Use of the CODMAN® MICROSENSOR™ Ventricular Catheter Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid (CSF) drainage applications.

Device Description

The CODMAN® MICROSENSOR™ Ventricular Catheter Kit consists of the following components:

Ventricular Catheter Triple-lumen catheter with a center drainage lumen (1) and dedicated lumens for the stylet and MICROSENSOR™ ICP Sensor,
Stylet Preloaded stylet sued for catheter insertion and placement, (2)
MICROSENSOR™ ICP Sensor Intracranial pressure (ICP) sensor (3) embedded in a dedicated lumen with direct CSF access,
Y -Connector Connection component allowing the catheter to be either (4) connected to an external drainage system or capped,
(૨) Suture Clip - Catheter anchoring clip, and
Tunneling Trocar with TEFLON® Tubing Trocar with sheath designed (6) to allow the catheter to be tunneled under the scalp to the craniotomy site.

AI/ML Overview

The provided text is a 510(k) summary for the CODMAN® MICROSENSOR™ Ventricular Catheter Kit. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain information regarding acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical performance studies.

The section titled "Device Testing" only mentions:

Reliance on ISO 10993-1 for biological testing.
"Tripartite Biocompatibility Guidelines for Medical Devices."
Material characteristics of the silicone elastomer.
The general statement "All testing supports the device for its intended use."

This indicates that the testing primarily focused on biocompatibility and material properties, which are safety aspects, rather than a clinical performance study with specific acceptance criteria related to the device's functional performance (e.g., accuracy of ICP measurement, duration of function, success rate of CSF drainage).

Therefore, I cannot provide the requested information from the provided text. The document does not include:

A table of acceptance criteria and reported device performance.
Sample size for a test set or data provenance for a performance study.
Number of experts or their qualifications for establishing ground truth in a performance study.
Adjudication method for a performance study test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
Information on a standalone algorithm-only performance study.
The type of ground truth used for performance (e.g., expert consensus, pathology, outcomes data).
Sample size for a training set (as this is not an AI/algorithm-based device from the description).
How ground truth was established for a training set.

This 510(k) summary relies on showing substantial equivalence to predicate devices based on similarities in intended use, materials, design, and principles of operation, along with biocompatibility testing, rather than a de novo clinical performance study with detailed acceptance criteria.

Summary

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510(k) Summary for the CODMAN® MICROSENSOR™ Ventricular Catheter Kit

Johnson & Johnson Professional, 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

Proprietary Name:	CODMAN® MICROSENSOR™ Ventricular Catheter Kit
Common Name:	Intracranial pressure (ICP) monitoring/cerebrospinal fluid(CSF) drainage catheter kit
Classification Name:	• Intracranial pressure monitoring device• Ventricular catheter

Device Classification

This device has been placed in Class II for intracranial pressure monitoring devices per 21 CFR § 882.1620 (84GWM) as well as for ventricular catheters per 21 CFR § 882.4100 (84HCA).

Statement of Substantial Equivalence

The CODMAN® MICROSENSOR™ Ventricular Catheter Kit is substantially equivalent to both the CODMAN® MICROSENSOR™ Catheter Kit and the CAMINO NeuroCare™, Inc. VentrixTM Ventricular Tunneling 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

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Physical Description

The CODMAN® MICROSENSOR™ Ventricular Catheter Kit consists of the following components:

Ventricular Catheter Triple-lumen catheter with a center drainage lumen (1) and dedicated lumens for the stylet and MICROSENSOR™ ICP Sensor,
Stylet Preloaded stylet sued for catheter insertion and placement, (2)
MICROSENSOR™ ICP Sensor Intracranial pressure (ICP) sensor (3) embedded in a dedicated lumen with direct CSF access,
Y -Connector Connection component allowing the catheter to be either (4) connected to an external drainage system or capped,
(૨) Suture Clip - Catheter anchoring clip, and
Tunneling Trocar with TEFLON® Tubing Trocar with sheath designed (6) to allow the catheter to be tunneled under the scalp to the craniotomy site.

Device Testing

This submission relied on appropriate testing in accordance with ISO 10993-1 "Biological Testing of Medical and Dental Materials and Devices, Part 1: Guidance on Selection of Tests" and the "Tripartite Biocompatibility Guidelines for Medical Devices" as well as material characteristics of the silicone elastomer as furnished by the material supplier. All testing supports the device for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 1999

Mr. James M. Flaherty, Jr., RAC Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K991222

Trade Name: Codman Microsensor Ventricular Catheter Kit Regulatory Class: II Product Code: GWM Dated: April 9, 1999 Received: April 12, 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 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 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 M. Flaherty, Jr., RAC

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 yours,

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

CODMAN® MICROSENSOR™ Ventricular Catheter Kit

Indications For Use:

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✗(Per 21 CFR §801.109)	OR	Over-the-Counter Use __
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(Optional Format 1-2-96)

at Restorative Devices K991222

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).