IDEAS' DUAL PORT

K962751 · Ideas For Medicine, Inc. · LJT · Sep 30, 1996 · General Hospital

Device Facts

• Record ID: K962751
• Device Name: IDEAS' DUAL PORT
• Applicant: Ideas For Medicine, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Sep 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ideas' Dual Port is a totally implantable system designed to provide repeated access to the vascular system. The Ideas' Port allows for the infusion of medications, total parenteral nutrition, blood products, imaging solution, as well as, venous blood sampling. Port access is performed by percutaneous needle insertion using a "Huber type" non-coring needle. The system includes an injection portal with self sealing septum, compression lock and Tecoflex® catheter.

Device Story

Totally implantable venous access port; provides repeated vascular access for infusion therapy and blood sampling. System components: injection portal with self-sealing septum, compression lock, and Tecoflex® catheter. Operated by clinicians via percutaneous insertion of Huber-type non-coring needle. Enables chronic venous access for medications, nutrition, and blood products. Benefits: facilitates repeated access while minimizing trauma; superior tensile strength at catheter-port junction compared to predicates.

Clinical Evidence

Bench testing only; no clinical data provided. Device meets or surpasses performance specifications for competitive ports.

Technological Characteristics

Totally implantable venous access system. Materials: Tecoflex® catheter, titanium portal outlet. Features self-sealing septum and compression lock. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring repeated vascular access for infusion of medications, total parenteral nutrition, blood products, imaging solutions, and 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

• Life Port
• Vital Port

Submission Summary (Full Text)

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Ideas for Medicine, Inc.
Ideas Dual Port
510(k) Notification
X962751

# SAFETY and EFFECTIVENESS SUMMARY

## PROPRIETARY NAME

Ideas Dual Port

## COMMON/USUAL NAME

Venous Access Port

## CLASSIFICATION

Class II

## CLASSIFICATION NUMBER

80 LJT

## DEVICE DESCRIPTION

The Ideas' Dual Port is a totally implantable system designed to provide repeated access to the vascular system. The Ideas' Port allows for the infusion of medications, total parenteral nutrition, blood products, imaging solution, as well as, venous blood sampling. Port access is performed by percutaneous needle insertion using a "Huber type" non-coring needle. The system includes an injection portal with self sealing septum, compression lock and Tecoflex® catheter.

## SUBSTANTIAL EQUIVALENCE

The Ideas Dual Port is substantially equivalent in its intended use to other (Life Port and Vital Port) marketed dual ports: - to provide chronic venous access. The separate chamber allows for intermittent infusion therapy and/or blood sampling. Its' size, dimensions and geometry are comparable to other ports. Materials are identical to other Ideas Ports except the portal outlet, which is a different grade titanium from the one used in other Ideas Ports. The material, however, is fully biocompatibility. It meets or surpasses the performance specifications in the guidelines on competitive ports and has superior tensile strength at the junction of the catheter and port.

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