YP 45/15-BP; YP 53/15-BP; YP 60/15-BP

K993139 · Biotronik, Inc. · DTB · Dec 17, 1999 · Cardiovascular

Device Facts

• Record ID: K993139
• Device Name: YP 45/15-BP; YP 53/15-BP; YP 60/15-BP
• Applicant: Biotronik, Inc.
• Product Code: DTB · Cardiovascular
• Decision Date: Dec 17, 1999
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

BIOTRONIK's YP xx/15-BP leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators. The leads may be used with single or dual chamber pacing systems. The YP xx/15-BP lead models are intended for placement in either the patient's right atrium or right ventricle.

Device Story

Transvenous, bipolar, active fixation endocardial pacing leads; used in conjunction with implantable pulse generators for permanent pacing and sensing. Lead features quadrifilar MP35N wire conductor in coaxial configuration; silicone insulation; fractal iridium-treated electrode surfaces; IS-1 connector. Available in 45, 53, and 60 cm lengths. Implanted by physicians in clinical settings; placed in right atrium or right ventricle. Provides electrical connection between pulse generator and cardiac tissue to facilitate pacing therapy.

Technological Characteristics

Bipolar, active fixation endocardial pacing lead. Materials: quadrifilar MP35N wire conductor, silicone tubing insulation, fractal iridium-treated electrode surfaces. Configuration: coaxial. Connector: IS-1. Lengths: 45, 53, 60 cm. Passive/Active: Active fixation.

Indications for Use

Indicated for patients requiring permanent pacing and sensing via single or dual chamber implantable pulse generators. Leads are intended for placement in the right atrium or right ventricle.

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

• BIOTRONIK Retrox family (K990483)
• BIOTRONIK DY (K841451/A)
• BIOTRONIK FH (K910608)
• Cardiac Pacemakers Inc. (CPI) Sweet Tip (K873888)

Submission Summary (Full Text)

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# YP xx/15-BP Active Fixation Endocardial Lead 510(k) Premarket Notification

### 1. 510(K) SUMMARY

Name and Address of Sponsor:

BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035

Establishment Registration Number: 1028232

Device Name:

Proprietary Names: YP 45/15-BP, YP 53/15-BP, and YP 60/15-BP Classification: Class III (21 CFR 870.3680(b)) Classification Name: Cardiovascular permanent pacemaker electrode

Date Prepared: September 17, 1999

#### General Description and Predicate Devices:

BIOTRONIK's YP xx/15-BP leads are transvenous, bipolar, active fixation, endocardial pacing leads. The lead conductor is quadrifilar MP35N wire in a coaxial configuration, insulated with silicone tubing, and electrodes surfaces with a fractal iridium surface treatment. The leads are available in 45, 53, and 60 cm lenaths and have IS-1 connectors. The predicate devices upon which BIOTRONIK is basing its claim of substantial equivalence are the following:

- BIOTRONIK's Retrox family of bipolar, active fixation, endocardial leads with Elgiloy® (#K990483, . cleared 06/03/99).
- BIOTRONIK's DY unipolar, active fixation, endocardial lead (#K841451/A, cleared 02/07/85). .
- BIOTRONIK's FH bipolar, active fixation, endocardial lead (#K910608, cleared 07/30/91). .
- Cardiac Pacemakers Inc. (CPI) Sweet Tip, bipolar, active fixation, endocardial lead (#K873888, . cleared 05/17/88)

#### Indications for Use:

BIOTRONIK's YP xx/15-BP leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators. The leads may be used with single or dual chamber pacing systems.

The YP xx/15-BP lead models are intended for placement in either the patient's right atrium or right ventricle.

#### Name and Address of Manufacturing Site:

BIOTRONIK GmbH & Co.(reg. no. 7010992) Woermannkehre 1, Berlin, Germany 011-49-30-689-05-304

#### Sponsor Contact Person and Phone Number:

Jon Brumbaugh, Director of Regulatory Affairs Phone [phone] Fax [phone]

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC | 7 1999

Mr. Jon Brumbaugh Director of Requlatory Affairs BIOTRONIK, Inc. 6024 Jean Road 97035 Lake Oswego, OR

Re : K993139 Active-Fixation Endocardial Pacing Lead Model Trade Name: YP 45/15-BP, YP 53/15-BP and YP 60/15-BP Requlatory Class: III Product Code: DTB Dated: September 17, 1999 Received: September 20, 1999

Dear Mr. Brumbaugh:

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 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 You may, therefore, market the device, subject to the Act (Act). 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Mr. Jon Brumbaugh

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.

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

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Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 2. INDICATIONS FOR USE

BIOTRONIK's YP xx/15-BP leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators. The leads may be used with single or dual chamber pacing systems.

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The YP xx/15-BP lead models are intended for placement in either the patient's right atrium or right ventricle.

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