SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES

K980360 · Scimed Life Systems, Inc. · DQX · Apr 29, 1998 · Cardiovascular

Device Facts

• Record ID: K980360
• Device Name: SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The SCIMED Quest Floppy and Moderate Support 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 Quest Floppy and Moderate Support 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 guide wire; 0.014-inch diameter; 182 or 300 cm length; Floppy or Moderate Support tip options; distal 2 cm radiopaque; straight or J-tip configurations. Used in clinical settings by physicians to facilitate placement/exchange of balloon dilatation catheters or therapeutic devices during PTCA or intravascular interventions. Device provides mechanical support and navigation through vasculature to target site; enables catheter delivery. Sterile, single-use device.

Clinical Evidence

Bench testing only. Evaluated tip tensile strength, tip torsion strength, combined load strength, tip flexibility, tip prolapse, J-tip curve retention, torque response, proximal spring coil joint shear strength, PTCA catheter compatibility/wire movement, and lubricious coating adherence.

Technological Characteristics

Steerable guide wire; 0.014-inch diameter; 182/300 cm lengths; radiopaque distal tip; straight or J-tip; lubricious coating. Materials and construction methods identical to predicate SCIMED ChoICE, Luge, and Sceptor lines. Sterile, single-use.

Indications for Use

Indicated for patients undergoing PTCA or other intravascular interventional procedures requiring placement and exchange of balloon dilatation catheters or therapeutic devices. 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

• ChoICE (K943192, K945129, K950113, K950141, K961015, K964551, K965023, K970244)
• Luge Guide Wire (K973945)
• Sceptor and Sceptor Exchange (K942333, K946240, K950534, K960563)

Submission Summary (Full Text)

{0}------------------------------------------------

## APR 2 9 1998

510(k) Notification SCIMED® Quest™ Guide Wires

# 1980560

## Summary of Safety and Effectiveness

### Section 4

### (Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)

| General Provisions | Submitter's Name and Address | SCIMED Life Systems, Inc.<br>One SCIMED Place<br>Maple Grove, MN 55311 |
|------------------------------|------------------------------|------------------------------------------------------------------------------------------------------|
| | Contact Person | Jill Townsend<br>[phone] |
| | Classification Name | Catheter Guide Wire |
| | Common or Usual Name | PTCA Guide Wire |
| | Proprietary Name | SCIMED ® Quest ™ Floppy and<br>Moderate Support Guide Wires |
| Name of Predicate<br>Devices | Predicate Device | 510(k) Reference No.<br>K943192, K945129, K950113,<br>K950141, K961015, K964551,<br>K965023, K970244 |
| | Luge Guide Wire | K973945 |
| | Sceptor and Sceptor Exchange | K942333, K946240, K950534,<br>K960563 |

{1}------------------------------------------------

్టేటు వ

## Summary of Safety and Effectiveness, continued

| Device Description | The SCIMED Quest Floppy and Moderate Support Guide Wires are<br>steerable guide wires available in a nominal diameter of 0.014 inches<br>and nominal lengths of 182 and 300 centimeters. The available tip<br>flexibilities will be Floppy and Moderate Support. The distal two<br>centimeters of both models are radiopaque and available in either a<br>straight shapeable or a pre-formed J-Tip. |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SCIMED Quest Floppy and Moderate Support Guide Wires are<br>intended to facilitate the placement and exchange of balloon<br>dilatation catheters or other therapeutic devices during PTCA or other<br>intravascular interventional procedures. The Quest Floppy and<br>Moderate Support Guide Wires are not intended for use in the<br>cerebral vasculature. The devices are provided sterile and intended<br>for one procedure only. |
| Summary of<br>Technological<br>Characteristics | The SCIMED Quest Floppy and Moderate Support Guide Wires<br>utilize the same materials and methods of construction as the<br>currently marketed SCIMED Guide Wires (ChoICE, Luge and<br>Sceptor Families of Guide Wires). |
| Non-Clinical Test<br>Summary | Testing and evaluation of the guide wires included tip tensile<br>strength, tip torsion strength, combined load strength, tip flexibility,<br>tip prolapse, J-tip curve retention, torque response, proximal spring<br>coil joint shear strength, PTCA catheter compatibility/wire movement<br>and lubricious coating adherence. Shelf Life testing is currently<br>being conducted and will be submitted when it is completed. |

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

APR 2 9 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jill Townsend Requlatory Affairs Associate SCIMED Life Systems, Incorporated One SCIMED Place Maple Grove. MN 55311-1566

Re : K980360 SCIMED® Quest™ and Zig Zag Guide Wires Trade Name: Regulatory Class: II Product Code: DOX Dated: March 17, 1998 Received: March 18, 1998

Dear Ms. Townsend:

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 leqally marketed predicate 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions.. Failure to comply with the GMP requlation may result in 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

{3}------------------------------------------------

Page 2 - Ms. Jill Townsend

obligation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

. Sincerely yours,

Thomas J. Callahan, M.D.

Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Notification SCIMED® Quest™ Guide Wires

#### Indications for Use

| 510(k) Number | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SCIMED® Quest™ Guide Wires |
| Indications for Use | <p>The SCIMED Quest Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Quest Guide Wires are not intended for use in the cerebral vasculature.</p> |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ----

Concurrence of CDRH, Office of Device Evaluation (ODE) Over The Counter Use_ OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) 101 (Nusion Sign-Off) ് T ar urbin and Devices ﺘﺮ ్లా 4KI Number ___________________________________________________________________________________________________________________________________________________________________ 180360