LifeSciences Corporation have signed a supplier agreement to allow use of their titanium pins as a component of the IMRIS HFD100 system. Integra is responsible for the regulatory approvals of this product.
IMRIS 3-pin and 4-pin HFD100 attached to the OR table assembly is part of the IMRISneuro system. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. The HFD100 can be used individually or with the IMRIS Flexible Intra-operative Head Coils and third party accessories, such as retractor systems and navigation mounts. The HFD100 provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images.
Image /page/5/Picture/4 description: The image contains two separate photos. The photo on the left shows a black medical device attached to a black cushion on top of a wooden surface. The photo on the right shows a medical room with a large MRI machine, a medical bed, and several monitors on the wall. There are also some medical supplies and equipment in the room.
Figure 2 IMRIS Neuro System with HFD100 and OR table
The IMRISneuro 1.5T/3T Systems (Neuro III-SV) are traditional MRI units that have been suspended on an overhead rail system to facilitate intra-operative, interventional and diagnostic use. The main components of the IMRISneuro systems are the MRI system, the magnet mover system, the OR Table assembly, the Intra-operative Coil and the Head Fixation Device. The IMRISneuro intraoperative imaging systems are tools for radiologists and surgeons, used to acquire images for diagnosis and surgical planning and monitoring during surgery. When images are requested by the surgeon, the magnet is brought into the operating room or Angiography room moving on a pair of overhead rails. The patient remains stationary throughout the procedure and the magnet moves into the room and over the patient for imaging. The magnet can be moved into and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. The surgeon has access to updated MR
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images in the surgical field, but does not have to change the surgery would typically be performed. Obtaining images intra-operatively allows surgeons to verify the absence of surgical complications before releasing the patient from the operating room. IMRIS 1.5T (Neuro II-SE) is cleared by K061916 and K071099 and IMRIS 3T (Neuro III-SV) is cleared by K093137 and K091166.
Intended Use:
The IMRIS Head Fixation Device Rocker Arm Accessory is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.
Comparison with Predicate Devices:
The IMRIS Head Fixation Device (HFD100) Rocker Arm Accessory is substantially equivalent to the currently cleared and marketed IMRIS HFD100 (K103493). The only design change to the current HFD100 is the addition of the Rocker Arm Accessory allowing the physician to choose between a 3-pin configuration and a 4-pin configuration.
The current HFD100 is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization. It uses one rocker arm with 2 pins and stationary pin holder on the opposite side. The HFD100 Rocker Arm Accessory is also an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization, however, it allows the physician to choose the current 3-pin configuration of the HFD100 or they have the option to switch out the stationary pin holder for the Rocker Arm Accessory adding an additional pin to the configuration; distributing the weight evenly over all 4 pins. These differences have been identified and assessed in risk management and verification and validation testing.
Standards:
No product standards have been referenced within this submission.
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Summary of Studies:
HFD100 Rocker Arm Accessory performance has been evaluated in verification and validation to ensure the 4-pin configuration maintains the performance of the 3-pin HFD100 system components.
HFD100 Rocker Arm Accessory verification and validation supports a determination of substantial equivalence.
Conclusion:
The IMRIS Head Fixation Device (HFD100) with the Rocker Arm Accessory is substantially equivalent to the currently cleared and marketed IMRIS HFD100 (K103493).
§ 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).