MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING

K020340 · Guidant Corp. · DQX · Mar 1, 2002 · Cardiovascular

Device Facts

• Record ID: K020340
• Device Name: MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING
• Applicant: Guidant Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 1, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

Guide wire used to facilitate placement of balloon dilatation catheters and stents during PTCA/PTA procedures. Device consists of 0.014" diameter stainless steel core wire with tapered distal segment; tip coil provides radiopacity. Distal 30 cm features polyurethane jacket with hydrophilic coating; proximal section coated with PTFE. Available in 175 cm, 190 cm (extendable), and 300 cm (exchange) lengths. Used by physicians in clinical settings (e.g., cath lab) to navigate vasculature. Proximal end compatible with guide wire extensions for catheter exchange. Device provides mechanical support and guidance for interventional tools, potentially improving procedural success and patient outcomes.

Clinical Evidence

Bench testing only. Verification testing demonstrated that the device meets established acceptance criteria and performs in a manner equivalent to the predicate device.

Technological Characteristics

0.014" diameter guide wire; stainless steel core; tungsten material; polyurethane jacket with hydrophilic coating; PTFE proximal coating; radiopaque tip coil; 175 cm, 190 cm, and 300 cm lengths. Sterilization and packaging identical to predicate.

Indications for Use

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

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 (K002206)
• HI-TORQUE WHISPER™ LS and MS Guide Wires (K013092)

Submission Summary (Full Text)

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MAR 1 2002

K02D340

### 510(k) SUMMARY

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

| Submitter's Name: | Guidant Corporation<br>Vascular Intervention |
|-----------------------------|----------------------------------------------|
| Submitter's Address: | 26531 Ynez Road<br>Temecula, CA 92591 |
| Telephone:<br>Fax: | [phone]<br>[phone] |
| Contact Person: | Jennifer Pae Riggs |
| Date Prepared: | January 25, 2002 |
| Device Trade Name: | HI-TORQUE WHISPER™ LS and MS |
| Device Common Name: | Guide Wire |
| Device Classification Name: | Guide Wire Catheter |
| Device Classification: | Class II |

## Summary of Substantial Equivalence:

The design, materials, method of delivery and intended use features of the HI-TORQUE WHISPER™ LS and MS Guide Wires are substantially equivalent with regard to these features in their predicate device, the HI-TORQUE WHISPER™ LS and MS Guide Wires (K002206, August 24, 2000 and K013092, December 13, 2001).

#### Device Description:

The HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrocoat Hydrophilic Coating are guide 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 190 cm models are tapered to fit into the hypotube portion 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

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segment tapers in diameter to the tip. Attached to the distal core is a tip coil that provides radiopacity. The distal 30 cm of the core wire is jacketed with a polyurethane coating that is coated with a hydrophilic coating. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J".

#### Intended Use:

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

#### Technological Characteristics:

Comparisons of the proposed and predicate device show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed predicate device. The only change is the new tungsten material.

#### Performance Data:

The results of the verification testing demonstrate that the HI-TORQE WHISPER™ LS and MS Guide Wires meet the established acceptance criteria and performs in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during the testing program.

#### Conclusions:

The HI-TOROUE WHISPER™ LS and MS Guide Wires with the new material has the same intended use, technological characteristics, performance properties, identical sterilization and substantially equivalent materials. Therefore, there are no new safety or effectiveness issues. The HI-TORQUE WHISPER™ LS and MS Guide Wires with the new material are substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2002

Ms. Jennifer Pae Riggs Guidant Corporation 26531 Ynez Road Temecula, CA 92591-4628

Re: K020340

HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrophilic Coating Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II (two) Product Code: DQX Dated: January 31, 2002 Received: February 1, 2002

Dear Ms. Riggs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Jennifer Pae Riggs

comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Hot Crequirements (1); good manufacturing practice requirements as set CI N Far 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quind) byovisions (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) This letter wification. The FDA finding of substantial equivalence of your device to a legally premated notificated wice 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 11 you doelly 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -Compinatee at (301) 594-666 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 Ource goneral 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,

Lhe

Bram 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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# Indications for Use Statement 510(k) Number K020340 (if known) HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrophilic Device Name Coating To facilitate the placement of balloon dilatation catheters during percutaneous Indications for transluminal coronary angioplasty (PTCA) and percutaneous transluminal Use angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Over-The-Counter Use_ Prescription Use OR (Per 21 CFR 801.109) Division of Cardiovascular & Respiratory Devices
510(k) Number _ 1/202 C C 340 510(k) Number