(21 days)
The ERA 300 is intended for use during invasive pacemaker procedures in the following activities:
- Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, AAI, or AOO modalities during implantable pacemaker procedures or physician evaluations.
- Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time.
- Pacemaker Function Test Tests and analyzes the in vitro operation of external or implantable pulse generators. Deternines the following parameters: pulse and width, sensitivity, refractory period, AV delay, and rate/interval.
The ERA 300 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system or operate as a temporary external pulse generator at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. The ERA 300 utilizes a touch-proof configuration to help prevent hazardous connection between patients and electrical power sources.
I am unable to provide a response based on the request. The document describes a medical device called the BIOTRONIK ERA 300 Pacing System Analyzer and a modification made to it. It also references a 510(k) summary and an FDA clearance letter.
However, the provided text does not contain any information about acceptance criteria, device performance results, sample sizes for testing, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, or how ground truth for the training set was established.
The document primarily focuses on:
- The device's name, classification, and general description.
- The specific modification made (plastic foil on the battery).
- Predicate devices.
- Indications for use.
- Manufacturing and contact information.
- The FDA's 510(k) clearance letter stating substantial equivalence to predicate devices.
Therefore, I cannot fulfill the request as the necessary information is not present in the provided input.
§ 870.3720 Pacemaker electrode function tester.
(a)
Identification. A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.(b)
Classification. Class II (performance standards).