(38 days)
Not Found
No
The device description and performance studies focus solely on mechanical fixation and structural integrity, with no mention of AI/ML terms or functionalities.
No
The device is described as a skull clamp used for rigid fixation of the head during surgery to provide support and resist rotation. It is a surgical accessory rather than a device that directly treats a disease or condition.
No
The device is a surgical skull clamp used for rigid fixation of the skull during surgery, not for diagnosing medical conditions.
No
The device description explicitly states the device is made from aluminum and stainless steel, and the performance studies involve mechanical testing of physical components. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Dinkler Surgical Skull Clamp is a surgical instrument used on the patient's body during surgery to physically hold the head and neck in a fixed position. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for holding the head and neck during surgical procedures like craniotomies and spinal surgery. This is a mechanical function, not a diagnostic one.
The description and intended use of the Dinkler Surgical Skull Clamp align with a surgical instrument used for physical support and fixation during procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Dinkler Surgical 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 Dinkler Surgical Skull Clamp is a device used for rigid fixation of the skull.
The design of the Skull Clamp allows the surgeon more freedom in positioning the skull pins. Avoidance of critical areas of the skull is made possible by a swiveling rocker arc which rotates 360°.
The main body of the clamp is made from aluminum. The rocker arc assembly, which houses an additional skull pin, is made from stainless steel. A torque screw device on the main body of the clamp is used to apply load to the skull mainly for support and an additional torque screw, on the arc, provides load to resist head rotation. To accommodate the different sizes of patient heads, the skull clamp can be slid opened or closed and then locked.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skull, head and neck
Indicated Patient Age Range
Not Found
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)
Non-Clinical Tests:
- Vertical Loading in a Skull Clamp: Mechanical testing of the clamp was performed by simulating the loads on it as they are applied during surgery. A load was applied to fixate a test block "head" in the clamp. Another load was applied to the test block to simulate the patient's head weight and an external load being pressed down on the head during surgery.
- Maximum Horizontal Loading in a Skull Clamp: A load was applied to the clamp in order to spread the "C" arms apart.
Conclusions of Non-Clinical Tests: The results of the 2 tests show the Dinkler Surgical Skull Clamp performance to be more than adequate and very acceptable in fixating the skull.
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
SECTION 5: 510(k) SUMMARY
510(k) Owner/Submitter:
ﻧﺘﻴ
ﻌﻨﺖ
Dinkler Surgical Devices, Inc. 174 Lookout Drive Dayton, Ohio 45419 Phone: (513) 310-0017 Fax:(937) 395-0787
APR 2 3 2009
Contact Name: Charles E. Dinkler II Contact Title: President
Summary Preparation Date: February 13, 2009
Trade Name: Dinkler Surgical Skull Clamp Common/Usual Name: Skull Clamp Classification Name: Holder, Head, Neurosurgical (Skull Clamp §882.4460)
Identification of legally marketed device to which equivalence is claimed
(Predicate Device): Dinkler Surgical Devices believes based on the information provided that the Skull Clamp is substantially equivalent to the Mayfield A2000 Skull Clamp (Kg32807) and the Sugita Multi-Purpose Head Frame (K955012 non-Radiolucent Model),
Device Description:
The Dinkler Surgical Skull Clamp is a device used for rigid fixation of the skull.
The design of the Skull Clamp allows the surgeon more freedom in positioning the skull pins. Avoidance of critical areas of the skull is made possible by a swiveling rocker arc which rotates 360°.
The main body of the clamp is made from aluminum. The rocker arc assembly, which houses an additional skull pin, is made from stainless steel. A torque screw device on the main body of the clamp is used to apply load to the skull mainly for support and an additional torque screw, on the arc, provides load to resist head rotation. To accommodate the different sizes of patient heads, the skull clamp can be slid opened or closed and then locked.
Indications for Use:
The Dinkler Surgical 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.
