(54 days)
Not Found
No
The summary describes a mechanical skull clamp used for rigid fixation during surgery and imaging. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The device's function is purely mechanical stabilization.
No
The device is a skull clamp used for rigid skeletal fixation during surgery and imaging. It does not treat or cure any disease or condition, which is the definition of a therapeutic device.
No
The device is described as a skull clamp used for rigid skeletal fixation during surgery and imaging. Its function is to hold the head in place, not to diagnose medical conditions.
No
The device description clearly describes a physical skull clamp with mechanical components (rocker arm, torque screw, optional removable force applicator) used for rigid skeletal fixation. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The MAYFIELD® Infinity XR2 Skull Clamp is a surgical device used to physically hold a patient's head and neck in a fixed position during surgery and imaging procedures. It does not analyze or process biological specimens.
- Intended Use: The intended use clearly states its purpose is for rigid skeletal fixation during surgical procedures and for use with imaging modalities. This is a mechanical and positioning function, not a diagnostic one based on analyzing biological samples.
The device's function and intended use fall squarely within the realm of surgical instruments and patient positioning devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MAYFIELD® Infinity XR2 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 skeletal fixation is necessary.
In addition, the clamp is indicated for use during utilization of imaging modalities such as intra-operative CT imaging, C-Arm x-ray, and digital subtraction techniques.
Product codes (comma separated list FDA assigned to the subject device)
HBL
Device Description
The MAYFIELD® Infinity XR2 Skull Clamp is designed to be a multifunctional, cranial stabilization/fixation device. Its basic configuration delivers standard MAYFIELD Skull Clamp performance, that is, provide rigid skeletal fixation in conjunction with various Olamp porteRase Units. The MAYFIELD® Infinity XR2 Skull Clamp is suitable for Digital Subtraction Angiography (DSA), Fluoroscopy and CT imaging modalities.
With the use of the optional removable Force Applicator, the user can temporarily detach this component of the clamp prior to scanning; thereby removing a potential source of imaging artifact. Interchangeable components allow the surgeon to tailor the skull clamp and the cranial stabilization equipment to the requirements of their patient's surgical procedure and the use of image-guided surgery systems.
The MAYFIELD® Infinity XR2 Skull Clamp is designed to allow the surgeon freedom in positioning the skull pins for fixation. Avoidance of critical areas of the skull is facilitated by a two-pin rocker arm that swivels 360º degrees. To simplify patient repositioning after pin impingement, the rocker arm can be rotated without adjustment of the Torque Screw force on the single-pin side of the clamp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intra-operative CT imaging, C-Arm x-ray, digital subtraction techniques, Digital Subtraction Angiography (DSA), Fluoroscopy
Anatomical Site
patient's skull, head and neck
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)
Not Found
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.
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
§ 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
MAYFIELD® Infinity XR2 Skull Clamp
510(k) Summary
APR 2 0 2009
Submitter's name and address:
Integra LifeSciences Corporation 4900 Charlemar Drive, Building A Cincinnati, Ohio 45227 USA
Contact person and telephone number:
Helder A. Sousa
Regulatory Affairs Project Manager Integra LifeSciences Corporation 4900 Charlemar Drive, Building A Cincinnati, Ohio 45227 USA Phone: (781) 565-1235 Fax: (781) 238-0645
Date prepared:
February 23td 2009
Name of device:
| Trade Name: | MAYFIELD® Infinity XR2 Skull Clamp |
|---|---|
| Common Name: | Skull Clamp |
| Classification Name: | Holder, Head, Neurosurgical (Skull Clamp) |
| Regulation Number: | 21 CFR 882.4460 |
| Product Code: | HBL |
Substantial Equivalence:
The MAYFIELD® Infinity XR2 Skull Clamp is substantially equivalent in function and intended use to the MAYFIELD® MR/CT Skull Clamp (K050319) and the MAYFIELD® Infinity Skull Clamp (K051440).
Indications Use:
The MAYFIELD® Infinity XR2 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 skeletal fixation is necessary.
In addition, the clamp is indicated for use during utilization of imaging modalities such as intra-operative CT imaging, C-Arm x-ray, and digital subtraction techniques.
|
1
Integra LifeSciences Corporation Premarket Notification Traditional 510(k) MAYFIELD® Infinity XR2 Skull Clamp
Device Description:
The MAYFIELD® Infinity XR2 Skull Clamp is designed to be a multifunctional, cranial stabilization/fixation device. Its basic configuration delivers standard MAYFIELD Skull Clamp performance, that is, provide rigid skeletal fixation in conjunction with various Olamp porteRase Units. The MAYFIELD® Infinity XR2 Skull Clamp is suitable for Digital Subtraction Angiography (DSA), Fluoroscopy and CT imaging modalities.
With the use of the optional removable Force Applicator, the user can temporarily detach this component of the clamp prior to scanning; thereby removing a potential source of imaging artifact. Interchangeable components allow the surgeon to tailor the skull clamp and the cranial stabilization equipment to the requirements of their patient's surgical procedure and the use of image-guided surgery systems.
The MAYFIELD® Infinity XR2 Skull Clamp is designed to allow the surgeon freedom in positioning the skull pins for fixation. Avoidance of critical areas of the skull is facilitated by a two-pin rocker arm that swivels 360º degrees. To simplify patient repositioning after pin impingement, the rocker arm can be rotated without adjustment of the Torque Screw force on the single-pin side of the clamp.
Conclusion:
The MAYFIELD® Infinity XR2 Skull Clamp is substantially equivalent to the MAYFIELD® MR/CT Skull Clamp (K050319) and the MAYFIELD® Infinity Skull Clamp (K051440). The MAYFIELD® Infinity XR2 Skull Clamp is similar to the predicate devices in the intended use, the fundamental scientific technology of the device, and does not raise new issues of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Integra Life Sciences Corporation c/o Mr. Helder A. Sousa Regulatory Affairs Project Manager 4900 Charlemar Drive, Bldg. A Cincinnati OH 45227
APR 2 0 2009
Re: K090506
Trade/Device Name: Mayfield® Infinity XR2 Skull Clamp Regulation Number: 21 CFR 882.4460 Regulation Name: head, neurosurgical (skull clamp) Regulatory Class: Class II Product Code: HBL Dated: February 23, 2009 Received: February 25, 2009
Dear Mr. Sousa:
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Egleston, m.D.
Malvina B. Eydelman, M.D. Director . Division of Ophthalmic and Ear, Nose and Throat Devices . Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K090506
Indications for Use
510(k) Number (if known):
MAYFIELD® Infinity XR2 Skull Clamp Device Name:
Indications For Use:
The MAYFIELD® Infinity XR2 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 skeletal fixation is necessary.
In addition, the clamp is indicated for use during utilization of imaging modalities such as intra-operative CT imaging, C-Arm x-ray, and digital subtraction techniques.
Prescription Use × (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 Device Evaluation (ODE)
Lee Hutter
Division Sign-Off
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
KO40506 510(k) Number _
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