ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE

K980119 · Guidant Corp. · DQX · Mar 20, 1998 · Cardiovascular

Device Facts

• Record ID: K980119
• Device Name: ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE
• Applicant: Guidant Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.

Device Story

Steerable guide wire; 0.035-inch nominal diameter; 145, 190, and 300 cm lengths. Used by physicians during intravascular procedures to facilitate placement and exchange of diagnostic/therapeutic devices. Mechanical device; no electronic or software components. Operates via manual manipulation by clinician to navigate vasculature. Benefits include improved procedural efficiency during device exchange and placement.

Clinical Evidence

Bench testing only. Tests included distal tip pull, turns-to-failure, rotational accuracy, and tip flexibility. Results demonstrated performance equivalent to predicate Wholey Hi-Torque Standard® Guide Wire.

Technological Characteristics

Steerable guide wire; 0.035-inch diameter; 145/190/300 cm lengths. Materials, biocompatibility, and performance properties equivalent to predicate. Sterilization and packaging identical to predicate.

Indications for Use

Indicated for facilitating placement and exchange of diagnostic and therapeutic devices during intravascular procedures. Contraindicated 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

• Wholey Hi-Torque Standard® Guide Wire (K852123, K861765)
• Hi-Torque S'Port-T™ Guide Wire (K915554)
• Medi-tech Amplatz Super Stiff Guide Wire (K942382)

Submission Summary (Full Text)

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K980119

# MAR 20 1998

## 510(k) SUMMARY

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

| 1. | Submitter's Name: | Guidant Corporation |
|----|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Submitter's Address: | Advanced Cardiovascular Systems, Inc.<br>3200 Lakeside Drive<br>Santa Clara, CA 95054 |
| | Telephone: | 408-235-3995 |
| | Fax: | 408-235-3743 |
| | Contact Person: | Susan Silavin, Ph.D. |
| | Date Prepared: | January 12, 1998 |
| 2. | Device Trade Name: | ACS HI-TORQUE WHOLEY SUPRA CORE™<br>Guide Wire |
| | Device Common Name: | Guide Wire |
| | Device Classification Name: | Catheter Guide Wire (74DQX) |
| 3. | Predicate Devices: | Wholey Hi-Torque Standard® Guide Wire (K852123,<br>approved June 19, 1985 and K861765 approved May 30, 1986),<br>Hi-Torque S'Port-T™ Guide Wire (K915554, approved<br>February 9, 1993) and<br>Medi-tech Amplatz Super Stiff Guide Wire<br>(K942382, approved August 22, 1994) |

4. Device Description:

> The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is a steerable guide wire with a nominal diameter of 0.035 inches and three lengths: a 145, a 190 cm and a 300 cm exchange length.

ડ. Intended Use:

> The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures.

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- Technological Characteristics: 6.
Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties (see below), sterilization, and packaging are identical or substantially equivalent to the currently marketed predicate device.

- Performance Data: 7.
Bench testing was performed to demonstrate that the ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire met the acceptance criteria and performed similar to the predicate Wholey Hi-Torque Standard® Guide Wire. The following tests were performed:

- Distal Tip Pull Test .
- Turns-to-Failure Test .
- Rotational Accuracy Test .
- . Tip Flexibility Test

The results from the bench tests showed that the new ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire met acceptance criteria and performed in a manner equivalent to the predicate Wholey Hi-Torque Standard® Guide Wire. No new safety or effectiveness issues were raised during the testing program.

- 8. Conclusions:
Since the new guide wire has the same intended use, similar design and technological characteristics, equivalent performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire may be considered substantially equivalent to the predicate Wholey Hi-Torque Standard®, Hi-Torque S'Port-T™ and the Medi-tech Amplatz Super Stiff Guide Wires.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or a bird in flight, composed of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 20 1998

Susan Silavin, Ph.D. Senior Requlatory Affairs Coordinator Guidant Corporation Advanced Cardiovascular Systems, Inc. 3200 Lakeside Drive Santa Clara, CA 95054

510 (k) Number K980119 Re : Trade Name: ASC HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire Regulatory Class: II Product Code: DQX Dated: January 12, 1998 Received: January 13, 1998

Dear Dr. Silavin:

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 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 Requlations, 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 regulation may result in requlatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Reqister. this

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Page 2 - Dr. Silavin

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

# Device Name: ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire

Indications for Use:

The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:inline-block; vertical-align:middle;">✓</div> OR Over-The-Counter ______ |
| | (Optional Format 1-1-96) |
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory,<br>and Neurological Devices | |
| 510(k) Number | K980119 |