Arox bipolar, passive-fixation, endocardial pacing leads (Arox xx-BP and Arox xx-JBP) are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.

Device Description

The BIOTRONIK Arox lead is a bipolar, passive-fixation, endocardial pacing lead available in straight and " J"-shaped configurations, for placement in the ventricle or atrium. The designation Arox xx-BP refers to Arox straight leads, which are available in lengths (xx) of 53 or 60 cm; Arox xx-JBP refers to Arox "J"-shaped leads, which are available in lengths of 45 and 53 cm.

The Arox xx-JBP model has a permanent bend proximal to both lead electrodes, resulting in the distal portion of the lead body having what is commonly referred to as a "U" or "J" shape. This lead shape facilitates placement in the right atrial appendage.

Arox xx-BP and Arox xx-JBP leads feature four silicone tines for passive-fixation in the heat's trabeculae. The tip electrode is made of a platinum/iridium base material, with a fractal iridium surface and electrically active surface area of 3.5 mm². The ring electrode is made of a platinum/iridium base material, with a fractal iridium surface and electrically active surface area of 22.6 mm². The lead conductor consists of quadrifilar MP35N wire in a coaxial configuration, insulated with silicone rubber tubing. All Arox leads utilize a 3.2 mm IS-1 connector.

AI/ML Overview

The provided text is a 510(k) summary for the BIOTRONIK Arox Passive-Fixation, Bipolar, Endocardial Pacing Lead. This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement for a study proving device performance against acceptance criteria.

The 510(k) process is primarily a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device, not necessarily a comprehensive clinical study to prove performance against specific acceptance criteria in the way a clinical trial would. Therefore, I cannot extract the requested information from this document.

The document mainly focuses on:

Device Description: Physical characteristics, materials, and configurations.
Device Modification: Differences from a previously marketed device (Merox leads) and similarities to another (Polyrox leads).
Predicate Devices: Identification of existing devices to which the Arox leads are compared for substantial equivalence.
Indications for Use: The medical conditions and manner in which the device is intended to be used.

To answer your questions, one would typically need access to the full 510(k) submission, including any testing reports, bench test results, or, if applicable, clinical study summaries, which are not provided in this specific excerpt.

Summary

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MAY 01 2002

BIOTRONIK, Inc.

K021217

April 16, 2002

Arox Passive-Fixation, Bipolar, Endocardial Pacing Lead Special 510(k) Premarket Notification

1. 510(K) SUMMARY

Name and Address of Sponsor:

6024 Jean Road Lake Oswego, OR 97035 Establishment Registration Number: 1028232 Device Name: Proprietary Name: Arox Leads Classification: Class III (21 CFR 870.3680(b)) Classification Name: Cardiovascular Permanent Pacemaker Electrode Product Code: DTB Date Prepared: April 16, 2002

General Description:

Device Modification:

The Arox leads introduced in this Special 510(k) notification are modified versions of BIOTRONIK's currently marketed Merox leads (#K010281, dated 04-09-02). The modifications are a change in the tip electrode surface area from 1.3 mm² to 3.5 mm² and a change in the shape of the tip from segmented to lenticular. The tip electrode surface area size and shape are identical to BIOTRONIK's currently marketed Polyrox family of passive-fixation, endocardial leads (#K000763, dated 04-06-00).

Predicate Devices:

BIOTRONIK proposes the following leads cleared through 510(k) notifications as predicate devices for the Arox leads:

BIOTRONIK's Merox passive-fixation, endocardial leads (#K010281, dated 04-09-02)
BIOTRONIK's Polyrox passive-fixation, endocardial leads (#K000763, dated 04-06-00) ●

Indication for Use:

Name and Address of Manufacturing Site:

BIOTRONIK GmbH & Co. (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-304

Contact Person(s) and Phone Number:

Jon Brumbaugh Director, Regulatory Affairs Phone (888) 345-0374 Fax (503) 635-9936

Name and Address of Contract Manufacturing Site:

BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-1-864-5169

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked one above the other.

Public Health Service

MAY 01 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K021217

Trade Name: Arox Passive-Fixation, Bipolar Pacemaker Lead Regulation Number: 21 CFR 870.3680 Regulation Name: Permanent Pacemaker Electrode Regulatory Class: Class III (three) Product Code: DTB Dated: April 16, 2002 Received: April 17, 2002

Dear Mr. Brumbaugh:

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. Jon Brumbaugh

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Touse be actived a determination that your device complies with other requirements of the Act that i Dr Haral statutes and regulations administered by other Federal agencies. You must or uny 1 vith 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 Of A ratt 007), accems (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 premated 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Dale Tull

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): KO2 1217

Device Name: Arox Passive-Fixation, Bipolar Pacemaker Lead

Indications For Use:

Arox bipolar, passive-fixation, endocardial pacing leads (Arox xx-JBP) are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _(Per 21 CFR 801.109)
(Optional Format 3-10-98)

ratory Devi ) Number

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.