NEUROCATH AG

K081942 · Vygon Neuro · JXG · Aug 12, 2008 · Neurology

Device Facts

• Record ID: K081942
• Device Name: NEUROCATH AG
• Applicant: Vygon Neuro
• Product Code: JXG · Neurology
• Decision Date: Aug 12, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neurocath Ag catheter is designed to be temporarily implanted (less than 30 days) for the drainage of cerebrospinal fluid (CSF) to reduce and control increased intracranial pressure (ICP).

Device Story

Neurocath Ag is an external drainage catheter for cerebrospinal fluid (CSF) management; used to reduce and control increased intracranial pressure. Device is temporarily implanted for <30 days. Construction consists of polyurethane impregnated with silver ions for radiopacity. Available in various lengths (15.5, 23.5, 32 cm) with 3 or 16 drainage holes. Kit includes stainless steel stylet for ventricular introduction, stainless steel subgaleal trochar for tunneled placement, male luer connector, slitted wing, and compression hub. Operated by clinicians in a hospital setting. Output is the drainage of CSF via connection to an external tubing set. Benefits include controlled pressure reduction in patients with elevated intracranial pressure.

Clinical Evidence

Bench testing only. Biocompatibility testing confirmed the material is non-irritant and non-toxic. Performance testing verified that the design changes do not affect safety or efficacy.

Technological Characteristics

Polyurethane catheter impregnated with silver ions for radiopacity. Includes stainless steel stylet and subgaleal trochar. Available in 15.5cm, 23.5cm, and 32cm lengths with 3 or 16 hole configurations. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring temporary (less than 30 days) cerebrospinal fluid (CSF) drainage to reduce and control increased intracranial pressure.

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

• Fifth Ventricle External Drainage Catheter (K800168)
• Fifth Ventricle External Drainage Catheter (K870660)
• Extracorporeal Ventricular Catheters (preamendment)

Submission Summary (Full Text)

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VYCON

AUG 1 2 2008

KOB1942

US

Office Fax: [phone]

## PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93)

Date of Preparation: June 20, 2008

Applicant:

Vyeon Neuro 2495 General Armistead Ave. Norristown, PA 19403

Contact Individual:

Courtney Smith, Regulatory Affairs Manager 610-539-9300 Ext. 110

Trade Name: Neurocath Ag

Common Name: External Drainage Catheter

ાપ્રત

882.5550 Regulation Number:

Product Code:

Device Description:

Classification Name: Shunt, Central Nervous System and Components

ിമടം ന Classification:

Fifth Ventricle External Drainage Catheter (K800168/ K870660), Predicate Device Name: Extracorporeal Ventricular Catheters (preamendment)

> The Neurocath Ag is an external drainage catheter composed of polyurethane and impregnated with the silver ions for the purpose of radionacity.

The catheter is available with 3 holes off-set at 120" or 16 holes, in lengths of 32, 23.5, and 15.5cm. Biocompatibility and performance testing demonstrates the safety and efficacy of these devices.

The Neurocath Ag is supplied with a stainless steel stylet (for introducing it into the ventricle), a stainless steel subgaleal trochar (for tunneled catheter placement), a male luer connector, a slitted wing and a compression hub (for connecting the cathetex to the tubing set). The Neurocath Ag eatherer is available individually or packaged with the tubing set.

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The Neurocath Ag catheters are as follows:

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Intended Use:

The Neurocath Ag catheter is designed to be temporarily implanted (less than 30 days) for the drainage of cerebrospinal fluid (CSF) to reduce and control increased intracranial pressure (ICP).

Technology Characteristies: The fundamental scientific technology of the Neurocatio Ag is substantially equivalent to the predicate devices.

## Summary of Design Control Activities:

Blocompatibility testing of the material demonstrate that it is nonirritant and non-toxic. Performance testing demonstrates that the changes do not affect safety or efficacy. Risk Assessment was conducted in compliance with ISO 14971.

Conclusion:

The only change between the prodicate device (Fifth Ventricle Drainage Catheter K800168 and K853365) and the preamendment prodicate device and the Neurocath Ag is the change in material from barium impregnated silicone and silver impregnated silicone, respectively, to polyurethane impregnated with silver ions. Biocompatibility testing, performance testing and risk assessment demonstrate that the Neurocath Ag is safe and effective to use, when used in accordance with the supplied instructions for use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2008

Vygon Neuro % Courtney Smith Regulatory Affairs Manager 2495 General Armistead Avenue Norristown, Pennsylvania 19403

Re: K081942

Trade/Device Name: Neurocath Ag Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: July 7, 2008 Received: July 16, 2008

Dear Courtney Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Courtney Smith

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at [phone]. For questions regarding the reporting of device adverver events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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.

Mark M. Millican

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

Enclosure

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## Indications for Use 510(k) Number (if known);

Neurocath Ag Device Name:

Indications For Use:

The Neurocath Ag catheter is designed to be temporarily implanted (less than 30 days) for the drainage of ecrebrospinal fluid (CSF) to reduce and control increased intracranial pressure ાજી.

Prescription Use _____X__X__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)

(Division Sign-Off)

Division of General, Restorative, and Neurological

510(k) Number 6081942