TRIUMPH VTX WITH LIFEVALVE CATHETER

K032557 · Horizon Medical Products, Inc. · LJT · Sep 9, 2003 · General Hospital

Device Facts

• Record ID: K032557
• Device Name: TRIUMPH VTX WITH LIFEVALVE CATHETER
• Applicant: Horizon Medical Products, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Triumph™ VTX® Port with LifeValve® Catheter is a totally implantable vascular access system intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products. The Triumph™ VTX® Port with LifeValve® Catheter is also indicated for the withdrawal of blood samples.

Device Story

Totally implantable vascular access system; consists of port reservoir and intravascular catheter. Port available in titanium or polysulfone with self-sealing silicone rubber septum for anti-coring needle access. Catheter features distal bidirectional valve assembly and pre-threaded stiffening stylet for insertion. Components secured via locking mechanism. Used by clinicians for infusion of fluids, medications, nutrition, blood products, and blood sampling. Benefits include reliable long-term venous access.

Clinical Evidence

Bench testing only. Device design qualified through design verification testing following established Design Control procedures and risk analysis.

Technological Characteristics

Materials: Titanium or polysulfone port, silicone rubber septum. Features: Bidirectional valve at distal catheter tip, locking mechanism for port-catheter connection, pre-threaded stiffening stylet. Sterile, single-use, implantable. No software or electronic components.

Indications for Use

Indicated for patients requiring a totally implantable vascular access system for the delivery of medications, intravenous fluids, parenteral nutrition, or blood products, and for the withdrawal of blood samples.

Regulatory Classification

Identification

A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

• Triumph-1® Port Systems (K933986, K951814)
• Vortex® Access Systems (K010189)
• LifeValve® Central Venous Catheter (K031718)

Submission Summary (Full Text)

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

# SEP - 9 2003

KO 3253-7

#### 510(K) SUMMARY [AS REQUIRED BY 21 CFR 807.92(C)] 6

#### Submitter's Name / Contact Person

| Manufacturer | Contact |
|--------------------------------|----------------------------------------------|
| Horizon Medical Products, Inc. | Scott Moeller |
| One Horizon Way | Director of Quality Assurance and Regulatory |
| Manchester, Georgia 31816 | Affairs |

#### General Information

| Trade Name | Triumph™ VTX® Port with LifeValve® Catheter |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Vascular access port with intravascular catheter |
| Classification Name | Subcutaneous, implanted, intravascular infusion port and catheter<br>Classification Number: 21 CFR §880.5965<br>Classification Panel: General Hospital<br>Product Code: LJT |
| Equivalent Devices | Product; Manufacturer; 510(k) #<br>• Triumph-1® Port Systems; Horizon Medical Products; K933986, K951814<br>• Vortex® Access Systems; Horizon Medical Products; K010189<br>• LifeValve® Central Venous Catheter; Horizon Medical Products; K031718 |

### Device Description

The Triumph™ VTX® Port with LifeValve® Catheter is a device comprised of a vascular access port and a catheter. The Triumph™ VTX® Port is available in a titanium or polysulfone configuration with a self sealing silicone rubber septum designed to maintain integrity after repeated punctures with an anti-coring needle. The LifeValve® Catheter incorporates a bidirectional valve assembly at the distal tip. The catheter is equipped with a pre-threaded stiffening stylet to facilitate passage of the catheter through the introducer. The positioned LifeValve® Catheter is secured to the Triumph™ VTX® Port reservoir with a locking mechanism. The products are packaged in a sterile tray with an introducer kit and components.

### Intended Use

The Triumph™ VTX® Port with LifeValve® Catheter is a totally implantable vascular access system intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products. The Triumph™ VTX® Port with LifeValve® Catheter is also indicated for the withdrawal of blood samples.

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

#### Substantial Equivalence Comparison

The Triumph™ VTX® Port with LifeValve® Catheter is substantially equivalent to the Horizon Medical Products, Inc. (HMP) Triumph-1® Port System, Vortex® Access System and LifeValve® Central Venous Catheter.

The subject and predicate devices are substantially equivalent in intended use and fundamental scientific technology. The Triumph™ VTX® Port and the Triumph-10 and Vortex® Access System predicates are substantially similar in configuration, dimensions, and materials. The LifeValve® Catheter is essentially identical to the previously cleared LifeValve® Catheter. The Triumph™ VTX® Port with LifeValve® Catheter design was evaluated through Horizon Medicals risk analysis and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness for implantable ports or central venous catheters were raised by the risk analysis or testing of the Triumph™ VTX® Port with LifeValve® Catheter.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping lines forming a human figure.

Public Health Service

SEP - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott Moeller Director of Quality Assurance and Regulatory Affairs Horizon Medical Products, Incorporated 1 Horizon Way Manchester, Georgia 31816

Re: K032557

Trade/Device Name: Triumph™ VTX® Port with life Valve® Catheter Regulation Number: 21CFR 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: August 18, 2003 Received: August 19, 2003

Dear Mr. Moeller:

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 vour 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.

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

Page 2 -Mr. Moeller

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 vour 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 yours.

Patuca Cuceritofoc

Susan Runner, DDS, MA Interim Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Triumph™ VTX® Port with LifeValve® Catheter

Indications for Use:

The Triumph™ VTX® Port with LifeValve Catheter is a totally implantable vascular access system intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products. The Triumph™ VTX® Port with LifeValve® Catheter is also indicated for the withdrawal of blood samples.

Susan Runse

(Division Sign-Off) General Hospital. Division of Anesthesiolog Infection Control, Denta 510(k) Number:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1