SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS

K974559 · Scimed Life Systems, Inc. · DQO · Feb 23, 1998 · Cardiovascular

Device Facts

• Record ID: K974559
• Device Name: SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Feb 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The SCIMED IMPULSE Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

Device Story

Single lumen angiographic catheter; used to deliver contrast media to vascular sites. Three-layer shaft construction: inner layer for dye delivery/guide wire movement; middle layer for torque control/kink resistance; outer layer for stiffness/curve retention with radiopaque markers for visualization. Available in Selective, Pigtail, and Multipurpose models; includes optional Pigtail Straightener. Operated by physicians in clinical settings during angiographic procedures. Provides pathway for contrast media; enables visualization of vascular anatomy via fluoroscopy. Benefits patient by facilitating diagnostic imaging of vascular system.

Clinical Evidence

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

Technological Characteristics

Single lumen catheter; three-layer construction. Radiopaque materials in outer layer for visualization. Available in 6 French size. Non-powered, mechanical device. No software or electronic components.

Indications for Use

Indicated for use as a pathway for delivering contrast media to selected sites in the vascular system during angiographic procedures. For prescription use only.

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® 6 French EXPO™ Angiographic Catheter
• SCIMED 5 French IMPULSE™ Angiographic Catheter

Submission Summary (Full Text)

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### Section 4

# Summary of Safety and Effectiveness

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

FEB 2 3 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 | Diagnostic Intravascular Catheters<br>(21CFR Part 870.1200) |
| Common or Usual Name | Diagnostic Intravascular Catheter |
| Proprietary Name | SCIMED® 6 French IMPULSE™<br>Angiographic Catheters |
| Name of Predicate Devices | SCIMED® 6 French EXPO™ Angiographic<br>Catheter, and SCIMED 5 French<br>IMPULSE™ Angiographic Catheter |

#### III. Device Description

II.

N

The 6 French SCIMED IMPULSE Angiographic Catheters are single lumen catheters which will be available in Selective, Pigtail and Multipurpose models.

The shafts of all models utilize common biocompatible materials and consist of the following three layers: 1) The inner layer provides a smooth surface to allow for dye delivery and ease of guide wire movement. 2) The middle layer provides torque control, kink resistance and support, and 3) The outer layer provides stiffness and curve retention. Radiopaque materials are utilized in the outer layer to allow visualization of the catheter during the procedure.

A Pigtail Straightener is available to aid the physician in straightening the Pigtail curve while being introduced into the introducer sheath.

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### Section 4

#### IV. Intended Use

The SCIMED IMPULSE Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

#### V. Summary of Technological Characteristics

The 6 French SCIMED IMPULSE Angiographic Catheters are a modification of SCIMED's currently marketed 5 French Impulse Angiographic Catheters.

#### VI. Non-clinical Test Summary

Functional testing consisted of pressure burst, tip bond tensile, hub tensile, dye flow, tip coefficient of friction, force transmitted by catheter tip, torque response and torque to fail. Test results verified that the 6 French IMPULSE Angiographic Catheters are adequate for their intended use. The 6 French IMPULSE Angiographic Catheters are considered substantially equivalent to angiographic catheters currently marketed by SCIMED based on a comparison of intended use, the design and the results of in-vitro testing and evaluation.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

. ***

FEB 2 3 1998

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

Re: K974559 SCIMED® 6 French IMPULSE™ Angiographic Catheters Regulatory Class: II (two) Product Code: DOO Dated: December 4, 1997 Received: December 5, 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, Druq, 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 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 requlation 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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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 requlation 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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## Section 2

Indications for Use

510(k) Number (if known) 1474559

Device Name: SCIMED® 6 French IMPULSE™ Angiographic Catheters

Indications for Use:

The SCIMED 6 French IMPULSE™ Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system ----------during an angiographic procedure.

(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

(Division Sign Off)

Division of Cardiovascular, Respirator(Optional Format 1-2-96)
and Neurological Devices

| 510(k) Number | K974559 |
|---------------|---------|
|---------------|---------|