CORDIS VANGUARD STEERABLE GUIDEWIRES

K974560 · Cordis Corp. · DQX · May 11, 1998 · Cardiovascular

Device Facts

• Record ID: K974560
• Device Name: CORDIS VANGUARD STEERABLE GUIDEWIRES
• Applicant: Cordis Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: May 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Cordis Vanguard Steerable Guidewires are designed for use in angiographic procedures to introduce and position catheters and interventional devices within the peripheral vasculature.

Device Story

The Cordis Vanguard Steerable Guidewire is a medical device used in angiographic procedures. It features a multi-tapered stainless steel corewire with a soft, flexible, highly radiopaque platinum alloy coil at the tip. A steering/torquing device may be attached to the proximal end to assist the clinician in navigating the wire through the peripheral vasculature. The device acts as a track to guide catheters and interventional devices to a target site. It is operated by a physician in a clinical or interventional setting. The device benefits the patient by facilitating precise placement of diagnostic or therapeutic equipment within the peripheral vascular system.

Clinical Evidence

Bench testing only. Biocompatibility testing was successfully performed per ISO 10993-1.

Technological Characteristics

Multi-tapered stainless steel corewire; soft, flexible, radiopaque platinum alloy coil tip. Optional steering/torquing device. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for use in angiographic procedures to introduce and position catheters and interventional devices within the peripheral vasculature.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• TAD II Guide Wire System (510K Number Unknown)
• Wholey Hi-Torque Guide Wire System (K861765)

Submission Summary (Full Text)

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00-00008
K974560

MAY | | 1998

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## 510(k) Summary of Safety and Effectiveness

Date: December 4, 1997

General Information

| Manufacturers Address | Contact |
|--------------------------------------------------------------------------|----------------|
| Cordis Corporation<br>14201 NW 60th Avenue<br>Miami Lakes, Florida 33014 | Dennis Griffin |

| Proprietary Name | Common/Usual Name |
|----------------------------------------|---------------------|
| Cordis Vanguard Steerable<br>Guidewire | Catheter Guide Wire |

| Classification | Catheter Guide Wire |
|----------------|----------------------------------|
| | Class II, 21 CFR 870.1330, 74DQX |

| Predicate | TAD II Guide Wire System 510K Number Unknown |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Devices | Wholey Hi-Torque Guide Wire System K861765 |
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Performance standards have not been established by the FDA under section 514 of the Food Performance and Drug Cosmetic Act. Standards

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The Cordis Vanguard Steerable Guidewires have a multi-tapered stainless steel corewire Device with a soft, flexible, highly radiopaque platinum alloy coil over the tip. A steering / Description torquing device may be attached to aid in steering/torquing the guidewire.

Continued on next page

PREMARKET NOTIFICATION Cordis Corporation Vanguard Steerable Guidewire

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## 510(k) Summary of Safety and Effectiveness, Continued

Biocompatibility

All appropriate Biocompatibility tests were successfully performed on the materials used for the Cordis Vanguard Steerable Guidewires per ISO 10993-1.

Summary of Substantial Equivalence

I

The Cordis Vanguard Steerable Guidewire is similar in design, construction, indication for use and performance characteristics to other commercially available steerable guidewires.

Any statement of substantial equivalence to another product is required by 21 CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, "... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520, et seg. (1977).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY | | 1998

Mr. Dennis S. Griffin Manager, Regualtory and Clinical Affairs Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014

Re : K974560 Cordis Vanguard Steerable Guidewires Trade Name: Requlatory Class: II Product Code: DQX Dated: March 30, 1998 Received: March 31, 1998

Dear Mr. Griffin:

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 leqally 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 obliqation you might have under sections 531 through 542 of the Act

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Page 2 - Mr. Dennis S. Griffin

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,

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 Radioloqical Health

Enclosure

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## INDICATIONS FOR USE

| | 510(K) Number (if known): [To be assigned by the FDA] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Vanguard Steerable Guidewire |
| Indications for Use: | The Cordis Vanguard Steerable Guidewires are designed for use in<br>angiographic procedures to introduce and position catheters and<br>interventional devices within the peripheral vasculature. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Th. A. R.

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular, Res Division of ourological Devices 510(k) Number

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OR

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Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

PREMARKET NOTIFICATION Cordis Corporation Vanguard Steerable Guidewire