(71 days)
CODMAN® MicroSensor™ Skull Bolt, Camino ICP Bolt
Not Found
No
The device description focuses on mechanical components for securing an ICP transducer and does not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" section is explicitly "Not Found".
No
The device is described as a component of an ICP monitoring system and is used to secure a transducer, not to provide therapy itself. Its function is diagnostic (monitoring), not therapeutic.
No
The device is a component of an ICP monitoring system used to secure a transducer, not a device that directly measures or diagnoses.
No
The device description explicitly lists multiple physical components made of materials intended for implantation, indicating it is a hardware device, not software-only.
Based on the provided information, the CODMAN® Intracranial Bolt is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices 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).
- CODMAN® Intracranial Bolt Function: The description clearly states the device is used to secure an ICP transducer for direct ICP monitoring. This involves placing the transducer inside the body (intracranially) to measure pressure directly.
- Lack of Specimen Testing: The device description and intended use do not mention the collection or analysis of any biological specimens.
Therefore, the CODMAN® Intracranial Bolt is a medical device used for direct physiological monitoring in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CODMAN® Intracranial Bolt is indicated for use as a component of an intracranial pressure (ICP) monitoring system designed to achieve direct ICP monitoring. Specifically, the CODMAN® Intracranial Bolt is intended to secure an ICP transducer during direct ICP monitoring in both subdural and intraparenchymal applications.
Product codes
GWM
Device Description
The CODMAN® Intracranial Bolt is composed of the following six components: (1) bolt, (2) wing nut, (3) compression cap, (4) compression grommet, (5) washer, and (6) obturator/dura pierce (packaged with bolt assembly). The bolt component is screwed into the cranium in order to secure the transducer. This is achieved through compression of the grommet via tightening of the compression cap. Additionally, a wing nut is provided as a component of the assembly as a means of bolt insertion, and a washer is provided if thread depth variation is desired. Finally, an obturator/dura pierce is provided to clear the inner lumen of the bolt and pierce the dura prior to transducer insertion. All patient contacting components are constructed of fully biocompatible implant materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium (for securing transducer in subdural and intraparenchymal applications)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CODMAN® MicroSensor™ Skull Bolt, Camino ICP Bolt
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).
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JAN - 9 1998
510(k) Summary for the CODMAN® Intracranial Bolt
Johnson & Johnson Professional, Inc. 325 Paramount Drive Ravnham, MA 02767-0350
Contact Person_
James M. Flaherty, Jr. Associate Regulatory Affairs Specialist Telephone Number: (508) 880-8404 Fax Number: (508) 828-3212
Name of Device________________________________________________________________________________________________________________________________________________________________
CODMAN® Intracranial Bolt Proprietary Name: Common Name: Intracranial Bolt Classification Name: Intracranial pressure monitoring device
Device Classification
This device has been placed in Class II for intracranial pressure monitoring devices per 21 CFR § 882.1620 (84GWM).
Statement of Substantial Equivalence
The CODMAN® Intracranial Bolt is substantially equivalent to both the CODMAN® MicroSensor™ Skull Bolt and Camino ICP Bolt based on the subject device's similarity to the predicate devices in intended use, materials, design, and principles of operation.
Indications for Use
The CODMAN® Intracranial Bolt is indicated for use as a component of an intracranial pressure (ICP) monitoring system designed to achieve direct ICP monitoring. Specifically, the CODMAN® Intracranial Bolt is intended to secure an ICP transducer during direct ICP monitoring in both subdural and intraparenchymal applications.
1
Physical Description__________________________________________________________________________________________________________________________________________________________
The CODMAN® Intracranial Bolt is composed of the following six components: (1) bolt, (2) wing nut, (3) compression cap, (4) compression grommet, (5) washer, and (6) obturator/dura pierce (packaged with bolt assembly). The bolt component is screwed into the cranium in order to secure the transducer. This is achieved through compression of the grommet via tightening of the compression cap. Additionally, a wing nut is provided as a component of the assembly as a means of bolt insertion, and a washer is provided if thread depth variation is desired. Finally, an obturator/dura pierce is provided to clear the inner lumen of the bolt and pierce the dura prior to transducer insertion. All patient contacting components are constructed of fully biocompatible implant materials.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 1998
Mr. James M. Flaherty, Jr. Associate Regulatory Affairs Specialist Johnson & Johnson Professionals, Incorporated 325 Paramount Drive Raynham, Massachusetts 02767-0350
K974088 Re: Trade Name: Codman Intracranial Bolt Regulatory Class: II Product Code: GWM Dated: October 29, 1997 Received: October 30, 1997
Dear Mr. Flaherty:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the---current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
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Page 2 - Mr. Flaherty Jr.
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
ticolleto
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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974088
510(k) Number (if known) Device Name Indications For Use:
CODMAN® Intracranial Bolt
The CODMAN® Intracranial Bolt is indicated for use as a component of an intracranial pressure (ICP) monitoring system designed to achieve direct ICP monitoring. Specifically, the CODMAN® Intracranial Bolt is intended to secure an ICP transducer during direct ICP monitoring in both subdural and intraparenchymal applications.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
bcothe
(Division Sign-Off)
Division of General Restorative Devicess