(84 days)
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 skull fixation is necessary.
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 determination via an integral force gauge in the torque screw opposite the rocker arm. The device is equipped with an adjustable ratchet arm to allow the surgeon to adjust the clamp for various head sizes. The ratchet arm is released by side-acting pawls, which facilitate the removal of the clamp from the patient. The MAYFIELD Skull Clamp is available in three configurations, including the base configuration, A-3059. The A-3059 C clamp is equipped with a child rocker assembly, and is suitable for patients with smaller head sizes. The A-3059 S clamp is equipped with an adjustment knob at the base of the clamp, which allows the user to limit free play between the clamp base and ratchet extension. The MAYFIELD Skull Clamp does not directly contact the patient. The MAYFIELD Skull Pins used with the skull clamp are the components which contact the patient. The skull pins are supplied separately and are not the subject of this 510(k). The MAYFIELD Skull Clamp is intended to be used non-sterile. It can be autoclaved and cleaned using detergents ranging from a pH of 3 to a pH of 11 as part of the cleaning and decontamination process.
The Mayfield Skull Clamp (K120633) is a cranial stabilization device.
Here's an analysis of its acceptance criteria and the study proving it meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Skull Clamp Gauge Characteristics (Force Gauge Accuracy) | Indicate impingement force in 20lb increments up to 80lbs, accurate within ± 4lbs. | Pass – The skull clamp was capable of indicating impingement force in increments of 20 lbs up to 80 lbs, and was accurate to within the ± 4 lb limit at each force graduation. |
| Skull Clamp Range (Physical Adjustment Limits) | Provide a range of positions from 4 inches through 9 inches. | Pass – The clamp provided a range of positions from 4 inches through 9 inches. |
| Skull Clamp Static Load (Ability to Sustain Load) | Support 160 lbs (2x factor of safety for 80lb load) for ≥ 24 hours without mechanical failure. | Pass – The clamp supported 160 lb for no less than 24 hours without mechanical failure. |
| Skull Clamp Load Loss (Maintain User-Defined Load) | Maintain an 80lb static clamping force for 24 hours with ≤ 5% loss of loading. | 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 (Resist Dynamic Torque) | Withstand a dynamic torque of 20 lb/ft for 30 seconds without mechanical failure. | Pass – The swivel locking mechanism was capable of withstanding a dynamic torque of 20 lb/ft for 30 seconds without mechanical failure. |
| Skull Clamp Static Torque (Resist Applied Torque) | Withstand a static torque of 10 lb/ft for 24 hours without slippage or mechanical failure. | 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 (Support Vertical Load) | Withstand a vertical shear loading of at least 100 lbs at 80 lbs pin loading. | Pass – The loading mechanism was capable of withstanding a vertical shear loading of at least 100 lbs at 80 lbs pin loading. |
| Skull Pin Compatibility (Compatibility with MAYFIELD Pins and Base Units) | Compatible with MAYFIELD Skull Pins and A3100 series MAYFIELD Base Units. | Pass – The skull clamp demonstrated compatibility with MAYFIELD Skull Pins and the A3100 series of MAYFIELD Base Units. |
| Manual Cleaning Validation (Effectiveness of Manual Cleaning) | Protein level < 6.4 µg/cm² and hemoglobin < 2.2 µg/cm². | Pass – The skull clamp demonstrated a protein level < 6.4 µg/cm² and hemoglobin < 2.2 µg/cm² following the manual cleaning process. |
| Low Level Disinfection Validation (Effectiveness of Low-Level Disinfection) | 6 log10 reduction or better for S. aureus, E. coli, K. pneumoniae and P. aeruginosa. | Pass – The skull clamp demonstrated a 6 log10 reduction or better for S. aureus, E. coli, K. pneumoniae and P. aeruginosa following the low level disinfection process. |
| Thermal Disinfection Validation (Effectiveness of Thermal Disinfection) | 6 log10 reduction or better for S. aureus, E. coli, K. pneumoniae and P. aeruginosa. | Pass – The skull clamp demonstrated a 6 log10 reduction or better for S. aureus, E. coli, K. pneumoniae and P. aeruginosa following the thermal disinfection process. |
| WHO Performance Test (Withstand Repeated Decontamination Cycles) | Withstand 15 cycles of WHO decontamination process without mechanical failure. | Pass – The skull clamp was capable of withstanding 15 cycles of the WHO decontamination process without mechanical failure. |
