VORTEX EZ VASCULAR ACCESS PORT

K050176 · Rita Medical Systems, Inc. · LJT · Feb 25, 2005 · General Hospital

Device Facts

• Record ID: K050176
• Device Name: VORTEX EZ VASCULAR ACCESS PORT
• Applicant: Rita Medical Systems, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Feb 25, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vortex® EZ Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.

Device Story

Vortex® EZ Port Access System is a subcutaneous, implanted vascular access port and catheter system. Components include a Delrin port body with a self-sealing silicone septum, a silicone port base for suturing, and a polyurethane or silicone catheter (with or without radiopaque tip). Used by clinicians to provide repeated access to the vascular system or other body sites for infusion therapy (medications, fluids, blood products, nutrition) and blood sampling. The device is implanted; the clinician accesses the port via a non-coring needle through the skin. The system facilitates long-term venous access, reducing the need for repeated venipuncture and potentially improving patient comfort and clinical efficiency during chronic treatment regimens.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design verification testing and risk analysis.

Technological Characteristics

Materials: Delrin (port body), silicone (septum, port base, catheter), polyurethane (catheter). Features: Self-sealing septum for non-coring needles, radiopaque catheter tip options. Sterilization: Sterile trays. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring repeated vascular or body site access for delivery of medications, nutritional supplements, fluids, blood products, or blood sampling.

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

• LifePort® VTX® Access System (K010767)
• LifePort® LPS 7013 (K905852)

Submission Summary (Full Text)

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

K050176

Premarket Notification - Special 510(k): Device Modification 510(k) Summary RITA Medical Systems, Inc. Vortex® EZ Port Access System

January 2005

Page 17 of 23

# 510(k) Summary [as required by 21 CFR 807.92(c)]

FEB 2 5 2005

## Submitter's Name / Contact Person

| Manufacturer | Contact |
|----------------------------|-----------------------------|
| RITA Medical Systems, Inc. | Mary Gossard, M.S. |
| One Horizon Way | Manager, Regulatory Affairs |
| Manchester, Georgia 31816 | |

### General Information

| Trade Name | Vortex® EZ Port Access System |
|---------------------|-------------------------------------------------------------------|
| Common Name | Vascular access port |
| Classification Name | Subcutaneous, implanted, intravascular infusion port and catheter |
| | Classification Number: |
| | Classification Panel: |
| | Product Code: |
| Modified Devices | LifePort® VTX® Access System (K010767) |
| | LifePort® LPS 7013 (K905852) |

# Device Description

The Vortex® EZ Port Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex® EZ Port is available in a Delrin port body configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The port base is crafted of silicone so that the port can be sutured to the underlying tissue anywhere around this base. A pre-attached or a detached/attachable catheter is offered in either polyurethane or silicone models with or without a highly radiopaque tip molded on. The products are packaged in sterile trays with introduction components.

# Intended Use / Indications

The Vortex® EZ Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.

### Substantial Equivalence Comparison

The Vortex® EZ Port Access System and the modified devices, LifePort® VTX® Access System and the LPS 7013 model of the LifePort® ports with silicone and polyurethane catheters share identical intended uses and fundamental scientific technology. The subject and modified devices are substantially similar in configuration, dimensions, and materials. The Vortex® EZ Port Access System design was evaluated through 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® EZ Port Access System.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings, symbolizing health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

FEB 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Gossard Manager, Regulatory Affairs RITA Medical Systems One Horizon Way Manchester. Georgia 31816

Re: K050176

Trade/Device Name: Vortex® EZ Port Access System Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: January 25, 2005 Received: January 26, 2005

Dear Ms. Gossard:

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.

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

#### Page 2 - Ms. Gossard

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-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clint Little, Ph.D.

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

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

# Indications for Use

510(k) Number (if known): ¥050176

Vortex® EZ Port Access System Device Name:

Indications for Use:

The Vortex® EZ Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cinta Umar

:::) Number

on Sinn-Off) ാവ ടിപ്രീംവം
മാന of Anesthesiology, General Hospital crion Control, Dental Devices