OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES

K022939 · Osypka Medical, Inc. · DTE · Oct 3, 2002 · Cardiovascular

Device Facts

• Record ID: K022939
• Device Name: OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
• Applicant: Osypka Medical, Inc.
• Product Code: DTE · Cardiovascular
• Decision Date: Oct 3, 2002
• 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

SSI temporary pulse generator provides demand or asynchronous cardiac pacing; inputs include intrinsic cardiac signals via pacing leads; device processes signals to inhibit or trigger pulses based on user-adjusted rate and amplitude; outputs include electrical pacing pulses to heart and optical/acoustic indicators for sensing and pacing events. Used in clinical settings (intensive care) by healthcare professionals. Features include high-rate pacing for atrial tachycardia, battery voltage surveillance, and runaway protection (max 200 ppm). Accessories include extension cables and arm straps for patient attachment. Benefits include stabilization of heart rhythm and monitoring during critical cardiac procedures.

Clinical Evidence

No clinical data. Bench testing only; modifications did not require additional clinical evaluation or bench testing.

Technological Characteristics

Battery-powered, stand-alone external pulse generator. Features insulated connector terminals compliant with 21 CFR Part 898. Includes optical (LED) and acoustic indicators for sensing/pacing. Provides demand or asynchronous pacing modes. Includes runaway protection circuit and battery voltage surveillance.

Indications for Use

Indicated for patients requiring temporary atrial or ventricular pacing for therapeutic, diagnostic, or prophylactic purposes, including heart block, symptomatic sinus bradycardia, arrhythmias, Sick Sinus Syndrome, acute myocardial infarction-induced heart block, ventricular asystole, pre/post-operative cardiac surgery, and 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 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)

Reference Devices

• PACE 203 Dual-Chamber Pulse Generator

Submission Summary (Full Text)

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10022939

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CONFIDENTIA({{ \$10(k) Summary
CONFIDENTIAL

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## 510(k) Summary

OCT 0 3 2002

| Date: | 3 September 2002 | | | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Submitter: | Osypka Medical GmbH<br>Grossbeerenstrasse 184, 12277 Berlin, Germany | | | |
| Contact Person: | Markus Osypka, Ph.D., President<br>Osypka Medical, Inc.<br>7463 Draper Avenue, La Jolla, California 92037, USA<br>Phone: [phone] Fax: [phone] | | | |
| Device Trade<br>Names: | OSCOR®<br>ST. JUDE MEDICAL™<br>CARDIOTRONIC™<br>Accessories including: | | PACE 101™ / PACE 101H™<br>Model 3077<br>PACE 101™<br>XI.TME / XI.RAC™ Extension Cables;<br>AS.45™ Arm Strap. | and Accessories;<br>and Accessories;<br>and Accessories; |
| Common /<br>Usual Names: | SSI Temporary Pulse Generator, Single-Chamber Temporary Cardiac<br>Pacemaker;<br>Extension Cable, Patient Cable, Arm Strap. | | | |
| Classification<br>Names: | 870.3600 | Pulse-Generator, Pacemaker, External | | |
| | 870.2900 | Cables, Transducer and Electrode | | |
| Predicate<br>Devices: | 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<br>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. | | | |
| | 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. | | | |

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

The PACE 101 / PACE 101H / Model 3077 has two modes of high-rate pacing for the treatment of atrial tachycardia. Pacing frequency can easily doubled or quadrupled; the PACE 101 / PACE 101H / Model 3077 will then pace in asynchronous mode. An acoustic signal is automatically emitted during highrate pacing. Errors that occur during operation are indicated optically and acoustically. A special circuit allows for automatic surveillance of the battery voltage. With the help of an LED and an acoustic signal, complete drainage of the battery can be prevented. The PACE 101 / PACE 101H / Model 3077 has an additional feature - runaway protection. Run-away protection limits the impulse emission to a maximum of 200 ppm and prevents the delivery of too high a pacing rate in the event of a defect in the frequency generator. The Series XI Extension Cables support proper connection of the PACE 101 / PACE 101H / Model 3077 to various types of pacing lead systems (accessories). The Series AS Arm Straps ensure proper attachment of the PACE 101 / PACE 101H / Model 3077 to the patient's arm (accessory). The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is Intended Use: designed to be used with cardiac pacing lead systems for temporary atrial or ventricular pacinq. 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. .

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FNTIAL510(k) Summary
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Image /page/2/Picture/1 description: The image shows the title of a document. The title includes the words "CA MEDICAL", "CONFIDENTIAL", and "510(k) Summary". The text also indicates that the document is page 3 of 3 and that it was created in San Diego, California, USA.

| 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 Series XI 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. The Series XI Extension Cables and Series<br>AS Arm Strap have been previously market-released in combination with the<br>PACE 203 Dual-Chamber Pulse Generator. |
| | Based on the limited impact of the modifications made, it is concluded that the<br>PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is as<br>safe, as effective, and performs as well as the predicate devices. |

ny • San Diego, California, USA

OSYPKA MEDICAL, the company logo, PACE 101, PACE 101H and CARDIOTRONIC 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 03 2002

Opsypka Medical, Inc. c/o Markus J. Osypka, Ph.D. President 7463 Draper Avenue La Jolla, CA 92037

Re: K022939

Trade Name: PACE 101/PACE 101H/Model 3077 SSI Temporary Pulse Generator Regulation Number: 21 CFR 870.3600 Regulation Name: Pulse Generator, External Pacemaker Regulatory Class: Class III (three) Product Code: DTE Dated: September 3, 2002 Received: September 4, 2002

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, 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 - 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 (OS) 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,

V. Degett Telleh

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:

Device Names:

K022939 OSCOR PACE 101 / PACE 101H

ST. JUDE MEDICAL MODEL 3077 CARDIOTRONIC PACE 101 XI.TME and XI.RAC Extension Cables

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

Division of Cardiovascular & Respiratory Devices
510(k) Number K022939

(Optional Format 1-2-96)