HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE

K021228 · Guidant Corp. · DQX · May 15, 2002 · Cardiovascular

Device Facts

• Record ID: K021228
• Device Name: HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE
• Applicant: Guidant Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: May 15, 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 wires (0.014'' diameter) used to facilitate placement of balloon dilatation catheters and stents during PTCA/PTA procedures. Available in 175 cm and 190 cm extendable lengths and 300 cm exchange length. Proximal end tapers to fit ACS DOC Guide Wire Extension for length adjustment during catheter exchanges. Distal tips available in straight (shapeable) or pre-shaped 'J' configurations. Operated by physicians in clinical settings to navigate vasculature; provides trackability for interventional devices. Benefits include improved procedural efficiency during catheter exchanges.

Clinical Evidence

Bench testing only. Verification testing demonstrated that the guide wires meet established acceptance criteria and perform equivalently to the predicate device.

Technological Characteristics

0.014'' diameter guide wires; 175 cm, 190 cm, and 300 cm lengths. Features proximal taper for extension compatibility and distal tip options (straight/shapeable or pre-shaped 'J'). Materials, performance, and sterilization are substantially equivalent to currently marketed predicates.

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.

Reference Devices

• ACS DOC Guide Wire Extension

Submission Summary (Full Text)

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#### 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: | April 17, 2002 |
| Device Trade Name: | HI-TORQUE BALANCE®<br>HI-TORQUE BALANCE MIDDLEWEIGHTTM<br>HI-TORQUE BALANCE HEAVYWEIGHT™<br>HI-TORQUE BALANCE TREKTM<br>HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSALTM |
| 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 BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires are substantially equivalent with regard to these features in their predicate device.

#### Device Description:

The HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVESAL™ Guide Wires guide wires with a 0.014'' diameter and available in 175 cm and

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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 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 devices show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed predicate devices.

#### Performance Data:

The results of the verification testing demonstrate that the HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ 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-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires have the same intended use, technological characteristics, performance properties, identical sterilization and substantially equivalent materials. Therefore, there are no new safety or effectiveness issues. HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires are substantially equivalent to the predicate devices.

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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 & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2002

Ms. Jennifer Pae Riggs, RAC Sr. Regulatory Affairs Associate Guidant Corporation 26531 Ynez Road Temecula, CA 92591-4628

K021228 Re:

HI-TORQUE Balance® Balance Middleweight™, Balance Heavyweight™, Balance TrekTM and Balance Middleweight Universal™ Guide Wires Regulation Number: 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II (two) Product Code: 74 DQX Dated: April 17, 2002 Received: April 18, 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 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. 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,

NOahtill

Donna-Bea Tillman, Ph.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 (if known) | K021228 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and the BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires |
| Indications for 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. |

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺎ Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Division of Cardiovascular & Respiratory Devices
510(k) Number K021225