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 Description

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device (an active fixation endocardial lead), not a study report. It does not contain information on acceptance criteria, device performance, sample sizes used, ground truth establishment, or any comparative effectiveness studies. Therefore, it is impossible to extract the requested information from this document.

The document primarily focuses on:

Device Description: General characteristics, materials, and predicate devices.
Indications for Use: What the device is intended for.
Regulatory Information: Classification, manufacturing site, and contact details.

To answer your questions, a study report detailing the device's performance against specific criteria would be needed.

Summary

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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 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:

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 (888) 345-0374 Fax (503) 635-9936

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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 (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ohitoplam. Ah-for

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

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

Chritolyn. Ah. for wittel

Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal 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.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is 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.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.