CORDIS HYDRONOL STEERABLE GUIDEWIRE

K973845 · Cordis Corp. · DQX · Jan 5, 1998 · Cardiovascular

Device Facts

• Record ID: K973845
• Device Name: CORDIS HYDRONOL STEERABLE GUIDEWIRE
• Applicant: Cordis Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

Cordis Hydronol Steerable Guidewire is a manual surgical instrument used by clinicians during angiographic procedures. It consists of a superelastic nitinol core wire, a hydrophilic coating to reduce friction, and a flexible, shapeable, radiopaque platinum alloy coil at the distal tip. The device is inserted into the peripheral vasculature to facilitate the navigation and placement of catheters and other interventional devices. It is a mechanical tool operated by a physician; it does not involve electronic signals, software, or automated processing. The device benefits patients by enabling precise access to target sites within the peripheral vascular system during minimally invasive procedures.

Clinical Evidence

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

Technological Characteristics

Superelastic nitinol core wire; hydrophilic coating; distal tip features flexible, shapeable, radiopaque platinum alloy coil. Biocompatibility per ISO 10993-1. Mechanical device; no energy source or software.

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

• Terumo Radifocus Glidewire
• LRM Steerable Hydrophilic Guidewire

Submission Summary (Full Text)

{0}------------------------------------------------

00-000008
K973845

JAN - 5 1998

## Summary Of Safety And Effectiveness

| General<br>Provisions | The name of the device is: |
|-----------------------|----------------------------|
|-----------------------|----------------------------|

| Proprietary Name | Common or Usual Name |
|-------------------------------------|----------------------|
| Cordis Hydronol Steerable Guidewire | Catheter Guide Wire |

| Predicate<br>Device | The name of the predicate devices are: |
|---------------------|----------------------------------------|
| | • Terumo Radifocus Glidewire |
| | • LRM Steerable Hydrophilic Guidewire |

| Classification | The FDA has classified catheter guide wires as: |
|----------------|-------------------------------------------------|
| | • Class II, 21CFR 870.1330, 74 DQX |

| Performance<br>Standards | Performance standards have not been established by the FDA under Section 514 of the Food, Drug, and Cosmetic Act. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------|
|--------------------------|-------------------------------------------------------------------------------------------------------------------|

| Indications for<br>Use | The Cordis Hydronol Steerable Guidewires are designed for use in angiographic procedures to introduce and position catheters and interventional devices within the peripheral vasculature. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Device<br>Description | The Cordis Hydronol Steerable Guidewire is constructed from a superelastic nitinol core wire. A hydrophilic coating is applied over the guidewire. Cordis Hydronol Steerable Guidewires have a flexible, shapeable, and highly radiopaque platinum alloy coil on the distal tip. |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Continued on next page PREMARKET NOTIFICATION Cordis Corporation
Hydronol Steerable Guidewire

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## Summary Of Safety And Effectiveness, Continued

| Biocompatibility | All appropriate Biocompatibility tests were successfully performed on the materials used for the Cordis Hydronol Steerable Guidewires per ISO 10993-1. |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Substantial<br>Equivalence | The Cordis Hydronol Steerable Guidewire is similar in design, construction, indication for use and performance characteristics to other commercially available hydrophilic 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 & Human Services. The logo features a stylized image of an eagle with three lines representing its head and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jacqueline Zimovan Regulatory Affairs Associate Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700

JAN - 5 1998

Re : K973845 Cordis Hydronol Steerable Guidewire Regulatory Class: II (two) Product Code: DQX Dated: October 7, 1997 Received: October 8, 1997

Dear Ms. Zimovan:

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 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 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 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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## INDICATIONS FOR USE

| 510(K) Number (if known): | [To be assigned by the FDA] |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Hydronol Steerable Guidewire |
| Indications for Use: | The Cordis Hydronol 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)

Tina A Ry

(Division Sign-Off) Division of Cardinvoscular Respiratory, - ad New .

510(k) Number K973843

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use _

PREMARKET NOTIFICATION Cordis Corporation Hydronol Steerable Guidewire