CARDIOSERV P

K962547 · Marquette Electronics, Inc. · DRO · Mar 6, 1997 · Cardiovascular

Device Facts

• Record ID: K962547
• Device Name: CARDIOSERV P
• Applicant: Marquette Electronics, Inc.
• Product Code: DRO · Cardiovascular
• Decision Date: Mar 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia. CardioServ is intended to be used by trained operators CardioServ is designed for external and internal defibrillation (including cardioversion) CardioServ is capable of monitoring the heart rate with adjustable alarm limits. CardioServ is designed for external pacing with adjustable current and frequency.

Device Story

Portable defibrillator with integrated ECG monitor, recorder, and external transcutaneous pacemaker; used for emergency resuscitation and dysrhythmia management. Device inputs include cardiac electrical signals via electrodes/paddles; processes signals for heart rate monitoring and alarm triggering; delivers therapeutic electrical shocks or pacing pulses. Operated by trained clinicians in clinical settings. Output includes real-time ECG visualization, heart rate data, and therapeutic energy delivery. Assists clinicians in rapid cardiac rhythm assessment and intervention; facilitates life-saving resuscitation.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI DF2-1989, ANSI/AAMI ES1 1993, IEC 601-1, IEC 601-1-2, IEC 601-2-4, and EN 60601-2-31. Quality assurance included requirements specification reviews, code inspections, software/hardware testing, safety/environmental testing, and independent final validation.

Technological Characteristics

Portable defibrillator/monitor/pacemaker. Sensing: ECG monitoring. Actuation: Defibrillation and external pacing (adjustable current/frequency). Standards: ANSI/AAMI DF2-1989, ANSI/AAMI ES1 1993, IEC 601-1, IEC 601-1-2, IEC 601-2-4, EN 60601-2-31. Includes built-in recorder.

Indications for Use

Indicated for cardiac arrest victims and patients with clinical cardiac dysrhythmia requiring emergency resuscitation, defibrillation, cardioversion, or external pacing. Intended for use by trained operators.

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

• HELLIGE CardioServ SCP 910
• Marquette Series 1500 Responder

Submission Summary (Full Text)

{0}

K962547
5

# SECTION 2 - SUMMARY AND CERTIFICATION

MAR - 6 1997

## 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: | CardioServ P |
| --- | --- | --- |
| | Classification Name: | DC-Defibrillator, low energy (including paddles)
Pacemaker, Cardiac, External Transcutaneous (Non-invasive) |

**Certificate Devices:**

- HELLIGE CardioServ SCP 910
- Marquette Series 1500 Responder

**Device Description:**

CardioServ is a portable defibrillator with ECG monitor, built-in recorder, and the capability of external pacing with adjustable current and frequency.

**Intended Use:**

CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia.

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

The intended use of CardioServ is identical to the intended use of the predicate devices.

510(k) Notification "CardioServ P" - June 26, 1996

{1}

6

Technology:
CardioServ employs the same technology as the predicate devices.

Performance:
CardioServ complies with the voluntary standards ANSI/AAMI DF2-1989, ANSI/AAMI ES1 1993, IEC 601-1, IEC 601-1-2, IEC 601-2-4, EN 60601-2-31.

The following quality assurance measures were applied to the development of CardioServ:

Requirements specification reviews, code inspections, software and hardware testing, safety testing, environmental testing, final validation testing by an independent test group, field tests.

The results of these measurements demonstrated that CardioServ is as safe, as effective, and performs as well as the predicate devices CardioServ SCP 910 and Marquette Series 1500 Responder.

510(k) Notification "CardioServ P" - June 26, 1996