(67 days)
Not Found
No
The document describes a mechanical skull clamp and its intended use, with no mention of AI or ML technology. The changes are limited to labeling updates for MR compatibility and cleaning instructions.
No
The device is a cranial stabilization device used to hold the head and neck in a secure position during surgery (craniotomies and spinal surgery) and for imaging purposes. It does not provide any therapeutic effect.
No
The device is a skull clamp used for rigid skeletal fixation during surgery and imaging. Its primary function is to secure the patient's head, not to diagnose medical conditions.
No
The device is a physical skull clamp used for rigid skeletal fixation during surgery and imaging, not a software-only device.
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® Infinity XR2 Skull Clamp is a physical device used to stabilize a patient's head and neck during surgical procedures and imaging. It does not analyze biological samples.
- Intended Use: The intended use clearly describes a mechanical function for rigid skeletal fixation and positioning during surgery and imaging.
- Device Description: The description reinforces that it's a cranial stabilization device.
The information provided focuses on the device's mechanical function, its use in surgical and imaging settings, and its safety in an MR environment. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
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, digital subtraction techniques, and MR imaging.
Product codes (comma separated list FDA assigned to the subject device)
HBL
Device Description
The MAYFIELD Infinity Skull Clamp is a cranial stabilization device, designed to provide rigid skeletal fixation. 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.
The MAYFIELD Infinity XR2 Skull Clamp has not been modified since its clearance to market by United States Food and Drug Administration (FDA) on April 20, 2009 under K090506.
The proposed MAYFIELD Infinity XR2 Skull Clamp is identical in every way to the currently marketed MAYFIELD Infinity XR2 Skull Clamp except for revised labeling which includes information regarding the safe use of this device when used in an MR environment and updated cleaning/decontamination instructions.
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, and MR imaging.
Anatomical Site
skull, head and neck
Indicated Patient Age Range
Not recommended for children under 5 years of age
Intended User / Care Setting
Used in the operating room of the hospital. Also used in the diagnostic and or the intra-operative operating suite.
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)
Additional bench testing was performed to determine the safe use conditions for this product in an MR environment. No attraction to the magnet in either 1.5T or 3T ASTM F2052.
Testing demonstrated that the MAYFIELD Infinity XR2 Skull Clamp can be used in an MR Environment.
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.
MAYFIELD® Infinity XR2 Skull Clamp (K090506)
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
Integra LifeSciences Corporation - Traditional 510(k) MAYFIELD® Infinity XR2 Skull Clamp
510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| 807.92(a)(1) - Submitter Information | |
|---|---|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive |
| Plainsboro, NJ 08536 USA | |
| Phone number | 609-936-5526 |
| Fax number | 609-275-9445 |
| Establishment Registration Number | 3003418325 |
| Name of contact person | Aakash Jain |
| Date prepared | February, 12 2012 |
| Manufacturing Site Information | |
| Name | Integra LifeSciences Corporation |
| Address | 4900 Charlemar Drive, Bldg. A |
| Cincinnati, OH 45227 | |
| Establishment Registration Number | 3004608878 |
| 807.92(a)(2) - Name of device | |
| Trade or proprietary name | MAYFIELD® Infinity XR2 Skull Clamp |
| Classification name | Holder, Head, Neurosurgical (Skull Clamp) |
| Common or usual name | Neurosurgical head holder (skull clamp) |
| Classification panel | Neurology |
| Product Code(s) | HBL |
| Regulation Number | 882.4460 |
| Device Class | Class II |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| MAYFIELD® Infinity XR2 Skull Clamp (K090506) | |
| 807.92(a)(4) - Device description |
The MAYFIELD Infinity Skull Clamp is a cranial stabilization device, designed to provide rigid skeletal fixation. 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.
The MA YFIELD Infinity XR2 Skull Clamp has not been modified since its clearance to market by United States Food and Drug Administration (FDA) on April 20, 2009 under K090506.
The proposed MAYFIELD Infinity XR2 Skull Clamp is identical in every way to the currently marketed MAYFIELD Infinity XR2 Skull Clamp except for revised labeling which includes information regarding the safe use of this device when used in an MR environment and updated cleaning/decontamination instructions.
