(24 days)
No
The device description and intended use focus on mechanical fixation and compatibility with imaging, with no mention of AI/ML processing or analysis.
No
The device is used to hold the patient's head and neck in position during surgical procedures and is not intended for treating, diagnosing, or preventing a disease or condition.
No
The device is described as skull pins used for rigid skeletal fixation during surgical procedures, not for identifying a disease, condition, or state of health.
No
The device description clearly states the device is a physical, single-use skull pin used with a skull clamp, indicating 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 used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The MAYFIELD® Radiolucent Skull Pins A-2020 are physical devices used on the patient's skull during surgery to provide rigid fixation. They are not used to analyze biological samples.
- Intended Use: The intended use clearly states their purpose is for holding the head and neck in position during surgical procedures, particularly when imaging is used. This is a surgical support device, not a diagnostic test.
The fact that imaging is used in conjunction with the device doesn't make the device itself an IVD. The imaging is a separate diagnostic tool.
N/A
Intended Use / Indications for Use
The Mayfield® Radiolucent Skull Pins are intended for use with a skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative CT or MR imaging is used.
The Mayfield® Radiolucent Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and vhen Intra-Operative CT or MR imaging of the patient is used.
Product codes
HBL
Device Description
The Mayfield® Radiolucent Skull Pins are single use devices which are used with Mayfield® Skull Clamps for approaches that require rigid skeletal fixation. In preparation for surgery three Radiolucent Skull Pins are installed in a Mayfield® Skull Clamp. Two Radiolucent Skull Pins are inserted in the Rocker Arm side of the Clamp and a single Radiolucent Skull Pins is inserted on the opposite side. The Mayfield® Radiolucent Skull Pins may be used in surgical procedures when rigid fixation is desired and Intra-Operative CT or MR imaging is used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intra-Operative CT or MR imaging
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)
Reference Device(s)
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
Confidential
Integra LifeSciences Corporation Special 510(k): Device Modification Mayfield® Radiolucent Skull Pins
KOSZOUS
Mayfield® Radiolucent Skull Pins 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 Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 (609) 936- 2397
Date prepared: October 20, 2005
Name of device:
| Proprietary Name: | Mayfield® Radiolucent Skull Pins |
|---|---|
| Common Name: | Skull Pins |
| Classification Name: | Neurological Head Holder |
Substantial Equivalence:
The Mayfield® Radiolucent Skull Pins are substantially equivalent in function and intended use to the unmodified Mayfield® Radiolucent Skull Pins which have been cleared to market under Premarket Notification 510(k) K021604.
Indications Use:
The Mayfield® Radiolucent Skull Pins are intended for use with a skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative CT or MR imaging is used.
The Mayfield® Radiolucent Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and vhen Intra-Operative CT or MR imaging of the patient is used.
Device Description:
The Mayfield® Radiolucent Skull Pins are single use devices which are used with Mayfield® Skull Clamps for approaches that require rigid skeletal fixation. In preparation for surgery three Radiolucent Skull Pins are installed in a Mayfield® Skull Clamp. Two Radiolucent Skull Pins are inserted in the Rocker Arm side of the Clamp and a single Radiolucent Skull Pins is inserted on the opposite side. The Mayfield® Radiolucent Skull Pins may be used in surgical procedures when rigid fixation is desired and Intra-Operative CT or MR imaging is used.
Conclusion:
The modified Mayfield® Radiolucent Skull Pins is substantially equivalent to the unmodified Mayfield® Radiolucent Skull Pins. The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not reise new issues of safety and effectiveness.
E-001
1
Image /page/1/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 enclosed in a circle of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
NOV 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Donna R. Wallace, RAC Director Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K053045
Trade/Device Name: MAYFIELD® Radiolucent Skull Pins Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: October 27, 2005 Received: October 31, 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 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.
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
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Bucheld
for
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
KOS3CHS 510(k) Number (if known):
Device Name: MAYFIELD® Radiolucent Skull Pins
Indications For Use:
The MAYFIELD® Radiolucent Skull Pins A-2020 are intended for use with a skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative CT or MR imaging is used.
The MAYFIELD® Radiolucent Skull Pins A-2020 are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative CT or MR imaging of the patient is used.
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 BuellMD
Division of General, Restorative, and Neurological Devices
510(k) Number K053045 Page 1 of 1
D-001