MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS

K062599 · Integra LifeSciences Corporation · JXG · Sep 27, 2006 · Neurology

Device Facts

• Record ID: K062599
• Device Name: MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
• Applicant: Integra LifeSciences Corporation
• Product Code: JXG · Neurology
• Decision Date: Sep 27, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MoniTorr ICP™ External CSF Drainage and Monitoring Systems allow for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP. The Integra Pole Mount Assemblies are utilized with the MoniTorr ICP™ External Drainage and Monitoring Systems to provide support and alignment on an I.V. Pole.

Device Story

System drains/monitors CSF from lateral ventricles or lumbar subarachnoid space; connects via luer to patient line and drainage bag; includes graduated burette for measurement; antimicrobial vent prevents contamination. Pole mount assembly provides support/alignment on IV pole using pointer, line level, or Class II laser level. Used in clinical settings; operated by healthcare professionals. Laser alignment ensures accurate pressure level setting relative to patient's anatomical reference point. Benefits include controlled ICP reduction and temporary CSF management.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with electrical safety and laser safety standards (BS EN 60601-1-2, EN 61000 series, 21 CFR 1040.10/1040.11) demonstrated.

Technological Characteristics

System includes disposable drainage components and reusable pole mount assembly. Pole mount features graduated rail, sliding bracket, and alignment aids (pointer, line level, Class II laser). Laser complies with 21 CFR 1040.10/1040.11. Electrical safety compliance per BS EN 60601-1-2, EN 61000-4-2, EN 61000-4-3, and EN 61000-4-8.

Indications for Use

Indicated for patients requiring CSF drainage or ICP monitoring via lateral ventricles or lumbar subarachnoid space, including those with infected CSF shunts.

Regulatory Classification

Identification

A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.

Predicate Devices

• MoniTorr™ External CSF Drainage and Monitoring Systems (K920156)
• MoniTorr™ External CSF Drainage and Monitoring Systems (K022554)

Submission Summary (Full Text)

{0}------------------------------------------------

Integra NeuroSciences

K062499

Special 510(k): Device Modification
MoniTorr ICP™ External CSF Drainage and Monitoring Systems

Page 1 of 2

# MoniTorr ICP™ External CSF Drainage and Monitoring Systems

### 510(k) SUMMARY

### Submitter's name and address:

SEP 2 7 2006

Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536

#### Contact person and telephone number:

Darlene M. Welsh, RAC Sr. Regulatory Affairs Project Manager Telephone: [phone] Facsimile: 609-275-9445

### Date summary was prepared:

August 30, 2006

## Name of the device:

| Proprietary Name: | MoniTorr ICP™ External CSF Drainage and Monitoring Systems |
|----------------------|-------------------------------------------------------------|
| Common Name: | External Cerebrospinal Fluid Drainage and Monitoring System |
| Classification Name: | Central Nervous System Shunt and Components JXG |

## Substantial Equivalence:

The MoniTorr ICPTM External CSF Drainage and Monitoring Systems are substantially equivalent in function and intended use to the unmodified MoniTorr™ External CSF Drainage and Monitoring Systems which have been cleared to market under Premarket Notification 510(k)'s K920156 and K022554.

## Intended use:

The MoniTorr ICPTM External CSF Drainage and Monitoring Systems allow for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.

The Integra Pole Mount Assemblies are utilized with the MoniTorr ICP™ External Drainage and Monitoring Systems to provide support and alignment on an I.V. Pole.

# Device Description:

The Integra Pole Mount Assembly has been modified to include a line level and a laser level. The MoniTorr ICP™ External CSF Drainage and Monitoring Systems can be used

{1}------------------------------------------------

Kob 25-99

Page 2 of 2

Integra NeuroSciences Special 510(k): Device Modification MoniTorr ICPTM External CSF Drainage and Monitoring Systems

> with a pole mount assembly. The Integra Pole Mount Assemblies are designed provide support and alignment to the MoniTorr ICP™ External CSF Drainage and Monitoring Systems on an I.V. Pole. The Integra Pole Mount Assemblies are designed to be reusable. The reusable Integra Pole Mount Assembly is comprised of a graduated rail with a grooved profile to support the sliding bracket which facilitates setting the pressure level while using the disposable external drainage system. The Pole Mount Assembly is aligned with the patient's anatomical reference point by using a pointer, line level or laser.

> The MoniTorr ICP™ External CSF Drainage and Monitoring Systems are designed to externally drain cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space to a drainage bag in selected patients. The systems connect to a ventricular or lumbar catheter via a luer connection to a patient line and ultimately to a drainage bag. In most of the systems, the patient line is connected to a graduated burette that is then connected to the drainage bag. CSF can be collected and measured in the burette and subsequently emptied into the drainage bag by opening the stopcock placed in line between the burette and the drainage bag. In systems with this burette, an antimicrobial vent is included in the burette cap. This antimicrobial vent allows air to enter the burette to facilitate drainage from the burette to the drainage bag while protecting the system from microbial contamination. These systems are designed for single use only.

# Safety

The Integra Pole Mount Assemblies are accessories for the MoniTorr ICP™ External CSF Drainage and Monitoring Systems. Alignment can be achieved through the use of a line level or laser level. The laser level is a Class II Laser and complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50 dated July 26, 2001.

The laser is fully compliant with the following standards:

BS EN 60601-1-2 (1993) EN 60601-1-2 (2003) EN 61000-4-2 (1995) EN 61000-4-3 (1996) above 1 GHz EN 61000-4-8 (1993) in accordance with EN 60601-1-2 (2001)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 7 2006

Integra NeuroSciences % Darlene M. Welsh, RAC Senior Regulatory Affairs Project Manager 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K062599

K002.577
Trade/Device Name: MoniTorr ICP™ External Drainage and Monitoring System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt components Regulatory Class: Class II Product Code: JXG Dated: August 31, 2006 Received: September 1, 2006

Dear Ms. Welsh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the 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 enclosure) to regard) at the Medical Device Amendments, or to conninerec prof to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat nave been recuired in assere approval of a premarket approval application (PMA). alle Cosmetic Act (1107 market the device, subject to the general controls provisions of the Act. The 1 ou may, merclore, market the Act include requirements for annual registration, listing of general controls provisions of the rice 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 is classified (500 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controller s, 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 Prease be advised that I Dri s issuated of a badewines with other requirements of the Act that TDA has made a dolorimiation administered by other Federal agencies. You must of any Peteral statures and regalations and limited to: registration and listing (21 comply with an the Act s requirements) newslag, which and securing practice requirements as set CTN Fall 807), adomig (21 CFR Part 820); and if applicable, the electronic .
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1950 rorth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Darlene M. Welsh, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This tetter will anow you to oegin manies.ing 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 (24 CFR Part 801), please If you desire specific darioliance 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 other geleral information on your responser Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

far Dale

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K062599
```

INDICATIONS FOR USE STATEMENT

# 510(k) Number: K062599

Device Name: MoniTorr ICP™ External CSF Drainage and Monitoring Systems

# Indications for Use:

The MoniTorr ICP™ External CSF Drainage and Monitoring Systems allow for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and to monitor ICP.

ription Us (Part 21 CFR 801 Subpart D

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

510(k) Number k062155