1
Integra LifeSciences Corporation – Traditional 510(k) MAYFIELD® Infinity XR2 Skull Clamp
| 510(k) Summary | |
|---|---|
| 807.92(a)(5) Intended use of the device | |
| 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, digital subtraction techniques, and MR | |
| imaging. |
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
| Characteristics | MAYFIELD Infinity XR2
Skull Clamp | Predicate: MAYFIELD
Infinity XR2 Skull Clamp
(K090506) |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Shape | Curved uprights | Same |
| Adjustment for various
head sizes | Ratchet arm is adjustable | Same |
| Load Range | 0-80 lbs | Same |
| 80 lb force applicator | Yes | Same |
| Three point fixation | Yes | Same |
| Rocker Arm | | |
| 2 pin | Yes | Same |
| 360° rotation under full
impingement force | Yes | Same |
| Removable | Yes | Same |
| Secured using the
swivel lock knob | Yes | Same |
| Child Rocker Arm | Yes (Interchangeable Child
Rocker Arm Accessory) | Same |
| Hinged base plate | Yes | Same |
| Clamp Release | Plunger | Same |
| Multiple pawls | Yes | Same |
| 510(k) Summary | | |
| Characteristics | MAYFIELD Infinity XR2
Skull Clamp | Predicate: MAYFIELD
Infinity XR2 Skull Clamp
(K090506) |
| Target Patient Population | Not recommended for children
under 5 years of age | Same |
| Materials | PEEK / Carbon fiber
composite
Radel R (Polyphenylsulphone)
Teflon
Hastelloy
Nylon
Titanium 6ALV4
Polyamide-imide
Viton | Same |
| Cleaning/
Decontamination | Intended to be used non-sterile.
Intended to be cleaned by user
between uses. | Same |
| | pH range 3-11 and high
temperature | Neutral pH and high
temperature |
| | Can be autoclaved
Disinfection: Pre cycle vacuum
at 2psia then steam disinfect at
132°C to 135°C for 3 minutes
Decontamination: Immersion
in each solution for 1 hour then
autoclave at 134°C for 18
minutes to 1 hour | Can be autoclaved
Disinfection: Pre cycle
vacuum at 2psia then steam
disinfect at 132°C to 135°C
for 3 minutes |
| Where Used | Used in the operating room of
the hospital.
Also used in the diagnostic and
or the intra-operative operating
suite. | Same |
| Pins | Uses existing MAYFIELD
Skull pins | Same |
| Accessories | Interchangeable Child rocker
arm, Metal-free conversion
accessory, Removable force
applicator | Same |
Page 2 of 4
2
Integra LifeSciences Corporation - Traditional 510(k) MAYFIELD® Infinity XR2 Skull Clamp
of composition to the currently ma identical to the currently marketed device, all performance testing relating to the performance of the predicate device remains unchanged.
Additional bench testing was performed to determine the safe use conditions for this
3
Integra LifeSciences Corporation - Traditional 510(k) MAYFIELD® Infinity XR2 Skull Clamp
510(k) Summary
product in an MR environment.
No attraction to the magnet in either 1.5T or 3T ASTM F2052
807.92(b)(3) CONCLUSIONS DRAWN FROM NON-CLINICAL DATA
Testing demonstrated that the MAYFIELD Infinity XR2 Skull Clamp can be used in an MR Environment . . . . .
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23,2013
Integra Lifesciences Corporation c/o Ms. Janet Kay Director, Regulatory Affairs 22 Terry Avenue Burlington, MA 01803
Re: K130389
Trade/Device Name: Mayfield® Infinity XR2 Skull Clamp Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: Class II Product Code: HBL Dated: February 12, 2013 Received: February 15, 2013
Dear Ms. Kay:
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. 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.
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.
5
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number: K130389
Device Name: Mayfield® Infinity XR2 Skull Clamp
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, digital subtraction techniques, and MR imaging.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whang -S
(Division Sign Off)
Division of Neurological and Physical
Medicine Devices (DNPMD)
510(k) Number : K130389
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