(29 days)
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. .
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).
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.
This is a 510(k) summary for a temporary pulse generator (pacemaker) and its accessories, not a study that proves device meets acceptance criteria. The document explicitly states that modifications made to the device did not require additional bench testing or clinical evaluation. Therefore, the information typically requested regarding acceptance criteria and a study proving device performance is not present in this document.
The document focuses on demonstrating substantial equivalence to predicate devices based on modifications primarily related to the Instructions for Use/User's Manual and the previous market release of accessories in combination with another device.
Based on the provided information, I cannot fulfill your request for the following reasons:
- No Acceptance Criteria or Reported Device Performance: This document does not specify any quantitative acceptance criteria or provide performance data from a study for the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator. The filing states that the modifications did not require additional testing or evaluation.
- No Study Conducted (for the current submission): The 510(k) summary explicitly states: "The modifications made do not require additional bench testing," and "The modifications made do not require additional clinical evaluation." This means a new study to prove the device meets acceptance criteria was not conducted for this particular submission.
- No information on sample size, data provenance, experts, adjudication, MRMC, standalone performance, ground truth, or training set: Because no new study was conducted for this submission, there is no information available regarding these elements. The submission relies on the substantial equivalence to previously cleared predicate devices.
Summary of Device and its Equivalence Claim:
The document describes the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator and its accessories (extension cables and arm straps). It claims substantial equivalence to several predicate devices (K970497, K923621, K020896). The basis for this 510(k) submission is "modifications related to a revision of the Instructions for Use / User's Manual, without changing the intended use or the fundamental scientific technology." The accessories had also been previously market-released with another pulse generator.
Conclusion stated in the document:
"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."
Therefore, the provided text does not contain the information necessary to complete your detailed request regarding acceptance criteria and a study proving device performance.
§ 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.