HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE

K060449 · Guidant Corporation · DQX · May 30, 2006 · Cardiovascular

Device Facts

• Record ID: K060449
• Device Name: HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE
• Applicant: Guidant Corporation
• Product Code: DQX · Cardiovascular
• Decision Date: May 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

To facilitate the placement of interventional percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) catheters, and other interventional devices including: intravascular stents, intravascular ultrasound devices and intravascular drug eluting stents.

Device Story

Steerable guide wires (0.014" diameter; 190 cm or 300 cm lengths) designed to facilitate placement of interventional catheters and devices (stents, IVUS) in coronary and peripheral vasculature. Distal segment features Hydrocoat hydrophilic coating to reduce friction; proximal end features PTFE and Microglide coating. Distal tip available in straight shapeable or pre-shaped 'J' configurations. Used by clinicians in interventional settings to navigate vasculature for device delivery.

Clinical Evidence

Bench testing only. In vitro performance evaluations demonstrated that the Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires meet acceptance criteria and perform comparably to the predicate device.

Technological Characteristics

Steerable guide wire; 0.014" max diameter; 190 cm/300 cm lengths. Materials: Hydrocoat hydrophilic coating (distal), PTFE and Microglide coating (proximal). Distal tip: straight shapeable or pre-shaped 'J'.

Indications for Use

Indicated for patients undergoing interventional percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) procedures requiring the placement of catheters, intravascular stents, intravascular ultrasound devices, or drug-eluting 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

• ACS 0.014" Hi-Torque Floppy PATHFINDER™ Guide Wire (K914638)

Submission Summary (Full Text)

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Koboyy9

MAY 30 2006

## SECTION 7.0

### 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 |
|--------------------------------|------------------------------------------------|
| | Vascular Intervention |
| 2. Submitter's Address: | 26531 Ynez Road, Temecula, CA 92591 |
| 3. Telephone: | [phone] |
| 4. Fax: | [phone] |
| 5. Contact Person: | Jennifer Pae Riggs |
| 6. Date Prepared: | February 17, 2006 |
| 7. Device Trade Name: | HI-TORQUE ADVANCE™ and ADVANCE LITE™ |
| | Guide Wires with Hydrocoat Hydrophilic Coating |
| 8. Device Common Name: | Guide Wire |
| 9. Device Classification Name: | Catheter Guide Wire (74DQX) |
| 10. Predicate Device: | ACS 0.014" Hi-Torque Floppy PATHFINDER™ |
| | Guide Wire (cleared November 4, 1991) |

#### 11. Device Description:

The Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires are steerable guide wires available in a maximum diameter of 0.0140" and in lengths of 190 cm DOC® extendable length and a 300 cm exchange length. The distal segment of the guide wire is coated with Hydrocoat to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal end of the guide wire is coated with polytetrafluorethylene (PTFE) and Microglide, which reduces friction of the wire within a catheter.

### 12. Intended Use:

To facilitate the placement of interventional percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) catheters, and other interventional devices including: intravascular stents, intravascular ultrasound devices and intravascular drug eluting stents.

13. Technological Characteristics:

Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate device.

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14. Performance Data:

In vitro bench testing performance evaluations demonstrated that the Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires meet the acceptance criteria and performed comparable to the predicate device. No new safety or effectiveness issues were raised during the testing program and therefore, the Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires may be considered substantially equivalent to the predicate device.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three wavy lines below it, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 30 2006

Guidant Corp. c/o Ms. Jennifer Pae Riggs Principal Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92591

K060449 Re:

Hi-Torque (HT) ADVANCE™ and ADVANCE LITE™ Guide Wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: May 8, 2006 Received: May 9, 2006

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.

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### Page 2 - Ms. Jennifer Pae Riggs

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 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]. 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 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/industry/support/index.html.

Sincerely yours.

Duma R- lochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health 11.00

Enclosure

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# INDICATION FOR USE K 06 0449

510(k) Number (if known):

Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires Device Names:

To facilitate the placement of interventional percutaneous Indications for Use: transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) catheters, and other interventional devices including: intravascular stents, intravascular ultrasound devices and intravascular drug eluting stents.

Prescription Use X (Per 21 CFR 801.109)

OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suana D. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Ko 60449

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