EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE

K033542 · Galt Medical Corp. · DQX · Dec 5, 2003 · Cardiovascular

Device Facts

• Record ID: K033542
• Device Name: EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE
• Applicant: Galt Medical Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

Easy Pass Hydrophilic Coated Vascular Guidewire is a medical device used in percutaneous procedures. It functions as a guide to introduce and position catheters, pacing leads, and other interventional devices within the coronary and peripheral vasculature. The device is operated by clinicians in a clinical setting. It consists of a wire core (stainless steel, nitinol, or platinum) with a hydrophilic coating to facilitate smooth navigation through the vasculature. The wires are available in various configurations (straight, angled, or 'J' end), diameters (.014" to .065"), and lengths (20cm to 360cm). By providing a track for interventional devices, it assists physicians in reaching target sites within the vascular system, potentially improving procedural efficiency and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Materials: stainless steel, nitinol, platinum. Coating: hydrophilic plastic. Dimensions: .014" to .065" diameter; 20cm to 360cm length. Configurations: straight, angled, or 'J' end. Energy source: none (manual). Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for use in percutaneous procedures to introduce and position catheters, pacing leads, 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

• K982559
• K021990
• K031916

Submission Summary (Full Text)

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DEC = 5 2003

LD33542

## 510(k) Summary of Safety and Effectiveness for Galt Medical's Hydrophilic Coated Vascular Guidewires (Prepared in accordance with 21 CFRPart 807.92) Date 11/18/03

- (1) Submitter: Galt Medical Corp. 2475 Merritt Drive Garland, TX 75041 [phone] Contact Person: David Catlin
- (2) Device Name: Guidewire Trade Name: Easy Pass Hydrophilic Coated Vascular Guidewire Classification Name: Wire, Guide, Catheter Classification Code: DQX
- (3) Substantial Equivalency: Galt Medical Corp. guidewires are substantially equivalent to guidewires from K982559, K021990, and K031916
- (4) Device Description: The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, angled or with "J" end. The wires range from .014" diameter through .. 065" diameter and lengths from 20cm. to 360 cm. The wires are coated with a plastic hydrophilic or hydrophilic coating.

These guidewires are intended for use in percutaneous procedures to introduce and position catheters, pacing leads 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) Conclusions: Based on the information presented in this 510(k) premarket notification, Galt Medical's hydrophilic coated vascular guidewires are considered substantially equivalent to the currently marketed predicate devices.

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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 an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 5 2003

Galt Medical Corporation c/o Mr. David G. Catlin Executive Vice President 2475 Merrit Drive Garland, TX 75041-6146

Re: K033542

Hydrophilic Coated Vascular Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: November 6, 2003 Received: November 10, 2003

Dear Mr. Catlin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. David G. Catlin

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Alva D. Herz for

Bram D. Zuckerman. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): ___ Lt 335542_

Device Name: Hydrophilic Coated Vascular guidewire

Indications For Use: These guidewires are intended for use in percutancous procedures to introduce and position catheters, pacing leads, and other interventional devices within the coronary and peripheral vasculature.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**,
(Per 21 CFR 801.109)

12/5/3

Prescription Use OR Over-the Counter Use
(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number

(Optional Format 1-2-96)

12/5/3