5F MEDTRONIC LAUNCHER GUIDE CATHETER

K030779 · Medtronic Vascular · DQY · Apr 24, 2003 · Cardiovascular

Device Facts

• Record ID: K030779
• Device Name: 5F MEDTRONIC LAUNCHER GUIDE CATHETER
• Applicant: Medtronic Vascular
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Medtronic Launcher Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended for used in the coronary or peripheral vascular system.

Device Story

Medtronic 5F Launcher Guide Catheter; percutaneous catheter; provides pathway for introduction of therapeutic devices into coronary or peripheral vascular system. Construction: inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band, soft distal tip; inner lumen features thin lubricious coating. Used by clinicians in vascular procedures. Device facilitates delivery of interventional tools; benefits patient by enabling access to target vascular sites for therapy.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 (acute intracutaneous reactivity, acute systemic toxicity, cytotoxicity, hemolysis, sensitization). Functional testing included hub-to-shaft/distal tip-to-shaft tensile strength, torque response, lumen lubricity, radiopacity, pressure shaft burst, hub leak, and tip compression. All tests passed specifications.

Technological Characteristics

Percutaneous catheter; materials include stainless steel braid, inner liner, outer shaft jacket, marker band, and lubricious coating. External-communicating device, circulating blood, limited exposure (≤24 hours). Dimensions: 5F. No software or electronic components.

Indications for Use

Indicated for use in the coronary or peripheral vascular system to provide a pathway for the introduction of therapeutic devices.

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

• Medtronic 6F Launcher™ Guide Catheter (K021256)
• Medtronic 5F Genius™ Guide Catheter (K010579)

Submission Summary (Full Text)

{0}------------------------------------------------

# Section 9

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)

## 1. Identifying Information

(a) Submitters Name:

Medtronic AVE, Inc. 37A Cherry Hill Drive Danvers, MA 01923

- Fred L. Boucher R.A.C. (b) Contact Person: [phone]
- Percutaneous Catheter (c) Classification Name: (21 CFR Part 870.1250)
- Medtronic 5F Launcher™ Guide (d) Proprietary Name: Catheter
- (e) Name of Predicate Devices Catheter

Medtronic 6F Launcher™ Guide K021256

Medtronic 5F Genius™ Guide Catheter K010579

### 2. Description

The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a thin lubricious coating.

#### 3. Intended Use

The Medtronic Launcher Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended for used in the coronary or peripheral vascular system.

#### 4. Technological Characteristics

The 5F Launcher Guide Catheters are manufactured similar to the legally marketed predicate 6F Guide Catheters.

The manufacturing processes, materials and design are substantially equivalent to the 6F Launcher Guide Catheter and 5F Genius.

{1}------------------------------------------------

- 5. Biocompatibility tests performed per ISO10993 were chosen based on Guide Catheters categorized as external-communicating devices, circulating blood, limited exposure (≤24 hours). The following test results reports have been received and the results demonstrate that the tests were successfully performed. All materials used for the Medtronic Launcher Guiding Catheter passed the following tests:
Acute Intracutaneous Reactivity Acute Systemic Toxicity Cytotoxicity Hemolysis Sensitization

- Functional testing consisted of hub to shaft, shaft, distal tip to shaft tensile, torque 6. response, lumen lubricity, radiopacity, pressure shaft burst and hub leak, tip compression (softness). Results verified that the Medtronic Launcher Guiding Catheter meets all of the applicable specifications and considered an appropriate device for the intended use. Based on a comparison of the intended use, design, invitro test results and the fact that the fundamental scientific technology has not changed, the Launcher guide catheter is considered to be substantially equivalent to the following device:
- o Medtronic 6F Launcher Guiding Catheter
- Medtronic 5F Genius Guiding Catheter O

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or other bird with three curved lines representing its wings or feathers.

APR 2 4 2003

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic, Inc. Mr. Fred L. Boucher, R.A.C. Sr. Regulatory Affairs Manager 37A Cherry Hill Drive Danvers, MA 01923

Re: K030779

Trade/Device Name: 5F Launcher™ Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: April 7, 2003 Received: April 8, 2003

Dear Mr. Boucher:

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

{3}------------------------------------------------

Page 2 - Mr. Fred L. Boucher, R.A.C.

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. 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 Part 807.97) you may obtain. 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 yours,

N. Oele VTu
Bram D. Zuckerman, M.D.

m D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### INDICATIONS FOR USE

510(k) Number:

1630779

Device Name:

Medtronic® 5F Launcher™ Guiding Catheter

Indications for Use:

The Medtronic® Launcher™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Launcher catheter is intended to be used in the coronary or peripheral vascular system.

## 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)

Over-The-Counter Use _ OR

N. Delette

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K030779