NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100

K050720 · Integra Neurosciences · GWM · May 11, 2005 · Neurology

Device Facts

• Record ID: K050720
• Device Name: NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
• Applicant: Integra Neurosciences
• Product Code: GWM · Neurology
• Decision Date: May 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.

Device Story

NeuroSensor system provides continuous real-time measurement of cerebral blood flow (CBF) and intracranial pressure (ICP). Input: laser Doppler signals for CBF; MEMS silicon strain gauge for ICP. System includes single-use probe and monitor. Monitor displays measured parameters and computes derived values: cerebral perfusion pressure (CPP) and cerebrovascular resistance (CVR) using systemic arterial pressure (SAP) data from bedside monitors. Used in clinical settings by qualified clinicians. Probe inserted via cranial access bolt; indwelling time up to 5 days. Output: real-time monitoring data for clinical decision-making regarding cerebral ischemia risk and intracranial pressure management.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per FDA G95-1 and ISO 10993. Performance testing confirmed probe design is technically sound and safe for intended use.

Technological Characteristics

Probe: Type 304 stainless steel or titanium; 6F (2.0mm) diameter; 25mm working length. CBF sensing: Fiberoptic Laser Doppler Flowmetry. ICP sensing: MEMS silicon strain gauge. Sterilization: 100% Ethylene Oxide (SAL 10^-6). Connectivity: Interface with hospital bedside monitors for SAP data and ICP display.

Indications for Use

Indicated for patients at risk of cerebral ischemia requiring monitoring of cerebral blood flow and direct intraparenchymal intracranial pressure monitoring. For use by qualified clinicians.

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® Cerebral Blood Flow and Intracranial Pressure Monitoring System (K013930)

Submission Summary (Full Text)

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**CONFIDENTIAL**

MAY 1 1 2005

050720

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#### 510(k) SUMMARY

## Submitter's name and address:

Integra NeuroSciences 5955 Pacific Center Blvd. San Diego, CA 92121, USA

## Contact person and telephone number:

Nancy A. Mathewson, Esq. Director, Regulatory Affairs [phone] ext. 185

#### Date summary was prepared:

March 18, 2005

#### Name of the device:

| Proprietary Name: | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------|
| Modified: | NeuroSensor ® Cerebral Blood Flow and Intracranial Pressure<br>Monitoring System |
| Unmodified | NeuroSensor ® Cerebral Blood Flow and Intracranial Pressure<br>Monitoring System, 510(k) K013930 |
| Common Name: | Cerebral Blood Flow and Intracranial Pressure Monitoring<br>System |
| Classification Name: | Extravascular Blood Probes<br>Product Code DPT, 21 CFR 870.2120<br>Blood Flowmeters<br>Product Code DPW, 21 CFR 2100 |
| Classification Panel: | Cardiovascular Device Panel |
| Classification Name: | Intracranial Pressure Monitoring Device<br>Product Code GWM, 21 CFR 882.1620 |
| Classification Panel: | Neurology Device Panel |

#### Substantial Equivalence:

ﺔ ﺗ

The modified NeuroSensor® System has the following similarities to the unmodified NeuroSensor® System.

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| | | Table II - Substantial Equivalence | |
|--|--|------------------------------------|--|
|--|--|------------------------------------|--|

