STRATEGY CORONARY WIRE GUIDE

K983771 · Cook, Inc. · DQX · Nov 12, 1998 · Cardiovascular

Device Facts

• Record ID: K983771
• Device Name: STRATEGY CORONARY WIRE GUIDE
• Applicant: Cook, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 12, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

Intended for use in facilitating delivery of a PTCA balloon catheter or other cardiovascular device into the cardiovascular system.

Device Story

Strategy™ Coronary Wire Guide is a guide wire used to facilitate delivery of PTCA balloon catheters or other cardiovascular devices into the cardiovascular system. Device consists of stainless steel and platinum core with hydrophilic coating; available in 0.014-inch diameter and 180 or 300 cm lengths with straight or J-curve distal tips. Used in clinical settings by physicians during cardiovascular procedures. Device is supplied sterile for single-use. Facilitates navigation of vasculature to target site for interventional device placement.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: stainless steel and platinum. Coating: hydrophilic. Dimensions: 0.014-inch OD, 180/300 cm lengths. Tip configurations: straight and J-curve. Sterilization: standard methods.

Indications for Use

Indicated for use in facilitating the delivery of PTCA balloon catheters or other cardiovascular devices into the cardiovascular system.

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

• Roadrunner™ RLTF Guide Wire
• ACS Hi-Torque Cross-It™ Guide Wire with Hydrocoat™ Coating

Submission Summary (Full Text)

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# 1983771

Special 510(k) Premarket Notification StrategyTM Coronary Wire Guide COOK INCORPORATED

#### Safety and Effectiveness Information 0

Submitted By: April Lavender, RAC Vice President, Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 [phone]

#### Device:

Trade Name: Proposed Classification Name:

Strategy™ Coronary Wire Guide Wire, Guide, Catheter 21 CFR Part 870.1330 (74DQX)

### Predicate Devices:

The Strategy™ Coronary Wire Guide has the same intended use, materials of construction, and technological characteristics as the Roadrunner™ RLTF Guide Wire and the ACS Hi-Torque Cross-It™ Guide Wire with Hydrocoat™ Coating.

## Device Description:

The Strategy™ Coronary Wire Guide is used to facilitate delivery of a PTCA balloon catheter or other cardiovascular device into the cardiovascular system. The device will be constructed of stainless steel and platinum with hydrophilic coating. The Strategy™ Coronary Wire Guide outside diameter is 0.014-inch and will be available in 180 and 300 cm lengths with straight and J-curve distal tips. It will be supplied sterile, intended for one-time use.

### Substantial Equivalence:

The Strategy™ Coronary Wire Guide is constructed using similar materials as the Roadrunner™ RLTF Guide Wire and the ACS Hi-Torque Cross-It™ Guide Wire with Hydrocoat™ Coating. The device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by COOK INCORPORATED. This device will undergo sterilization similar to the devices currently marketed and distributed.

G.2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 1998

Ms. April Lavender, RAC Vice President Regulatory Affairs Cook Incorporated 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402

Re : K983771 Trade Name: Strategy™ Coronary Wire Guide Requlatory Class: II Product Code: DQX Dated: November 4, 1998 November 5, 1998 Received:

Dear Ms. Lavender:

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, labelinq, 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 Requlation (QS) for Medical Devices: General requlation (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

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Page 2 - Ms. April Lavender

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 requlations.

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,

Thomas J. Callahon

Thomas J. Callahan Ph.D. Director Division of Cardiovascular, Respiratory And Neurological Deveces Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification Strategy™ Coronary Wire Guide COOK INCORPORATED

12983771 510(k) Number (if known):_

Device Name:

Strategy™ Coronary Wire Guide

Indications for Use:

Intended for use in facilitating delivery of a PTCA balloon catheter or other cardiovascular device into the cardiovascular system.

(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

Tut. R. for A. Doyle Gantt

(Division Sign-Division of Cardiovas and Neurological De 510(k) Number