SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS

K980453 · Boston Scientific Scimed, Inc. · DQY · Aug 11, 1998 · Cardiovascular

Device Facts

• Record ID: K980453
• Device Name: SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
• Applicant: Boston Scientific Scimed, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices. They are intended to facilitate the placement of interventional devices into the peripheral and coronary systems and, in addition for the XF models, into the neurovascular system.

Device Story

SCHNEIDER GUIDER Softip® Guiding Catheters are medical devices used to facilitate the placement of interventional devices into the peripheral, coronary, and neurovascular systems. Available in 6-9 French sizes with various distal stem configurations and lengths. Used by clinicians in clinical settings to navigate the vasculature for interventional procedures. The device acts as a conduit for other interventional tools. Benefit includes improved access to target anatomy for therapeutic or diagnostic interventions.

Clinical Evidence

Bench testing only. Testing performed in simulated aortic and carotid anatomy to evaluate insertion force requirements for interventional devices.

Technological Characteristics

Catheter available in 6-9 French sizes with multiple distal stem configurations and lengths. Design is identical to previously cleared devices. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring the introduction and placement of interventional devices into the peripheral, coronary, and (for XF models) neurovascular systems.

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

• SCHNEIDER GUIDER Softip® Guiding Catheters (K961999)
• Cordis Vista brite tip™ guiding catheter

Submission Summary (Full Text)

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1980453

AUG 1 1 1998

510(k) Summary

Date Prepared

August 7, 1998

Submitter

Address:

Schneider (USA) Inc 5905 Nathan Lane Minneapolis, MN 55442

| Phone: | [phone] |
|--------|----------------|
| Fax: | [phone] |

Contact Person

Ronald W. Bennett Senior Regulatory Affairs Specialist

# Device Name and Classification

| Trade Name | SCHNEIDER GUIDER Softip® Guiding Catheters |
|-------------------|-----------------------------------------------------------------------------------------------------|
| Classification | Class II |
| Predicate Devices | SCHNEIDER GUIDER Softip® Guiding Catheters<br>(K961999)<br>Cordis Vista brite tip™ guiding catheter |

# Device Description

The SCHNEIDER GUIDER Softip® Guiding Catheter in this 510(k) is available in four French sizes (6 through 9 Fr) with multiple distal stem configurations and lengths. SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices.

### Indication

SCHNEIDER GUIDER Softip® Guiding Catheters are intended to facilitate the placement of interventional devices into the peripheral and coronary systems and, in addition for the XF models, into the neurovascular system.

### Technological Characteristics

The design of the SCHNEIDER GUIDER Softip® Guiding Catheter remains the same as for the previous cleared devices. These have been tested in simulated aortic and carolid anatomy with appropriate interventional devices to test that the force needed for insertion is acceptable.

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# Summary

In summary Schneider (USA) Inc has demonstrated that the SCHNEIDER GUIDER Softip® Guiding Catheters are substantially equivalent based on design, test results, and indications for use to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with overlapping lines creating a sense of depth.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 1998

Mr. Ronald W. Bennett Schneider (USA) Inc. Pfizer Medical Technology Group 5905 Nathan Lane Minneapolis, MN 55442

Re: K980453 SCHNEIDER GUIDER Softip® Guiding Catheter Requlatory Class: II (two) Product Code: 74 DQY Dated: May 26, 1998 Received: May 28, 1998

Dear Mr. Bennett:

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 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 regulation 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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#### Paqe 2 - Mr. Ronald W. Bennett

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 requlation (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.qov/cdrh/dsma/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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Page

510(k) Number (if known):

Device Name: SCHNEIDER GUIDER Softip® Guiding Catheter

Indications for Use:

The SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices. They are intended to facilitate the placement of interventional devices into the peripheral and coronary systems and, in addition for the XF models, into the neurovascular system.

Tara A. Re

(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices 980453 510(k) Number

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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)