(84 days)
Not Found
No
The device description and performance studies focus on mechanical properties and physical function, with no mention of AI or ML.
No
The device is a cranial stabilization device used to hold the head and neck securely during surgical procedures, not to treat or alleviate a medical condition.
No
The device is utilized to secure the patient's head and neck in a stable position during surgical procedures and has a "means for skull pin force determination via an integral force gauge in the torque screw." The device description does not indicate that it collects or analyzes data to identify health conditions or pathologies. While it has a force gauge that measures force, this is for operational feedback rather than diagnostic purposes.
No
The device description clearly details a physical, mechanical device (skull clamp) with components like a rocker arm, force gauge, and ratchet arm. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Mayfield Skull Clamp Function: The Mayfield Skull Clamp is a surgical device used on the patient's skull to provide rigid fixation during surgery. It is a mechanical device that physically interacts with the patient's body (via the skull pins) to hold their head in place.
The description clearly states its purpose is for physical stabilization during surgical procedures, not for analyzing 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 (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Non-radiolucent
Anatomical Site
patient's 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)
Nonclinical tests were submitted, including:
- Skull Clamp Gauge Characteristics: 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: Pass – The clamp provided a range of positions from 4 inches through 9 inches.
- Skull Clamp Static Load: Pass – The clamp supported 160 lb for no less than 24 hours without mechanical failure.
- Skull Clamp Load Loss: 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: 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: 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: 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: Pass – The skull clamp demonstrated compatibility with MAYFIELD Skull Pins and the A3100 series of MAYFIELD Base Units.
- Manual Cleaning Validation: Pass – The skull clamp demonstrated a protein level
§ 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
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 Drive |
| Plainsboro, NJ 08536 USA | |
| Phone number | 609-936-5583 |
| Fax number | 609-275-9445 |
| Establishment Registration | |
| Number | 3003418325 |
| Name of contact person | Lindsay Mignone |
| Date prepared | February 29, 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® 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 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 |
1
・・
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 |
.
.
:
2
Integra LifeSciences Corporation
Premarket Notification Traditional 510(k)
MAYFIELD Skull Clamp
| | MAYFIELD Skull Clamp | Predicate MAYFIELD Infinity
XR2 Skull Clamp (K090506) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Rocker Arm
2 pin | Yes | Same |
| 360° rotation under full
impingement force | Yes | Same |
| Removable | No | Yes |
| Secured using the
swivel lock knob | Yes | Same |
| Child Rocker Arm | Yes (Catalog No. A-3059 C
only) | Yes (Interchangeable Child
Rocker Arm Accessory) |
| Hinged base plate | No | Yes |
| Clamp Release | Side acting pawls | Plunger |
| Adjustment knob | Yes (Catalog No. A-3059 S
only) | No |
| 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 | PEEK / Carbon fiber
composite
Radel R (Polyphenylsulphone)
Teflon
Hastelloy
Nylon
Titanium 6ALV4
Polyamide-imide
Viton |
| 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
Neutral pH - high temp
Same
Disinfection: Pre cycle
vacuum at 2psia then steam
disinfect at 132°C to 135°C for
3 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