(103 days)
Not Found
No
The summary describes a mechanical skull clamp and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a surgical fixation device that holds the head and neck in a stable position during surgery, but it does not directly treat a disease or condition.
No
Explanation: The device description states it is a "cranial stabilization device, designed to provide rigid skeletal fixation." Its intended use is to "hold their head and neck securely in a particular position when rigid fixation is desired," primarily for surgical procedures. It does not perform any diagnostic functions like image analysis or disease detection.
No
The device description clearly describes a physical cranial stabilization device (skull clamp) and mentions nonclinical tests related to mechanical performance (static load, torque, shear, etc.), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is placed on the patient's skull to hold their head and neck securely during surgical procedures (craniotomies and spinal surgery). This is a surgical device used directly on the patient's body for mechanical support and fixation.
- Device Description: The description reinforces its function as a cranial stabilization device providing rigid skeletal fixation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any such specimens.
- Anatomical Site: The device is applied to the skull, head, and neck, which are external anatomical sites for the purpose of surgical support.
- Care Setting: It is used in the operating room, which is consistent with a surgical device.
In summary, the MAYFIELD Skull Clamp is a surgical instrument used for physical stabilization during procedures, not a device used for in vitro diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The MAYFIELD 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.
Product codes
HBL
Device Description
The MAYFIELD Skull Clamp is a cranial stabilization device, designed to provide rigid skeletal fixation.
The MAYFIELD Skull Clamp supports a 2-pin rocker arm, which allows for 360° rotation under full impingement force. The device has the means for skull pin force
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Non-radiolucent
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)
Skull Clamp Static Load – Verifies the ability of the skull clamp to sustain an 80lb load to a 2x factor of safety. Result: Pass – The clamp supported 160 lb static load for no less than 24 hours without mechanical failure.
Skull Clamp Load Loss – Verifies the ability of the skull clamp to maintain a user defined load in use. Result: Pass - The clamp provided a static clamping force of 80 lbs for 24 hours without a loss of loading greater than 5%.
Skull Clamp Transient Torque – Verifies the ability of the skull clamp to resist transient torque while in use. Result: Pass - The swivel locking mechanism was capable of withstanding a dynamic torque of 20 lb/ft for 30 seconds without mechanical failure.
Skull Clamp Swivel Static Torque – Verifies the ability of the skull clamp to resist applied torque while in use. Result: Pass - The swivel locking mechanism was capable of withstanding a static torque of 10 lb/ft for 24 hours without slippage or mechanical failure.
Skull Clamp Vertical Shear - Verifies the ability of the skull clamp to support an applied vertical load. Result: Pass - The loading mechanism was capable of withstanding a vertical shear loading of at least 100 lbs at 80 lbs pin loading.
WHO Performance Test - Verifies the ability of the skull clamp to withstand repeated cycles of the WHO (World Health Organization) recommended guidelines for decontamination without mechanical failure. Result: Pass - The skull clamp was capable of withstanding 15 autoclave cycles of 134°C for 60 minutes in accordance with the WHO decontamination process without mechanical failure.
Reliability Test – Verification that the locking knob mechanism meets manufacturer's warranty period. Result: Pass - The Skull Clamp met a minimum MTBF (Mean Time Between Failures) of 1 year, at a 95% confidence level.
Unlock torque Over Time – Verification that the index lock meets internal requirements. Result: Pass - The product met internal specification for unlocking after prescribed force was applied over time.
Biocompatibility
No component contacts the patient; therefore, no biocompatibility studies are required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MAYFIELD Skull Clamp (K120633)
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of a human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2014
Integra LifeSciences Corporation Mr. Brian Hoy Project Manager, Regulatory Affairs 4900 Charlemar Drive, Building A Cincinnati, OH 45227
K142238 Trade/Device Name: MAYFIELD Skull Clamp Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: August 25, 2014 Received: August 26, 2014
Dear Mr. Brian Hoy,
Re:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142238
Device Name MAYFIELD Skull Clamp
Indications for Use (Describe)
The MAYFIELD 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 is provided below.
