(193 days)
K#892005
K#892005
No
The description focuses on a "shock advisory algorithm" that analyzes ECG rhythm to determine if a shockable rhythm is present. While this involves analysis, the language used (algorithm, standard guidelines, fixed energy sequences) suggests a rule-based or traditional signal processing approach rather than AI/ML. There is no mention of learning, training data, or adaptive capabilities typically associated with AI/ML in this context.
Yes
The device is described as a defibrillator, which explicitly terminates ventricular fibrillation by applying an electrical shock to the heart, and also provides pacing and pulse oximetry, which are all therapeutic functions.
Yes
The device performs ECG rhythm analysis, determines if a shockable rhythm is present, and provides pulse oximetry for arterial oxygen-saturation and pulse rate measurement, indicating diagnostic capabilities.
No
The device is described as a "software modification operating in the M1722A/B, M1723A/B, and M2475B CodeMaster defibrillator/monitors." While the Shock Advisory Option itself is software, it is explicitly stated to be integrated into existing hardware components (defibrillator/monitors) and relies on those hardware components (electrodes, cables, display, discharge buttons, etc.) to function as a medical device. Therefore, it is not a software-only medical device.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- The core function of the Shock Advisory Option is to analyze the electrocardiographic rhythm (ECG) of a patient. This analysis is performed on biological signals (electrical activity of the heart) obtained from the patient.
- The analysis is used to determine if a "shockable rhythm is present." This is a diagnostic determination based on the interpretation of the ECG data.
- While the device also delivers therapy (defibrillation), the diagnostic component (analyzing the ECG to advise on shocking) is a key part of its intended use.
The definition of an In Vitro Diagnostic (IVD) device generally includes devices used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. While ECG is not a "specimen" in the traditional sense of a fluid or tissue sample, the analysis of the electrical activity of the heart falls under the umbrella of diagnostic information derived from the human body.
The fact that the device also provides therapy does not preclude it from being considered an IVD, as many devices have both diagnostic and therapeutic functions. The critical aspect here is the diagnostic analysis of the ECG data to inform the decision to deliver a shock.
N/A
Intended Use / Indications for Use
The Shock Advisory Option for CodeMaster defibrillators is intended for use by medical personnel who have completed training and certification requirements applicable to the use of a semi-automatic defibrillator and under a physician approved protocol. It is indicated for use on victims of cardiac arrest where is apparent lack of circulation as indicated by unconsciousness, absence of breathing, and absence of pulse. The Shock Advisory Option is intended for use in terminating ventricular fibrillation by application of a brief electrical shock to the heart via external adhesive electrodes.
The Shock Advisory Option for CodeMaster is contraindicated for use on patients that are conscious, breathing, pulsatile, or have an implanted pacemaker. The Shock Advisory Option is not intended for pediatric use.
The intended use of the CodeMaster Shock Advisory Option is identical to the intended use of the Physio Control LifePak 9 and 9A defibrillator/monitors used with the Shock Advisory Adapter which received FDA's substantial equivalence determination under K#892005.
CodeMaster defibrillators with Shock Advisory capability may be operated as standard manual defibrillators. Standard CodeMaster defibrillator/monitors are low energy DC-defibrillators (with interchangeable paddles) as described in 21 CFR 870.5300. They are also intended for use by trained medical personnel under a physician approved protocol. Standard CodeMaster defibrillators are intended for use in terminating ventricular fibrillation by application of a brief electrical shock to the heart via external or internal electrodes. They may also be used to treat arrhythmias. This procedure, called synchronized cardioversion, requires that the defibrillator discharge occur on the ECG R wave in order to avoid inducing ventricular fibrillation.
The M1722A/B and the M2475B are also intended for external, non-demand or demand pacing if the patient is in a life-threatening asystole, profound bradycardia or any other condition in which the clinician determines that pacing must be initiated immediately. The noninvasive pacer is intended for adult or pediatric use. With regards to pediatric pacing, a determination of the suitability of external pacing for any patient must be made by the clinician. Also, the correct rate and current levels for the patient must be determined and set by the physician.
The M1722A/B and the M2475B provide pulse oximetry. The pulse oximeter is an arterial oxygen-saturation and pulse rate measurement capability which augments the ECG monitoring capability of the device. The pulse oximeter produces the numeric for the oxygen saturation value and pulse rate. The pulse oximeter is intended to be used to determine the oxygen saturation of the blood in cases where the patient's oxygenation is of direct concern and to determine the pulse rate.
Product codes
Not Found
Device Description
The CodeMaster Shock Advisory Option is a software modification operating in the M1722A/B, M1723A/B, and M2475B CodeMaster defibrillator/monitors. The hardware components of CodeMaster with Shock Advisory Option are present in the currently marketed predicate devices.
The CodeMaster Shock Advisory Option acquires and analyzes the electrocardiographic rhythm of a victim suspected to be in cardiac arrest and delivers a defibrillation shock upon operator command. This type of defibrillator operation is generally referred to as semi-automatic external defibrillation.
To use the CodeMaster Shock Advisory Option the operator must first attach adhesive electrode pads. Two disposable adhesive electrodes are used to receive ECG signals and to deliver defibrillation shocks. The electrodes are attached to the patient in the transthoriac position and connected to the device through a detachable cable. ECG rhythm analysis is initiated by the operator after verifying that the patient is unconscious, pulseless and not breathing. The shock advisory algorithm analyzes the electrical activity of the heart and determines if a shockable rhythm is present. If a shockable rhythm is present the defibrillator is automatically charged and a message is displayed on the CRT indicating that a shock is advised. The defibrillation shock is delivered when the operator depresses the discharge buttons on the defibrillator. The operator may repeat the analysis/defibrillation cycle by pressing the Analyze button to start a new analysis period.
