ERA 3000 PACING SYSTEM ANALYZER

{0}------------------------------------------------ OCT 2 0 2004 BIOTRONIK, Inc., ERA 3000 Pacing System Analyzer, Special 510(k) K04d708 September 29, 2004 # ERA 3000 Pacing System Analyzer Special 510(k) 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: | ERA 3000 Dual Chamber Pacing System Analyzer | | Classification: | Class II/III | | Classification Name: | External Pacemaker Pulse Generator (21 CFR 870.3600)<br>Pacemaker Electrode Function Tester (21 CFR 870.3630)<br>Pacemaker Generator Function Analyzer (21 CFR 870.3720) | | Product Code: | DTA, DTC, DTE | | Date Prepared: | September 29, 2004 | ### General Description: The ERA 3000 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. It can also operate as a temporary external pulse generator during the above mentioned procedures. The ERA 3000 utilizes a touch-proof configuration to help prevent hazardous connection between patients and electrical power sources. ### Device Modification: The ERA 3000 PSA software was updated to correct several anomalies. The modified software is designated as ERA 301.4. #### Predicate Devices: BIOTRONIK proposes the following Pacing System Analyzer cleared through 510(k) notification as a predicate device for the ERA 3000 Pacing System Analyzer: - BIOTRONIK's ERA 3000 Pacing System Analyzer (#K022360, cleared 01-27-03) ● ### Indications for Use: The ERA 3000 is intended for use during invasive pacemaker procedures in the following activities: - . Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, AAI, or AOO modalities during implantable pacemaker procedures or physician evaluations. - t Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time. . Pacemaker Function Test Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, A/V delay, and rate/interval. Name and Address of Manufacturing Site: BIOTRONIK GmbH & Co. KG (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany Phone: 011-49-30-689-05-1210 Name and Address of Contract Manufacturing Site: BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6, 8180 Bülach, Switzerland Phone: 011-41-1-864-5169 Contact Person and Phone Number: Jon Brumbaugh Director, Regulatory Affairs Phone: (888) 345-0374 Fax: (503) 635-9936 Page 4 of 26 page 1 of 1 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 0 2004 Biotronik, Inc. c/o Mr. Jon Brumbaugh Director, Regulatory Affairs 6024 Jean Road Lake Oswego, OR 97035 K042708 Re: Era 3000 Pacing System Analyzer Regulation Number: 21 CFR 870.3600 Regulation Name: Pulse Generator, Pacemaker, External Regulatory Class: III Product Code: DTE Dated: September 29, 2004 Received: September 30, 2004 Dear Mr. Brumbaugh: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security (10(x) promation is substantially equivalent (for the indications referenced above and have determined the device is substantials in interstate referenced above and nave delemined the devices marketed in interstate for use stated in the enclosure) to legally marketed predicate device. Amendments for use stated in the enclosure) to regally manced produced as a caracters, or to commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the enaculiers with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with approval approval application (PMA). and Cosmetic Act (Act) that do not require approval approval approval ons of the A and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to the geniret for annual registration, listing of general controls provisions of the Act include requirements misbranding and general controls provisions of the recements of them. 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 If your device is classified (see above) mito exist on the percentations affecting your device can may be subject to such additional controls. Tim may be subject to such additional controlist Extrong might of 0998 In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarations, your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies or a subscription with other requirements of the Act that FDA has made a determination that your device of a concies . You must that FDA has made a determination that Jointer Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21 comply with all the Act s requirements, mortaing, carefally, careforments as set {2}------------------------------------------------ Page 2 – Mr. Jon Brumbaugh forth in the quality systems (QS) regulation (21 CFR Part 820); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctors over device as described in your Section 510(k) This letter will anow you to ocgin manieting of substantial equivalence of your device to a legally premarket notheadon: "The PDF mining of cation 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), please If you desire specific at not 10. Jour 2011) 276-0120. Also, please note the regulation entitled, Coliable of Compullier of Compullies in (21CFR Part 807.97). You may obtain Misoraliums by releveloc to premaintentibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or 101) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, B Zimmerman for R. D. Zuckerman, M.D. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): < >4 2708 Device Name: ERA 3000 Pacing System Analyzer Indications For Use: The ERA 3000 is intended for use during invasive pacemaker procedures in the following activities: Temporary External Pacing . Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO modalities during implantable pacemaker procedures or physician evaluations. #### Lead Threshold Determination . Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time. #### Pacemaker Function Test . Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, A/V delay, and rate/interval. Prescription Use (Part 21 CFR 801 Subpart D) ✓ AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) B. Simmons Division Sian-Off Division of Cardiovascular Devices 510(k) Number Page 1 of