CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM

K042728 · Novus Monitoring, Ltd. · GWM · Oct 22, 2004 · Neurology

Device Facts

• Record ID: K042728
• Device Name: CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
• Applicant: Novus Monitoring, Ltd.
• Product Code: GWM · Neurology
• Decision Date: Oct 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

The Camino Slim-Line™ Intracranial Monitoring System has been designed for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.

Device Story

System comprises 1.3mm diameter single-use parenchymal/sub-dural catheter and in-line cable monitor. Solid-state sensor at catheter tip measures ICP in real-time. Factory-calibrated sensor stores identification/calibration data on probe; no user calibration required. Monitor displays ICP digitally and as real-time trace on LCD; relays data to external patient monitoring systems. Used by neurosurgeons in clinical settings for direct ICP monitoring. Parenchymal application requires cranial access port/bolt; sub-dural application requires tunneling trocar. Provides continuous ICP data to assist clinical decision-making in neurosurgical patients.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

1.3mm diameter single-use parenchymal/sub-dural catheter; solid-state pressure sensor; in-line cable monitor with LCD display; factory-calibrated; connectivity to external patient monitoring systems.

Indications for Use

Indicated for use by qualified neurosurgeons for direct intracranial pressure (ICP) monitoring in sub-dural and intraparenchymal applications.

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

• NeuroSensor™ System (K013930)
• Codman ICP monitoring system and Microsensor™ ICP transducer (K914479)
• Camino Intracranial Pressure Monitoring Kit (K853864)

Submission Summary (Full Text)

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# OCT 2 2 2004

510(k) Summary KO42728 September 29th 2004

#### Submitter 1

Novus Monitoring Ltd Greenways Abbotts Ann, Andover Hampshire, SP11 7BH United Kingdom

| Contact Person: | Prof. Peter F Gibson |
|-----------------|----------------------|
| Telephone: | [phone] |
| Facsimile: | [phone] |

#### Name of Device 2

| Proprietary Name: | Camino Slim-Line™ Intracranial Pressure Monitoring<br>System, comprising:<br><br>a) Camino Slim-Line™ monitor<br>b) Camino Slim-Line™ parenchymal and sub-<br>dural ICP catheter |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | a) Intracranial Pressure<br>monitor<br>b) Parenchymal and sub-dural catheter for<br>intracranial pressure measurement |
| Device Classification: | Intracranial pressure monitoring devices have been placed in<br>Class II as per 21 CFR Regulation Number 882.1620 and<br>assigned the Product Code GWM. |

#### Predicate Devices 3

The components of the Camino Slim-Line™ system are substantially equivalent to the following legally marketed devices:

| K013930 | NeuroSensor™ System |
|---------|-----------------------------------------------------------------|
| K914479 | Codman ICP monitoring system and Microsensor™ ICP<br>transducer |
| K853864 | Camino Intracranial Pressure Monitoring Kit |

This statement is based on the subject device's similarity to the predicate devices in intended use, materials, design and principles of operation.

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### Device Description

The Camino Slim-Line™ system consists of a single-use 1.3mm diameter parenchymal and sub-dural catheter for the real-time measurement of intracran pressure (ICP) and an in-line cable monitor for the display of measured pressure. The Camino Slim-Line™ monitor can be connected to an external patient monitoring system to relay ICP measurements.

ICP is monitored directly by a solid state sensor mounted on the side of the Camino Slim-Line™ ICP catheter close to its tip. The sensor is precalibrated in the factory with probe identification and calibration values stored within each probe and there is no requirement for the user to calibrate the probe before use.

The Camino Slim-Line™ monitor uses a small LCD display to show the measured ICP continuously in real time, both in digital form and as a real-time trace. The monitor can relay this measured information to an external patient monitoring system.

In parenchymal applications, the Camino Slim-Line™ ICP catheter is used with an ing single-use Camino cranial access port or bolt, and an existing C ence procedure kit for cranial access. For Sub-dural applie eTM ICP catheter may be used with an existing tunneling trocar and convenience procedure kit for cranial access.

### Intended Use

The Camino Slim-Line™ system has been designed for use by a qualific neurosurgeon in the dire monitoring of intracranial pressure in both subintraparenchymal applications.

### Summary of Substantial Equivalence

The Camino Slim-Line™ Intracranial Monitoring System is similar in struction, materials, intended use and performance characteristic In vitro testing shows that the device meets similar per se for the predicate devices. No new issues of sa iced by using this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes extending from its head, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

OCT 2 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Novus Monitoring Ltd c/o Ms. Judith E. O'Grady Senior Vice President, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K042728

K042720
Trade/Device Name: Camino Slim-Line™ Intracranial Pressure Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: September 30, 2004 Received: October 1, 2004

Dear Ms. O'Grady:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasin b r (s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de vices that have been rocksonied in avire approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that ac not required to the general controls provisions of the Act. The r ou may, increrere, mass of the Act include requirements for annual registration, listing of general controll pro reversive, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device to such additional controls. Existing major regulations affecting your device can may be subject to back as a sublimations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that I 197 Has made a and regulations administered by other Federal agencies. You must or any I odetar bated and stequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set of I rat 007), as extens (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Judith E. O'Grady

This letter will allow you to begin marketing your device as described in your Section 510(k) rms retet notification. The FDA finding of substantial equivalence of your device to a legally premailed nevice 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), pleasc 11 Jou dome of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if Known): |くOY2728

Camino Slim-Line™ Intracranial Pressure Monitoring Device Name: System The Camino Slim-Line™ Intracranial Monitoring Indications for Use: System has been designed for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.

Prescription Use __ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Muriam C Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________