PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS

K961580 · Sims Deltec, Inc. · LJT · Sep 20, 1996 · General Hospital

Device Facts

• Record ID: K961580
• Device Name: PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS
• Applicant: Sims Deltec, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Sep 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Because of its low profile, the P.A.S. PORT II system is intended for peripheral placement in the arm. The portal can be implanted in the upper arm above the antecubital space below the axilla, or below the antecubital space in the upper part of the forearm. A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Device Story

Implantable venous access system for peripheral arm placement; consists of portal, catheter, and connector. Portal implanted in upper arm or forearm; provides access for repeated injection, infusion, or blood sampling. Device modifications include new portal shape, increased septum diameter, increased septum puncture life, and polysulfone/titanium housing. System includes vein pick and winged infusion set. Operates as passive conduit for fluids/blood; no active electronic components. Benefits include reliable, repeated venous access for long-term therapy.

Clinical Evidence

No clinical data. Bench testing only. In-vitro testing conducted per FDA 'Guidance on 510(k) Submissions for Implanted Infusion Ports' (Oct 1990) including septum puncture, system leakage, and clearance. Biocompatibility testing performed on all components.

Technological Characteristics

Portal housing: Polysulfone/Titanium; Septum: Silicone; Catheter: Polyurethane; Connector: Titanium. ULTRA-LOCK® connector system. Dimensions: 8.75mm height, 29.5mm length, 16.3mm width, 9.5mm septum diameter. Passive implantable device; no energy source or software.

Indications for Use

Indicated for patients requiring repeated venous access for injection, infusion therapy, or venous blood sampling via peripheral arm 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

• PORT-A-CATH® P.A.S. PORT® Implantable Venous Access Systems (SIMS Deltec, Inc.)
• PeriPort™ Peripheral Access System (Strato Medical Corp.)

Submission Summary (Full Text)

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SEP 20 1996

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K96/580

# PORT-A-CATH® P.A.S. PORT® II Implantable Venous Access Systems

April 23, 1996

## I. GENERAL INFORMATION

Applicant’s Name and Address: SIMS Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112

Contact Person: Lisa Stone
Manager, Regulatory Affairs
Tel. [phone]

Common/Usual Name: Subcutaneously Implanted Intravascular Infusion Port and Catheter

Proprietary Name: PORT-A-CATH® P.A.S. PORT® II Implantable Venous Access Systems

PORT-A-CATH® P.A.S. PORT® II Fluoro-Free™ Implantable Venous Access Systems

Equivalence Device Comparison: PORT-A-CATH® P.A.S. PORT® Implantable Venous Access Systems (manufactured by SIMS Deltec, Inc.)

PeriPort™ Peripheral Access System (manufactured by Strato Medical Corp.)

## II. DEVICE DESCRIPTION

The P.A.S. PORT® II System is similar to the current commercially available P.A.S. PORT® System. The systems have the identical outlet tube, catheter connector and catheter. The systems are also identical in that the P.A.S. PORT® II System will be made available with a sensor assembly and/or introducer set.

The P.A.S. PORT® II System will be modified to include a new portal shape, an increased septum diameter, an increased septum puncture life, a change in portal housing material (i.e. polysulfone/titanium), the rear suture hole will be filled with silicone, and a vein pick and a winged infusion set will be included with the systems.

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510(k) Summary of Safety and Effectiveness
Page 2 of 3

## III. INTENDED USE OF DEVICE

Because of its low profile, the P.A.S. PORT II system is intended for peripheral placement in the arm. The portal can be implanted in the upper arm above the antecubital space below the axilla, or below the antecubital space in the upper part of the forearm. A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

## IV. DEVICE COMPARISON

| | PORT-A-CATH®
P.A.S. PORT® II
Systems | PORT-A-CATH®
P.A.S. PORT® Systems | PeriPort™ Peripheral
Access System |
| --- | --- | --- | --- |
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Strato Medical Corp. |
| INDICATION FOR USE | Because of its low profile, the P.A.S. PORT system is intended for peripheral placement in the arm. The portal can be implanted in the upper arm above the antecubital space below the axilla, or below the antecubital space in the upper part of the forearm. A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling. | Because of its low profile, the P.A.S. PORT system is intended for peripheral placement in the arm. A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling. | The PeriPort System is indicated for peripheral placement in the midarm, above the anticubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling. |
| PORTAL DIMENSIONS
(Nominal)
Height
Length
Width
Septum Diameter | 8.75 mm
29.5 mm
16.3 mm
9.5 mm | 10.0 mm
26.7 mm
16.5 mm
6.6 mm | 10.2 mm
19.5 mm
10.2 mm
5.7 mm |
| CATHETER DIMENSIONS
(Nominal)
I.D.
O.D.
Length | 1.0 mm
1.9 mm
76 cm | 1.0 mm
1.9 mm
76 cm | 1.0 mm
1.7 mm
76 cm |

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510(k) Summary of Safety and Effectiveness
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| | PORT-A-CATH®
P.A.S. PORT® II
Systems | PORT-A-CATH®
P.A.S. PORT® Systems | PeriPort™ Peripheral
Access System |
| --- | --- | --- | --- |
| MATERIALS | | | |
| Portal Housing | Polysulfone/Titanium | Titanium | Polysulfone/Titanium |
| Septum | Silicone | Silicone | Silicone |
| Connector | Titanium | Titanium | Titanium |
| Catheter | Polyurethane | Polyurethane | Polyurethane |
| CATHETER CONNECTOR | ULTRA-LOCK® Connector | ULTRA-LOCK® Connector | Strain relief connection |

## V. SUMMARY OF STUDIES

### A. Functional Testing

In-vitro testing was conducted in accordance with the FDA “Guidance on 510(k) Submissions for Implanted Infusion Ports,” dated October 1990. The testing included septum puncture, system leakage and clearance testing.

Biocompatibility testing was conducted on all system components.

### B. Clinical Studies

Clinical studies were not deemed necessary regarding the PORT-A-CATH® P.A.S. PORT® II Implantable Venous Access System due to its similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems.

### C. Conclusion Drawn from the Studies

The results of the testing indicated that the PORT-A-CATH® P.A.S. PORT® II Implantable Venous Access System functions according to specification and the materials used in the system are biocompatible. Therefore, the system is considered acceptable for human use.