BRESAGEN CATHETER, MODEL CS-3000

K021481 · Bresagen, Inc. · HCA · Aug 6, 2002 · Neurology

Device Facts

• Record ID: K021481
• Device Name: BRESAGEN CATHETER, MODEL CS-3000
• Applicant: Bresagen, Inc.
• Product Code: HCA · Neurology
• Decision Date: Aug 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4100
• Device Class: Class 2

Intended Use

For injection of material into, or removal of material from, the mendou over I or any intracranial procedures. This device is not intended for implant. This device is ETO sterilized and intended for one time use only.

Device Story

Bresagen Catheter (Model CS-3000) is a ventricular catheter used for intracranial procedures; facilitates injection or removal of materials. Device is ETO sterilized; intended for single-use; not for implantation. Operated by clinicians in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ventricular catheter; ETO sterilized; single-use; non-implantable.

Indications for Use

Indicated for injection or removal of material during intracranial procedures. Not for implant. Single-use only.

Regulatory Classification

Identification

A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 6 2002

Bresagen, Inc. John Kucharczyk, Ph.D. VP Imaging and Cell Delivery 111 Riverbend Road Athens, Georgia 30605

Re: K021481

Trade/Device Name: Bresagen Catheter, Model CS-3000 Regulation Number: 882.4100 Regulation Name: Venticular Catheter Regulatory Class: Class II Product Code: HCA Dated: May 2, 2002 Received: May 8, 2002

Dear Dr. Kucharczyk:

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 - Dr. John Kucharczyk

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely vours

Sincerely yours,

Mark N. Milken

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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510(k) NUMBER (IF KNOWN): K021481
DEVICE NAME: Bresagen Catheter
INDICATIONS FOR USE:

Intended Use: For injection of material into, or removal of material from, the mendou over I or any intracranial procedures. This device is not intended for implant. This device is ETO sterilized and intended for one time use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

for Mark N. Wilkerson
Division S. in OM

n-OH Division of Ceneral, Restorative and Neuro! gical Devices

510(k) Number K02148

Over-The-Counter-Use (Optional Format 1-2-