AURORA

K972065 · Neurovena Corp. · DQY · Jan 27, 1999 · Cardiovascular

Device Facts

• Record ID: K972065
• Device Name: AURORA
• Applicant: Neurovena Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The AURORA is intended to provide a pathway through which a physician can introduce therapeutic devices into the general and neurovasculature.

Device Story

AURORA Guide Catheter; single lumen radiopaque catheter with proximal Luer fitting. Used by physicians in clinical settings to provide access pathway for therapeutic devices into general and neurovasculature. Device facilitates navigation and delivery of interventional tools. Sterile, single-use design.

Clinical Evidence

Bench testing only. Testing evaluated flow rate, torque, static pressure, bond strength, and dimensional equivalence to confirm product specifications.

Technological Characteristics

Single lumen radiopaque catheter; proximal Luer fitting. Biocompatible materials. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for use as a pathway for physicians to introduce therapeutic devices into the general and neurovasculature. Prescription use only.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• FasGuide Catheter from Target Therapeutics, Inc.

Submission Summary (Full Text)

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K972065

JAN 27 1999

# 510(k) Summary

General Information

| Classification | Class II |
|----------------|-------------------------------------------------------------------------------|
| Trade Name | AURORA™ Guide Catheter |
| Submitter | Neurovena<br>1879 Buerkle Road<br>White Bear Lake, MN 55110<br>[phone] |

| Contact | Jim Segermark |
|---------|----------------|
| | Vice President |

### Intended Use

The AURORA is intended to provide a pathway through which a physician can introduce therapeutic devices into the general and neurovasculature.

#### Predicate Devices

FasGuide Catheter from Target Therapeutics, Inc.

#### Device Description

The AURORA is a single lumen radiopaque catheter with a proximal Luer fitting. The AURORA is pakaged sterile and is intended for single use only.

## Materials

All materials used in the manufacture of the AURORA are biocompatible and have been used in numerous previously cleared products.

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### Testing

Product testing was conducted to evaluate conformance to product specification. Testing included flow rate, torque, static pressure, bond strength and demensional equivalence.

### Summary of Substantial Equivalence

The AURORA is equivalent to the predicate productfrom Target Therapeutics. The clinical indications for use, basic overall function, · methods of manufacturing, and materials used are substantially equivalent. Neurovena believes the AURORA Guide Catheter is substantially equivalent to existing marketed devices.

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JAN 27 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ann Quinlan-Smith Vice President, Quality Assurance and Regulatory Affairs Microvena Corporation 1861 Buerkle Road White Bear Lake, Minnesota 55110

Re:

K972065 Trade Name: MICROVENA Aurora™ Guide Catheter Regulatory Class: II Product Code: DQY Dated: November 23, 1998 Received: November 24, 1998

#### Dear Ms. Quinlan-Smith:

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 (OS) 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 - Ms. Ann Quinlan-Smith

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 yours,

pcoelle

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K972065

AURORA Guide Catheter

# Indications for Use

510(k) Number (if known):

:

This application

Device Name:

Indications for Use:

Intended to provide a pathway through physician can introduce which a therapeutic devices into the general and neurovasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription UseX OR Over-The-Counter Use_
(Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices R972065
510(k) Number