SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE
K960657 · Scimed Life Systems, Inc. · DQX · Apr 29, 1996 · Cardiovascular
Device Facts
| Record ID | K960657 |
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| Device Name | SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE |
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| Applicant | Scimed Life Systems, Inc. |
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| Product Code | DQX · Cardiovascular |
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| Decision Date | Apr 29, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 870.1330 |
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| Device Class | Class 2 |
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Intended Use
The SCIMED ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
Device Story
Steerable PTCA guide wires; 0.014-inch diameter; 190, 182, or 300 cm lengths. Distal 35 cm features stainless steel core wire, radiopaque polymer jacket, and ICE hydrophilic coating. Proximal section coated with PTFE or FEP. Extra Support models feature specific core wire taper lengths (2.25 or 3.5 inches) to provide increased support. Used by physicians during intravascular interventional procedures to navigate and exchange therapeutic devices. 182 cm version includes magnetic proximal section for use with SCIMED Magnet Exchange Device; 300 cm version allows exchange without additional docking systems. Disposable, single-use, sterile.
Clinical Evidence
Bench testing only. Evaluation included tip tensile, torsion, combined load, flexibility, torque response, and J-Tip curve retention. Results verified that the Extra Support and Extra Support Long Taper models met all minimum requirements.
Technological Characteristics
Materials: stainless steel core, radiopaque polymer jacket, ICE hydrophilic coating, PTFE/FEP proximal coating. Dimensions: 0.014-inch diameter; 190, 182, 300 cm lengths. Taper lengths: 2.25 inches (Extra Support) or 3.5 inches (Extra Support Long Taper). Sterilization: sterile, single-use. Mechanical sensing/actuation: steerable wire for catheter delivery.
Indications for Use
Indicated for facilitating placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. Not for use in cerebral vasculature.
Regulatory Classification
Identification
A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
Special Controls
*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Predicate Devices
- SCIMED ChoICE PT Exchange PTCA Guide Wire
- SCIMED ChoICE PT Plus PTCA Guide Wire
- SCIMED ChoICE PT PTCA Guide Wire
Reference Devices
- SCIMED Magnet Exchange Device
Related Devices
- K970244 — SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES · Scimed Life Systems, Inc. · Mar 28, 1997
- K032183 — IQ HYDROPHILIC GUIDE WIRE · Boston Scientific Corp · Aug 1, 2003
- K962572 — SCIMED CHOICE PT VISION PTCA GUIDE WIRE · Scimed Life Systems, Inc. · Dec 17, 1996
- K980294 — ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING · Guidant Corp. · Apr 24, 1998
- K980360 — SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES · Scimed Life Systems, Inc. · Apr 29, 1998
Submission Summary (Full Text)
{0}
K960657
SCIMED LIFE SYSTEMS, INC.
APR 29 1996
# SECTION TWO
## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
(Pursuant To Section 12 of the 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: Connie J. Del Toro
(612) 494-2656
Classification Name: Catheter Guide Wire
Common or Usual Name: PTCA Guide Wire
Proprietary Name:
SCIMED ChoICE™ PT Exchange
Extra Support PTCA Guide Wire
SCIMED ChoICE™ PT Exchange
Extra Support Long Taper PTCA Guide Wire
SCIMED ChoICE™ PT Plus
Extra Support PTCA Guide Wire
SCIMED ChoICE™ PT Plus
Extra Support Long Taper PTCA Guide Wire
SCIMED ChoICE™ PT
Extra Support PTCA Guide Wire
SCIMED ChoICE™ PT
Extra Support Long Taper PTCA Guide Wire
## II. Name of Predicate Devices:
SCIMED ChoICE™ PT Exchange PTCA Guide Wire
SCIMED ChoICE™ PT Plus PTCA Guide Wire
SCIMED ChoICE™ PT PTCA Guide Wire
Corporate Headquarters
One SCIMED Place
Maple Grove, MN 55311-1566 USA
612-494-1700
{1}
SCIMED LIFE SYSTEMS, INC.
## III. Device Description:
The ChoICE PT, ChoICE PT Plus, and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are steerable guide wires available in nominal diameters of 0.014 inches and nominal lengths of 190, 182 and 300 centimeters. The magnetic proximal section of the 182 cm length is designed to facilitate exchange of devices when used with SCIMED's Magnet Exchange Device. The 300 cm length allows exchange of therapeutic devices without the use of other exchange devices, e.g., docking systems or extension wires. The distal 35 centimeters on the entire ChoICE PT family of guide wires contains a stainless steel core wire that is jacketed with a radiopaque polymer and coated with ICE™ Hydrophilic Coating. The distal two centimeters of the guide wire are straight shapeable or available in a pre-formed J-Tip. The proximal wire is coated with either polytetrafluoroethylene (PTFE) or fluorinated ethylene propylene (FEP). The distal core wire tapers have increased in thickness or length to differentiate the Extra Support and Extra Support Long Taper models from the ChoICE PT, ChoICE PT Plus, and ChoICE PT Exchange Guide Wires. The Extra Support designates a taper of 2.25 inches proximal to the distal tip, whereas the Extra Support Long Taper designates a taper of 3.5 inches proximal to the distal tip. The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper Guide Wires will be provided sterile and are intended for one procedure use only (disposable).
## IV. Intended Use:
The SCIMED ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
Corporate Headquarters
One SCIMED Place
Maple Grove, MN 55311-1566 USA
612-494-1700
{2}
SCIMED®
LIFE SYSTEMS, INC.
## V. Summary of Technological Characteristics:
The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires utilize the same materials and methods of construction as the currently marketed ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange PTCA Guide Wires. The only difference is the increase in thickness or length of the core wire tapers proximal to the tip.
## VI. Non-Clinical Test Summary:
Testing and evaluation of the guide wires included tip tensile, torsion, combined load, and flexibility. Additionally, torque response and J-Tip curve retention were determined. Test results verified that the ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires met all of the minimum requirements and are adequate for their intended use.
No additional testing was performed on the ChoICE PT and ChoICE PT Plus Extra Support and Extra Support Long Taper models as a result of their identical distal design.
The ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Extra Support and Extra Support Long Taper PTCA Guide Wires are considered to be substantially equivalent to guide wires currently marketed by SCIMED (ChoICE PT, ChoICE PT Plus and ChoICE PT Exchange Guide Wires) based on a comparison of intended use, design and the results of in vitro testing and evaluation.
Corporate Headquarters
One SCIMED Place
Maple Grove, MN 55311-1566 USA
612-494-1700
