LOCATOR MODEL 4036

K972814 · Pacesetter, Inc. · DTB · Feb 23, 1998 · Cardiovascular

Device Facts

• Record ID: K972814
• Device Name: LOCATOR MODEL 4036
• Applicant: Pacesetter, Inc.
• Product Code: DTB · Cardiovascular
• Decision Date: Feb 23, 1998
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 3

Intended Use

The Locator™ Steerable Stylet is intended for use when implanting the Pacesetter Tendril® model 1188 T/K pacemaker leads, in 46, 52, and 58 cm lengths in patients requiring long-term lead implantation to provide cardiac pacing.

Device Story

The Locator™ steerable stylet is a mechanical accessory for permanent pacemaker electrode implantation. It consists of a curved wire housed within a thin-walled tube. By manipulating the handle to slide the tube relative to the wire, the operator adjusts the curvature of the stylet, which in turn alters the shape of the pacemaker lead. This allows for controlled lead advancement through the vasculature without requiring the stylet to be removed from the lead. The device is used by clinicians during surgical implantation procedures. It benefits the patient by facilitating precise lead placement.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by preclinical and qualification bench testing.

Technological Characteristics

Mechanical steerable stylet consisting of a curved wire and a thin-walled tube. Dimensions and materials are consistent with standard pacemaker lead stylets. Manual operation via handle manipulation to adjust curvature.

Indications for Use

Indicated for patients requiring long-term lead implantation for cardiac pacing during the implantation of Pacesetter Tendril® model 1188 T/K pacemaker leads.

Regulatory Classification

Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

Predicate Devices

• Pacesetter ball-tipped stylets - straight and j-shaped

Reference Devices

• Pacesetter Tendril® model 1188 T/K pacemaker leads

Submission Summary (Full Text)

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**St. Jude MEDICAL**

**CARDIAC RHYTHM MANAGEMENT DIVISION**

15900 Valley View Court Sylmar, CA 91342 818 362-6822 800 777-2237 www.sjm.com

K972814

**FEB 23 1998**

## 510(K) SUMMARY

Name of Sponsor:

Sponsor Address:

Pacesetter, Inc., A St. Jude Medical Company

15900 Valley View Court PO Box 9221 Sylmar, CA 91392-2991 [phone]

[phone]
Ana Wood

December 3, 1997

Proprietary - The Locator™

Common Name - steerable stylet

74DTB - accessory to permanent pacemaker electrode

Class III - Division of Cardiovascular, Respiratory and

Pacesetter ball-tipped stylets - straight and j-shaped

The Locator™ steerable stylet consists of a curved wire

that fits inside a thin-walled tube. Sliding the tube relative to the wire by manipulating the handle allows different curvatures on the stylet, and thus the lead, to be

· To facilitate advancement of the lead in the vasculature

· To allow control the shape of the lead without removing

Both preclinical and qualification testing of the Locator™

Neurological Devices

Ana Wood

12/5/97
Date

Date of Summary Preparation:

Name of Device:

Contact:

Classification:

Predicate Devices:

Device Description:

Intended Use:

Nonclinical Testing:

Clinical Testing:

indicate that this device is substantially equivalent with regard to safety and effectiveness to a marketed device.

the stylet from the lead

No clinical testing was performed.

obtained.

**000033**

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 1998

Ms. Ana Wood St. Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court Sylmar, CA 91392-9221

Re: K972814 Locator™ Steerable Stylet, Model 4036 III (three) Regulatory Class: Product Code: DTB December 5, 1997 Dated: Received: December 8, 1997

Dear Ms. Wood: ... . .

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements Please note: this concerning your device in the Federal Register. response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 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 (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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<10(k) Number: K972814 The Locator™ Steerable Styler Device Name: Indication for Use: The Locator"™ Steerable Stylet is intended for use when implanting the Pacesetter Tendril® model 1188 T/K pacemaker leads, in 46, 52, and 58 cm lengths in patients

requiring long-term lead implantation to provide cardiuc pacing.

(PLEASE DO NOT WRITE BELOW THIS I.INE - CONTINUE ()N ANOTHER PAGE IF NEEDED)

Tan A-R Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 972811

510(k) Number

Prescription Use
(Per 21 C.FR 801.109)

.... Over The Counter I Jse ... .............................................................................................................................................. (Optional Format 1-2-96)

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