(312 days)
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No
The description mentions a "software algorithm" for ECG analysis, which is a standard component of AEDs and does not necessarily imply AI/ML. There are no mentions of AI, ML, or related terms like DNN, nor is there information about training or test sets typically associated with AI/ML development.
Yes
The device is described as "applying a brief, high energy pulse of electricity to the heart" to "terminate certain potentially fatal cardiac arrhythmias," which directly treats a medical condition.
Yes
The device analyzes the patient's electrocardiogram (ECG) to detect a shockable rhythm, which is a form of diagnosis to determine the need for defibrillation.
No
The device description clearly states it is a portable battery-powered device that applies an electrical pulse via electrodes, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the LIFEPAK 500 Automated External Defibrillator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- LIFEPAK 500 Function: The LIFEPAK 500 is a device that analyzes the patient's electrocardiogram (ECG) and delivers an electrical shock directly to the patient's chest. It operates in vivo (within the living body) rather than in vitro (in a test tube or other artificial environment).
- Intended Use: The intended use clearly states it is used to "terminate certain potentially fatal cardiac arrhythmias" by applying electricity to the heart. This is a therapeutic intervention, not a diagnostic test performed on a sample.
Therefore, the LIFEPAK 500 falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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Device 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 (BCG) 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
hospital or pre-hospital setting by authorized personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.5310 Automated external defibrillator system.
(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
3014804204:# 2
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
Sherri L. Pocock Contact Person: (206) 867-4332
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 (BCG) 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.
1
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.