(110 days)
Not Found
Not Found
No
The description focuses on mechanical components and surgical positioning, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No.
The device is a surgical fixation/stabilization tool used during craniotomies and spinal surgery, not a device intended to treat or cure a disease or medical condition.
No
The device is described as a "cranial stabilization/fixation device" used to hold the patient's head and neck in a particular position during surgery. Its function is mechanical support, not to diagnose a condition or disease.
No
The device description clearly describes a physical skull clamp and its accessories, which are hardware components used for patient fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Mayfield® Infinity Skull Clamp is a surgical device used to physically hold and stabilize a patient's head and neck during surgery. It is applied directly to the patient's skull.
- Intended Use: The intended use clearly describes a physical fixation and stabilization function during surgical procedures, not the analysis of biological samples.
Therefore, the function and intended use of the Mayfield® Infinity Skull Clamp fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Mayfield® Infinity 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 us in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. The accessories provided with the skull clamp also allow it to be used where stabilization is desired instead of complete fixation.
Product codes
HBL
Device Description
The Mayfield® Infinity Skull clamp is designed to be a multifunctional cranial stabilization/fixation device. It's basic configuration delivers standard Mayfield Skull Clamp performance. The accessories enhance the clamp's capability and enable it to provide rigid skeletal fixation in conjunction with the Infinity Support System. The contours and length of the skull clamp uprights allow the clamp to maintain a lower profile than standard clamps. When this clamp is used to provide auxiliary skeletal fixation, the Reduced Load Torque Screw may be used for procedures that demand lower pin impingement forces. The device allows the surgeon to select the most suitable combination of components for each procedure and is designed to allow the surgeon freedom in positioning the fixation pins. Avoidance of critical areas of the skull is facilitated by a swiveling rocker arm that also rotates 360°. To simplify patient repositioning after pin impingement, the rocker may be rotated without adjustment of the impingement force imposed by the Torque Screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Modified Mayfield® Skull Clamp, Mayfield A2000 Skull Clamp, DORO® Skull Clamp.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Kostikko
Integra LifeSciences Corporation Premarket Notification 510(k) Mayfield® Infinity Skull Clamp
Confidential
SEP 2 0 2005
Mayfield® Infinity Skull Clamp 510(k) Summary
Submitter's name and address:
Integra LifeSciences Corporation 4900 Charlemar Drive, Building A Cincinnati, Ohio 45227 USA
Contact person and telephone number:
Donna R. Wallace Director Regulatory Affairs (609) 936-2397
Date prepared: May 24, 2005
Name of device:
| Proprietary Name: | Mayfield® Infinity Skull Clamp |
|---|---|
| Common Name: | Head Holder or Skull Clamp |
| Classification Name: | Neurological Head Holder |
Substantial Equivalence:
The Mayfield® Infinity Skull Clamp is substantially equivalent to the Modified Mayfield® Skull Clamp, Mayfield A2000 Skull Clamp, and the DORO® Skull Clamp.
Indications Use:
The Mayfield® Infinity 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 us in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. The accessories provided with the skull clamp also allow it to be used where stabilization is desired instead of complete fixation.
Device Description:
The Mayfield® Infinity Skull clamp is designed to be a multifunctional cranial stabilization/fixation device. It's basic configuration delivers standard Mayfield Skull Clamp performance. The accessories enhance the clamp's capability and enable it to provide rigid skeletal fixation in conjunction with the Infinity Support System. The contours and length of the skull clamp uprights allow the clamp to maintain a lower profile than standard clamps. When this clamp is used to provide auxiliary skeletal fixation, the Reduced Load Torque Screw may be used for procedures that demand lower pin impingement forces. The device allows the surgeon to select the most suitable combination of components for each procedure and is designed to allow the surgeon freedom in positioning the fixation pins. Avoidance of critical areas of the skull is facilitated by a swiveling rocker arm that also rotates 360°. To simplify patient repositioning after pin impingement, the rocker may be rotated without adjustment of the impingement force imposed by the Torque Screw.
Conclusion:
The Mayfield® Infinity Skull Clamp is substantially equivalent to the commercially marketed predicate device and does not raise new issues of safety and effectiveness.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, arranged in a row.
SEP 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna R. Wallace, RAC Director Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K051440
Trade/Device Name: MA YFIELD® Infinity Skull Clamp Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: September 9, 2005 Received: September 12, 2005
Dear Ms. Wallace:
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 for use sured in the encreativent of 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). and Oosmette Prov, I ro, hartet 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.
2
Page 2- Ms. Donna R. Wallace, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin manceling your antial equivalence of your device to a legally premarket notification. The PDA Indianal equivalian equivelies 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
r the latest of the man and for the collection and other antiled If you desire specific advice for your ac not on one on one mote the regulation entitled, contact the Office of Complaned at (210) 276 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -"Misbranding by relevence to premance noutheans.com the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toldsmamain btml Manufacturers, International and Oolisanter Piscess http://www.fda.gov/cdrh/dsmamain.html
Sincerely yours,
Barbara Buehr
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K05/440
510(k) Number (if known):
MA YFIELD® Infinity Skull Clamp Device Name:
Indications For Use:
The Mayfield® Infinity 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 skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. The accessories provided with the skull clamp also allow it to be used where stabilization is desired instead of complete fixation.
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 Device Evaluation (ODE)
Barbara Buelum
(Division Division of General, Restorative. and Neurological Devices
510(k) Number K051440
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