LIFEPAK 500

K955854 · Physio-Control Corp. · MKJ · Nov 4, 1996 · Cardiovascular

Device Facts

• Record ID: K955854
• Device Name: LIFEPAK 500
• Applicant: Physio-Control Corp.
• Product Code: MKJ · Cardiovascular
• Decision Date: Nov 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The LIFEPAK 500 Automated External Defibrillator may be used in the hospital or pre-hospital setting by authorized personnel to terminate certain potentially fatal cardiac arrhythmias.

Device Story

Portable, battery-powered AED; applies high-energy electrical pulses to heart via chest electrodes. Input: patient ECG signals. Processing: software algorithm analyzes ECG to identify shockable rhythms. Output: visual/audible prompts to operator. Operation: authorized personnel (hospital/pre-hospital) confirm patient is unconscious, pulseless, and apneic; operator initiates shock via button. Benefit: rapid termination of fatal arrhythmias; restores cardiac rhythm.

Clinical Evidence

Bench testing only. Performance testing conducted per AAMI DF39-1993 and AAMI DF2-1989 standards. Tests included environmental stress (temperature, humidity, altitude), energy accuracy, pulse characteristics, charge time, battery capacity, defibrillation recovery, rhythm detector function, EMC, dielectric withstand, leakage current, and mechanical durability (vibration/shock).

Technological Characteristics

Portable, battery-powered AED. Energy source: internal battery. Sensing: ECG via chest electrodes. Output: high-energy electrical pulse. Software: arrhythmia detection algorithm. Standards: AAMI DF39-1993, AAMI DF2-1989.

Indications for Use

Indicated for patients experiencing potentially fatal cardiac arrhythmias requiring defibrillation; for use by authorized personnel in hospital or pre-hospital settings.

Regulatory Classification

Identification

An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

Predicate Devices

• Physio-Control LIFEPAK 300 (K943301)
• SurVIVAlink automated external defibrillator (K940445)

Submission Summary (Full Text)

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SENT BY: XEROX Telecopier 7017;10-30-96 ; 2:37PM ; QUALITY ASSURANCE 3014804204;# 2
K955854
Nov. 4, 1996

510(k) Summary
(Summary of information contained in the 510(k) premarket notification)

Submitter's Name and Address: Physio-Control Corporation
11811 Willows Road Northeast
P.O. Box 97006
Redmond, WA 98073

Contact Person: Sherri L. Pocock
[phone]

Date Summary Prepared: October 30, 1996

Device:
Physio-Control Corporation LIFEPAK® 500 Automated External Defibrillator

Classification:
Low-Energy DC - Defibrillators (including Paddles): Class II (21 CFR 870.5300) (Federal Register Vol. 45, No., 25; Tuesday, February 5, 1980)

Automatic External Defibrillators have been considered Class III devices by FDA.

Substantial Equivalence:
This defibrillator is substantially equivalent to the currently marketed Physio-Control LIFEPAK 300 automated external defibrillator (510(k) no. K943301) and the SurVIVAlink automated external defibrillator (510(k) no. K940445).

Description:
The LIFEPAK 500 Automated External Defibrillator (AED) is a portable battery powered device which applies a brief, high energy pulse of electricity to the heart via defibrillation electrodes on the chest. A software algorithm analyzes the patients electrocardiogram (ECG) and informs the operator whether it detects a shockable rhythm. The operator can then press the shock button to deliver energy after confirming that the patient is unconscious, pulseless and apneic.

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Intended Use:

The LIFEPAK 500 Automated External Defibrillator may be used in the hospital or pre-hospital setting by authorized personnel to terminate certain potentially fatal cardiac arrhythmias.

Technological characteristics of new and predicate devices:

The LIFEPAK 500 AED uses the same arrhythmia detection algorithm that is used in the LIFEPAK 300 AED.

Summary of Performance Information:

Performance test information provided in the 510(k) demonstrates substantial compliance with applicable sections of AAMI DF39-1993, "Automated External Defibrillators and Remote-Control Defibrillators," AAMI DF2-1989, "Cardiac Defibrillator Devices," and the FDA Reviewers Guidance for Premarket Notifications.

Tests include high and low temperature, high and low humidity, altitude, energy accuracy, pulse shape and duration, charge time, battery capacity, defibrillation recovery, rhythm detector function, EMC, dielectric withstand, leakage current, vibration and shock resistance, and rhythm detection.

Test information demonstrates that the safety and effectiveness of the LIFEPAK 500 are substantially equivalent to those of the predicate devices.