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.

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.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the CODMAN® Intracranial Bolt, a medical device for intracranial pressure (ICP) monitoring. The document asserts "substantial equivalence" to predicate devices, but does not describe acceptance criteria, performance data, or a specific study proving the device meets acceptance criteria.

The 510(k) summary focuses on device description, intended use, and its substantial equivalence to previously marketed devices (CODMAN® MicroSensor™ Skull Bolt and Camino ICP Bolt), circumventing the need for extensive clinical performance studies that newer, novel devices might require.

Therefore, for this specific document:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission relies on "substantial equivalence" to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set or performance data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical instrument, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. No training set is described.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text from the 510(k) submission does not contain information regarding acceptance criteria or a study proving the device meets such criteria. Instead, the submission relies on demonstrating substantial equivalence to predicate devices based on intended use, materials, design, and principles of operation.

Summary

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K974088

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

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Physical Description__________________________________________________________________________________________________________________________________________________________

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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

(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<974088
510(k) Number

Prescription Use (Per 21 CFR §801 109)

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).