| Autoclave Preconditioning Test (Withstand Repeated Autoclave Cycles) | Withstand 15 autoclave cycles of 134°C for 60 minutes and pass all mechanical testing afterward. | Pass – The skull clamp was capable of withstanding 15 autoclave cycles of 134°C for 60 minutes, and passed all mechanical testing following autoclave preconditioning. |
| Shipping Verification Test (Packaging Protection during Transit) | Packaging not breached, device undamaged, and passes all function checks during inspection to ISTA Procedure 2A standards. | Pass – The packaging for the skull clamp was not breached during the ship test. The skull clamp remained undamaged and passed all function checks during inspection. |
| Biocompatibility (Patient Contact) | N/A (no patient contact by the device itself) | No component contacts the patient; therefore, no biocompatibility studies are required. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of units or samples) used for each specific test. However, the tests are primarily engineering and laboratory-based performance tests on the device itself (e.g., strength, load-bearing, cleaning efficacy).
The data provenance is retrospective, as the tests were conducted prior to the 510(k) submission to demonstrate the device's performance against predefined specifications. The country of origin of the data is implicitly the USA, given the submitting company's address and the FDA submission context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of device (a mechanical skull clamp) does not involve subjective interpretation or a "ground truth" derived from expert consensus in the way medical imaging AI devices do. The "ground truth" for the performance tests listed (e.g., ability to sustain a load, accuracy of a force gauge, effectiveness of cleaning) is based on objective, measurable engineering specifications and standardized testing protocols (e.g., WHO guidelines, ISTA standards). Therefore:
- Number of experts: Not applicable in the context of expert medical review. The "experts" involved would be the engineers, technicians, and potentially microbiologists designing and conducting the tests, and interpreting the results against the predetermined specifications.
- Qualifications of those experts: Not specified in the document, but they would be professionals skilled in mechanical engineering, materials science, microbiology, and quality assurance relevant to medical device testing.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used in studies where there is subjective interpretation (e.g., reading medical images) and a need to reach consensus among experts. For the objective, laboratory-based performance tests conducted for the MAYFIELD Skull Clamp, no such adjudication method was used or needed. The results were directly measured against predefined numerical or qualitative criteria (e.g., "Pass" if within ± 4 lb limit, "Pass" if ≥ 6 log10 reduction).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive devices (e.g., AI in radiology) where human readers (e.g., radiologists) interpret cases (e.g., medical images) with and without AI assistance to measure the AI's impact on diagnostic performance. The MAYFIELD Skull Clamp is a mechanical surgical instrument, not an interpretive device, so an MRMC study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone performance study was not done. This concept is also specific to AI/software algorithms. The performance of the skull clamp is its inherent mechanical and functional characteristics, not an algorithm's output. The performance tests evaluate the device itself, not an algorithm running independently.
7. The Type of Ground Truth Used
The "ground truth" for these tests is based on objective, measurable physical and chemical properties, and adherence to defined standards or specifications. This includes:
- Engineering specifications: For force, range, load bearing, torque resistance.
- Microbiological standards: For cleaning and disinfection efficacy (e.g., 6 log10 reduction of specific bacteria).
- Mechanical integrity standards: For resistance to repeated cycles (WHO performance, autoclave preconditioning).
- Industry packaging standards: For shipping verification (ISTA Procedure 2A).
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of these specific tests.
