CATHETER INTRODUCER

K043525 · Galt Medical Corp. · DYB · Feb 9, 2005 · Cardiovascular

Device Facts

• Record ID: K043525
• Device Name: CATHETER INTRODUCER
• Applicant: Galt Medical Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Sheath Introducer system is indicated for use in percutaneous introduction of catheters and other intravascular devices into the vasculature.

Device Story

Catheter introducer sheath system; facilitates percutaneous access for intravascular devices. Available in 4 French to 9 French sizes; sheath lengths 5cm to 110cm. Used by clinicians in clinical settings to provide a conduit for catheter placement. Device performance verified via bench testing including tensile strength and valve leakage assessments.

Clinical Evidence

Bench testing only. Testing included tensile strength and valve leakage to demonstrate functional performance comparable to predicate devices.

Technological Characteristics

Catheter introducer sheath; 4F to 9F diameter; 5cm to 110cm length. Materials consistent with existing predicate introducers. Mechanical device; no energy source or software.

Indications for Use

Indicated for percutaneous introduction of catheters and other intravascular devices into the vasculature.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Galt Catheter Introducer (K000313)

Submission Summary (Full Text)

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### FEB - 9 2005

# 510(k) Summary of Safety and Effectiveness for Galt Medical Corp. Catheter Introducer

Ko43525

(Prepared in accordance with 21 CFRPart 807.92) Date 12/14/04

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

- (2) Device Name: Catheter Introducer Trade Name: No proprietary name has been established. Classification Name: Catheter Introducer Classification Code: DYB
- (3) Substantial Equivalency: Galt Medical Catheter Introducer is substantially equivalent to Catheter Introducers from:

#### K000313 Galt

- (4) Device Description: The materials of construction are consistent with introducers presently in Device Description. The product is available in 4 French to 9 French. The sheath lengths are 5cm to 110cm.
- (5) Technological Characteristics: Galt Medical's Catheter Introducer has 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 Non-Chilter Tistis. The introducers are comparable to the currently marketed introducers. Test performed included: tensile strength, and valve leakage.
- (7) Conclusions: Based on the information presented in this 510(k) premarket notification, Galt Medical's Coliciusious. Dasco on the internation provinally 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a triple-stranded helix, rendered in black.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 2005

Mr. David G. Catlin Executive Vice President Galt Medical Corp. 2475 Merritt Drive Garland, TX 75041-6146

K043525 Re:

Trade/Device Name: Catheter Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: II Product Code: DYB Dated: January 7, 2005 Received: January 10, 2005

### Dear Mr. Catlin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Securer 11 (2) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surver in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prior conner as 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 1 ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls provision 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 r reaso be action and 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

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Page 2 – Mr. David G. Catlin

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2001). In the marketing your device as described in your Section 510(k) This letter will anow you to ough maniening of substantial equivalence of your device to a legally premarket notification: "The PDF intelligstification 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 If you desire specific advice for your at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoraning of reference to presensibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duma R. de Anes

Bram D. Zuckerman, M.D. Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K043525

## Indications for Use

510(k) Number (if known): K043525

Device Name: Catheter Introducer

Indications For Use: The Sheath Introducer system is indicated for use in percutaneous manodione For See. Theatheters and other intravascular devices into the vasculature..

Prescription Use

(Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vochner

(Division Sign-Off)
Division of Cardiovascular Devices

510(K) Number_K O

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