1
K090695
| FEATURE | Dinkler Surgical
Skull Clamp | Mayfield
A2000 Skull
Clamp | Sugita Multi-
Purpose Head
Frame |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Is placed on the patient's
skull to hold their head
and neck securely in a
particular position | Is placed on the patient's
skull to hold their head
and neck securely in a
particular position | Clamping of a patient's
head and neck in a
particular position during
surgical procedures. |
| Indications for
Use | Indicated for use in open
and percutaneous
craniotomies as well as
spinal surgery when rigid
fixation is necessary. | Indicated for use in open
and percutaneous
craniotomies as well as
spinal surgery when rigid
fixation is necessary. | Clamping of a patient's
head and neck in a
particular position during
surgical procedures. |
| Materials | Aluminum and stainless
steel. | Aluminum and stainless
steel. | Aluminum and stainless
steel. |
| Manufacturing | Components are
machined by
conventional methods
using manual or CNC
machinery. | Components are
machined by
conventional methods
using manual or CNC
machinery. | Components are
machined by
conventional methods
using manual or CNC
machinery. |
| Preparation
for Surgery | Thoroughly clean by
scrubbing with a brush
and neutral pH detergent. | Thoroughly clean by
scrubbing with a brush
and neutral pH detergent. | Wash with running water
and neutral detergents. |
| Method of Use | Install (3) skull pins in
clamp, maneuver into
position, seat opposing
skull pins to desired
reading, adjust and seat
rocker arc pin to desired
reading, readjust
opposing pin readings if
necessary. | Install (3) skull pins in
clamp, maneuver into
position, adjust rocker
arm, seat skull pins to
desired reading and then
back off one quarter turn. | Maneuver head into
position, seat opposing
pins to desired reading,
seat angled pins to
desired reading, and
readjust opposing pin
reading if necessary. |
| Performance | Load Testing
- Vertical Loading in a
Skull Clamp - Maximum horizontal
clamp loading | Load Testing - Vertical Loading in a
Skull Clamp - Maximum horizontal
clamp loading | Load Testing - Vertical Loading in a
Skull Clamp - Maximum horizontal
clamp loading |
| K-Number | To Be Assigned | K932807 | K955012
Non-Radiolucent Model |
| Manufacturer | Dinkler Surgical Devices,
Inc. | Integra Lifesciences | Mizuho America Inc. |
Summary of Technological Characteristics
Design:
Both the Dinkler Surgical Skull Clamp and A2000 predicate device are adjustable to accept various head sizes of the patient. Each device has a rocker on one end similar to the A2000. In addition, the Dinkler Surgical Skull Clamp can be converted to having a rocker arc on both ends similar to having 4-point fixation like the Sugita Multi-Purpose Head Frame.
The Dinkler Surgical Skull Clamp rocker arc retains a single skull pin, whereas the predicate skull clamp retains 2 skull pins. Both have the means for skull pin force calibration by advancing a torque screw.
Both devices have a release mechanism that allows for quick removal of the clamp.
2
The Sugita Multi-Purpose Head Frame is a fixed clamp with no adjustability for head sizes. It has no rocker pin features, but uses a four (4) point system to clamp a patient's head during surgical procedures.
The Dinkler Surgical Skull Clamp and both predicate devices are placed on the patient's skull to hold their head and neck securely during neurosurgical and cervical spine procedures. Various clamp positions are obtainable by using a table adapter, which is fixed to the table and supports the clamp. The table adapter is provided separately and is not the subject of this 510(k).
Materials:
ﻬﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
ー
All three devices do not directly contact the patient and they utilize similar materialsaluminum and stainless steel.
Sterilization:
All three skull clamps are supplied to the customer in a clean, non-sterile condition. The skull clamp does not come into direct contact with the patient. Before each use the clamp and its components should be wiped with a disinfectant per hospital protocol.
Non-Clinical Tests
Vertical Loading in a Skull Clamp 1)
Mechanical testing of the clamp was performed by simulating the loads on it as they are applied during surgery. A load was applied to fixate a test block "head" in the clamp. Another load was applied to the test block to simulate the patient's head weight and an external load being pressed down on the head during surgery.
- Maximum Horizontal Loading in a Skull Clamp
A load was applied to the clamp in order to spread the "C" arms apart.
Conclusions of Non-Clinical Tests
The results of the 2 tests show the Dinkler Surgical Skull Clamp performance to be more than adequate and very acceptable in fixating the skull.
Conclusion:
The Dinkler Skull Clamp and the two (2) predicate devices have the same indications for use. They are manufactured similarly from like materials and use the same method of cleaning before use. The method of use is slightly different among the three (3) skull clamps.
The bench testing that was performed shows that the clamp can support the loads that are imposed on it. Historical use of the predicate devices shows that they too can support the loads that are necessary.
Based on the information provided above, Dinkler Surgical Devices, Inc. considers the Skull Clamp, CAT. No. 0308, to be substantially equivalent to the predicate devices,
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dinkler Surgical Devices, Inc. c/o Charles E. Dinkler II President 174 Lookout Drive Dayton OH 45410
Re: K090695
Trade/Device Name: Dinkler Surgical Clamp Regulation Number: 21 CFR 882.4460 Regulation Name: Holder, head, neurosurgical (skull clamp) Regulatory Class: Class II Product Code: HBL Dated: March 12, 2009 Received: March 16, 2009
Dear Mr. Dinkler:
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.
APR 2 3 2009
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.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Malvina B. Eplemus, mD.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Kogobils
SECTION 4: INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Dinkler Surgical Skull Clamp
Indications For Use:
The Dinkler Surgical 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 clare is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.
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 OF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K090695