8. The Sample Size for the Training Set
Not applicable. The MAYFIELD Skull Clamp is a mechanical device, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no training set for this type of device.
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510(k) SUMMARY
MAY 2 4 2012
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 DrivePlainsboro, NJ 08536 USA |
| Phone number | 609-936-5583 |
| Fax number | 609-275-9445 |
| Establishment RegistrationNumber | 3003418325 |
| Name of contact person | Lindsay Mignone |
| Date prepared | February 29, 2012 |
| Manufacturing Site Information | |
| Name | Integra LifeSciences Corporation |
| Address | 4900 Charlemar Drive, Bldg. ACincinnati, OH 45227 |
| Establishment RegistrationNumber | 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 Infinity XR2 Skull Clamp (K090506) | |
| 807.92(a)(4) - Device description | |
| The MAYFIELD Skull Clamp is a cranial stabilizationdevice, designed to provide rigid skeletal fixation. | |
| The MAYFIELD Skull Clamp supports a 2-pin rocker arm,which allows for 360° rotation under full impingementforce. The device has the means for skull pin force |
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・・
determination via an integral force gauge in the torque
screw opposite the rocker arm. The device is equipped
with an adjustable ratchet arm to allow the surgeon to
adjust the clamp for various head sizes. The ratchet arm is
released by side-acting pawls, which facilitate the removal
of the clamp from the patient.
The MAYFIELD Skull Clamp is available in three
configurations, including the base configuration,
A-3059. The A-3059 C clamp is equipped with a child
rocker assembly, and is suitable for patients with smaller
head sizes. The A-3059 S clamp is equipped with an
adjustment knob at the base of the clamp, which allows
the user to limit free play between the clamp base and
ratchet extension.
The MAYFIELD Skull Clamp does not directly contact the
patient. The MAYFIELD Skull Pins used with the skull
clamp are the components which contact the patient. The
skull pins are supplied separately and are not the subject
of this 510(k).
The MAYFIELD Skull Clamp is intended to be used non-
sterile. It can be autoclaved and cleaned using detergents
ranging from a pH of 3 to a pH of 11 as part of the cleaning
and decontamination process.
| 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 |
| MAYFIELD Skull Clamp | Predicate MAYFIELD Infinity XR2 Skull Clamp (K090506) | |
|---|---|---|
| Design | ||
| Shape | Parallelogram | Curved uprights |
| 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 |
.
.
:
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Integra LifeSciences Corporation
Premarket Notification Traditional 510(k)
MAYFIELD Skull Clamp
| MAYFIELD Skull Clamp | Predicate MAYFIELD InfinityXR2 Skull Clamp (K090506) | |
|---|---|---|
| Rocker Arm2 pin | Yes | Same |
| 360° rotation under fullimpingement force | Yes | Same |
| Removable | No | Yes |
| Secured using theswivel lock knob | Yes | Same |
| Child Rocker Arm | Yes (Catalog No. A-3059 Conly) | Yes (Interchangeable ChildRocker Arm Accessory) |
| Hinged base plate | No | Yes |
| Clamp Release | Side acting pawls | Plunger |
| Adjustment knob | Yes (Catalog No. A-3059 Sonly) | No |
| Multiple pawls | Yes | Same |
| Target PatientPopulation | Not recommended for childrenunder 5 years of age | Same |
| Materials | PEEK / Glass fiber compositeRadel R (Polyphenylsulphone)TeflonHastelloyStainless SteelSilicone | PEEK / Carbon fibercompositeRadel R (Polyphenylsulphone)TeflonHastelloyNylonTitanium 6ALV4Polyamide-imideViton |
| Cleaning/Decontamination | Intended to be used non-sterile. Intended to be cleanedby user between uses.pH range 3-11 and high tempsCan be autoclavedDisinfection: Pre cycle vacuumat 2psia then steam disinfect at132°C to 134°C for 4 minutesDecontamination: Immersion inbleach solution for 1 hour thenautoclave at 134°C for 18minutes to 1 hour | SameNeutral pH - high tempSameDisinfection: Pre cyclevacuum at 2psia then steamdisinfect at 132°C to 135°C for3 minutes |
| Imaging Modality | Non-radiolucent | Radiolucent |
| MAYFIELD Skull Clamp | Predicate MAYFIELD Infinity XR2 Skull Clamp (K090506) | |
