XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM

K992226 · Radionics, Inc. · JXG · Aug 4, 2000 · Neurology

Device Facts

• Record ID: K992226
• Device Name: XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
• Applicant: Radionics, Inc.
• Product Code: JXG · Neurology
• Decision Date: Aug 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XDS allows 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.

Device Story

Closed-loop system for cerebrospinal fluid (CSF) drainage and intracranial pressure (ICP) monitoring. Components include disposable drainage bag, drainage tubing set, calibrated scale, and graduated drip chamber. Used in clinical settings for patients requiring temporary CSF diversion or pressure management. Operated by healthcare professionals. Provides visual estimation of drainage volume and pressure monitoring to assist in clinical decision-making regarding ICP reduction and shunt infection management. Sterile, single-use device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Closed-loop drainage system; includes drainage bag, tubing, calibrated scale, and graduated drip chamber. Sterile, single-use. Mechanical operation for fluid collection and pressure monitoring.

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) drainage and intracranial pressure (ICP) monitoring via lateral ventricles or lumbar subarachnoid space, including patients 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

• Medtronic Becker External Drainage and Monitoring System (K984053)

Submission Summary (Full Text)

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# AUG = 4 2000

992226

Attachment V: Summary of Safety and Effectiveness Information [510(k) Summary]

SUBMITTER:

Radionics Inc. 76 Cambridge Street Burlington, MA 01803 Tel .: [phone] Fax: [phone]

Contact: Kevin J. O'Connell Regulatory Engineer

PROPRIETARY NAME:

COMMON OR USUAL NAME:

CLASSIFICATION CODE:

PREDICATE DEVICE:

DESCRIPTION:

INTENDED USE:

Radionics External CSF Drainage and Monitoring System (XDS) External Drainage System

Shunt, Central Nervous System and Components 21 CFR, Section: 882.5550

Medtronic Becker External Drainage and Monitoring System, K984053

The XDS provides a simple to use, closed loop system for the drainage of cerebrospinal fluid (CSF) and allows for pressure monitoring. XDS consists of a disposable drainage bag attached to a drainage tubing set that incorporates a calibrated scale and a graduated drip chamber used for estimation of drainage fluids. The systems will be provided sterile and will be labeled for single use only.

The XDS allows 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.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above three wavy lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 4 2000 AUG

Mr. Kevin J. O'Connell Senior Regulatory Associate Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803

K992226 Re:

Trade Name: External CSF Drainage and Monitoring System Regulatory Class: II Product Code: JXG Dated: May 9, 2000 Received: May 10, 2000

Dear Mr. O'Connell:

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 ass bated in 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 (QS) 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. Kevin J. O'Connell

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 vours.

Danne R. Lochner.

1 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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#### 2.0 ODE Indications Statement

Page 1 of 1

510(k) Number (if known): K992226

Device Name: Radionics External CSF Drainage and Monitoring System

Indications for use: Allows for drainage and monitoring of cerebrospinal fluid (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.

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

Dana R. bochner

Division Sign-Off) Division of General Restorative Devices 510(k) Number 4992226

PRESCRIPTION USE

(Per 21 CFR 801.109

OR

### Over-The-Counter Use

(Optional Format 1-2-96)