SPINNAKER

K965189 · Target Therapeutics · KRA · Mar 24, 1997 · Cardiovascular

Device Facts

• Record ID: K965189
• Device Name: SPINNAKER
• Applicant: Target Therapeutics
• Product Code: KRA · Cardiovascular
• Decision Date: Mar 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spinnaker is indicated for use in facilitating access through distal, tortuous vasculature, and may be used for the controlled, regional infusion of diagnostic agents, such as contrast media and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature. It is not intended for use in the coronary vasculature. The Spinnaker Infusion Catheter is Contraindicated for use with any other occlusion oils. Note: Compatibility testing has been conducted with the Berenstein Liquid Coil -10 only.

Device Story

Single lumen infusion catheter; graded shaft stiffness (flexible tip to semi-rigid proximal section) for navigation through distal, tortuous vasculature. Features HYDROLENE hydrophilic coating to reduce friction. Includes stylet with torque device for rigidity during introduction and steam shaping mandrel for distal end customization. Radiopaque tip and body for fluoroscopic visualization. Used by physicians in clinical settings to access peripheral and neuro vasculature. Facilitates controlled infusion of contrast media and specific liquid coils. Benefits include improved access to difficult anatomy and precise delivery of diagnostic/therapeutic agents.

Clinical Evidence

Bench testing only. Performance testing included flow rate measurements, tip flexibility, tensile strength, static rupture, and coefficient of friction. Biocompatibility testing was performed to support safety claims.

Technological Characteristics

Single lumen catheter with graded shaft stiffness. Materials include HYDROLENE hydrophilic surface coating. Features include luer fitting, radiopaque tip/body, stylet with torque device, and steam shaping mandrel. Dimensions vary by catalog number (lengths 60-165 cm).

Indications for Use

Indicated for patients requiring access to distal, tortuous peripheral and neuro vasculature for controlled, regional infusion of diagnostic agents (contrast media) and Berenstein Liquid Coil-10. Contraindicated for use in coronary vasculature and with occlusion oils other than Berenstein Liquid Coil-10.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• Balt Magic Infusion Catheter (K923368)
• Zephyr Infusion Catheter (K921247)

Submission Summary (Full Text)

{0}

03/24/97 MON 10:59 FAX [phone] TARGET FREMONT 004
K965189 MAR 24 1997

# TARGET
## THERAPEUTICS

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance
with the requirements of SMDA 1990 and 21 CFR 807.92.

## CONTACT PERSON:

- Laraine Pangelina
Sr. Manager, Regulatory Affairs
Target Therapeutics, Inc.
47201 Lakeview Blvd.
Fremont, CA 94538-6530

## DEVICE NAME:

SPINNAKER™ Infusion Catheter, Class II

## DEVICE DESCRIPTION:

Spinnaker Infusion Catheter is a single lumen device with a graded shaft stiffness, ranging
from a highly flexible tip to a semi-rigid proximal section that allows ease of advancement by
the physician. A lure fitting located on the catheter hub is used for the attachment of
accessories. Spinnaker is manufactured with HYDROLENE®, a hydrophilic surface coating
that reduces friction during manipulation in the vessel.

The Spinnaker Infusion Catheter will be made available as a system consisting of a Spinnaker
Infusion Catheter, a stylet with a torque device attached, and a steam shaping mandrel.

## INDICATIONS FOR USE:

The Spinnaker is indicated for use in facilitating access through distal, tortuous vasculature,
and may be used for the controlled, regional infusion of diagnostic agents, such as contrast media
and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature. It
is not intended for use in the coronary vasculature.

The Spinnaker Infusion Catheter in Contraindicated for use with any other occlusion oils.

Note: Compatibility testing has been conducted with the Berenstein Liquid Coil -10 only.

## PREDICATE DEVICE:

- Balt Magic Infusion Catheter, K923368
- Zephyr Infusion Catheter, K921247

## TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION:

Substantial equivalence is based on the fact that the Spinnaker has similar technological
characteristics and intended use as the predicate devices. The results of performance testing
(flow rates, tip flexibility, tensile, static rupture, and coefficient of friction) and
Biocompatibility testing support the claim of substantial equivalence to the predicate device.
Results of the performance and Biocompatibility testing in conjunction with the substantial
equivalence claims as outlined in this premarket notification, effectively demonstrate that the
Spinnaker is substantially equivalent to the predicate devices.

{1}

03/24/97 MON 10:59 FAX [phone]
TARGET FREMONT
003

# DEVICE DESCRIPTION

SPINNAKER with HYDROLENE Infusion Catheter (SPINNAKER) is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guiding catheter. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section allows ease of advancement by the physician. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip and body facilitate fluoroscopic visualization. SPINNAKER is manufactured with HYDROLENE, a hydrophilic surface that reduces friction during manipulation in the vessel. The stylet accompanying the SPINNAKER is used to increase rigidity of the distal section during introduction into the guiding catheter. The steam shaping mandrel packaged with the SPINNAKER is used when the physician desires to shape the catheter's distal end.

# INTENDED USE

The Spinnaker is indicated for use in facilitating access through distal, tortuous vasculature, and may be used for the controlled, regional infusion of diagnostic agents, such as contrast media and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature. It is not intended for use in the coronary vasculature.

The Spinnaker Infusion Catheter is Contraindicated for use with any other occlusion oils.

Note: Compatibility testing has been conducted with the Berenstein Liquid Coil -10 only.

Table 1 SPINNAKER Infusion Catheter

| | SPINNAKER Catheter Lengths (cm) | | | | Approximate Flow Rates at 100 psi (690 kPa) (cc/sec) | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| SPINNAKER Catalog No. | Proxi. Section (cm) | Mid Section (cm) | Distal Section (cm) | Total Length (cm) | Dead Space Volume (cc) | Water | 60% Ionic Contrast | 76% Ionic Contrast |
| 191601 | 30 | 20 | 10 | 60 | .17 | .75 | .23 | .11 |
| 191010 | 120 | 25 | 10 | 155 | .37 | .37 | .10 | .05 |
| 191020 | 120 | 25 | 20 | 165 | .40 | .42 | .11 | .05 |

# POTENTIAL COMPLICATIONS

Potential complications include, but are not limited to: hematoma at the site of entry, vessel perforation, emboli, hemorrhage, ischemia, vasospasm, neurological deficits including stroke and death.