| 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 | Interchangeable Child rocker arm, Metal-free conversion accessory, Removable force applicator |
| 807.92(b)(1-2) NONCLINICAL TESTS SUBMITTED | ||
| Test | Result | |
| Skull Clamp Gauge Characteristics –Establishes the characteristics of the integral force gauge on the skull clamp | Pass – The skull clamp was capable of indicating impingement force in increments of 20 lbs up to 80 lbs, and was accurate to within the ± 4 lb limit at each force graduation. | |
| Skull Clamp Range – Determines the physical limits of the skull clamp adjustment | Pass – The clamp provided a range of positions from 4 inches through 9 inches. | |
| 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 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 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. | |
| Skull Pin Compatibility - Verifies compatibility of the skull clamp with MAYFIELD Skull Pins and Base Units. | Pass – The skull clamp demonstrated compatibility with MAYFIELD Skull Pins and the A3100 series of MAYFIELD Base Units. | |
| Manual Cleaning Validation - Validates the effectiveness of the manual cleaning process on the skull clamp | Pass – The skull clamp demonstrated a protein level < 6.4 µg/cm² and hemoglobin < 2.2 µg/cm² following the manual cleaning process | |
| Low Level Disinfection Validation –Validates the effectiveness of the low leveldisinfection process on the skull clamp | Pass – The skull clamp demonstrated a 6 log10reduction or better for S. aureus, E. coli, K.pneumoniae and P. aeruginosa following thelow level disinfection process. | |
| Thermal Disinfection Validation –Validates the effectiveness of the thermaldisinfection process on the skull clamp | Pass – The skull clamp demonstrated a 6 log10reduction or better for S. aureus, E. coli, K.pneumoniae and P. aeruginosa following thethermal disinfection process. | |
| WHO Performance Test – Verifies theability of the skull clamp to withstandrepeated cycles of the WHO (World HealthOrganization) recommended guidelines fordecontamination without mechanical failure | Pass – The skull clamp was capable ofwithstanding 15 cycles of the WHOdecontamination process without mechanicalfailure. | |
| Autoclave Preconditioning Test –Verifies the ability of the skull clamp towithstand repeated autoclave cycleswithout mechanical failure | Pass – The skull clamp was capable ofwithstanding 15 autoclave cycles of 134°C for60 minutes, and passed all mechanical testingfollowing autoclave preconditioning. | |
| Shipping Verification Test – Verifies thatthe packaging for the skull clamp iscapable of protecting the device duringtransit to ISTA Procedure 2A standards | Pass – The packaging for the skull clamp wasnot breached during the ship test. The skullclamp remained undamaged and passed allfunction checks during inspection. | |
| Biocompatibility | No component contacts the patient; therefore,no biocompatibility studies are required |
.
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:
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な
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. .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Integra Life Sciences Corporation c/o Ms. Lindsay Mignone Regulatory Affairs Associate 311 Enterprise Dr. Plainsboro. NJ 08536
MAY 2 4 2012
Re: K120633
Trade/Device Name: Mayfield A-3059, A-3059C, A-3059S Skull Clamp Regulation Number: 21 CFR 882.4460 Regulation Name: Neurological Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: February 29, 2012 Received: March 1, 2012
Dear Ms. Mignone:
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.
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Page 2 - Ms. Lindsay Mignone
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Malvina B. Eydelman, M.D.
Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K | 20 43 3
Device Name:__Mayfield A-3059, A-3059C, A-3059S Skull Clamp
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 skull fixation is necessary.
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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K120633
§ 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).