ACUITY STEERABLE STYLET ACCESSORY

K053019 · Guidant Corporation · DRB · Mar 3, 2006 · Cardiovascular

Device Facts

• Record ID: K053019
• Device Name: ACUITY STEERABLE STYLET ACCESSORY
• Applicant: Guidant Corporation
• Product Code: DRB · Cardiovascular
• Decision Date: Mar 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1380
• Device Class: Class 2

Intended Use

For use with compatible, transvenous, left ventricular, pace/sense leads.

Device Story

ACUITY Steerable Stylet is a manual accessory used to facilitate delivery of transvenous, left ventricular, pace/sense leads into coronary veins. Device consists of stainless steel wire with proximal polypropylene knob/cap assembly; distal end features taper and bullet-shaped tip. Available in soft or standard stiffness variants, differentiated by distal taper diameter. Operated by clinicians during lead placement procedures. Stylet provides structural support and steerability to lead during navigation through venous anatomy. No electronic components, software, or automated processing involved.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: stainless steel wire, polypropylene knob/cap. Design: steerable stylet with tapered distal end and bullet tip. Energy source: none (manual). Connectivity: none. Sterilization: standard method used. Software: none.

Indications for Use

Indicated for use with compatible, transvenous, left ventricular, pace/sense leads in patients requiring cardiac pacing or sensing.

Regulatory Classification

Identification

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

Predicate Devices

• Firm Straight 0.016 Stylet, Model 6602 (K905674)
• Tapered 0.016 Stylet, Model 6583 (K843060)

Submission Summary (Full Text)

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SFCTION 21: OTHER

#### MAR 3 2006

K053019

## 510(K) SUMMARY

| Submitter: | Guidant Corporation<br>Cardiac Rhythm Management (CRM)<br>4100 Hamline Avenue North<br>St. Paul, Minnesota 55112-5498 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer X. Tang<br>Senior Regulatory Affairs Associate<br>Telephone: [phone] or direct [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Date of Summary: | February 20, 2006 |
| Common Name: | Stylet |
| Trade Name: | ACUITY™ Steerable Stylet Accessory |
| Classification Name: | Class II<br>Per 21 CFR 870.1380, Catheter Stylet, Cardiovascular Panel |
| Predicate: | Firm Straight 0.016 Stylet, Model 6602, K905674, cleared January 30, 1991 Tapered 0.016 Stylet, Model 6583, K843060, cleared September 20, 1984 |

#### DEVICE DESCRIPTION 1.1.

The ACUITY Steerable Stylet is intended for delivery of the ACUITY Steerable Lead in the coronary veins. The stylets come in either soft or standard stiffness, and in three lengths (to match the ACUITY Steerable Lead lengths).

The stylet consists of a stainless steel wire with a polypropylene knob/cap assembly at the proximal end. The distal end of the wire has a taper and terminates in a bullet shaped tip. Both soft and standard stylets have the same base wire diameter. The difference in stiffness is due to a slight difference in the diameter within the taper at the distal end of the wire.

#### 1.2. INTENDED USE

For use with compatible, transvenous, left ventricular, pace/sense leads.

page 1 of 2

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#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 1.3.

Comparisons of the ACUITY Steerable Stylet and the predicate devices show that the technological characteristics such as Intended Use, material, nominal diameter, assembly, dispensing hoop design, package pouch, sterilization method, sterilization indicator, and shelf life are substantially equivalent to the currently marketed predicate devices.

#### TESTING DATA 1.4.

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

#### CONCLUSION 1.5.

The Guidant ACUITY Steerable Stylets are substantially equivalent to the currently marketed Firm Straight 0.016 Stylet, Model 6602 (K905674, cleared 1/30/1991) and Tapered 0.016 Stylet, Model 6583 (K843060, cleared 9/20/1984).

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Image /page/2/Picture/11 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 2006

Guidant Corporation c/o Ms. Jennifer X. Tang Senior Regulatory Affairs Associate 4100 Hamline Avenue North St. Paul, MN 55112-5798

Re: K053019

Trade Name: ACUITYTM Steerable Stylet Accessory Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: II (two) Product Code: DRB Dated: February 06, 2006 Received: February 07, 2006

### Dear Ms. Tang:

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 interstatc 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 cl 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 Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, MLA شھر publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Jennifer X. Tang

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 (OS) 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,

Bffimmumator

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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# INDICATION FOR USE STATEMENT

| 510(k) Number (if known): | K053019 |
|------------------------------------------------|----------------------------------------------------------------------------------|
| Device Name: | ACUITY™ Steerable Stylet Accessory |
| Indications For Use: | For use with compatible, transvenous, left ventricular, pace/sense leads |
| Prescription Use: (Part 21 CFR 801 Subpart D) | <div>X</div> AND/OR Over-The-Counter Use: (21 CFR 807 Subpart C) <div></div> |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bflimmmon

(Division Sign-Division of Caraiovascular Devices 510(k) Number k05 3019

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