MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT

K033473 · Horizon Medical Products, Inc. · LJT · Nov 18, 2003 · General Hospital

Device Facts

• Record ID: K033473
• Device Name: MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
• Applicant: Horizon Medical Products, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Nov 18, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vortex® MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Device Story

Vortex® MP Vascular Access System is a subcutaneous implanted port and catheter system. Components include titanium port with self-sealing silicone septum, catheter (polyurethane or silicone), locking mechanism, and introduction components. Used for repeated venous access for infusion therapy or blood sampling. Implanted by clinicians in clinical settings. Port design maintains integrity after repeated punctures with non-coring needles. System facilitates long-term venous access, reducing need for frequent venipuncture and improving patient comfort during therapy.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Titanium port housing; self-sealing silicone septum; polyurethane or silicone catheter. System is a subcutaneous implanted port and catheter. Sterile packaging. No software or electronic components.

Indications for Use

Indicated for patients requiring repeated central venous access for injection, infusion therapy, or venous blood sampling via peripheral or chest placement.

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

• Horizon Medical Products Vortex® MP Peripheral Access System (K032754)

Submission Summary (Full Text)

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Premarket Notification – Special 510(k): Device Modification
Horizon Medical Products, I Horizon Medical Products, Inc. Vortex® MP Vascular Access System

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510(k) Summary

# 510(K) SUMMARY [AS REQUIRED BY 21 CFR 807,92(C){

#### Submitter's Name / Contact Person

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

## General Information

| Trade Name | Vortex® MP Vascular Access System | |
|---------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Common Name | Vascular access port | |
| Classification Name | Classification Number:<br>Classification Panel:<br>Product Code: | Subcutaneous, implanted, intravascular infusion port and catheter<br>21 CFR §880.5965<br>General Hospital<br>LJT |
| Equivalent Device | Horizon Medical Products Vortex® MP Peripheral Access System<br>(K032754) | |

## Device Description

The Vortex® MP Vascular Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex MP® Port is available in a titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The catheter is offered in polyurethane and silicone models. The products are packaged in sterile trays with introduction components.

## Intended Use / Indications

The Vortex® MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

#### Substantial Equivalence Comparison

The subject and predicate devices utilize the identical fundamental scientific technology and are identical in configuration and dimensions. The subject and predicate devices are substantially similar in materials of construction. The Vortex MP Vascular Access System was evaluated through HMP risk analysis and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness were raised for the Vortex MP Vascular Access System.

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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 8 2003

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

Re: K033473

Trade/Device Name: Modification to Vortex MP Vascular Access Port Regulation Number: 880.5965 Regulation Name: Subcutaneous Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: October 31, 2003 Received: November 3, 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 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.

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### 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 (OS) 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]. 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,

Clupis

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ LO33413

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Vortex MP Vascular Access System Device Name:

Indications for Use:

The Vortex® MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Latica Cuscante

510(k) Number: K053475