ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.

• K Number: K022360
• Device Name: ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.
• Manufacturer: BIOTRONIK, INC.
• Date Cleared: 2003-01-27 ( 192 days)
• Product Code: DTA
• Regulation Number: 870.3720
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K964190

Intended Use

The ERA 3000 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, A00, or ODO 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. Determines the following parameters: pulse amplitude and width, A/V delay, and rate/interval.

Device Description

The ERA 3000 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. It can also operate as a temporary external pulse generator during the above mentioned procedures. The ERA 3000 utilizes a touch-proof confiquration to help prevent hazardous connection between patients and electrical power sources.

AI/ML Overview

The provided text describes the ERA 3000 Dual Chamber Pacing System Analyzer and its indications for use, but does not contain information about acceptance criteria, device performance, or any studies conducted to prove device performance.

Therefore, I cannot provide the requested information in the format specified. The document is primarily a 510(k) summary for regulatory clearance, outlining the device's purpose, predicate devices, and an FDA clearance letter. It does not include the results of performance studies or validation data.

Regulation Number and Section

§ 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).