PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR

K033130 · Osypka Medical, Inc. · DTE · Oct 31, 2003 · Cardiovascular

Device Facts

• Record ID: K033130
• Device Name: PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
• Applicant: Osypka Medical, Inc.
• Product Code: DTE · Cardiovascular
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular pacing. When combined with a stimulation lead system, the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator can be used whenever temporary atrial or ventricular pacing is indicated. The device can be employed for therapeutic as well as diagnostic purposes or may be used prophylactically. Specific indications for temporary pacing include, but are not limited to: • Complete (third-degree) or intermittent heart block; • Symptomatic sinus bradycardia; • Atrial and/or ventricular ectopic arrhythmia; • Sick Sinus Syndrome (SSS); • Atrial tachyarrhythmia; • Acute myocardial infarction-induced heart block; • Stimulation during ventricular asystole; • Use during the replacement of an implantable pulse generator; • Stimulation and monitoring before the implantation of a cardiac pulse generator; • Stimulation and monitoring following heart surgery.

Device Story

External, battery-powered, single-chamber (SSI) temporary pulse generator; provides demand or asynchronous pacing therapy. Inputs: cardiac signals via pacing leads. Outputs: electrical pacing pulses; optical/acoustic indicators for sensing and pacing events. Operated by clinicians in intensive care or surgical settings. Features include adjustable pacing rate/amplitude, high-rate pacing modes for atrial tachycardia, battery voltage surveillance, and runaway protection (max 200 ppm). Accessories include XI Series extension cables and AS Series arm straps. Benefits: provides temporary cardiac rhythm management for patients with conduction defects or rhythm disturbances.

Clinical Evidence

No clinical data. Modifications were limited to labeling revisions; no additional clinical evaluation required.

Technological Characteristics

Battery-powered, stand-alone external pulse generator. Features insulated connector terminals meeting 21 CFR Part 898. Includes optical/acoustic indicators for sensing/pacing. Runaway protection limits impulse emission to 200 ppm. Accessories include extension cables and arm straps.

Indications for Use

Indicated for patients requiring temporary atrial or ventricular cardiac pacing due to conditions including complete/intermittent heart block, symptomatic sinus bradycardia, ectopic arrhythmia, Sick Sinus Syndrome, atrial tachyarrhythmia, acute myocardial infarction-induced heart block, ventricular asystole, pre/post-operative heart surgery, or during implantable pulse generator replacement.

Regulatory Classification

Identification

An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment. (2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source ( *i.e.,* battery power, AC mains connections, or both).(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following: (i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling; (ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use; (iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices ( *e.g.* data storage, printing), and indicator(s) functionality under intended use conditions; and(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated. (4) Appropriate software verification, validation, and hazard analysis must be performed. (5) Labeling must include the following: (i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use; (ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals; (iii) The labeling must list all pacing modes available in the device; (iv) Labeling must include a detailed description of any special capabilities ( *e.g.,* overdrive pacing or automatic mode switching); and(v) Appropriate electromagnetic compatibility information must be included.

Predicate Devices

• OSCOR PACE 101 / PACE 101H / ST. JUDE MEDICAL Model 3077 / CARDIOTRONIC PACE 101 (K022939)
• OSCOR PACE 101H External Pacemaker (K970497)
• OSCOR PACE 100H External Pacemaker (K923621)
• XI.TME and XI.RAC Extension Cables (K020896)
• OSCOR D-1 / D-3 / D-5 / D-9 / D-10 Extension Cables / PACE 101H Arm Strap (K970497)
• OSCOR DX-2 / D-5 / D-10 Extension Cables / PACE 100H Arm Strap (K923621)

Submission Summary (Full Text)

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## 510(k) Summary

| Date: | 28 September 2003 | | | |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------|--|
| Submitter: | Osypka Medical GmbH<br>Grossbeerenstrasse 184, 12277 Berlin, Germany | | | |
| Contact Person: | Markus Osypka, Ph.D., President<br>Osypka Medical, Inc.<br>7855 Ivanhoe Avenue, Suite 226, La Jolla, California 92037, USA<br>Phone: [phone] Fax: [phone] | | | |
| Device Trade Names: | OSCOR® | PACE 101™/PACE 101H™ | and Accessories; | |
| | ST. JUDE MEDICAL™ | Model 3077 | and Accessories; | |
| | CARDIOTRONIC™ | PACE 101™ | and Accessories; | |
| | Accessories including: XI Series™ Extension Cables:<br>XI.TPE™, XI.TME™, XI.HWR™, XI.RAC™,<br>XI.XTP™, XI,XHW™;<br>AS.45™ Arm Strap. | | | |
| Common / Usual Names: | SSI External Pulse Generator, Single-Chamber Temporary Cardiac Pacemaker;<br>Extension Cable, Patient Cable, Arm Strap. | | | |
| Classification Names: | 870.3600 | Pulse-Generator, Pacemaker, External<br> | | |
| | 870.2900 | Cables, Transducer and Electrode | | |
| Predicate Devices: | K022939 | OSCOR® PACE 101™ / PACE 101H™ External Pacemaker<br>ST. JUDE MEDICAL™ Model 3077<br>CARDIOTRONIC™ PACE 101™ | | |
| | K970497 | OSCOR® PACE 101H External Pacemaker | | |
| | K923621 | OSCOR® PACE 100H External Pacemaker | | |
| | K020896 | XI.TME™ and XI.RAC™ Extension Cables | | |
| | K970497 | OSCOR® D-1 / D-3 / D-5 / D-9 / D-10 Extension Cables<br>PACE 101H Arm Strap | | |
| | K923621 | OSCOR® DX-2 / D-5 / D-10 Extension Cables<br>PACE 100H Arm Strap | | |
| Device Description: | The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is<br>used for temporary intensive care pacing of the heart in cases of rhythm<br>disturbances and conduction defects, including: | | | |
| | • Treatment of bradycardia | | | |
| | • Treatment of atrial tachyarrhythmia | | | |
| | • Treatment of special causes of acute myocardial infarction | | | |
| | • Pre-, intra- and postoperative pacing of the heart. | | | |

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OSYPKA MEDICAL Berlin, Germany · San Diego, California, USA

## 510(k) Summary

1

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| The PACE 101 / PACE 101H / Model 3077 can be used as either an<br>intracardiac signal-inhibited pulse generator or as an asynchronous pulse<br>generator. Pacing rate and amplitude can be adjusted over a wide range,<br>conforming to actual therapeutic requirements. Sensed intrinsic activity and<br>paced pulses are indicated optically by a light-emitting diode (LED).<br>Additionally, acoustic signals for sensing and pacing can be switched on and<br>off. | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| The PACE 101 / PACE 101H / Model 3077 has two modes of high-rate pacing<br>for the treatment of atrial tachycardia. Pacing frequency can easily doubled or<br>quadrupled; the PACE 101 / PACE 101H / Model 3077 will then pace in<br>asynchronous mode. An acoustic signal is automatically emitted during high-<br>rate pacing. | | |
| Errors that occur during operation are indicated optically and acoustically. A<br>special circuit allows for automatic surveillance of the battery voltage. With the<br>help of an LED and an acoustic signal, complete drainage of the battery can<br>be prevented. | | |
| The PACE 101 / PACE 101H / Model 3077 has an additional feature - run-<br>away protection. Run-away protection limits the impulse emission to a<br>maximum of 200 ppm and prevents the delivery of too high a pacing rate in<br>the event of a defect in the frequency generator. | | |
| The XI Series™ Extension Cables support proper connection of the<br>PACE 101 / PACE 101H / Model 3077 to various types of pacing lead<br>systems (accessories). | | |
| The AS Series™ Arm Straps ensure proper attachment of the PACE 101 /<br>PACE 101H/Model 3077 to the patient's arm (accessory). | | |
| Intended Use: | The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is<br>designed to be used with cardiac pacing lead systems for temporary atrial or<br>ventricular pacing. | |
| | When combined with a stimulation lead system, the PACE 101 / PACE 101H /<br>Model 3077 SSI Temporary Pulse Generator can be used whenever<br>temporary atrial or ventricular pacing is indicated. The device can be<br>employed for therapeutic as well as diagnostic purposes or may be used<br>prophylactically. | |
| | Specific indications for temporary pacing include, but are not limited to: | |
| | • Complete (third-degree) or intermittent heart block; | |
| | • Symptomatic sinus bradycardia; | |
| | • Atrial and/or ventricular ectopic arrhythmia; | |
| | • Sick Sinus Syndrome (SSS); | |
| | • Atrial tachyarrhythmia; | |
| | • Acute myocardial infarction-induced heart block; | |
| | • Stimulation during ventricular asystole; | |
| | • Use during the replacement of an implantable pulse generator; | |
| | • Stimulation and monitoring before the implantation of a cardiac pulse generator; | |
| | • Stimulation and monitoring following heart surgery. | |
| Technology: | The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator<br>and its predicate device have the same fundamental technological<br>characteristics in design, material, shape and energy source. | |
| | The aforementioned devices are stand-alone devices that provide temporary<br>atrial or ventricular demand or asynchronous pacing therapy. The<br>aforementioned devices are battery powered. Indicator lights flash to show<br>atrial and ventricular sensing and atrial and ventricular pacing functions. | |
| | The PACE 101 / PACE 101H / Model 3077 is equipped with insulated<br>connector terminals matching the protected pins of the XI Series™ Extension<br>Cables and meets the 21 CFR Part 898 performance standard. | |
| Summary Bench<br>Testing: | The modifications made do not require additional bench testing. | |
| Summary Clinical<br>Evaluation: | The modifications made do not require additional clinical evaluation. | |
| Conclusion: | The modifications made to the device are related to a revision of the<br>Instructions for Use / User’ Manual, without changing the intended use or the<br>fundamental scientific technology. Some of the Series XI Extension™ Cables,<br>and the AS Series™ Arm Strap, have been previously market-released in<br>combination with the PACE 101™ Single-Chamber External Pulse Generator<br>and PACE 203™ Dual-Chamber External Pulse Generator. | |
| | Based on the limited impact of the modifications made, it is concluded that the<br>PACE 101 / PACE 101H / Model 3077 SSI External Pulse Generator is as<br>safe, as effective, and performs as well as the predicate devices. | |

Osypka Medical GmbH Grossbeerenstrasse 184 ● 12277 Berlin ● Germany
Phone [phone] ● Fax [phone] ● www.osypkamed.com

02 002

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K033Bci

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510(k) Summary

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OSYPKA MEDICAL, the company logo, PACE 101, PACE 101H, CARDIOTRONIC, XI SERIES, AS SERIES, XI.TPE, XI.TME, XI.HWR, XI.RAC, XI.XHW and AS.45 are trademarks of OSYPKA MEDICAL GMBH, Berlin (Germany), and OSYPKA MEDICAL, INC., La Jolla, CA. OSCOR is a trademark of OSCOR, INC., Palm Harbor, FL. ST. JUDE MEDICAL is a trademark of ST. JUDE MEDICAL INC., St. Paul, MN.

Osypka Medical GmbH Grossbeerenstrasse 184 · 12277 Berlin · Germany Phone [phone] · Fax [phone] · www.osypkamed.com

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2003

Osypka Medical, Inc. c/o Markus J. Osypka, Ph.D. President 7855 Ivanhoe Avenue, Suite 226 La Jolla, CA 92037

Re: K033130

Trade Name: PACE 101/PACE 101H, Model 3077 SSI Temporary Pulse Generator Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: Class III (three) Product Code: DTE Dated: September 28, 2003 Received: September 30, 2003

Dear Dr. Osypka:

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. Iisting 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 -- Markus J. Osypka, Ph.D.

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.

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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| 510(k) Number: | K033130 |
|----------------|-------------------------------------------------------------------------------|
| Device Names: | OSCOR PACE 101 / PACE 101H |
| | ST. JUDE MEDICAL MODEL 3077 |
| | CARDIOTRONIC PACE 101 |
| | XI Series Extension Cables:<br>XI.TPE, XI.TME, XI.HWR, XI.RAC, XI.XTP, XI.XHW |
| | AS.45 Arm Strap |

Indications For Use:

The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular pacing.

- When combined with a stimulation lead system, the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator can be used whenever temporary atrial or ventricular pacing is indicated. The device can be employed for therapeutic as well as diagnostic purposes or may be used prophylactically.
- Specific indications for temporary pacing include, but are not limited to:
- . Complete (third-degree) or intermittent heart block;
- Symptomatic sinus bradycardia; .
- Atrial and/or ventricular ectopic arrhythmia; .
- . Sick Sinus Syndrome (SSS);
- Atrial tachyarrhythmia;
- Acute myocardial infarction-induced heart block; .
- Stimulation during ventricular asystole; ●
- . Use during the replacement of an implantable pulse generator;
- Stimulation and monitoring before the implantation of a cardiac pulse generator; ●
- Stimulation and monitoring following heart surgery. .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109 Or

Over-The-Counter-Use

Elias Mallis

ion of Cardiovascular Devices

510(k) Number_KO33130

(Optional Format 1-2-96)