(30 days)
Not Found
No
The device description and intended use focus solely on the mechanical function of skull pins for rigid skeletal fixation during surgery with intra-operative MR imaging. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is used to hold the head and neck in a particular position during surgery for rigid skeletal fixation, which is a supportive rather than a therapeutic function.
No
Explanation: The device is a skull pin used for rigid skeletal fixation during surgical procedures, specifically to hold the head and neck in position. It is not described as providing any diagnostic information or functionality.
No
The device description clearly describes physical skull pins made of titanium, which are hardware components used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The MAYFIELD® Disposable and Reusable Titanium Skull Pins are physical devices used during surgical procedures to provide rigid skeletal fixation of the head and neck. They are applied directly to the patient's skull.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The device's function is mechanical support and positioning.
Therefore, the device's intended use and mechanism of action clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are intended for use with a MAYFIELD 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 MR imaging is used.
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative MR imaging of the patient is used.
Product codes
HBL
Device Description
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are available in two sizes, Adult and Child which are used with MAYFIELD® Skull Clamps that are applied to the patient's skull to hold their head and neck in a particular position during surgical procedures where rigid skeletal fixation is desired and intra-operative MR imaging is used.
In preparation for surgery three Titanium Skull Pins are installed in a MAYFIELD® Skull Clamp. Two Titanium Skull Pins are inserted in the Rocker Arm side of the Clamp and a single Titanium Skull Pin is inserted on the opposite side.
The MAYFIELD® Disposable and Reusable Titanium Skull Pins will be used during open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative MR imaging of the patient is used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intra-Operative MR imaging
Anatomical Site
patient's skull, head, neck
Indicated Patient Age Range
Adult and Child
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
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® Disposable and Reusable Titanium Skull Pins
510(k) Summary 1072208
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 Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 (609) 936- 6850
Date prepared:
August 7, 2007
Name of device:
| Trade Name: | MAYFIELD® Disposable and Reusable Titanium Skull Pins |
|---|---|
| Common Name: | Skull Pins |
| Classification Name: | Neurological head holder (Skull Clamp) |
| Regulation Number: | 21 CFR 882.4460 |
| Product Code: | HBL |
Substantial Equivalence:
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are substantially equivalent in function and intended use to the MAYFIELD® Disposable Steel Skull Pins (K932860), MAYFIELD® Reusable Steel Skull Pins (pre-amendment), MAYFIELD® Radiolucent Disposable Skull Pins (K071458) and DORO Titanium Pins (K063494).
The MAYFIELD® Disposable and Reusable Titanium Skull Pins like the predicate devices are used in a skull clamp that is placed on the patient's head to hold the patient's head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired. The MAYFIELD® Disposable and Reusable Titanium Skull Pins like the predicate devices may be used in open and percutaneous craniatories and spinal surgeries when rigid skeletal fixation is necessary.
The MAYFIELD® Disposable and Reusable Titanium Skull Pins as the MAYFIELD® Radiolucent Disposable Skull Pins (K071458) and the DORO Titanium Pins (K063494) may be used in surgical procedures when Intra-Operative MR imaging of the patient is used.
SEP - 7 2007
1
Indications Use:
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are intended for use with a MAYFIELD 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 MR imaging is used.
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative MR imaging of the patient is used.
Device Description:
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are available in two sizes, Adult and Child which are used with MAYFIELD® Skull Clamps that are applied to the patient's skull to hold their head and neck in a particular position during surgical procedures where rigid skeletal fixation is desired and intra-operative MR imaging is used.
In preparation for surgery three Titanium Skull Pins are installed in a MAYFIELD® Skull Clamp. Two Titanium Skull Pins are inserted in the Rocker Arm side of the Clamp and a single Titanium Skull Pin is inserted on the opposite side.
The MAYFIELD® Disposable and Reusable Titanium Skull Pins will be used during open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative MR imaging of the patient is used.
Conclusion:
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are substantially equivalent to the MAYFIELD® Disposable Steel Skull Pins (K932860), MAYFIELD® Reusable Steel Skull Pins (pre-amendment), MAYFIELD® Radiolucent Disposable Skull Pins (K071458) and DORO® Skull Pins (K063494). The MAYFIELD® Disposable and Reusable Titanium Skull Pins are 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
Image /page/2/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 heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Integra LifeSciences corpration % Helder A. Sousa Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, New Jersey 08536
- 2007
Re: K072208
Trade/Device Name: MAYFIELD® Disposable and Reusable Titanium Skull Pins Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: August 7, 2007 Received: August 8, 2007
Dear Helder A. 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. 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.
3
Page 2 - Helder A. Sousa
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, permitte 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) 633-241 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
for Pete
Mark N. Melkerson
Director
DEP D.RS gof
9/7/07
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K072208
MAYFIELD® Disposable and Reusable Titanium Skull Pins Device Name: Indications For Use:
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are intended for use with a MAYFIELD skull clamp that is placed on the patient's skull to held their bead and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative MR imaging is used.
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skouled fir ation is necessary and when Intra-Operative MR imaging of the patient is used.
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)
(Division Sign-Off) Division of General, Restarativest 1 and Neurological Devices
510(k) Number K072207
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