| 807.92(a)(1) - Submitter Information | |
|---|---|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive |
| Plainsboro, NJ 08536 USA | |
| Phone number | 513-533-7544 |
| Fax number | 513-271-0957 |
| Establishment Registration | |
| Number | 3003418325 |
| Name of contact person | Brian Hoy |
| Date prepared | August 8, 2014 |
| 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® 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 Skull Clamp (K120633) | |
| 807.92(a)(4) - Device description | |
| The MAYFIELD Skull Clamp is a cranial stabilization | |
| device, designed to provide rigid skeletal fixation. |
The MAYFIELD Skull Clamp supports a 2-pin rocker arm,
which allows for 360° rotation under full impingement
force. The device has the means for skull pin force |
4
| 807.92(a)(5) Intended use of the device | |||
|---|---|---|---|
| Indications for use | The MAYFIELD 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. | |||
| 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate | |||
| Design | MAYFIELD Skull Clamp | Predicate MAYFIELD Skull | |
| Clamp (K120633) | |||
| Shape | Parallelogram | 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 | MAYFIELD Skull Clamp | Predicate MAYFIELD Skull | |
| Clamp (K120633) | |||
| 2 pin | Yes | Same | |
| 360° rotation under full | |||
| impingement force | Yes | Same | |
| Removable | No | Same | |
| Secured using the | |||
| swivel locking knob | Yes | Same | |
| Child Rocker Arm | No | Yes (Catalog No. A-3059 C | |
| only) | |||
| Hinged base plate | No | Same | |
| Clamp Release | Side acting pawls | Same | |
| Adjustment knob | No | Same | |
| Multiple pawls | Yes | Same | |
| Target Patient | |||
| Population | Not recommended for children | ||
| under 5 years of age | Same | ||
| Materials | PEEK / Glass fiber composite | ||
| Radel R (Polyphenylsulphone) | |||
| Teflon | |||
| Hastelloy | |||
| Stainless Steel | |||
| Silicone | Same | ||
| Cleaning/ | |||
| Decontamination | Intended to be used non- | ||
| sterile. Intended to be cleaned | |||
| by user between uses. | |||
| pH range 3-11 and high temps | |||
| Can be autoclaved | |||
| Disinfection: Pre cycle vacuum at 2psia then steam disinfect at 132°C to 134°C for 4 minutes | |||
| Decontamination: Immersion in bleach solution for 1 hour then autoclave at 134°C for 18 minutes to 1 hour | Same | ||
| Imaging Modality | Non-radiolucent | Same | |
| MAYFIELD Skull Clamp | Predicate MAYFIELD Skull Clamp (K120633) | ||
| 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 | None | Same |
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6
| 807.92(b)(1-2) NONCLINICAL TESTS SUBMITTED | |
|---|---|
| Test | Result |
| Skull Clamp Static Load – Verifies the ability of the skull clamp to sustain an 80lb load to a 2x factor of safety | Pass – The clamp supported 160 lb static load for no less than 24 hours without mechanical failure. |
| Skull Clamp Load Loss – Verifies the ability of the skull clamp to maintain a user defined load in use | Pass - The clamp provided a static clamping force of 80 lbs for 24 hours without a loss of loading greater than 5%. |
| Skull Clamp Transient Torque – Verifies the ability of the skull clamp to resist transient torque while in use | Pass - The swivel locking mechanism was capable of withstanding a dynamic torque of 20 lb/ft for 30 seconds without mechanical failure. |
| Skull Clamp Swivel Static Torque – Verifies the ability of the skull clamp to resist applied torque while in use | Pass - The swivel locking mechanism was capable of withstanding a static torque of 10 lb/ft for 24 hours without slippage or mechanical failure. |
| Skull Clamp Vertical Shear - Verifies the ability of the skull clamp to support an applied vertical load | Pass - The loading mechanism was capable of withstanding a vertical shear loading of at least 100 lbs at 80 lbs pin loading. |
| WHO Performance Test - Verifies the ability of the skull clamp to withstand repeated cycles of the WHO (World Health Organization) recommended guidelines for decontamination without mechanical failure | Pass - The skull clamp was capable of withstanding 15 autoclave cycles of 134°C for 60 minutes in accordance with the WHO decontamination process without mechanical failure. |
| Reliability Test – Verification that the locking knob mechanism meets manufacturer's warranty period. | Pass - The Skull Clamp met a minimum MTBF (Mean Time Between Failures) of 1 year, at a 95% confidence level. |
| Unlock torque Over Time – Verification that the index lock meets internal requirements. | Pass - The product met internal specification for unlocking after prescribed force was applied over time |
| Biocompatibility | No component contacts the patient; therefore, no biocompatibility studies are required |
| 807.92(b)(3) CONCLUSIONS DRAWN FROM NON-CLINICAL DATA | |
| Testing confirmed that the performance of the MAYFIELD Skull Clamp meets the product |
specifications of the device.