SCIMED DISPATCH GOLD CORONARY CATHETER

• K Number: K961294
• Device Name: SCIMED DISPATCH GOLD CORONARY CATHETER
• Manufacturer: SCIMED LIFE SYSTEMS, INC.
• Date Cleared: 1996-07-03 ( 90 days)
• Product Code: KRA
• Regulation Number: 870.1210

Intended Use

The Dispatch Gold Coronary Infusion Catheter is intended for controlled and selective infusion of solution(s), including thrombolytic agents, into the vessel.

Device Description

The Dispatch Gold Coronary Infusion Catheter is a non-dilatation, over-the-wire device designed for localized delivery of solution(s), through the openings located in the distal segment, into the selected coronary artery. The device has a single lumen shaft with a distally located inflation coil 20 mm, 30 mm or 50 mm in length. The number of coils increases with length. The inflation coil, encapsulated by a thin polyurethane sheath, may be inflated to further localize or isolate delivery to subselected vasculature. The lumen of the shaft is used to transport solutions, as well as to house an inner tube and inflation tube running the length of the shaft and situated concentrically within the lumen. The inner tube permits the use of coronary guide wires < 0.014" to advance the device through the anatomy to the intended infusion site. The distal tip is tapered to facilitate the advancement of the device through the vasculature. Radiopaque markers are located at both the proximal and distal ends of the balloon coil to assist in the placement of the device's distal assembly. Shaft locating markers are printed proximally on the outer shaft of the catheter to ensure proper placement of the distal infusion segment with respect to the guide catheter. One marker is designated by two parallel white stripes located at 100 cm and the other is designated by a single white stripe located at 90 cm from the distal tip for femoral and brachial approaches respectively. The proximal portion of the device consists of a manifold with a blue inflation port and a yellow infusion port. The inner lumen is connected to an unmarked thru port for guide wire insertion, which also has a luer lock fitting for the connection of a Y-adapter if desired.

Predicate Devices

K953133, BK940029, K950615

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical components and fluid delivery, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as being intended for "controlled and selective infusion of solution(s), including thrombolytic agents, into the vessel," which directly describes a therapeutic action (delivery of medication for treatment).

Diagnostic

No

The device is described as an infusion catheter for delivering solutions, including thrombolytic agents, into coronary arteries. Its purpose is therapeutic delivery, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with a shaft, lumen, inflation coil, ports, and radiopaque markers, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the controlled and selective infusion of solutions (including thrombolytic agents) into the vessel (coronary artery). This is a therapeutic intervention performed directly on the patient's body.
• Device Description: The description details a catheter designed for delivering substances into the coronary artery, not for analyzing samples from the body. It describes features like an inflation coil, lumens for infusion and guide wires, and radiopaque markers for placement within the vasculature.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct treatment within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Dispatch Gold Coronary Infusion Catheter is intended for controlled and selective infusion of solution(s), including thrombolytic agents, into the vessel.

Product codes

Not Found

Device Description

The Dispatch Gold Coronary Infusion Catheter is a non-dilatation, over-the-wire device designed for localized delivery of solution(s), through the openings located in the distal segment, into the selected coronary artery. The device has a single lumen shaft with a distally located inflation coil 20 mm, 30 mm or 50 mm in length. The number of coils increases with length. The inflation coil, encapsulated by a thin polyurethane sheath, may be inflated to further localize or isolate delivery to subselected vasculature. The lumen of the shaft is used to transport solutions, as well as to house an inner tube and inflation tube running the length of the shaft and situated concentrically within the lumen. The inner tube permits the use of coronary guide wires

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

K961294

Jul - 3 1996

Section Three--Summary of Safety and Effectiveness (Pursuant to Section 12, Safe Medical Devices Act of 1990) Prepared: April 3, 1996

I.	General Provisions:
	Submitter's Name and Address:	SCIMED Life Systems, Inc.
One SCIMED Place
		Maple Grove, Minnesota 55311
	Contact Person:	Deborah A. Frank
[phone]
	Classification Name:	Continuous Flush Catheter
		(21CFR870.1210)
	Common or Usual Name:	Infusion Catheter
	Proprietary Name:
Infusion	SCIMED Dispatch Gold Coronary
Catheter
	II. Name of Predicate Device(s):	SCIMED Dispatch Coronary
Infusion Catheter (K953133) and
SCIMED UltraFuse Coronary
		Infusion/Guide Wire Exchange
		Catheter (BK940029)
		LocalMed® InfusaSleeve™
		Coronary Infusion Catheter
(K950615)

III. Device Description:

The Dispatch Gold Coronary Infusion Catheter is a non-dilatation, over-the-wire device designed for localized delivery of solution(s), through the openings located in the distal segment, into the selected coronary artery. The device has a single lumen shaft with a distally located inflation coil 20 mm, 30 mm or 50 mm in length. The number of coils increases with length. The inflation coil, encapsulated by a thin polyurethane sheath, may be inflated to further localize or isolate delivery to subselected vasculature.

Image /page/0/Picture/6 description: The image shows the word "SCIMED" in large, bold, black letters. Below the word "SCIMED" is the text "Boston Scientific Corporation" in a smaller font size. The text is also in black. The image appears to be a logo or branding for a company called SCIMED, which is associated with Boston Scientific Corporation.

IMED Life Systems One SCIMED Plac Maple Grove, MN 55311-1566 6 - 194 - 100

1

Image /page/1/Picture/0 description: The image shows the logo for Scimed, a Boston Scientific Corporation. The word "SCIMED" is in large, bold, black letters at the top of the image. Below that, in smaller letters, is the text "Boston Scientific Corporation". There is a horizontal line below the text.

SCIMED Life Systems,

The lumen of the shaft is used to transport solutions, as well as to house an inner tube and inflation tube running the length of the shaft and situated concentrically within the lumen. The inner tube permits the use of coronary guide wires