SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER

K974684 · Scimed Life Systems, Inc. · DQY · Feb 19, 1998 · Cardiovascular

Device Facts

• Record ID: K974684
• Device Name: SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

SCIMED 7 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

7 French guide catheter; provides pathway for introduction of medical instruments (stents, balloon dilatation catheters, guide wires). Used in coronary and general intravascular procedures. Operated by physicians in clinical settings. Features three-layer shaft construction: inner layer for low friction; middle layer for kink resistance and torque control; outer layer for stiffness, backup support, and radiopacity. Distal tip radiopaque for fluoroscopic visualization. Single-use, sterile device.

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

Three-layer catheter shaft; biocompatible materials; variable durometer outer shaft for transitional flexibility; radiopaque distal tip. Dimensions: 7 French. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring general intravascular and coronary procedures for the introduction of therapeutic devices. Contraindicated for use in the cerebral vasculature.

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

• SCIMED® 8 French Wiseguide Guide Catheter
• SCIMED® 7 French Triguide®-Max Guide Catheter
• Cordis® Corporation 7 French Vista Brite Tip™ Guide Catheter

Submission Summary (Full Text)

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K974684

## Section 4

## Summary of Safety and Effectiveness

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

FEB 1 9 1998

#### I. General Provisions

| 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® 7 French Wiseguide™ Guide<br>Catheter |
| Name of Predicate Devices | SCIMED® 8 French Wiseguide™ and 7<br>French Triguide® -Max Guide Catheters,<br>and Cordis® Corporation 7 French Vista<br>Brite Tip™ Guide Catheters |

#### III. Device Description

II.

The shaft of the 7 F Wiseguide guide catheter utilizes common 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 a distal curve area of the catheter with transitional flexibility.

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

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

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## Section 4

# Summary of Safety and Effectiveness (cont.)

### IV. Intended Use

The 7 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.

#### Summary of Technological Characteristics: V.

The 7 F Wiseguide catheter is similar to SCIMED's currently marketed 8 F Wiseguide catheter.

## VI. Non-clinical Test Summary

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 7 F Wiseguide catheter is adequate for its intended use. The 7 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

FEB 1 9 1998

Ms. Melanie Raska Requlatory Affairs Specialist Scimed Life System, Inc. Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311-1566

Re : K974684 Scimed® 7 French Wiseguide™ Guide Catheter Regulatory Class: II (Two) Product Code: 73 DQY December 15, 1997 Dated: Received: December 16, 1997

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 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 requirements, as set forth in the Quality and him 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 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 for devices under the

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#### Page 2 - Ms. Melanie Raska

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,
Thomas J. Callahan

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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510(k) Notification SCIMED® 7 F Wiseguide Guide Catheter

## Section 2

Indications for Use

510(k) Number (if known) _

Device Name: SCIMED® 7 French Wiseguide™ Guide Catheter

Indications for Use:

SCIMED 7 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 (Per 21 CFR 801.109)

OR Over The Counter Use **__**

(Optional Format 1-2-96)

(Division Sign-Off) Division of Cardinvasc Dar and Neurological Devices 510(k) Number