RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM

K963120 · Marquette Electronics, Inc. · DRO · Feb 28, 1997 · Cardiovascular

Device Facts

• Record ID: K963120
• Device Name: RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
• Applicant: Marquette Electronics, Inc.
• Product Code: DRO · Cardiovascular
• Decision Date: Feb 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Responder 2500 is intended to be used in a hospital environment by emergency personnel in evaluating and treating life-threatening arrhythmias. - Responder 2500 is intended to be used by trained operators - Responder 2500 is designed for external and internal defibrillation (including cardioversion) - Responder 2500 is capable of monitoring the heart rate with adjustable alarm limits. - Responder 2500 is designed for external pacing with adjustable current and rate.

Device Story

Responder 2500 is an emergency cardiac monitor/defibrillator with external pacing capabilities; used in hospital environments by trained emergency personnel. Device inputs include ECG signals for heart rate monitoring and arrhythmia detection. Device transforms inputs via internal processing to provide visual monitoring and deliver therapeutic electrical shocks (defibrillation/cardioversion) or pacing pulses. Output includes real-time cardiac monitoring data, adjustable alarm alerts, and therapeutic energy delivery. Healthcare providers use output to assess patient cardiac status and determine necessity for intervention; device facilitates rapid treatment of life-threatening arrhythmias, potentially stabilizing patient cardiac rhythm.

Clinical Evidence

Bench testing, environmental testing, and animal studies conducted. Performance validated against voluntary standards: ANSI/AAMI DF2-1996, ES1 1993, EC13 1992; IEC 601-1, 601-1-2, 601-2-4, 601-2-27; UL 2601-1. Quality assurance included requirements specification reviews, code inspections, and final validation. No human clinical trial data reported.

Technological Characteristics

Emergency cardiac monitor/defibrillator/pacer. Standards compliance: ANSI/AAMI DF2-1996 (defibrillation), ANSI/AAMI ES1 1993 (safety), ANSI/AAMI EC13 1992 (ECG), IEC 601-1 (general safety), IEC 601-1-2 (EMC), IEC 601-2-4 (defibrillators), IEC 601-2-27 (ECG monitoring), UL 2601-1. Features adjustable alarm limits, adjustable pacing current/rate, and internal/external defibrillation capability.

Indications for Use

Indicated for patients requiring emergency cardiac monitoring, defibrillation (external/internal), cardioversion, or external transcutaneous pacing for treatment of life-threatening arrhythmias.

Regulatory Classification

Identification

An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.

Special Controls

*Classification.* Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and (2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”

Predicate Devices

• Marquette Series 900
• Marquette Series 1500 Responder

Submission Summary (Full Text)

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FEB 28 1997
K963120
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# SECTION 2 - SUMMARY AND CERTIFICATION

## 2.1 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter: | Marquette Electronics, Inc.
8200 W. Tower Avenue
Milwaukee, WI 53223
Telephone: [phone]
FAX: [phone] |
| --- | --- |

Contact Person: Kristin Pabst

| Device: | Trade Name: | Responder 2500 Defibrillator and Cardiac Care System |
| --- | --- | --- |
| | Classification Name: | DC-Defibrillator, low energy (including paddles) |
| | | Pacemaker, Cardiac, External Transcutaneous (Non-invasive) |

**Predicate Devices:**

Marquette Series 900<br/>Marquette Series 1500 Responder

**Device Description:**

Responder 2500 and Cardiac Care System is an emergency cardiac monitor/defibrillator with an external pacing option.

**Intended Use:**

Responder 2500 is intended to be used in a hospital environment by emergency personnel in evaluating and treating life-threatening arrhythmias.

- Responder 2500 is intended to be used by trained operators
- Responder 2500 is designed for external and internal defibrillation (including cardioversion)
- Responder 2500 is capable of monitoring the heart rate with adjustable alarm limits.
- Responder 2500 is designed for external pacing with adjustable current and rate.

510(k) Notification "Responder 2500" - August 9, 1996

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The intended use of Responder 2500 is identical to the intended use of the predicate devices.

## Technology:

Responder 2500 employs the same technology as the predicate devices.

## Performance:

Responder 2500 complies with the voluntary standards ANSI/AAMI DF2-1996, ANSI/AAMI ES1 1993, ANSI/AAMI EC13 1992, IEC 601-1, IEC 601-1-2, IEC 601-2-4, IEC 601-2-27, UL 2601-1.

The following quality assurance measures were applied to the development of Responder 2500.

Requirements specification reviews, code inspections, software and hardware testing, safety testing, environmental testing, field tests on the monitor function and animal studies on the defibrillation and pacing functions, and final validation.

The results of these measurements demonstrated that Responder 2500 is as safe, as effective, and performs as well as the predicate devices Marquette Series 900 and Marquette Series 1500 Responder.

510(k) Notification "Responder 2500" - August 9, 1996