SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER

K981788 · Scimed Life Systems, Inc. · DQO · Aug 18, 1998 · Cardiovascular

Device Facts

• Record ID: K981788
• Device Name: SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Aug 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

SCIMED 6 French Wiseguide guide catheter is intended for use in general intravascular and coronary applications. It provides a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

Device Story

6 F Wiseguide guide catheter; provides pathway for intravascular/coronary instruments (stents, balloons, guidewires). Three-layer shaft construction: inner layer (low friction), middle layer (kink resistance/torque control), outer layer (stiffness/backup support/radiopacity). Radiopaque for fluoroscopic visualization. Used by clinicians in clinical settings for single-procedure use. Benefits patient by facilitating delivery of therapeutic devices to coronary/intravascular sites.

Clinical Evidence

Bench testing only. Functional testing included pressure burst, tip bond tensile, shaft tensile, hub tensile, material adhesion, tip coefficient of friction, force transmitted by catheter tip, torque response, and dye flow.

Technological Characteristics

6 French guide catheter; three-layer shaft construction; biocompatible materials; radiopaque; variable durometer outer shaft for transitional flexibility; sterile; single-use.

Indications for Use

Indicated for general intravascular and coronary applications to provide a pathway for medical instruments (stents, balloon dilatation catheters, guide wires, therapeutic devices). Not for use in cerebral vasculature.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• SCIMED® 7 French Wiseguide Guide Catheter (K974684)
• 6 French Cyber Guide Catheters
• Cordis® Corporation 6 French Vista Brite Tip™ Guide Catheters

Submission Summary (Full Text)

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# AUG / 8 1998

510(k) Notification SCIMED® 6 F Wiseguide Guide Catheter

# 11981788

# Section 4

# Summary of Safety and Effectiveness

# (Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)

#### General Provisions I.

| Submitter's Name<br>and Address | SCIMED Life Systems, Inc.<br>One SCIMED Place<br>Maple Grove, Minnesota 55311 | |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person | Melanie Raska<br>[phone] | |
| Classification Name | Similar to Diagnostic Intravascular<br>Catheters (21CFR Part 870.1200) | |
| Common or Usual Name | Coronary Guide Catheter | |
| Proprietary Name | SCIMED® 6 French Wiseguide™ Guide<br>Catheter | |
| Name of Predicate Devices | SCIMED® 7 French Wiseguide™ and 6<br>French Cyber Guide Catheters,<br>and Cordis® Corporation 6 French Vista<br>Brite Tip™ Guide Catheters | |

### III. Device Description

II.

The shaft of the 6 F Wiseguide guide catheter utilizes biocompatible materials and consists of the following three layers: 1) the inner layer that provides a low coefficient of friction and facilitates passage of medical devices such as stents, balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer that extends from the shaft to the tip to provide kink resistance and torque control; and 3) the outer layer which provides stiffness, backup support, curve retention and radiopacity.

In addition, the outer primary catheter shaft is constructed of various material durometers providing transitional flexibility to the distal curve area of the catheter.

The catheter is radiopaque to allow visualization under fluoroscopy during a procedure.

The devices will be provided sterile and are intended for one procedure use only.

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

# Section 4

# Summary of Safety and Effectiveness (cont.)

### IV. Intended Use

The 6 F Wiseguide catheter is designed to provide a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

### V. Summary of Technological Characteristics:

The 6 F Wiseguide catheter is similar to SCIMED's currently marketed 7 F Wiseguide catheter (K974684).

### Non-clinical Test Summary VI.

Functional testing consisted of pressure burst, tip bond tensile, shaft tensile, hub tensile, material adhesion, tip coefficient of friction, force transmitted by catheter tip, torque response and dye flow. Test results verified that the 6 F Wiseguide catheter is adequate for its intended use. The 6 F Wiseguide catheter is considered substantially equivalent to guide catheters currently marketed by SCIMED and Cordis based on a comparison of intended use, the design, and the results of in-vitro testing and evaluation.

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AUG 1 8 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Melanie Raska Regulatory Affairs Specialist Scimed Life Systems, Inc. One Scimed Place Maple Grove, MN 55311-1566

Re: K981788 Scimed 6 French Wiseguide Guide Catheter Trade Name: Requlatory Class: II Product Code: DOO Dated: May 19, 1998 Received: May 20, 1998

Dear Ms. Raska:

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 Requlation (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 requlatory 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

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Page 2 - Ms. Melanie Raska

for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Director Division of Cardiovascular, Respirator and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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AUG | 8 1998

510(k) Notification SCIMED® 6 F Wiseguide Guide Catheter

Section 2

Indications for Use

510(k) Number (if known)

Device Name: SCIMED® 6 French Wiseguide™ Guide Catheter

Indications for Use:

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SCIMED 6 French Wiseguide guide catheter is intended for use in general intravascular and coronary applications. It provides a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
|------------------------------------------|--|
|------------------------------------------|--|

OR

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

| 510(k) Number | K981788 |
|---------------|---------|
|---------------|---------|

| Over The Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |

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