AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP

K023099 · Biotronik, Inc. · DTB · Oct 18, 2002 · Cardiovascular

Device Facts

• Record ID: K023099
• Device Name: AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP
• Applicant: Biotronik, Inc.
• Product Code: DTB · Cardiovascular
• Decision Date: Oct 18, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3680
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

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

Device Story

Arox and Merox leads are bipolar, passive-fixation, endocardial pacing leads. Modification introduces a specific 'J'-shape (45 or 53 cm lengths) to facilitate placement in the right atrial appendage. Leads connect to a compatible pulse generator to provide permanent cardiac pacing and sensing. Used by physicians in clinical settings for patients requiring cardiac rhythm management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bipolar, passive-fixation, endocardial pacing leads. Available in straight and 'J'-shaped configurations. Class III device (21 CFR 870.3680(b)).

Indications for Use

Indicated for patients requiring permanent pacing and sensing in the atrium or ventricle via endocardial placement, using a compatible pulse generator.

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

• Arox Leads (K021217)
• Merox Leads (K010281)

Submission Summary (Full Text)

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OCT 1 8 2002

K023099

BIOTRONIK, Inc., Arox and Merox J-Shape Specification, Special 510(k)

September 17, 2002

# Arox and Merox J-Shape Specification Special 510(k) Premarket Notification

#### 1. 510(K) SUMMARY

| Name and Address of Sponsor: | BIOTRONIK, Inc.<br>6024 Jean Road<br>Lake Oswego, OR 97035 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 1028232 |
| Device Name: | Proprietary Name: Arox Leads<br>Classification: Class III (21 CFR 870.3680(b))<br>Classification Name: Cardiovascular Permanent Pacemaker Electrode<br>Product Code: DTB |
| | Proprietary Name: Merox Leads<br>Classification: Class III (21 CFR 870.3680(b))<br>Classification Name: Cardiovascular Permanent Pacemaker Electrode<br>Product Code: DTB |
| Date Prepared: | September 11, 2002 |

#### General Description:

The BIOTRONIK Arox and Merox leads are bipolar, passive-fixation, endocardial pacing leads available in straight and "J"-shaped configurations, for placement in the ventricle or atrium. The Arox and Merox lead families have been approved by FDA for distribution in the U.S. (K021217, dated 05-01-02 and #K010281, dated 04-09-02, respectively).

The designations Arox xx-JBP and Merox xx-JBP refer to "J"-shaped leads, which are available in lengths of 45 and 53 cm. The Arox and Merox xx-JBP models have 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.

### Device Modification:

The device modification only applies to the atrial Arox xx-JBP bipolar, passive-fixation, endocardial, pacing leads. The modification consists of an exact specification for the J-shape of the leads. Previously, BIOTRONIK did not specify the precise J-shape of the leads.

#### Indication for Use:

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

### Name and Address of Manufacturing Site:

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

### Name and Address of Contract Manufacturing Site:

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

#### Contact Person(s) and Phone Number:

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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2002

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

Re: K023099

Trade Name: Arox and Merox Bipolar, Passive-Fixation Pacemaker Leads Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent or Temporary Pacemaker Electrode Regulatory Class: Class III (three) Product Code: DTB Dated: September 17, 2002 Received: September 18, 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 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 and additionally 21 CFR Part 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

i?

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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Ko23699 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Arox and Merox bipolar, passive-fixation pacemaker leads

Indications For Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number 4023006

(Optional Format 3-10-98)