HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG

K030549 · Guidcorp · DQX · May 14, 2003 · Cardiovascular

Device Facts

• Record ID: K030549
• Device Name: HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG
• Applicant: Guidcorp
• Product Code: DQX · Cardiovascular
• Decision Date: May 14, 2003
• 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.

Device Story

HI-TORQUE PILOT guide wires (50, 150, 200 models) facilitate placement of balloon dilatation catheters and stents during PTCA/PTA procedures. Device features 0.014" diameter, varying tip stiffness, and lengths of 175cm, 190cm, or 300cm. Distal tips available in straight (shapeable) or pre-shaped J configurations. Proximal section coated with PTFE; distal polyurethane-covered area features Hydrocoat hydrophilic coating. Brachial and femoral markers indicate guide wire position relative to guide catheter. Used by physicians in clinical settings (e.g., cath lab) to navigate vasculature, providing support and trackability for interventional devices. Benefits include improved access to target lesions and procedural convenience.

Clinical Evidence

Bench testing only. Verification testing demonstrated that the HI-TORQUE PILOT Guide Wires met established acceptance criteria and performed in a manner equivalent to the predicate device.

Technological Characteristics

Guide wire with 0.014" diameter; available in 175cm, 190cm, and 300cm lengths. Materials include PTFE (proximal) and polyurethane with Hydrocoat hydrophilic coating (distal). Features varying tip stiffness (50, 150, 200 models) and straight or pre-shaped J-tip options. Includes proximal brachial and femoral markers. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) requiring the placement of balloon dilatation catheters and 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 MS Guide Wire with Hydrocoat Hydrophilic Coating (K002206, K013092, K020340)

Submission Summary (Full Text)

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# Appendix A – 510(k) Summary

| Submitter | Guidant Corporation, Vascular Intervention |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's<br>Address | 26351 Ynez Road<br>Temecula, CA 92591 |
| Telephone | [phone] |
| Fax | [phone] |
| Contact Person | Stacey Brown |
| Date Prepared | February 20, 2003 |
| Device Trade<br>Name | HI-TORQUE PILOT™ 50 Guide Wire with Hydrocoat Hydrophilic Coating<br>HI-TORQUE PILOT™ 150 Guide Wire with Hydrocoat Hydrophilic Coating<br>HI-TORQUE PILOT™ 200 Guide Wire with Hydrocoat Hydrophilic Coating |
| Device<br>Common Name | Guide Wire |
| Device<br>Classification<br>Name | Guide Wire Catheter |
| Device<br>Classification | Class II |
| Summary of<br>substantial<br>equivalence | The design, materials, method of delivery and intended use features of the<br>HI-TORQUE PILOT™ Guide Wires with Hydrocoat Hydrophilic Coating are<br>substantially equivalent with regard to these features in the predicate device,<br>the HI-TORQUE WHISPER™ MS Guide Wire with Hydrocoat Hydrophilic<br>Coating (K002206, August 24, 2000; K013092, December 13, 2001; and<br>K020340, March 1, 2002). |

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| Device<br>description | The HI-TORQUE PILOT™ Guide Wire with Hydrocoat Hydrophilic<br>Coating is a guide wire with a maximum diameter of 0.0140" and is available<br>in 175 cm and 190cm extendable lengths and a 300 cm exchange length. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | There are three HI-TORQUE PILOT™ Guide Wire designs with varying<br>tip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150,<br>and HI-TORQUE PILOT™ 200 Guide Wires). |
| | The distal tip of the guide wire is available either as a straight tip that is<br>shapeable, or as a pre-shaped "J". The straight shape allows the physician<br>to shape the tip according to his/her preference; the J shapes provide the<br>physician the convenience of a J shape without manual shaping. Brachial<br>and femoral markers are located on the proximal segment of the 190 cm<br>and 300 cm guide wires to indicate when the tip of the guide wire is about<br>to exit the guide catheter. |
| | The proximal section of the wire is coated with polytetrafluroethylene<br>(PTFE). The distal, polyurethane-covered area, of the wire is coated with<br>hydrocoat hydrophilic coating. |
| Intended Use | To facilitate the placement of balloon dilatation catheters during percutaneous<br>transluminal coronary angioplasty (PTCA) and percutaneous transluminal<br>angioplasty (PTA) and compatible stent devices. |
| Technological<br>characteristics | The HI-TORQUE PILOT™ Guide Wire incorporates the same fundamental<br>scientific technology as the predicate device. |
| Performance<br>data | The results of the verification testing demonstrate that the HI-TORQUE<br>PILOT™ Guide Wires meet the established acceptance criteria and performs<br>in a manner equivalent to the predicate device. No new safety or effectiveness<br>issues were raised during the testing program. |

・・・・・・・・・

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 1 4 2003

Guidant Corporation Ms. Stacey Brown Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92591-4628

Re: K030549

Trade/Device Name: HI-TOROUE PILOT™ Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: April 15, 2003 Received: April 16, 2003

Dear Ms. Brown:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Stacey Brown

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), 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) you may obtain. 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,

Bram D. Zuckerman, M.D.

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

Enclosure

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,

## Appendix B – Indications for Use Statement

| 510(k) number (if known) | K030549 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | HI-TORQUE PILOT ^TM 50 Guide Wire with Hydrocoat Hydrophilic Coating<br>HI-TORQUE PILOT ^TM 150 Guide Wire with Hydrocoat Hydrophilic Coating<br>HI-TORQUE PILOT ^TM 200 Guide Wire with Hydrocoat Hydrophilic Coating |
| 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. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-The-Counter Use | |
|----------------------|-----------------------------------------------------------|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |
| | (Division Sign-Off)<br>Division of Cardiovascular Devices | | | |
| 510(k) Number | K030549 | | | |