The CODMAN® Single Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring applications.

The CODMAN® Double Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure sensors in place for intracranial monitoring applications.

Device Description

The CODMAN® Single and Double Lumen Skull Bolt Kits consist of bolts and associated components designed to achieve cranial access and facilitate the introduction and securing of intracranial sensors. Additional accessories supplied in the kits include a sensor introducer, connectors, drill bits, and other associated components supplied for the convenience of the user. All parts and accessories found in the CODMAN® Single and Double Lumen Skull Bolt Kits are manufactured from biocompatible materials suitable for their uses in these kits.

AI/ML Overview

The provided text describes a 510(k) summary for medical devices, specifically the "CODMAN® Single and Double Lumen Skull Bolt Kits." These are Class II devices intended for intracranial pressure monitoring applications.

The submission primarily relies on bench testing to demonstrate performance characteristics and equivalence to predicate products. This means the device's acceptance was based on engineering and material performance rather than clinical studies involving human patients or complex AI algorithms.

Therefore, many of the typical acceptance criteria and study details relevant to AI-powered diagnostics or clinical performance studies (e.g., sample size for test set, MRMC studies, expert qualifications, training set details) are not applicable to this type of device submission.

Here's a breakdown of the requested information based on the provided text, highlighting where information is not available or not relevant:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Torque Testing	Demonstrated "appropriate for their intended use."
Pullout Testing	Demonstrated "appropriate for their intended use."
Leak Testing	Demonstrated "appropriate for their intended use."
Biocompatibility	"Manufactured from biocompatible materials suitable for their uses in these kits."

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified, as the testing involved bench tests (e.g., mechanical stress tests) rather than patient data.
Data Provenance: Not applicable, as no patient data was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Ground truth for bench testing is typically established by engineering specifications and physical measurements, not clinical expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for clinical image interpretation or diagnostic tasks involving human judgment.

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

No MRMC study was done. This device is a mechanical bolt kit, not an AI diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is hardware, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance was established through engineering specifications and physical measurements demonstrating the structural integrity and functionality (torque resistance, pullout strength, leak prevention) of the bolts and components.

8. The sample size for the training set

Not applicable. Training sets are used for machine learning models.

9. How the ground truth for the training set was established

Not applicable. Training sets and their associated ground truth are used for machine learning models.

Summary

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510(k) Summary for the CODMAN® Single and Double Lumen Skull Bolt Kits

Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Contact Person

James M. Flaherty, Jr., RAC Regulatory Affairs Specialist Telephone Number: (508) 880-8404 Fax Number: (508) 828-3212

Name of Device

CODMAN® Single and Double Lumen Skull Bolt Kits Proprietary Name: Common Name: Intracranial Bolts Classification Name: Intracranial pressure monitoring devices

Device Classification

These devices have been placed in Class II for intracranial pressure monitoring devices per 21 CFR & 882.1620 (84GWM).

Statement of Substantial Equivalence

The CODMAN® Single and Double Lumen Skull Bolt Kits are substantially equivalent to both the CODMAN® MICROSENSOR™ Skull Bolt Kit and the CAMINO Micro Ventricular Bolt Pressure Monitoring Kit 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® Single Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring applications.

The CODMAN® Double Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure sensors in place for intracranial monitoring applications.

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Physical Description

Device Testing

This submission relied on bench testing to demonstrate equivalence of performance characteristics to predicate products. Torque, pullout, and leak testing of both the single and double lumen bolts demonstrated that the devices are appropriate for their intended use.

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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 features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1999

Mr. James Flaherty, Jr., RAC Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K992591

Trade Name: Codman Single and Double Lumen Skull Bolt Kits Regulatory Class: II Product Code: GWM Dated: July 30, 1999 Received: August 2, 1999

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 enclosures) 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 requirement, as set forth in the Quality System Regulation (OS) 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 -- Mr. James Flaherty

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 vour 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 yours,

Colin McWhirter, Ph.D., M.D.

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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510(k) Number (if known) Device Name

K 992591 CODMAN® Single and Double Lumen Skull Bolt Kits

Indications For Use:

The CODMAN® Single Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring applications.

The CODMAN® Double Lumen Skull Bolt Kit is designed to achieve cranial access and to introduce and secure sensors in place for intracranial monitoring applications.

(Please do not write below this line - Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pcolle

noral Rastorativa De

Prescription Use (Per 21 CFR §801.109) OR

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).