GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER

K140028 · Galt Medical Corp. · DYB · Aug 21, 2014 · Cardiovascular

Device Facts

• Record ID: K140028
• Device Name: GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER
• Applicant: Galt Medical Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The introducer system is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

Device Story

VTI Valved Tearaway Introducer is a single-patient-use, disposable device used in percutaneous procedures to facilitate the introduction or positioning of catheters and interventional devices into the peripheral vasculature. The device consists of a cylindrical cannula with a winged sheath hub and a locking dilator. It features an integral valve designed to minimize blood leakage and air embolism during device exchanges. The device is operated by clinicians in a clinical setting. The subject device is a modification of a previously cleared predicate, specifically incorporating a new valve design and material. The device is provided sterile and is intended for single use.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including dilator lock, cap retention, pressure/vacuum leak, prolonged insertion, valve separation, and insertion/extraction tests. Biocompatibility testing was performed for the new valve material.

Technological Characteristics

Tear-away introducer with winged sheath hub and locking dilator. Features an integral valve. Sizes: 6F-16F; lengths: 13cm and 23cm. Sterilization: Ethylene oxide. Materials are identical to the predicate except for the modified valve component.

Indications for Use

Indicated for patients requiring percutaneous introduction of catheters or other intravascular devices into the peripheral 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 VTI® Valved Tearaway Introducer Sheath (K112398)

Submission Summary (Full Text)

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Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three stylized human profiles facing to the right, with flowing lines connecting them.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002

August 21, 2014

Galt Medical Corp. David Derrick Director of Quality and Regulatory Affairs 2220 Merritt Dr. Garland, TX 75041 US

Re: K140028

> Trade/Device Name: VTI Valved Tearaway Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 10, 2014 Received: July 14, 2014

Dear Mr. David Derrick.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

for

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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## INDICATIONS FOR USE

510(K) number (if known):_ K140028

Device Name:_

Indications for Use:

The introducer system is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

Prescription Use_ X (Per 21 CFR 801 Subpart D) OR

Over-The-Counter Use_ (Per 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)

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| Date Prepared: | January 02, 2014 | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device Name: | VTI® Valved Tear Away Introducer | |
| Device Model Number: | TBD | |
| Classification Name: | Catheter Introducer (DYB), | |
| | 21 CFR 870.1340 | |
| Device Classification: | Class II (Cardiovascular) | |
| Predicate Device: | Galt VTI® Valved Tearaway Introducer Sheath, K112398<br>6F-16F | |
| Manufacturer: | Galt Medical<br>2220 Merritt Drive<br>Garland, TX 75041 | |
| Establishment | | |
| Registration Number: | 1649395 | |
| Official Contact: | David Derrick<br>Director of Quality and Regulatory Affairs<br>Galt Medical Corporation<br>2220 Merritt Dr.<br>Garland, TX 75041<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] | |

Intended Use: The introducer system is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

Device Description: The finished device is a valved tear-away introducer for use in percutaneous procedures to introduce or position catheters or other interventional devices into the peripheral vasculature. The unmodified predicate introducers are constructed using identical processes and material with the exception of the subject device was modified to add a new valve design and material. The performance characteristics to the current marketed predicate device are unchanged and are consistent with other legally marketed devices.

Comparison of Technological Characteristics: The Galt VTI® Valved Tearaway Introducer is substantially equivalent to the unmodified predicate in construction, materials, and device performance.

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| | Subject device | Predicate Device |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mfr. / Product | Galt VTI® Valved Tearaway Introducer<br>with Modified Valve | Galt VTI® Valved Tearaway Introducer |
| 510(k) Number | NA | K112398 |
| Device<br>Classification | 870.1340 | 870.1340 |
| Product Code | DYB | DYB |
| Intended use | The introducer system is intended for use<br>in percutaneous procedures to introduce<br>catheters and other intravascular devices<br>into the peripheral vasculature. | The introducer system is intended for use<br>in percutaneous procedures to introduce<br>catheters and other intravascular devices<br>into the peripheral vasculature |
| Design | Tear-away introducer with winged sheath<br>hub and locking dilator including an<br>integral valve to reduce leakage and air<br>embolism during device exchanges | Tear-away introducer with winged sheath<br>hub and locking dilator including an<br>integral valve to reduce leakage and air<br>embolism during device exchanges |
| Color | Gray cannula with color coded hub | |
| Shape | Cylindrical cannula with winged hub | |
| Sizes | 13cm, and 23cm lengths, sizes 6F - 16F | |

Use Type: The Galt VTI® Valved Tearaway Introducer is a single patient use, disposable device.

Summary of Non-Clinical Data Submitted: Functional testing on un-aged and 4 year aged product was conducted to verify that the modified Galt VTI® Valved Tearaway Introducer met product specifications. Testing was conducted according to protocols based on international standards and Galt Medical requirements. Functional Testing included the following:

- I Dilator lock Test
- 미 Cap Retention Test
- Pressure Leak Test
- ! Vacuum Leak Test
- 미 Prolonged Insertion Test
- Valve Separation Test
- 트 Insertion / Extraction Test

Additionally the modified Galt VTI® Valved Tearaway Introducer was adopted into the existing ethylene oxide sterilization cycle for the Galt VTI® Valved Tearaway Introducer Sheath cleared under K112389.

Biocompatibility testing was provided in K112398. The devices tested under K112398 included identical raw materials and package configuration and materials utilized in the Galt VTI® Valved Tearaway Introducer with the exception of the new valve design. Additional biocompatibility testing that includes the material utilized to manufacture new valve design was performed and is included in this 510(k) submission.

Packaging shelf life testing was provided in K112398.

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Conclusion: It has been shown in this 510(k) submission that the differences between the modified Galt VTI® Valved Tearaway Introducer and the predicate device do not raise any questions regarding safety and effectiveness. The modified Galt VTI® Valved Tearaway Introducer as designed and manufactured is determined to be substantially equivalent to the referenced predicate device.

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