HI-TORQUE WHISPER VIEW GUIDE WIRE

K061453 · Guidant Corp. · DQX · Jun 22, 2006 · Cardiovascular

Device Facts

• Record ID: K061453
• Device Name: HI-TORQUE WHISPER VIEW GUIDE WIRE
• Applicant: Guidant Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Jun 22, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The HI-TORQUE WHISPER VIEW GUIDE WIRE is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.

Device Story

Guide wire aids placement of implantable coronary venous leads in coronary venous vasculature; used by physicians in clinical settings. Device consists of stainless steel tapered core with flexible tip; distal portion jacketed in tungsten-loaded polyurethane; proximal portion jacketed in PTFE; hydrophilic coating applied for lubricity. Length 190 cm; outer diameter 0.0145 inches. Available with straight shapeable or preformed 'J' distal tip for coronary sinus access. Device functions as mechanical guide for lead delivery; no electronic or software components.

Clinical Evidence

Bench testing only. Verification testing demonstrated device meets acceptance criteria and performs equivalently to the predicate device.

Technological Characteristics

Stainless steel tapered core; tungsten-loaded polyurethane distal jacket; PTFE proximal jacket; hydrophilic coating. 190 cm length; 0.0145 inch outer diameter. Straight shapeable or preformed 'J' distal tip. Mechanical device; no energy source, connectivity, or software.

Indications for Use

Indicated for patients requiring placement of an implantable coronary venous lead in the coronary venous vasculature.

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 Guide Wire (K030019)

Submission Summary (Full Text)

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JUN 22 2006

Whisper View Special 510(k) Submission Attachment 4

K061453
page 1 of 2

# 510(K) SUMMARY

ﯩﭗ.

| Submitter: | Guidant Corporation |
|----------------------|----------------------------------------------------------|
| | Cardiac Rhythm Management (CRM) |
| | 4100 Hamline Avenue North |
| | St. Paul, Minnesota 55112-5498 |
| Contact: | Kathleen Vittum |
| | Regulatory Affairs Associate |
| Telephone: | [phone] or direct [phone] |
| FAX: | [phone] |
| Email: | [e-mail] |
| Date of Summary: | May 23, 2006 |
| Trade Name: | HI-TORQUE WHISPER VIEW™ Guide Wire, Model #4631-4639 |
| Common Name: | Guide Wire |
| Classification Name: | Catheter Guide Wire, (21 CFR 870.1330, Product Code DQX) |
| Predicate | HI-TORQUE WHISPER™ Guide Wire, K030019 |

### Device Description

The guide wire is comprised of a stainless steel tapered core with a flexible tip, jacketed by tungsten-loaded polyurethanc on the distal portion and polytetrafluoroethylenc (PTFE) on the proximal portion of the wire. The polyurethane is covered with a hydrophilic coating to increase lubricity. The guide wire is 190 cm long with a maximum outer diameter of 0.0145. The guide wires are available with cither a straight distal tip that is shapeable, or a preformed 'J' distal tip shaped specifically for accessing the coronary sinus.

#### Intended Use

The HI-TORQUE® WHISPER VIEW™ Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.

#### Technological Characteristics

The HI-TORQUE® WHISPER VIEW™ Guide Wire is identical to the predicate III-TORQUE® Whisper Wire in all respects with the exception of two modifications -- an

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Whisper View Special 510(k) Submission Attachment 4

061453
page 2 of 2

increased tungsten load in the polyurethane coating and a change in the tempering method for the stainless steel wire core.

## Performance data

The results of verification testing demonstrate that the HI-TORQUE® WHISPER VIEW™ Guide Wire meets established acceptance criteria and performs in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during testing.

### Conclusion

The Guidant HI-TORQUE® WHISPER VIEW™ Guide Wire is similar to the predicate WHISPER Guide Wire with respect to intended use, materials, technological characteristics and performance properties, and uses sterilization processes identical to the predicate device. Testing did not identify any new safety or effectiveness concerns. Therefore the HI-TORQUE® WHISPER VIEW™ Guide Wire is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with outstretched wings, stylized in a simple, bold line drawing. The eagle's head is turned to the right, and its wings are depicted with three parallel lines each.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 222 2006

Guidant Corporation c/o Ms. Kathleen Vittum Regulatory Affairs Associate 4100 Hamline Avenue North St. Paul, MN 55112-5798

Re: K061453

Trade Name: Hi-Torque Whisper View Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II (two) Product Code: DQX Dated: May 24, 2006 Received: May 25, 2006

Dear Ms. Kathleen Vittum:

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. Kathleen Vittum

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 (240) 276- 0120 (see bottom for #s). 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.

Bfimmimor for

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

Enclosure

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Whisper View Special 510(k) Submission Attachment 2

## INDICATION FOR USE STATEMENT

510(k) Number (if known):

K061453

Device Name:

Indications For Use:

HI-TORQUE WHISPER VIEW™ GUIDE WIRE

The HI-TORQUE WHISPER VIEW GUIDE WIRE is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.

Prescription Use: X AND/OR

Over-The-Counter Use:

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumena

(División Sign-Off)
Division of Cardiovascular Devices
510(k) Number K06453