AVE GL-1 GUIDING CATHETER

K984482 · Arterial Vascular Engineering Massachusetts, Inc. · DQY · Jul 30, 1999 · Cardiovascular

Device Facts

• Record ID: K984482
• Device Name: AVE GL-1 GUIDING CATHETER
• Applicant: Arterial Vascular Engineering Massachusetts, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

AVE guiding catheters are designed for use in the vascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. AVE Guiding catheters also allow pressure monitoring and injection of contrast agents.

Device Story

GL-1 Guiding Catheter; vascular access device. Provides pathway for introduction of dilatation systems and interventional devices; enables pressure monitoring and contrast agent injection. Used in clinical settings by physicians. Available in 6-8 French sizes with various curve styles. Performance verified via bench testing (tensile, stiffness, burst, torque, natural frequency) and ISO 10993 biocompatibility testing.

Clinical Evidence

No clinical data. Bench testing only: tensile, stiffness, burst, torque, and natural frequency testing. Biocompatibility testing per ISO 10993 (acute intracutaneous reactivity, acute systemic toxicity, cytotoxicity, hemolysis, material-mediated pyrogen, and sensitization). Shelf-life testing performed.

Technological Characteristics

Guiding catheter; 6-8 French sizes; various curve styles. Materials and construction similar to predicate AVEM Mainstay catheter. Biocompatibility compliant with ISO 10993. Non-powered, mechanical device.

Indications for Use

Indicated for use in the vascular system to provide a pathway for the introduction of dilatation systems and other interventional devices, and to allow for pressure monitoring and contrast agent injection. No known contraindications.

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

• AVEM Mainstay™ Guiding Catheter
• ACS Guidant Viking™ Guiding Catheter
• Cordis Brite™ Tip Guiding Catheter
• Schneider Guider™ Guiding Catheter

Submission Summary (Full Text)

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K984482

Image /page/0/Picture/1 description: The image shows a logo for Arter Vascular Engineering (AVE) along with the date JUL 30 1999. The AVE logo is large and stylized, with the letters "AVE" prominently displayed. The words "Arter" and "cular Engineering" are written in a smaller font below the logo. The date is printed at the top of the image.

# VI. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

- A. Submitter Information: Name:
Address: Phone: Fax: Contact Person:

Date of Preparation:

- B. Device Name Trade Name: Common Name: Classification Name:
C. Predicate Device Name(s):

D. Device Description

- E. Intended Use
/E Massachusetts. Inc

છ ( d Road

lerica. MA 01821-0566

1: 978 667-2511

vw.avei com

AVE Massachusetts, Inc. 129 Concord Road, Billerica, MA 01821 [phone] [phone] Fred L. Boucher Regulatory Affairs Manager July 15, 1999

AVEM GL-1 Guiding Catheter Guiding Catheter Diagnostic Intravascular Catheter/Percutaneous Catheter

- 1. AVEM Mainstay™ Guiding Catheter
- 2. ACS Guidant Viking™ Guiding Catheter
- 3. Cordis Brite™ Tip Guiding Catheter
- Schneider Guider™ Guiding Catheter 4.

The GL-1 catheter is a guiding catheter for use in the vascular system.

Guide catheters provide a pathway through which dilatation systems and other interventional devices are introduced.

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- F. Technological Characteristics Summary
The AVEM GL-1 Guiding Catheter is similar to the AVEM Mainstay guiding catheter regarding materials, construction, packaging and sterilization.

The indications for use are also similar to the AVEM Mainstay catheter and both the ACS Guidant Viking and the Cordis Brite Tip Giding catheters.

The proposed GL-1 indications for use are:

A VE guiding catheters are designed for use in the vascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. AVE guiding catheters also allow pressure monitoring and injection of contrast agents.

Similar to the Mainstay Guiding catheters, the GL-1 Guiding catheter will be available in 6 French - 8 French, and will be offered in various curve styles.

### G. Performance Data

A VEM conducted tensile, stiffness, burst, torque, and natural frequency testing. The test results demonstrate that the GL-1 Guiding Catheter is substantially equivalent to the AVEM Mainstay™ Guiding Catheter, the ACS Guidant Viking™ Guiding Catheter, the Cordis Brite™ Tip Guiding Catheter and/or the Schneider Guider™ Guiding Catheter.

AVEM also conducted the following biocompatibility tests in compliance with ISO 10993: acute intracutaneous reactivity, acute systemic toxicity, cytotoxicity, hemolysis, material-mediated pyrogen and sensitization test. All tests demonstrated that the GL-1 Guiding Catheter is biocompatible.

Shelf-life testing on the GL-1 Guiding catheter and its packaging demonstrates that the device and packaging meet all performance specifications within its labeled shelf-life expiration date.

Based on the results of the above testing, AVEM concludes that the AVE GL-1 Guiding Catheter is substantially equivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Mr. Fred L. Boucher Requlatory Affairs Manager AVE Massavchusetts, Inc. 129 Concord Road Billerica, MA 01821

Re : K984482 Trade Name: AVE GL-1 Guiding Catheter Regulatory Class: II Product Code: DQY Dated: July 15, 1999 Received: July 16, 1999

Dear Mr. Boucher:

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 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). 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, 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 Reqister. Please note: this response to

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Page 2 - Mr. Fred L. Boucher

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 requlations.

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" (21CFR 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE D.

AVEM GL-1 Guiding Catheter Device Name:

# Indications for Use:

AVE guiding catheters are designed for use in the vascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. AVE Guiding catheters also allow pressure monitoring and injection of contrast agents.

## Contraindications:

There are no known contraindications for this product.

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Christopher-Albr for Callahan.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K994482

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use