(29 days)
No
The device description focuses on basic electronic pacing functions, adjustable parameters, and safety features like runaway protection. There is no mention of learning, adaptation, or complex data analysis that would indicate AI/ML.
Yes
The device is explicitly stated to be employed for therapeutic as well as diagnostic purposes and is described as providing pacing therapy for conditions such as rhythm disturbances and conduction defects, including Treatment of bradycardia and Treatment of atrial tachyarrhythmia.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can be employed for therapeutic as well as diagnostic purposes or may be used prophylactically."
No
The device description clearly outlines a physical, battery-powered device with indicator lights (LEDs), acoustic signals, connector terminals, and accessories (extension cables, arm straps). These are all hardware components, indicating it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is a device that directly interacts with the heart through pacing lead systems to regulate heart rhythm. It provides electrical stimulation to the heart.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The device's function is to deliver therapy (pacing) and monitor the heart's electrical activity in vivo.
Therefore, this device falls under the category of a therapeutic and monitoring medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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. .
Product codes
DTE
Device Description
The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is used for temporary intensive care pacing of the heart in cases of rhythm 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 intracardiac signal-inhibited pulse generator or as an asynchronous pulse generator. Pacing rate and amplitude can be adjusted over a wide range, conforming to actual therapeutic requirements. Sensed intrinsic activity and paced pulses are indicated optically by a light-emitting diode (LED). Additionally, acoustic signals for sensing and pacing can be switched on and off. 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Summary Bench Testing: The modifications made do not require additional bench testing.
Summary Clinical Evaluation: The modifications made do not require additional clinical evaluation.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3600 External pacemaker pulse generator.
(a)
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.(b)
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.
0
10022939
Image /page/0/Picture/1 description: The image shows the logo for Osypka Medical. The logo consists of a black square with a white circle inside, followed by the text "OSYPKA MEDICAL" in a large, sans-serif font. Below the company name, the text "Berlin, Germany • San Diego, California, USA" is written in a smaller font, indicating the company's locations.
CONFIDENTIA({{ $10(k) Summary
CONFIDENTIAL
Page 1 of 3
510(k) Summary
OCT 0 3 2002
| Date: | 3 September 2002 | |||
|---|---|---|---|---|
| Submitter: | Osypka Medical GmbH | |||
| Grossbeerenstrasse 184, 12277 Berlin, Germany | ||||
| Contact Person: | Markus Osypka, Ph.D., President | |||
| Osypka Medical, Inc. | ||||
| 7463 Draper Avenue, La Jolla, California 92037, USA | ||||
| Phone: (858) 459-2312 Fax: (858) 459-2353 | ||||
| Device Trade | ||||
| Names: | OSCOR® | |||
| ST. JUDE MEDICAL™ | ||||
| CARDIOTRONIC™ | ||||
| Accessories including: | PACE 101™ / PACE 101H™ | |||
| Model 3077 | ||||
| PACE 101™ | ||||
| XI.TME / XI.RAC™ Extension Cables; | ||||
| AS.45™ Arm Strap. | and Accessories; | |||
| and Accessories; | ||||
| and Accessories; | ||||
| Common / | ||||
| Usual Names: | SSI Temporary Pulse Generator, Single-Chamber Temporary Cardiac | |||
| Pacemaker; | ||||
| Extension Cable, Patient Cable, Arm Strap. | ||||
| Classification | ||||
| Names: | 870.3600 | Pulse-Generator, Pacemaker, External | ||
| 870.2900 | Cables, Transducer and Electrode | |||
| Predicate | ||||
| 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 | |||
| PACE 101H Arm Strap | ||||
| K923621 | OSCOR® DX-2 / D-5 / D-10 Extension Cables | |||
| PACE 100H Arm Strap | ||||
| Device | ||||
| Description: | The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is | |||
| used for temporary intensive care pacing of the heart in cases of rhythm | ||||
| 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 | ||||
| intracardiac signal-inhibited pulse generator or as an asynchronous pulse | ||||
| generator. Pacing rate and amplitude can be adjusted over a wide range, | ||||
| conforming to actual therapeutic requirements. Sensed intrinsic activity and | ||||
| paced pulses are indicated optically by a light-emitting diode (LED). | ||||
| Additionally, acoustic signals for sensing and pacing can be switched on and | ||||
| off. |
1
Image /page/1/Picture/0 description: The image shows a black square with a white square inside. Inside the white square is a black circle. The black circle is centered within the white square.
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. .
02 002
FNTIAL510(k) Summary
Page 2 of 3
Page 2 of 3
2
Image /page/2/Picture/0 description: The image contains two figures. The first figure is a black square with a white border, and a black circle inside the white border. The second figure is a white circle with the text "Ber" below it.
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
and its predicate device have the same fundamental technological
characteristics in design, material, shape and energy source. |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The aforementioned devices are stand-alone devices that provide temporary
atrial or ventricular demand or asynchronous pacing therapy. The
aforementioned devices are battery powered. Indicator lights flash to show
atrial and ventricular sensing and atrial and ventricular pacing functions. |
| | The PACE 101 / PACE 101H / Model 3077 is equipped with insulated
connector terminals matching the protected pins of the Series XI Extension
Cables and meets the 21 CFR Part 898 performance standard. |
| Summary Bench
Testing: | The modifications made do not require additional bench testing. |
| Summary Clinical
Evaluation: | The modifications made do not require additional clinical evaluation. |
| Conclusion: | The modifications made to the device are related to a revision of the
Instructions for Use / User' Manual, without changing the intended use or the
fundamental scientific technology. The Series XI Extension Cables and Series
AS Arm Strap have been previously market-released in combination with the
PACE 203 Dual-Chamber Pulse Generator. |
| | Based on the limited impact of the modifications made, it is concluded that the
PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is as
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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three parallel lines extending from the top of the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
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.
4
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 (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,
V. Degett Telleh
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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)