(102 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) 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.
The provided document is a 510(k) summary for the IMRIS Head Fixation Device (HFD100). This type of submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It does not provide information about clinical studies or acceptance criteria typical for AI/ML devices, such as performance metrics (sensitivity, specificity, AUC), sample sizes for test and training sets, expert consensus for ground truth, or MRMC studies.
Therefore, many of the requested elements for describing acceptance criteria and study details cannot be extracted from this document, as they are not relevant to a 510(k) for a mechanical support system.
However, I can extract the information related to the device's functional and safety performance as demonstrated through non-clinical testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical tests passed by the HFD100 system, indicating that it meets product specifications. While specific numerical acceptance criteria (e.g., minimum load in Newtons) are not detailed in the summary, the fact that the tests were "passed" implies that the device met pre-defined criteria for each test.
| Acceptance Criteria (Implied by Passed Test) | Reported Device Performance |
|---|---|
| Biocompatibility: Meets ISO 10993-1:2003 and relevant series standards for invasive skull pins. | Pins verified for biocompatibility by Integra LifeSciences Corporation (K072208). IMRIS uses the same pins without modification. |
| Mechanical Loading: Withstand specified loads. | "Passed the Loading test." Supported load: 20kg (same as MAYFIELD® skull clamp). Pin force: 80lb (same as predicates). |
| MR Image Artifacts: Minimal artifacts in acquired images. | "Passed the MR image artifacts test." Provides rigid skeletal fixation within the optimal imaging envelope during intraoperative procedure with minimal artifacts. |
| MR Heating: No significant heating during MR. | "Passed the MR heating test." |
| Cleaning, Marking, & Labeling: Compliance with requirements. | "Passed the Cleaning, marking and labeling requirements." |
| Marking Durability: Markings remain legible. | "Passed Marking durability." |
| Flammability: Meets flammability requirements. | "Passed Flammability requirement." |
| Usability & Workflow: Meets usability metrics. | "Passed Usability requirements and workflow." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable to this 510(k) summary. The testing described is non-clinical bench testing of a mechanical device, not clinical performance evaluation using patient data. Therefore, there's no "test set" in the context of clinical data, no data provenance (country of origin), and no retrospective or prospective study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. Ground truth, in the context of expert consensus, is typically for evaluating diagnostic or predictive algorithms, not for mechanical device performance in non-clinical bench tests.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert assessments, which is not relevant for bench testing of a mechanical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. The device is a mechanical head fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and effects on human reader performance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a mechanical head fixation system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on engineering specifications, safety standards, and validated testing protocols (e.g., ISO standards for biocompatibility, specified load limits for mechanical strength, established methods for MR compatibility testing). For example, the biocompatibility "ground truth" relies on adherence to ISO 10993 standards and prior verification by the predicate device manufacturer.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is a mechanical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set.
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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 PlaceWinnipeg, ManitobaCanada, R3T 1N5 | |||
| Registration Number: | 3003807210 | |||
| Contact Person: | Mr. Sanjay ShahQA and Regulatory EngineerEmail: sshah@imris.comPhone: 1-204-480-7070Fax: 1-204-480-7071 | |||
| Date of SummaryPreparation: | 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 OFCLEARANCE | MANUFACTURER |
|---|---|---|---|
| MAYFIELD® MR/X-Ray SkullClamp | K081401 | Oct 8, 2008 | Integra LifeSciencescorporation |
| MAYFIELD® Disposable andReusable Titanium Skull Pins | K072208 | Sep 7, 2007 | Integra LifeSciencescorporation |
| DORO® Radiolucent/MRICompatible Cranial stabilization | K063494 | May 21, 2007 | Pro med instrumentsGmbH |
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- 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 LifeSciencesCorporation | IntegraLifeSciencesCorporation | Pro medinstruments GmbH | IMRIS Inc. |
|---|---|---|---|---|
| FDA 510(k) # | K081401 | K072208 | K063494 | Subject Device(K103493) |
