STEERABLE STYLET

K040001 · Synovis Surgical Innovations · DRB · Mar 9, 2004 · Cardiovascular

Device Facts

• Record ID: K040001
• Device Name: STEERABLE STYLET
• Applicant: Synovis Surgical Innovations
• Product Code: DRB · Cardiovascular
• Decision Date: Mar 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1380
• Device Class: Class 2

Intended Use

The Steerable Stylet is intended to allow the physician to define and vary the curvature of the distal end of a compatible pacemaker lead in patients requiring lead implantation for cardiac pacing.

Device Story

The Steerable Stylet is a sterile, single-use, disposable implantation tool. It is inserted into a pacemaker lead to allow the physician to manually define and vary the curvature of the lead's distal portion during cardiac pacing lead implantation. Used in a clinical setting by a physician; the device provides mechanical support and shape-adjustment capabilities to facilitate lead placement. It does not involve electronic processing or automated outputs; it functions as a manual surgical instrument.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Sterile, single-use, disposable catheter stylet. Mechanical device designed for manual manipulation of pacemaker lead curvature. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring pacemaker lead implantation. Used by physicians to define and vary the curvature of the distal end of a compatible pacemaker lead during the implantation procedure.

Regulatory Classification

Identification

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

Predicate Devices

• The Locator Steerable Stylet, Model 4036 (K972814)

Submission Summary (Full Text)

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| | 3.0 SUMMARY OF SAFETY AND EFFECTIVENESS |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by | Synovis Interventional Solutions, Inc.<br>475 Apollo Drive<br>Lino Lakes, MN 55014<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person | James Jenkins<br>Synovis Surgical Innovations<br>2575 University Avenue W.<br>St. Paul, Minn. 55114-1024<br>Tel. [phone] or 651-796-7368<br>Fax [phone] |
| Device Trade Name: | To be determined |
| Common Name | Catheter Stylet |
| Classification Name | Catheter Stylet<br>870.1380 |
| Predicate device | The Locator Steerable Stylet, Model 4036<br>K972814<br>St. Jude Medical |
| Device Description | The Steerable Stylet is a sterile, single-use, disposable<br>implantation tool which assists defining and varying the<br>curvature of the distal portion of the pacemaker lead during<br>implantation. |
| Statement of<br>Intended use | The Steerable Stylet is intended to aid in the placement of<br>pacemaker leads. |
| Technological<br>Comparisons | The Steerable Stylet is substantially equivalent to the<br>predicate device, having similar performance, technological<br>characteristics, and indication for use. |
| Testing | The Steerable Stylet is substantially equivalent to the<br>predicate device in terms of performance testing.<br>Test<br>results are included in submission. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three horizontal lines that resemble a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 2004

Synovis Interventional Solutions, Inc. c/o Mr. James Jenkins Regulatory Affairs Specialist 2575 University Avenue St. Paul, MN 55114-1024

Re: K040001

Trade Name: Steerable Stylet Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: Class II (two) Product Code: DRB Dated: December 31, 2003 Received: January 2, 2004

Dear Mr. Jenkins:

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 - Mr. James Jenkins

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/dsma/dsmamain.html

Sincerely yours.

Dona R. Kirchner

A 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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## Indications for Use

510(k) Number (if known): K040001

Device Name: Steerable Stylet

Indications For Use:

The Steerable Stylet is intended to allow the physician to define and vary the curvature of the distal end of a compatible pacemaker lead in patients requiring lead implantation for cardiac pacing.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)

Dung R. bochner

Sion Sign-Off) on of Cardiovascular Devices

< Number _ KO4000 |