(90 days)
The Dispatch Gold Coronary Infusion Catheter is intended for controlled and selective infusion of solution(s), including thrombolytic agents, into the vessel.
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.
This document describes a medical device, the SCIMED Dispatch Gold Coronary Infusion Catheter, and its comparison to existing predicate devices. It largely focuses on technical specifications and non-clinical testing to establish substantial equivalence.
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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(612) 494-2899 | |
| Classification Name: | Continuous Flush Catheter | |
| (21CFR870.1210) | ||
| Common or Usual Name: | Infusion Catheter | |
| Proprietary Name:Infusion | SCIMED Dispatch Gold CoronaryCatheter | |
| II. Name of Predicate Device(s): | SCIMED Dispatch CoronaryInfusion Catheter (K953133) andSCIMED 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
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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 < 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.
IV. Intended Use:
The Dispatch Gold Coronary Infusion Catheter is intended for controlled and selective infusion of solution(s), including thrombolytic agents, into the vessel.
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Image /page/2/Picture/0 description: The image shows the logo for SCIMED, which is a brand of Boston Scientific Corporation. The logo is in black and white, with the word "SCIMED" in large, bold letters. Below the brand name is the text "Boston Scientific Corporation" in a smaller font. The logo is simple and professional, and it is likely used on medical devices and other products manufactured by Boston Scientific.
SCIMED Life Systems, Inc
V.
Summary of Technological Characteristics:
The Dispatch Gold Coronary Infusion Catheter is a modification of the currently marketed Dispatch Coronary Infusion Catheter. The two catheters look and function alike, however the Dispatch Gold has a smaller overall outer shaft dimension and distal profile. The color of the Dispatch Gold shaft will be yellow instead of clear (natural). Other modifications include the configuration of the infusion openings and the length of the platinum marker band. The Dispatch Gold will be available in coil lengths of 20 mm. 30 mm and 50 mm with coil diameters ranging from 2.5 mm to 5.5 mm.
VI. Non-clinical Test Summary:
Testing and evaluation included infusion flow rate, inflation coil burst and distension, repeat inflation of coil assembly, catheter bond integrity and bond tensile strength, shaft diameter, inflation coil assembly profile, catheter withdrawal force and proximal mark integrity test. Test results verified that the Dispatch Gold Coronary Infusion Catheter met or exceeded all minimum requirements and is adequate for its intended use. The Dispatch Gold Coronary Infusion catheter is considered to be substantially equivalent to the currently marketed SCIMED Dispatch Coronary Infusion Catheter and the currently marketed SCIMED UltraFuse Coronary Infusion Catheter based on a comparison of intended use, design and the results of the in vitro testing and evaluation.
§ 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).