VASCULAR ACCESS PORT KIT

K955587 · Boston Scientific Corp · LJT · Mar 21, 1996 · General Hospital

Device Facts

• Record ID: K955587
• Device Name: VASCULAR ACCESS PORT KIT
• Applicant: Boston Scientific Corp
• Product Code: LJT · General Hospital
• Decision Date: Mar 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Implantation of a port and catheter is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples. The port kit, which is the subject of this premarket notification, provides procedural components necessary for percutaneous insertion of the implantable vascular access system.

Device Story

Venous access port kit; provides components for percutaneous insertion of implantable vascular access system. Includes implantable port, catheter, introducer sheath/dilator with hemostasis valve, non-coring needle, entry needle, blunt needle, and guidewires. Used by clinicians in clinical settings to establish long-term venous access. Facilitates repeated therapy delivery and blood withdrawal; benefits patient by reducing need for frequent venipuncture.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Kit components: implantable port, catheter, introducer sheath/dilator, needles, guidewires. Packaging: PETG blister tray, Tyvek/mylar pouch. Sterilization: Ethylene oxide gas. Monitoring: Bacterial endotoxin levels.

Indications for Use

Indicated for patients requiring repeated intravascular access for fluid/medication infusion, antibiotic/nutritional delivery, 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

• Cook's VITAL-PORT MINI Vascular Access Port with Detached Catheter
• Pharmacia Deltec's PORT-A-CATH Implantable Access System

Submission Summary (Full Text)

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K955587

# SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.

## A. GENERAL INFORMATION

Owner Operator Submitting Boston Scientific Corporation
this Premarket Notification: 480 Pleasant Street
Watertown, MA 02172
[phone]

Contact Person: Wanda M. Carpinella
Regulatory Affairs Department

Device Generic Name: Venous Access Port Kit
Device Classification: 80 LJT, Implanted Subcutaneous Port and Catheter

## B. INDICATIONS FOR USE

Implantation of a port and catheter is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples. The port kit, which is the subject of this premarket notification, provides procedural components necessary for percutaneous insertion of the implantable vascular access system.

## C. DESCRIPTIVE CHARACTERISTICS

The port kit provides an implantable port and catheter, an introducer sheath/dilator with a hemostasis valve, a 22 Ga. non-coring needle, a 21 Ga. entry needle, a 20 Ga. blunt needle, and 0.018" and 0.035" guidewires. All of these components have been found substantially equivalent through the premarket notification process for the use(s) for which the port vascular assess kit is intended.

## D. SUBSTANTIAL EQUIVALENCE

The proposed venous access port kit has been shown to be substantially equivalent to the individual devices sold individually and to other predicate vascular access port kits, such as Cook's VITAL-PORT MINI Vascular Access Port with Detached Catheter and Pharmacia Deltec's PORT-A-CATH Implantable Access System.

## E. PACKAGING, STERILIZATION, AND PYROGENICITY

Components comprising the kit are assembled in a PETG blister tray with a snap-fit lid. The tray is placed in a Tyvek/mylar pouch, which is then heat sealed. The kit is sterilized using ethylene oxide gas. Bacterial endotoxin levels are monitored for sterility release purposes.

## F. CONCLUSION

Based on the information presented, Boston Scientific Corporation believes that the proposed venous access port kit meets the minimum requirements that are considered acceptable for its intended use.

Premarket Notification
Vascular Access Kit
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