CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID

K964551 · Scimed Life Systems, Inc. · DQX · May 21, 1997 · Cardiovascular

Device Facts

Record IDK964551
Device NameCHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID
ApplicantScimed Life Systems, Inc.
Product CodeDQX · Cardiovascular
Decision DateMay 21, 1997
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.1330
Device ClassClass 2

Intended Use

The ChoICE Super Support and Super Support II Guide Wire models 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 Guide Wire family is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

Device Story

Steerable PTCA guide wire; 0.014" diameter; straight shapeable or pre-formed J-tip configurations. Features polymer sleeve over tapered core wire; ICE Hydrophilic Coating. Used by physicians during PTCA or intravascular interventional procedures to navigate and position therapeutic devices (e.g., balloon catheters). Facilitates access to target anatomy; provides support for device exchange. Sterile, single-use device.

Clinical Evidence

Bench testing only. Testing included tip tensile, tip torsion, combined load, tip flexibility, J-tip curve retention, torque response, and proximal spring coil joint shear strength. Results confirmed device met all minimum requirements.

Technological Characteristics

0.014" diameter steerable guide wire; polymer sleeve; fluorinated polymer coated core wire; ICE Hydrophilic Coating. Materials and construction methods consistent with predicate ChoICE family. Variations include distal core wire tapers and reduced polyurethane sleeve length. Sterile, single-use.

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} 510(k) Notification SCIMED ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires K964551 SCIMED Boston Scientific Corporation SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, MN 55311-1566 612·494·1700 MAY 21 1997 # Summary of Safety and Effectiveness ## Section 6 ### Submitter's Information **Name and Address** SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, Minnesota 55311 **Contact Person** Connie J. Del Toro (612) 494-2656 **Date** November 12, 1996 ### Device Name **Proprietary Name** SCIMED ChoICE Super Support PTCA Guide Wire SCIMED ChoICE Plus Super Support PTCA Guide Wire SCIMED ChoICE Exchange Super Support PTCA Guide Wire SCIMED ChoICE Super Support II PTCA Guide Wire SCIMED ChoICE Plus Super Support II PTCA Guide Wire SCIMED ChoICE Exchange Super Support II PTCA Guide Wire **Common or Usual Name** PTCA Guide Wire **Classification Name** Catheter Guide Wire (per 21CFR 870.1330) Continued on next page. {1} 510(k) Notification SCIMED ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires SCIMED Boston Scientific Corporation SCIMED Life Systems, Inc. # Summary of Safety and Effectiveness, continued ## Section 6 ### Predicate Devices The ChoICE Super Support and Super Support II Guide Wire models are substantially equivalent to the following SCIMED products. | Product | 510(k) | Clearance Date | | --- | --- | --- | | ChoICE | K943192 | November 22, 1994 | | | K950141 | March 3, 1995 | | | K961015 | May 15, 1996 | | ChoICE Plus | K945129 | March 3, 1995 | | | K961015 | May 15, 1996 | | ChoICE Exchange | K950113 | March 31, 1995 | | | K961015 | May 15, 1996 | | ChoICE PT Vision | K962572 | Currently under review. | ### Device Description The ChoICE Super Support and Super Support II Guide Wire models are steerable guide wires available in a nominal diameter of 0.014" and two tip configurations, straight shapeable and pre-formed J-Tip. A polymer sleeve extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE Hydrophilic Coating. The available lengths for the Super Support and Super Support II Guide Wire will be: - ChoICE -190 cm, - ChoICE Plus-182 cm, and - ChoICE Exchange-300 centimeters. Continued on next page. 6-2 {2} 510(k) Notification SCIMED ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires SCIMED Boston Scientific Corporation SCIMED Life Systems, Inc. # Summary of Safety and Effectiveness, continued ## Section 6 ### Intended Use The ChoICE Super Support and Super Support II Guide Wire models 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 Guide Wire family is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only. ### Summary of Technological Characteristics The ChoICE Super Support and Super Support II Guide Wire models utilize the same materials and methods of construction as the currently marketed ChoICE Guide Wire family and the recently submitted ChoICE PT Vision Guide Wire family. The differences necessary to create the Super Support and Super Support II Guide Wire models are the slight variation of the distal core wire tapers and the reduced length of the polyurethane sleeve. ### Non-Clinical Test Summary Testing and evaluation of the guide wires included: - Tip Tensile, - Tip Torsion, - Combined Load, - Tip Flexibility, - J-Tip Curve Retention, - Torque Response, and - Proximal Spring Coil Joint Shear Strength. ### Results Test results verified that the ChoICE Super Support and Super Support II Guide Wire models met all of the minimum requirements and are adequate for their intended use. Continued on next page. 6-3 {3} 510(k) Notification SCIMED ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires SCIMED Boston Scientific Corporation SCIMED Life Systems, Inc. # Summary of Safety and Effectiveness, continued ## Section 6 **Non-Clinical Test Summary, continued** ### Summary The Super Support and Super Support II models are considered to be substantially equivalent to the currently marketed ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires and the recently submitted ChoICE PT Vision Guide Wire family, based on a comparison of intended use, design and the results of *in vitro* testing and evaluation. 6-4 {4} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 21 1997 Ms. Connie J. Del Toro Regulatory Affairs Associate Scimed Life Systems, Inc. One Scimed Place Maple Grove, Minnesota 55311-1566 Re: K964551 SCIMED® ChoICE™ PTCA Guide Wires SCIMED® ChoICE™ Plus PTCA Guide Wires SCIMED® ChoICE™ Exchange PTCA Guide Wires Super Support and Super Support II Models Regulatory Class: II (two) Product Code: DQX Dated: March 3, 1997 Received: March 4, 1997 Dear Ms. Del Toro: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in {5} regulatory action. In addition, FDA may publish further announcements concerning your device in the *Federal Register*. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597. Sincerely yours, ![img-0.jpeg](img-0.jpeg) Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6} 510(k) Notification SCIMED ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires # Indications for Use ## Section 2 | 510(k) Number | K964551 | | --- | --- | | Device Name | ChoICE PTCA Guide Wires ChoICE Plus PTCA Guide Wires ChoICE Exchange PTCA Guide Wires | | Indications for Use | The SCIMED ChoICE Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Guide Wire family is not intended for use in the cerebral vasculature. | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ☑ OR (Per 21 CFR 801.109) ☑ TWA. 1/2 OR (Division Sign-Off) Over The Counter Use ☐ (Optional Format 1-2-96) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K964551 2-1
Innolitics
510(k) Summary
Decision Summary
Classification Order
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