GALT MEDICAL GUIDEWIRE

K031916 · Galt Medical Corp. · DQX · Jul 17, 2003 · Cardiovascular

Device Facts

• Record ID: K031916
• Device Name: GALT MEDICAL GUIDEWIRE
• Applicant: Galt Medical Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Jul 17, 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

Sitefinder vascular guidewire; mandrel-type wire used to introduce and position catheters, pacing leads, and interventional devices in coronary and peripheral vasculature. Operated by clinicians during percutaneous procedures. Device consists of stainless steel, nitinol, and platinum wire with transparent conformal coating; available in straight or 'J' tip configurations; diameters .014" to .065"; lengths 20cm to 360cm. Provides mechanical guidance for interventional tools.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: stainless steel, nitinol, platinum. Form factor: .014" to .065" diameter, 20cm to 360cm length. Tip: straight or 'J'. Coating: transparent conformal. Principle: mechanical guidance for catheter placement. No software or electronic components.

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

Submission Summary (Full Text)

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## JUL 17 2003

KC0319/6

## 510(k) Summary of Safety and Effectiveness for Galt Medical's Vascular Guidewires (Mandrel Type) (Prepared in accordance with 21 CFRPart 807.92) Date 6/14/02

- (1) Submitter: Galt Medical Corp. 2475 Merritt Drive Garland, TX 75041 [phone] Contact Person: David Catlin
- (2) Device Name: Guidewire Trade Name: Sitefinder Classification Name: Wire, Guide, Catheter Classification Code: DQX
- (3) Substantial Equivalency: Galt Medical Corp. Sitefinder guidewires are substantially equivalent to guidewires from K982559 and K021990.
- (4) Device Description: The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, 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 transparent conformal coating.

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) Conclusions: Based on the information presented in this 510(k) premarket notification, Galt Medical's Sitefinder guidewires are considered substantially equivalent to the currently marketed predicate devices.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2003

Galt Medical Corp. c/o David Catlin 2475 Merritt Dr. Garland, TX 75041

Re: K031916

> Galt Medical Guidewire Regulation Number: 870.1330 Regulation Name: Guidewire Regulatory Class: Class II Product Code: DQX Dated: June 18, 2003 Received: June 20, 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.

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

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## Page 2 - David Catlin

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]. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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 yours,

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

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

Device Name: Sitefinder Vascular Guidewire

Indications For 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.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) |
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| Division of Cardiovascular Devices |

| 510(k) Number | K031916 |
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| Prescription Use | X | OR | Over-the Counter Use |
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| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |