ATW MARKER WIRE STEERABLE GUIDEWIRE

K994358 · Cordis Corp. · DQX · Jan 13, 2000 · Cardiovascular

Device Facts

• Record ID: K994358
• Device Name: ATW MARKER WIRE STEERABLE GUIDEWIRE
• Applicant: Cordis Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 13, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Cordis ATW Marker Wire Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. In addition, the Cordis ATW Marker Wire Steerable Guidewires are intended to facilitate the alignment of interventional devices and function as a measurement tool.

Device Story

The ATW Marker Wire Steerable Guidewire is a manual interventional tool used by physicians during angiographic procedures. It consists of a stainless steel corewire, a radiopaque platinum/nickel coil, and radiopaque marker bands with optional spacing, finished with a PTFE shaft coating. The device is inserted into the coronary or peripheral vasculature to guide and position catheters or other interventional devices. The radiopaque markers allow the physician to visualize the wire's position under fluoroscopy and use the device as a measurement tool to estimate distances within the vasculature. It functions as a mechanical aid to facilitate the alignment of interventional equipment, assisting the clinician in precise device placement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel corewire; radiopaque platinum/nickel coil; radiopaque marker bands; PTFE shaft coating. Manual steerable guidewire; no energy source; no software.

Indications for Use

Indicated for use in patients undergoing angiographic procedures requiring catheter or interventional device placement within coronary and peripheral vasculature; serves as a measurement tool and alignment aid for interventional devices.

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

• Wizdom Marker Wire Steerable Guidewire
• Stabilizer Marker Wire Steerable Guidewire
• ST Steerable Guidewire

Submission Summary (Full Text)

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**Attachment 4**

AN 13 2000

Attachment 4

### Summary of Safety and Effectiveness

| General<br>Provisions | Trade Name: ATW Marker Wire Steerable Guidewire<br>Common/Classification Name: Catheter Guide Wire |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate<br>Devices | Wizdom Marker Wire Steerable Guidewire<br>Stabilizer Marker Wire Steerable Guidewire<br>ST Steerable Guidewire |
| Classification | Class II |
| Performance<br>Standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not established<br>performance standards. |
| Intended Use<br>and Device<br>Description | The Cordis ATW Marker Wire Steerable Guidewires are intended for use in<br>angiographic procedures to introduce and position catheters and interventional devices<br>within the coronary and peripheral vasculature. In addition, the Cordis ATW Marker<br>Wire Steerable Guidewires are intended to facilitate the alignment of interventional<br>devices and function as a measurement tool. |
| | The device description of the ATW Marker Wire Steerable Guidewire is as follows.<br>• Stainless Steel Corewire,<br>• Radiopaque platinum / nickel coilwire,<br>• Radiopaque Marker Bands with optional spacing (See package labeling), and<br>• PTFE coating on shaft. |
| Biocompatibility | All materials used in the ATW Marker Wire Steerable Guidewires are biocompatible. |
| Summary of<br>Substantial<br>Equivalence | The ATW Marker Wire Steerable Guidewires are substantially equivalent to the<br>previously cleared ST Steerable Guidewire, Wizdom Marker Wire, and Stabilizer<br>Marker Wire Steerable Guidewires. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### JAN 1 3 2000

Mr. Dennis Griffin Manager, Requlatory Affairs Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700

Re: K994358 Trade Name: ATW Marker Wire Steerable Guidewire Regulatory Class: II Product Code: DQX December 20, 1999 Dated: Received: December 27, 1999

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 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 A substantially equivalent determination assumes compliance to 895. 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

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Page 2 - Mr. Dennis Griffin

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.

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 (301) 594-Also, please note the requlation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 807.97). Other qeneral 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.tda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ouitopm. Al-for

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 2

# Indications for Use Statement

| 510(k) Number<br>(if known) | The 510(k) number has not yet been assigned. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | ATW Marker Wire Steerable Guidewire |
| Indications for<br>Use | The Cordis guidewires are intended for use in angiographic procedures to introduce<br>and position catheters and interventional devices within the coronary and peripheral<br>vasculature. In addition, the Cordis ATW Marker Wire Steerable Guidewires are<br>intended to facilitate the alignment of interventional devices and function as a<br>measurement tool. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

for Witten
Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K994358