THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602

K960350 · Biocontrol Technology, Inc. · LJT · Apr 15, 1996 · General Hospital

Device Facts

• Record ID: K960350
• Device Name: THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602
• Applicant: Biocontrol Technology, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Apr 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The theraPORT® is intended for use with patients that require repeated venous access for injection or infusion therapy and/or venous blood sampling.

Device Story

Totally implantable venous access system; consists of detached catheter and port. Used for repeated venous access; facilitates injection, infusion therapy, and blood sampling. Implanted subcutaneously; accessed percutaneously by clinician via needle through port septum. Provides reliable long-term vascular access; reduces need for repeated venipuncture; benefits patients requiring chronic therapy. No electronic components; purely mechanical device.

Clinical Evidence

No clinical data. Bench testing only: catheter-to-port connection strength, septum puncture durability, port leakage integrity, and port/catheter clearance tests performed per FDA guidance.

Technological Characteristics

Totally implantable venous access system; detached catheter and port design. Materials, processing, and sterilization identical to predicate devices. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring repeated venous access for injection, infusion therapy, or venous 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

• VITAL-PORT® Vascular Access Port with Detached Catheter (Cook Pacemaker Corporation)
• PORT-A-CATH® Implantable Access System (Pharmacia Deltec, Inc.)
• A-PORT® Implantable Vascular Access System (Therex, Inc.)

Submission Summary (Full Text)

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K960350
510(k) Summary for the
K960350
therePORT® Vascular Access System
APR 15 1996

## GENERAL INFORMATION:

| Common/Usual Names: | Implanted Subcutaneous Intravascular Catheter; Implantable Vascular Access System; Implanted Infusion Port |
| --- | --- |
| Proprietary Name: | **theraPORT®** Vascular Access System |
| Applicant: | Biocontrol Technology, Inc.
300 Indian Springs Road
Indiana, PA 15701
[phone] |
| Equivalence Device Comparison: | Cook Pacemaker Corporation, VITAL-PORT® Vascular Access Port with Detached Catheter; Pharmacia Deltec, Inc., PORT-A-CATH® Implantable Access System; and Therex, Inc., A-PORT® Implantable Vascular Access System. |

## DEVICE DESCRIPTION:

The **theraPORT®** Vascular Access System is a totally implantable venous access system consisting of a detached catheter and port.

## INTENDED USE:

The **theraPORT®** is intended for use with patients that require repeated venous access for injection or infusion therapy and/or venous blood sampling.

## ALTERNATIVE DEVICES:

Alternative devices to the **theraPORT®** Vascular Access System are other commercially available implantable vascular venous access systems such as the Cook Pacemaker Corporation, VITAL- PORT® Vascular Access Port with Detached Catheter, the Pharmacia Deltec, Inc., PORT-A-CATH® Implantable Access System, and the Therex Corporation, A-PORT® Implantable Vascular Access System.

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# POTENTIAL ADVERSE EFFECTS:

The following adverse effects, which are normally associated with the insertion or use of any implanted device or indwelling catheter, may occur when using the *theraPORT®* Vascular Access System: air embolism, bacteremia, catheter disconnection, catheter fragmentation, cardiac arrhythmia, cardiac puncture, cardiac tamponade, catheter occlusion, catheter rupture, catheter shearing, catheter/port erosion through blood vessel/skin, catheter/port migration, drug extravasation, hematoma, hemothorax, implant rejection, infection, laceration or puncture of vessels, pneumothorax, sepsis, thromboembolism, thrombophlebitis, thrombosis.

# SUMMARY OF STUDIES:

## Performance Testing:

Performance testing of the *theraPORT®* Vascular Access System was conducted in accordance with the “Guidance on 510(k) Submissions for Implanted Infusion Ports,” Center for Devices and Radiological Health, Office of Device Evaluation, Division of Gastroenterology/Urology and General Use Devices, Food and Drug Administration, October 1990. Catheter-to-port connection strength tests, septum puncture durability tests, port leakage integrity tests and port/catheter clearance tests were all performed.

Biocompatibility testing was not conducted since all materials, their processing, and their sterilization are identical to substantially equivalent devices.

## Clinical Studies:

Clinical studies were not conducted as they were determined to be not necessary due to the similarity in design, performance, materials, function and intended use of the *theraPORT®* Vascular Access System to other commercially available systems.

# CONCLUSIONS DETERMINED FROM TESTS:

The above described studies demonstrate that the *theraPORT®* Vascular Access System functions properly and is substantially equivalent to the aforementioned commercially available predicate devices. Therefore, the *theraPORT®* Vascular Access System is determined to be safe and effective for its intended use.

theraPORT® is a registered trademark of Biocontrol Technology, Inc.
A-Port® is a registered trademark of Therex, Corp.
Port-A-Cath® is a registered trademark of Pharmacia-Deltec, Inc.
Vital-Port® is a registered trademark of Cook Pacemaker Corp.