MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022

K991502 · Medtronic PS Medical · JXG · Sep 12, 2000 · Neurology

Device Facts

• Record ID: K991502
• Device Name: MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
• Applicant: Medtronic PS Medical
• Product Code: JXG · Neurology
• Decision Date: Sep 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The polyurethane-coated Delta Valves, polyurethane-coated CSF-Flow Control Valves, Contoured, and Burr Hole are components of polyurethane shunt systems designed for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity. The Polyurethane shunt and shunt components are designed to eliminate patient exposure to silicone elastomer. The polyurethane-coated Delta Valve minimizes the excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF, which may be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be created by the elevation of the ventricular catheter with respect to the distal catheter (i.e., when the patient sits, stands, or is held erect).

Device Story

Polyurethane shunt system designed to divert cerebrospinal fluid (CSF) from brain ventricles to right atrium or peritoneal cavity; intended to eliminate patient exposure to silicone elastomer. System comprises ventricular catheter, flow control valve (Delta Valve), and cardiac/peritoneal catheter. Delta Valve incorporates polyurethane-coated silicone elastomer housing and polypropylene base; functions to minimize excessive CSF drainage and intraventricular pressure reduction caused by hydrostatic siphoning when patient is upright. Used by neurosurgeons in clinical settings. Device provides mechanical flow regulation to prevent over-drainage; benefits patient by maintaining appropriate intracranial pressure during postural changes.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison.

Technological Characteristics

Components: ventricular catheter (polyurethane), flow control valve (polypropylene base, silicone elastomer housing, Tecoflex elastomer resin, polyurethane coating), cardiac/peritoneal catheter (polyurethane). Mechanical flow control mechanism. Non-electronic, non-software device.

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) shunting from brain ventricles to the right atrium or peritoneal cavity to manage hydrocephalus or related conditions.

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.

Submission Summary (Full Text)

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#### Safety and Effectiveness Summary X.

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 882.5550

## Establishment Registration Number: Address of Manufacturer:

2021898

Medtronic PS Medical Corporation 125 Cremona Drive Goleta CA, 93117 [phone] ext. 1770 Fax: [phone]

Contact Person:

Jeffrey Henderson

September 12, 2000

Date:

Trade or Proprietary Name:

Medtronic PS Medical Polyurethane Shunt

Common usual or Classification Name: CSF-Flow Control Shunt (882.5550)

A Ventricular Catheter manufactured of Description: Polyurethane tubing. A Flow Control Valve manufactured of a Polypropylene base and a silicone elastomer housing which incorporates a Tecoflex elastomer resin, polyurethane coating. A Cardiac/Peritoneal Catheter manufactured of Polyurethane tubina.

The polyurethane-coated Delta Valves, Intended Use: polyurethane-coated CSF-Flow Control Valves, Contoured, and Burr Hole are components of polyurethane shunt systems designed for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity. The Polyurethane shunt and shunt components are designed to eliminate patient exposure to silicone elastomer.

The polyurethane-coated Delta Valve minimizes the excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF, which may be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be created by the elevation of the ventricular catheter with respect to the distal catheter (i.e., when the patient sits, stands, or is held erect).

Medtronic PS Medical submits that the Technological comparison: materials of fabrication, intended uses, performance characteristics and design specifications of the Polyurethane Shunt are substantially equivalent to those of the predicate devices manufactured by Medtronic PS Medical and other currently marketed devices. Based upon the summary above, Medtronic PS Medical determines substantial equivalence, safety, and efficacy of the Polyurethane Shunt based upon the currently marketed devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2000

Mr. Jeffrey Henderson ·Vice President, Quality and Regulatory Affairs Medtronic PS Medical 125 Cremona Drive Goleta, California 93117

Re: K991502

> Trade Name: Medtronic PS Medical Polyurethane Shunt Regulatory Class: II Product Code: JXG Dated: June 12, 2000 Received: June 14, 2000

Dear Mr. Henderson:

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 May 28, 1976, 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. Jeffrey Henderson

This letter will allow you to begin marketing your device as described in your 510(k) Frido reter notification. The FDA finding of substantial equivalence of your device to a premainverleted 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 yours,

Neville Sayre

Sir 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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# Device Name: Polyurethane Shunt

#### 510(k) Number (if known): K991502

Indications for Use:

The polyurethane-coated Delta Valves, polyurethane-coated CSF-Flow Control Valves, Contoured, and Burr Hole are components of polyurethane shunt systems designed for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity. The Polyurethane shunt and shunt components are designed to eliminate patient exposure to silicone elastomer.

The polyurethane-coated Delta Valve minimizes the excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF, which may be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be created by the elevation of the ventricular catheter with respect to the distal catheter (i.e., when the patient sits, stands, or is held erect).

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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

NRo for cmw

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

Over the Counter Use: or Prescription Use: (Per 21 CFR 801.109)

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