(79 days)
For use in converting collet terminal outputs of pacing devices equipped with "For use in converting concernment will connect to extension cables and terminals spaced "1:25" on connected pin connectors."
Models 4820 and 4825 Pacing Adapters
I apologize, but the provided text ({0}, {1}, {2}) does not contain information about the acceptance criteria or a study proving that a device meets such criteria.
The text is a Food and Drug Administration (FDA) 510(k) Premarket Notification letter for the PACE Medical, Inc. Models 4820 and 4825 Pacing Adapters. This letter:
- Identifies the device and its manufacturer.
- States that the device has been found substantially equivalent to a legally marketed predicate device. This means the FDA determined the new device is as safe and effective as a device already on the market, based on the information provided by the manufacturer.
- Outlines the regulatory class and product code.
- Lists the "Indications for Use" which describe what the device is intended to be used for.
- Provides general information regarding compliance with FDA regulations.
There is no mention of:
- Specific acceptance criteria (e.g., performance thresholds for accuracy, sensitivity, specificity, etc.).
- A study design, methodology, or results demonstrating the device meets any particular performance metrics.
- Details about test sets, training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies.
Therefore, I cannot provide the requested table or answer the points about study details based on the given input.
§ 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.