EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.

K052965 · Guidant Corporation · DRB · Feb 13, 2006 · Cardiovascular

Device Facts

• Record ID: K052965
• Device Name: EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
• Applicant: Guidant Corporation
• Product Code: DRB · Cardiovascular
• Decision Date: Feb 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1380
• Device Class: Class 2

Intended Use

The EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant The EASYTRAK® 2 implantable venous lead in the coronary venous vasculature.

Device Story

EASYTRAK® 2 Stylet aids placement of Guidant EASYTRAK® 2 implantable venous lead in coronary venous vasculature; used by physicians in clinical settings. Device consists of stainless steel wire with polypropylene hub at proximal end; distal end features stop-coil to prevent stylet from exiting lead. Stylet provides structural support during lead delivery; removed after lead placement. Benefits include facilitated navigation and positioning of venous leads within coronary veins.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stainless steel wire with polypropylene hub; distal stop-coil. Available in three lengths corresponding to EASYTRAK® 2 lead lengths. Manual, non-powered device.

Indications for Use

Indicated for patients requiring placement of a Guidant EASYTRAK® 2 implantable venous lead within the coronary venous vasculature.

Regulatory Classification

Identification

A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.

Predicate Devices

• Stylet Accessory, Model 6602 (K905674)
• IRONMAN Guide Wire, Model 6725 (K021285)

Submission Summary (Full Text)

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K052965

### 510(K) SUMMARY 5.

| Owner: | Guidant Corporation | |
|----------------------|-----------------------------------------------------------------|-------------------------------------------------|
| | Cardiac Rhythm Management (CRM) | |
| | 4100 Hamline Avenue North | |
| | St. Paul, Minnesota 55112-5798 | |
| Contact: | Linda Kleinsasser, RAC | |
| | Senior Regulatory Affairs Associate | |
| | Telephone: | [phone], x24106 or direct [phone] |
| | Fax: | [phone] |
| | Email: | [e-mail] |
| Date of Summary: | October 20, 2005 | |
| Common Name: | Stylet | |
| Trade Name: | EASYTRAK® 2 Stylet | |
| Classification Name: | Class II | |
| | Per 21 CFR 870.1380, Catheter Stylet, Cardiovascular Panel | |
| Predicate: | Stylet Accessory, Model 6602, K905674, cleared January 30, 1991 | |
| | IRONMAN Guide Wire, Model 6725, K021285, | |
| | | cleared May 2, 2002 |

#### DEVICE DESCRIPTION 5.1.

The EASYTRAK® 2 Stylet is designed for delivery of the EASYTRAK® 2 lead in the coronary veins. The stylets come in three lengths corresponding to the lengths of the EASYTRAK® 2 leads.

The EASYTRAK® 2 Stylet consists of a stainless steel wire with a polypropylene hub at the proximal end. The distal end of the wire has a stop-coil designed to prevent the stylet from exiting through the distal end of the lead.

Gaetan Carpersona

way.guidant.com

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#### 5.2. INTENDED USE

The EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant The EASYTRAK® 2 implantable venous lead in the coronary venous vasculature.

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 5.3.

Comparisons of the EASYTRAK® 2 Stylet and the predicate devices show that the Comparisons of the Eristics such as Intended Use, material, packaging, shelf life and technological enaracteristion satin alles and and the currently marketed predicate devices.

#### 5.4. TESTING

Testing demonstrated that the EASYTRAK® 2 Stylet met the acceptance criteria. No new safety or effectiveness issues were raised during the testing program. The EASYTRAK® 2 Stylet may be considered substantially equivalent to the predicate devices.

#### 5.5. CONCLUSION

The Guidant EASYTRAK® 2 Stylet are substantially equivalent to the currently marketed The Saccessory, Model 6602 (K905674, cleared 1/30/1991) and the IRONMAN Guide Wire, Model 6725 (K021285, cleared 5/2/2002).

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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FEB 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Guidant Corporation c/o Ms. Linda Kleinsasser, RAC Senior Regulatory Affairs Associate 4100 Hamline Avenue North St. Paul, MN 55112-5798

Re: K052965 Trade Name: EASYTRAK® 2 Stylet Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: II (two) Product Code: DRB Dated: January 9, 2006 Received: January 10, 2006

Dear Ms. Kleinsasser:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of re(s) pe device is substantially equivalent (for the indications felerenced above and nave determined is a aveces marketed predicate devices marketed in interstate for use stated in the enerosale) to regary the Medical Device Amendments, or to Commerce prices that have been reclasion with the provisions of the Federal Food. Drug. de vices marchave been recuire approval of a premarket approval application (PMA). and Costinctle recry too, that do nover copied to the general controls provisions of the Act. The I ou may, dierelove, market 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), If your device is classified (566 acre) in the s. Existing major regulations affecting your device . FFA it may to subject to back as a segulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Ms. Linda Kleinsasser, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issuation of a basevice complies with other requirements of the Act that IDA has made a decommation administered by other Federal agencies. You must of any I ecolar statutes and regulations and limited to: registration and listing (21 Compry with an the Fee brequirements)01); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) rogans (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro hereins (oveting your device as described in your Section 510(k) This letter will anow you to ogin maneting your antial equivalence of your device to a legally prematication. "The PDTP Intentig seriestion 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 If you ucate specific advice for Jour as not on a more as note the regulation written, Contact the Office of Comphalled as (21 transmit (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] 01 [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blymmman for

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

Enclosure

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### INDICATIONS FOR USE STATEMENT 4.

# INDICATIONS FOR USE STATEMENT

510(K) Number (if known): k052965

Device Name: Stylet

Indication for Use:

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The EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant THE EXS FIRAK® 2 implantable venous lead in the coronary venous vasculature.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)

Over-The-Counter _____________________________________________________________________________________________________________________________________________________________

## (PLEASE DONOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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EASYTRAK® 2 Stylet Guidant Corporation Confidential October 20, 2005