HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

K013092 · Guidant Corp. · DQX · Dec 13, 2001 · Cardiovascular

Device Facts

• Record ID: K013092
• Device Name: HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• Applicant: Guidant Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

Device Story

HI-TORQUE WHISPER LS and MS guide wires facilitate placement of balloon dilatation catheters and stents during PTCA, PTA, and therapeutic intravascular procedures. Device features 0.014" diameter, available in 175 cm, 190 cm, and 300 cm lengths. Construction includes stainless steel core wire with tapered distal segment, tip coil, and polyurethane jacket with hydrophilic coating. Proximal end compatible with ACS DOC Guide Wire Extension for length adjustment during catheter exchanges. Available with straight shapeable or pre-shaped J-tips. Used by physicians in clinical settings to navigate vasculature for interventional device delivery.

Clinical Evidence

Bench testing only. In vitro testing demonstrated that the guide wires met all acceptance criteria.

Technological Characteristics

0.014" diameter guide wire; stainless steel core wire; polyurethane jacket with hydrophilic coating; tip coil; straight shapeable or pre-shaped J-tip configurations; compatible with ACS DOC Guide Wire Extension.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA), or therapeutic intravascular procedures requiring the placement of balloon dilatation catheters or compatible stent devices.

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

• HI-TORQUE WHISPER LS and MS Guide Wires with Hydrocoat Hydrophilic Coating (K002206)

Submission Summary (Full Text)

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## DEC 1 3 2001

K013092

#### 510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the SMDA of 1990.

| 1. Submitter's Name: | Guidant Corporation<br>Vascular Intervention |
|--------------------------------|------------------------------------------------------------------------------------------|
| 2. Submitter's Address: | 26531 Ynez Road |
| 3. Telephone: | [phone] |
| 4. Fax: | [phone] |
| 5. Contact Person: | Jennifer Pae Riggs |
| 6. Date Prepared: | September 14, 2001 |
| 7. Device Trade Name: | HI-TORQUE WHISPER™ LS and MS Guide Wires<br>with Hydrocoat Hydrophilic Coating |
| 8. Device Common Name: | Guide Wire |
| 9. Device Classification Name: | Catheter Guide Wire (74DQX) |
| 10. Predicate Device: | HI-TORQUE WHISPER™ LS and MS Guide Wires<br>with Hydrocoat Hydrophilic Coating (K002206) |

#### 11. Device Description:

The HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrocoat Hydrophilic The II - Ore Quide wires with a 0.014" diameter and available in 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 175 cm and extendable lengths and a 500 em enemange compression of the ACS DOC® Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The wires are constructed with a stainless steel core wire. The proximal section of the core wire has a constant diameter and the distal core segment tapers in diameter to the tip. Attached to the distal core is a tip coil that provides tapes in diamover to the up. Thathew re- wire is jacketed with a polyurethane coating that is coated with a hyrophilic coating. The proximal section of the wire is coated with 13 couted with a hyropinias countal tips of the guide wires are available either as a straight tip that is shapeable, or as a pre-shaped "J".

#### 12. Intended Use:

To facilitate the placement of balloon dilatation catheters during percutaneous ro raomate the pracement of one of CA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.

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### 13. Technological Characteristics:

There are no changes to the technological characteristics.

14. Performance Data:

In vitro bench testing demonstrated that the HI-TORQUE WHISPER™ Guide Wires met
the acceptance criteria and is acceptable for clinical use.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2001

Ms. Jennifer Pae Riggs Sr. Regulatory Affairs Coordinator Guidant Corporation 26531 Ynez Road Temecula, CA 92589-9018

K013092 Re:

K013092
HI-TORQUE™ WHISPER LS and MS Guide Wires with Hydrocoat Hydrophilic Coating Regulation Number: 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: September 14, 2001 Received: September 17, 2001

Dear Ms. Riggs:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 910(x) premained is substantially equivalent (for the indications felerenced above and nave determined the arredicate devices marketed in interstate for use stated in the ciclosure) to regally names of the Medical Device Amendments, or to commence prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been icclassified in acceraanse was a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA and Cosment Act (Act) that to not requent of the general controls provisions of the Act. The I ou may, merciolo, market the act include requirements for annual registration, listing of general controls provisions of the reviles, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it IT your device is classified (500 a0010) als. Existing major regulations affecting your device can inay be subject to suen additional connections, Title 21, Parts 800 to 898. In addition, FDA may or found in the Oous cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least of advised that I Dris issualites our device complies with other requirements of the Act that I DT has made a active and regulations administered by other Federal agencies. You must of any I cacial statutes and regaranents, including, but not limited to: registration and listing (21 compy with an tale 110 (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Jennifer Pae Riggs

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

K. Donka Telle

am Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATION FOR USE STATEMENT

KO13092 510(k) Number (if known): _ HI-TORQUE WHISPER™ LS (Light Support) Guide Wire with Device Names: . Hydrocoat Hydrophilic Coating

- HI-TORQUE WHISPER™ MS (Middle Support) Guide Wire . with Hydrocoat Hydrophilic Coating
To facilitate the placement of balloon dilatation catheters during Indications PTCA), percutaneous transluminal coronary angioplasty (PTCA), for Use: percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K015092

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter_ (Optional Format 1-1-96)