GUIDEWIRE

K982559 · Galt Medical Corp. · DQX · Feb 1, 1999 · Cardiovascular

Device Facts

• Record ID: K982559
• Device Name: GUIDEWIRE
• Applicant: Galt Medical Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

These guidewires are intended for use in percutaneous procedure to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

Device Story

Guidewires used in percutaneous procedures to facilitate introduction and positioning of catheters and interventional devices within coronary and peripheral vasculature. Device consists of stainless steel wire with PTFE coating; available in straight, J-tip, or moveable core configurations. Diameters range from .014" to .065"; lengths from 15cm to 400cm. Operated by clinicians in clinical settings to navigate vasculature. Performance relies on mechanical properties including tensile strength, torque strength, torqueability, and flexibility.

Clinical Evidence

Bench testing only. Tests included tensile strength, torque strength, torqueability, flexibility, and coating adherence. Results demonstrated performance characteristics comparable to currently marketed predicate devices.

Technological Characteristics

Materials: Stainless steel with PTFE coating. Configurations: Straight, J-tip, or moveable core. Dimensions: .014" to .065" diameter; 15cm to 400cm length. Mechanical properties: Tensile strength, torque strength, torqueability, flexibility.

Indications for Use

Indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and 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

• Cook (K920884)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness for Galt Medical's Guidewires (Prepared in accordance with 21 CFRPart 807.92) Date 1/28/99

510(k) Number: K982559

(1) Submitter: Galt Medical Corp. 2475 Merritt Drive Garland, TX 75041 [phone] Contact Person: David Catlin

- (2) Device Name: Guidewire Trade Name: No proprietary name has been established. Classification Name: Wire, Guide, Catheter Classification Code: 74DQX
- (3) Substantial Equivalency: Galt Medical Corp.'s guidewires are substantially equivalent to guidewires from: Argon Medical

Cordis Cook Acme 510(k) K920884

- (4) Device Description and Intended Use: The material of construction is stainless steel which is consistent with guidewires presently in commercial distribution. The wires are also manufactured using a PTFE coating. The wires are available straight, with "J" end, or moveable core. The wires range from .014" diameter through .065' diameter and lengths from 15cm. to 400cm.
These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

- (5) Technological Characteristics: Galt Medical's guidewires have the same indications for use and are otherwise technically the same as the predicate devices
- (6) Non-Clinical Tests: The results of these tests demonstrated that the functionality and performance characteristics of the guidewires are comparable to the currently marketed guidewires. Tests performed include: tensile strength, torque strength, torqueablility, flexibility, and coating adherence.
- (7) Conclusions: Based on the information presented in this 510(k) premarket notification, Galt Medical's guidewires are considered substantially equivalent to the currently marketed predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which is the department's symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1999

Mr. David G. Catlin Executive Vice President Galt Medical Corporation 2475 Merritt Drive Garland, TX 75041

K982559 Re : Guidewire Trade Name: Regulatory Class: II Product Code: DQX Dated: January 19, 1999 Received: January 20, 1999 :

Dear Mr. Catlin:

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 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 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

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Page 2 - Mr. David G. Catlin

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 requlation 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 Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:____ GILDELIRE

Indications For Use:

These guidewires are intended for use in percutaneous procedure to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER. PAGE IN NEEDED)

Conourrence of CDRH, Office of Device Evaluation (ODE)

Ohitorn Attr

(Division Sign-Off) · Division of Cardiovascular, Respiratory, and Neurological Devices 982559 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formst 1-2-96)