NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT

K051599 · Neurorecovery, Inc. · GWM · Jul 19, 2005 · Neurology

Device Facts

• Record ID: K051599
• Device Name: NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
• Applicant: Neurorecovery, Inc.
• Product Code: GWM · Neurology
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neurorecovery", Inc., Neurorecovery" Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is intended for single patient use for the measurement of intracranial pressures (ICP) and drainage of Cerebral Spinal Fluid (CSF). It is intended for short term management of patients with increased intracranial pressure.

Device Story

The NRI CIPER™ Kit is a single-use, sterile, disposable device designed for short-term management of increased intracranial pressure. It integrates a pressure transducer with components from cleared ICP monitoring devices and the Neurorecovery™ Main Valve Assembly. The device facilitates the measurement of ICP and the drainage of cerebrospinal fluid (CSF). It is intended for use in a clinical setting where healthcare providers monitor ICP and manage CSF drainage to treat patients with elevated intracranial pressure. The device connects to an external ICP monitoring system to provide pressure data, which clinicians use to guide therapeutic interventions for intracranial pressure management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

The device consists of a kit containing a pressure transducer and fluid drainage components. It is provided sterile, non-pyrogenic, and is intended for single-use. It is designed to interface with an external ICP monitoring device and the Neurorecovery™ Main Valve Assembly.

Indications for Use

Indicated for patients requiring short-term management of increased intracranial pressure, specifically for the measurement of intracranial pressure (ICP) and drainage of cerebrospinal fluid (CSF).

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

• Medex, Inc. Intracranial Pressure Monitoring Device (K822864)
• Medex, Inc. Transtar Intracranial Pressure Transducer (K020780)

Submission Summary (Full Text)

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

K05/599

# 510(k) Summary (Per 21 CFR807.92) Neurorecovery Comprehensive Intracranial Pressure Evaluation and Relief Kit (CIPER" Kit)

JUL 1 9 2005

#### 1. APPLICANT

Neurorecovery ", Inc. 1649 McFarland Blvd., N., Suite 203 Tuscaloosa, Alabama 35406

Landon C. G. Miller, JD, RPA, MSA, BA Contact Person: [phone] Telephone:

Date Prepared: July 11, 2005

#### DEVICE NAME 2.

| Proprietary Name: | NeurorecoveryTM, Inc. (NRI) Comprehensive<br>Intracranial Pressure Evaluation and Relief (CIPERTM) Kit | | | |
|----------------------|--------------------------------------------------------------------------------------------------------|--|--|--|
| Common/Usual Name: | Intracranial pressure monitoring device and accessories | | | |
| Classification Name: | Intracranial pressure monitoring device and accessories | | | |

#### DEVICE CLASSIFICATION 3.

Intracranial pressure monitoring devices and accessories (21 CFR 882.1620; ProCode: GWM) have been classified as Class II devices.

#### PREDICATE DEVICES 4.

- Medex, Inc. Intracranial Pressure Monitoring Device (K822864) ●
- Medex, Inc. Transtar Intracranial Pressure Transducer (K020780) .

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

#### DEVICE DESCRIPTION 5.

The Neurorecovery" Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is composed of many permanently connected components that incorporate a transducer for connection to an ICP monitoring device. The NRI CIPER™ Kit incorporates components of a cleared intracranial pressure monitoring device, an intracranial pressure transducer, and many components of the Neurorecovery™ Main Valve Assembly. The NRI CIPER™ Kit is designed to be used with the Neurorecovery " Main Valve Assembly. It is provided to the user sterile, non-pyrogenic (fluid path), single use, disposable, and not recommended for reuse of any kind.

#### INTENDED USE 6.

The Neurorecovery", Inc., Neurorecovery" Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is intended for single patient use for the measurement of intracranial pressures (ICP) and drainage of Cerebral Spinal Fluid (CSF). It is intended for short term management of patients with increased intracranial pressure.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 7.

The NRI CIPER™ Kit is equivalent to the cited predicate devices based on its indications for use, design, materials, and operational characteristics. Neurorecovery", Inc., believes that differences between devices are minor and raise no new issues of safety or effectiveness.

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

DEPARTMENT OF HÉALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it.

JUL 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rosina Robinson, RN, Med, RAC Senior Staff Consultant Medical Device Consultants, Inc. . . . . . 49 Plain Street North Attleboro, Massachusetts 02760

\$

Re: K051599

Trade/Device Name: Neurorecovery™, Inc., Neurorecovery™ Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: June 15, 2005 Received: June 16, 2005

Dear Ms. Robinson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bocurer 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 encreating of the enactment date of the Medical Device Amendments, or to conninered phor to May 20, 1978, are canomance with the provisions of the Federal Food, Drug, devices that have been rocksonied in avire approval of a premarket approval application (PMA). alla Cosmetic Ac. (1101) market the device, subject to the general controls provisions of the Act. The r ou may, mercere, mainer and as act include requirements for annual registration, listing of general controls provisions of ractice, 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 suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obavenents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Tcase oc advised that I DTT of ibrailers of your device complies with other requirements of the Act that I Dri has made a word regulations administered by other Federal agencies. You must or any I ederal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 form in the quality by evense (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

## Page 2- Ms. Rosina Robinson, RN, Med, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse ough finding of substantial equivalence of your device to a legally prematication. The PDF Printings 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 acrios in 15 % [phone]. Also, please note the regulation entitled, Connact the Office of Colline of Comment to notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

E. R. Allen

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

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

# 510(k) Number (if known): K051599

### Neurorecovery™, Inc., Neurorecovery™ Device Name: Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit)

Indications for Use:

The Neurorecovery™, Inc., Neurorecovery™ Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is intended for single patient use for the measurement of intracranial pressures (ICP) and drainage of Cerebral Spinal Fluid (CSF). It is intended for short term management of patients with increased intracranial pressure.

X Prescription Use _ (Per 21 CFR 801 Subpart D) OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Number KOS1599