| Parameter | Original NeuroSensor® System | Modified NeuroSensor® System |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Indications for Use | Intended for use by a qualified clinician in<br>monitoring cerebral blood flow in patients at risk<br>of cerebral ischemia, and for the direct monitoring<br>of intracranial pressure in intraparenchymal<br>applications. | Identical to the original<br>NeuroSensor® System |
| Measured parameters | Cerebral Blood Flow and Intracranial Pressure | Identical to the original<br>NeuroSensor® System |
| Operating Principle | Laser Doppler for measurement of blood flow and<br>MEMS strain gauge pressure sensor for<br>measurement of ICP | Identical to the original<br>NeuroSensor® System |
| Probe Construction | Type 304 stainless steel or titanium probe | Identical to the original<br>NeuroSensor® System |
| Probe Body Size | 6F (2.0mm) diameter | Identical to the original<br>NeuroSensor® System |
| Probe Working Length | 25mm with 5 depth markings at zero insertion<br>from bolt and at 5mm intervals | Identical to the original<br>NeuroSensor® System |
| System Specifications<br>(Cerebral Blood Flow) | Range<br>0 to 300 ml/100g/min<br>Resolution<br>1ml/100g/min | Identical to the original<br>NeuroSensor® System |
| CBF Sensor Type | Fiberoptic (Laser Doppler Flowmetry) | Identical to the original<br>NeuroSensor® System |
| ICP Sensor Type | MEMS (Micro-Electro Mechanical System)<br>silicon strain gauge | Identical to the original<br>NeuroSensor® System |
| Indwelling time | Five (5) days | Identical to the original<br>NeuroSensor® System |
| Method of Probe<br>Placement | Inserted through a cranial access bolt | Identical to the original<br>NeuroSensor® System |
| Packaging Method and<br>Materials | Tyvek lid heat sealed to a thermoformed tray<br>inserted into a second thermoformed tray. Boxed<br>individually. | Identical to the original<br>NeuroSensor® System |
| Sterilization Process | 100% Ethylene Oxide to a sterility assurance level<br>of 106. | Identical to the original<br>NeuroSensor® System |

#### Device Description:

Each NeuroSensor® system consists of a single-use probe and introducer for the continuous real-time measurement of Cerebral Blood Flow (CBF) and Intracranial Pressure (ICP), and a monitor for the display and storage of these measured parameters

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CONFIDENTIAL

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and the computation and display of derived parameters. The NeuroSensor® monitor can be connected to a hospital bedside monitor for display of ICP. The NeuroSensor® monitor can accept Systemic Arterial Pressure (SAP) data from a hospital bedside monitor, and can use this data and the measured CBF and ICP to compute Cerebral Perfusion Pressure (CPP) and Cerebrovascular Resistance (CVR).

#### Statement of Intended Use:

The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.

#### Safety:

Biocompatibility studies were conducted per FDA G95-1 and ISO 10993 and have demonstrated that the materials used to manufacture the NeuroSensor® probe are safe for their intended use.

In addition, the NeuroSensor® System was subjected to extensive performance testing. Results of the testing showed that the probe design was technically sound and the product safe for its intended use.

The NeuroSensor® System manufacturing process complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.

#### Conclusion:

ﺑﺮﺩ ﻣﺠ

In summary, the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring System described in this submission is substantially equivalent to the unmodified predicate device and the modifications made do not affect the intended use or fundamental scientific technology of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three figures in profile facing right. The figures are connected by a flowing line, representing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 2005

Integra Neurosciences Corporation Ms. Nancy Mathewson Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K050720

Trade/Device Name: NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: May 4, 2005 Received: May 5, 2005

Dear Ms. Mathewson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becareer on 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 entrebutes) 70 the enactment date of the Medical Device Amendments, or to conimered pror to rilly 20, 2011 accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic rear (110) market the device, subject to the general controls provisions of the Act. The r ou may, diereleve, mains of the Act include requirements for annual registration, listing of general controls provisions of use ice, 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 may be subject to such additional controls. Existing major regulations affecting your device it may of subject to Ston additions, 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 r lease of actived a determination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must of any I cueral statutes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fart 007), adoning (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant) byocal provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Nancy Mathewson

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manieting your and equivalence of your device to a legally premarket notification: "The PDF 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), please If you desire specific acrice ior your at [phone] . Also, please note the regulation entitled, Comact the Office of Compulance in (21 transmitted notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response in the toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Styph Rhodes
S. Michael C. Duncan, Ph.D.

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### CONFIDENTIAL

Special 510(k) Premarket Notification NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System Integra NeuroSciences

# Indications for Use

#### K050720 510(k) Number (if known):

Device Name: NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System

Indications For Use: The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.

Prescription Use _X (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B-001

Styp Kurdin

(Division Division of General, Restorative, and Neurological Devices

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