CODMAN MICROSENSOR VENTRICULAR CATHETER KIT

K991222 · Johnson & Johnson Professionals, Inc. · GWM · Jul 9, 1999 · Neurology

Device Facts

• Record ID: K991222
• Device Name: CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: GWM · Neurology
• Decision Date: Jul 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

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 Story

The CODMAN® MICROSENSOR™ Ventricular Catheter Kit is a triple-lumen catheter system designed for intraventricular ICP monitoring and CSF drainage. The kit includes a ventricular catheter, a preloaded stylet for insertion, an embedded ICP sensor, a Y-connector for drainage system attachment, a suture clip, and a tunneling trocar with TEFLON® tubing. The device is used by clinicians in a hospital setting to provide real-time pressure data and facilitate fluid management. By enabling direct monitoring and drainage, the device assists in the clinical management of intracranial pressure, potentially improving patient outcomes in neurosurgical or critical care contexts.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993-1 and Tripartite Biocompatibility Guidelines. No clinical data provided.

Technological Characteristics

Triple-lumen silicone elastomer catheter; includes integrated ICP sensor, stylet, Y-connector, and tunneling trocar with TEFLON® tubing. Designed for intraventricular placement.

Indications for Use

Indicated for patients requiring direct intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage via intraventricular access.

Regulatory Classification

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.

Predicate Devices

• CODMAN® MICROSENSOR™ Catheter Kit
• CAMINO NeuroCare™, Inc. VentrixTM Ventricular Tunneling Pressure Monitoring Kit

Submission Summary (Full Text)

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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: [phone] Fax Number: [phone]

## Name of Device

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

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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

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

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

at Restorative Devices K991222