| Trade/DeviceName | MAYFIELD® MR/X-RaySkull Clamp | MAYFIELD®Disposable andReusable TitaniumSkull Pins | DORO®Radiolucent/MRICompatible CranialStabilization andHalo Systems andaccessories | HFD100 |
| Product Code | HBL | HBL | HBL | HBL |
| FDAClassification | 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 foruse | The MAYFIELD® MR/X-Ray Skull clamp isplaced on the patient'sskull to hold their headand neck securely in aparticular position whenrigid fixation is desired.The clamp is indicatedfor use in open andpercutaneouscraniotomies as well asspinal surgery when rigidfixation is necessary. Inaddition, the clamp isindicated for use duringutilization of imagingmodalities such asintraoperative CT andMR imaging, C-Arm X-ray, and digitalsubtraction techniques. | The MAYFIELD®Disposable andReusable TitaniumSkull Pins areintended for use witha MAYFIELD skullclamp that is placedon the patient's skullto hold their headand neck in aparticular positionduring surgicalprocedures whenrigid skeletal fixationis desired and Intra-Operative MRimaging is used.The MAYFIELD®Disposable andReusable TitaniumSkull Pins areindicated for use inopen andpercutaneouscraniotomies andspinal surgerieswhen rigid skeletalfixation isnecessary and whenIntra-Operative MRimaging of the patientis used. | The RadiolucentMRI CompatibleSkull ClampHeadrest Systemwith Skull PinsThe DORO®Radiolucent / MRICompatible SkullClamp HeadrestSystem with SkullPins are componentsof a mechanicalsupport systemwhich is used in headand neck surgerywhen rigid skeletalfixation is required forcranial stabilizationand when intra-operative CT or MRImaging is used.The Radiolucent /MRI CompatibleHorseshoeHeadrest SystemThe DORO®Radiolucent / MRICompatibleHorseshoe HeadrestSystem arecomponentsof a mechanicalsupport systemwhich is used in headand neck surgerywhen non-invasivehead support isrequired and whenintra-operative CT orMR Imaging is used. | The IMRIS HeadFixation DeviceSystem is an MRcompatiblemechanical supportsystem which is usedin head, neck andspine surgery whenrigid fixation isrequired for cranialstabilization. |
|---|---|---|---|---|
| ----------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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6. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE: (807.92 (A) (6))
| CHARACTERISTIC | Integra LifeSciencesCorporationMAYFIELD® MR/X-RaySkull Clamp (K081401)andMAYFIELD® Disposableand Reusable TitaniumSkull (K072208) | Pro medinstruments GmbHDORO®Radiolucent/MRICompatible CranialStabilization andHalo Systems andaccessories(K063494) | IMRIS Inc.HFD100 | COMPARISION |
|---|---|---|---|---|
| Skull Clamp | 3-Pin Skull clamp | 3-Pin Skull clamp | 3-Pin Skull clamp | Same |
| MRI systemCompatibility | MRI compatible | MRI compatible | MRI compatible | Same |
| Material | Composite materials | NOVOTEXlaminated fabricwith phenolic resin(GRP) colored withBASANTOL blackX82 liquid andPOM (Delrin),PEEK andPolyurethan. | Titanium andCompositematerials | Different |
| Mounting | Two pin mountingmechanism On StandardOR Table | Two pin mountingmechanism OnStandard OR Table | Two pin mountingmechanism OnIMRIS design ORtable or Angiotable | Different |
| Support load | 20kg | 12.5kg | 20kg | Same(same asMAYFIELD®skull clamp) |
| Pin force | 80lb | 80lb | 80lb | Same |
| Application | • General neurosurgicalprocedures• Intra-operativeneurosurgicalprocedures | • Generalneurosurgicalprocedures• Intra-operativeneurosurgicalprocedures | • Generalneurosurgicalprocedures• Intra-operativeneurosurgicalprocedures | Same |
| Sterile Pins | TitaniumMAYFIELD® Disposableand Reusable TitaniumSkull Pins(K072208) | DORO®RadiolucentDisposable Single-Use Skull Pinsor Titanium X-rayand MRIcompatible. | TitaniumExactly the sameas IntegraLifeSciencesCorporation Pins | Same(same asIntegraLifeSciencesCorporationPins) |
| CHARACTERISTIC | Integra LifeSciencesCorporationMAYFIELD® MR/X-RaySkull Clamp (K081401)andMAYFIELD® Disposableand Reusable TitaniumSkull (K072208) | Pro medinstruments GmbHDORO®Radiolucent/MRICompatible CranialStabilization andHalo Systems andaccessories(K063494) | IMRIS Inc.HFD100 | COMPARISION |
| Titanium Disposable ChildSkull Pin A1119 | TitaniumDisposable ChildSkull Pin A1119 | Same | ||
| Titanium Disposable AdultSkull Pin A1120 | TitaniumDisposable AdultSkull Pin A1120 | Same | ||
| Adult Skull Pin, TitaniumA1121 | Adult Skull Pin,Titanium A1121 | Same | ||
| Child Skull Pin, TitaniumA1122 | Child Skull Pin,Titanium A1122 | Same |
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IMRIS
510(k) Summary for HFD100
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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 (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
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Indications for Use Statement
510(k) Number (if known):
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(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use(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
§ 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).