TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT

K112398 · Galt Medical · DYB · Apr 12, 2012 · Cardiovascular

Device Facts

• Record ID: K112398
• Device Name: TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT
• Applicant: Galt Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 12, 2012
• Decision: SESE
• Submission Type: Special
• 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

GaltVTI™ Valved Tearaway Introducer is a single-patient-use, disposable medical device designed for percutaneous access to the peripheral vasculature. It facilitates the introduction and positioning of catheters or other interventional devices. The device features a tear-away mechanism and a hemostasis valve, which is the primary modification from predicate introducers. It is operated by clinicians in a clinical setting. The device functions as a conduit for interventional tools; the hemostasis valve minimizes blood loss during the procedure. The tear-away feature allows for the removal of the introducer sheath while leaving the indwelling catheter or device in place. The device benefits patients by providing a secure, controlled access point for minimally invasive vascular procedures.

Clinical Evidence

Bench testing only. Design verification included leak testing, force testing, hub break force, perpendicular pull, and shelf-life testing. Biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, and hemocompatibility (complement activation and in-vivo thrombogenicity).

Technological Characteristics

Single-patient-use, disposable catheter introducer. Features a tear-away sheath and hemostasis valve. Constructed of materials similar to predicate devices. Biocompatibility verified per standard testing protocols. No electronic components, software, or energy sources.

Indications for Use

Indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature in patients requiring such interventional access.

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

• Tearaway Introducer Sheath (K000313)
• Catheter Introducer (K043525)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text "APR 12 2012" on the left side. On the right side, the text "K112398 Page 1 of 1" is present. The text appears to be handwritten and is likely part of a document or form.

## 510(k) SUMMARY (as required by section 807.92(c))

| Device Name: | GaltVTI™ Valved Tearaway Introducer |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Models: | The GaltVTI™ is offered with a standard or a flexible dilator and an<br>optional side port. The products are offered sterile or bulk non-sterile. |
| Classification Name: | Catheter Introducer (DYB), 21 CFR 870.1340 |
| Device Classification: | Class II (Cardiovascular) |
| Predicate Devices: | Tearaway Introducer Sheath, K000313<br>Catheter Introducer, K043525 |
| Manufacturer: | Galt Medical<br>2220 Merritt Drive<br>Garland, TX 75041 |
| Establishment | Registration Number: |
| Registration Number: | 1649395 |
| Official Contact: | Betsy Cortelloni<br>Corporate Director of Quality and Regulatory Affairs<br>Theragenics Corporation<br>5203 Bristol Industrial Way<br>Buford, GA 30518<br>Phone: [phone]; 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 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 of the same or similar materials. The device is being modified to add a tear-away hemostasis valve. The combined performance characteristics of the predicate devices are unchanged and are consistent with other legally marketed predicate devices.

Comparison of Technological Characteristics: The GaltVTI™ Valved Tearaway Introducer is substantially equivalent to the unmodified predicates in materials, construction, and in device performance.

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

Performance Testing: Design verification included leak testing, force testing, hub break force, perpendicular pull and shelf-life test. The following biocompatibility tests were also performed: cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, and hemocompatibility (complement activation and in-vivo thrombogenicity.)

Conclusion: The results of the DV testing confirmed that design inputs were achieved and the cumulative test results demonstrated the functionality, safety and effectiveness of the Valved Tearaway Introducer, as well as its substantial equivalence to the predicate devices.

{1}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

## Public Health Service

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

APR 1 2 2012

Theragenics Corporation c/o Ms. Betsy Cortelloni Corporate Director of Quality and Regulatory Affairs 5203 Bristol Industrial Wav Buford, GA 30518

Re: K112398

Trade/Device Name: GaltVTI™ Valved Tearaway Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 9, 2012 Received: March 13, 2012

Dear Ms. Cortelloni:

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 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 with all the Act's requirements, including, but not limited to: registration and listing

{2}------------------------------------------------

Page 2 - Ms. Betsy Cortelloni

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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

Enclosure

{3}------------------------------------------------

## INDICATIONS FOR USE FORM

510(K) number (if known):_____________________________________________________________________________________________________________________________________________________ K112398

GaltVTI™ Valved Tearaway Introducer Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Introducer System is intended for use in percutaneous procedures to introduce The Introducer Dystant to as a more of the peripheral vasculature.

× Prescription Use_ (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)

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K112398

Page 1 of 1