The standard semi-automatic external defibrillator operation of the CodeMaster Shock Advisory Option follows the American Heart Association guidelines using 200 joules for the first two shocks, followed by 360 joules for the third shock. An alternative 2001, 300J, 360J energy sequence can be selected using setup mode.
The front panel of the predicate defibrillator device has been modified to enable an additional switch position already present on the energy select switch of the CodeMaster defibrillators to activate the shock advisory capability and a button to initiate analysis.
The CodeMaster Advisory Event Summary record contains information about the resuscitation attempt. ECG strips are automatically recorded for some events and the operator my record other events by pressing the MARK button. Advisory Event Summary information may be reviewed after the device has been turned off. The information in memory is cleared when the unit is powered on and a new advisory recording occurs. Advisory Event Summary is not present on the CodeMaster XL (Model M1723A/B).
At any time, if the energy select switch is moved from Advisory to a manual energy setting, the defibrillators will operate in standard manual defibrillator mode. In the manual mode the operator controls defibrillator charging, energy selection, and defibrillation delivery. The Shock Advisory capability is not operational in the manual defibrillator mode.
CodeMaster defibrillator/monitor features include recorder, optional noninvasive pacer, and optional pulse oximeter. They can be used with adult/pediatric external paddles, anterior/posterior paddles, external pads. or internal paddles. Energy selection ranges from 2 joules to 360 joules based on a 50 ohm load. Internal paddles are limited to 50 joules output. CodeMaster defibrillators will charge to the selected energy level in five seconds and will disarm itself if not discharged within 60 seconds. They may be used to defibrillate, cardiovert, pace, monitor ECG, and monitor oxygen saturation. The M1722A/B and M2475B provide an Event Summary of data in a format that facilitates code documentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical personnel who have completed training and certification requirements applicable to the use of a semi-automatic defibrillator and under a physician approved protocol.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#892005
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Attachment I: 510(k) Summary of Safety and Effectiveness
General Information
K 954957 MAY -7 1996
Device Generic Name: Defibrillator with arrhythmia detector
Device Trade Name: Shock Advisory Option for CodeMaster
Legally marketed predicate device: Physio Control Likfepak 9 and 9A with Shock Advisory capaility
Applicant:
Hewlett-Packard Diagnostic Cardiology Division 1700 South Baker Street McMinnville, Oregon 97128
Indications for Use:
The Shock Advisory Option for CodeMaster defibrillators is intended for use by medical personnel who have completed training and certification requirements applicable to the use of a semi-automatic defibrillator and under a physician approved protocol. It is indicated for use on victims of cardiac arrest where is apparent lack of circulation as indicated by unconsciousness, absence of breathing, and absence of pulse. The Shock Advisory Option is intended for use in terminating ventricular fibrillation by application of a brief electrical shock to the heart via external adhesive electrodes.
The Shock Advisory Option for CodeMaster is contraindicated for use on patients that are conscious, breathing, pulsatile, or have an implanted pacemaker. The Shock Advisory Option is not intended for pediatric use.
The intended use of the CodeMaster Shock Advisory Option is identical to the intended use of the Physio Control LifePak 9 and 9A defibrillator/monitors used with the Shock Advisory Adapter which received FDA's substantial equivalence determination under K#892005.
CodeMaster defibrillators with Shock Advisory capability may be operated as standard manual defibrillators. Standard CodeMaster defibrillator/monitors are low energy DC-defibrillators (with interchangeable paddles) as described in 21 CFR 870.5300. They are also intended for use by trained medical personnel under a physician approved protocol. Standard CodeMaster defibrillators are intended for use in terminating ventricular fibrillation by application of a brief electrical shock to the heart via external or internal electrodes. They may also be used to treat arrhythmias. This
I: 510(k) Summary of Safety and Effectiveness
1
procedure, called synchronized cardioversion, requires that the defibrillator discharge occur on the ECG R wave in order to avoid induc ng ventricular fibrillation.
The M1722A/B and the M2475B are also intended for external, non-demand or demand pacing if the patient is in a life-threatening asystole, profound bradycardia or any other condition in which the clinician determines that pacing must be initiated immediately. The noninvasive pacer is intended for adult or pediatric use. With regards to pediatric pacing, a determination of the suitability of external pacing for any patient must be made by the clinician. Also, the correct rate and current levels for the patient must be determined and set by the physician.
The M1722A/B and the M2475B provide pulse oximetry. The pulse oximeter is an arterial oxygen-saturation and pulse rate measurement capability which augments the ECG monitoring capability of the device. The pulse oximeter produces the numeric for the oxygen saturation value and pulse rate. The pulse oximeter is intended to be used to determine the oxygen saturation of the blood in cases where the patient's oxygenation is of direct concern and to determine the pulse rate.
Device Description:
The CodeMaster Shock Advisory Option is a software modification operating in the M1722A/B, M1723A/B, and M2475B CodeMaster defibrillator/monitors. The hardware components of CodeMaster with Shock Advisory Option are present in the currently marketed predicate devices.
The CodeMaster Shock Advisory Option acquires and analyzes the electrocardiographic rhythm of a victim suspected to be in cardiac arrest and delivers a defibrillation shock upon operator command. This type of defibrillator operation is generally referred to as semi-automatic external defibrillation.
To use the CodeMaster Shock Advisory Option the operator must first attach adhesive electrode pads. Two disposable adhesive electrodes are used to receive ECG signals and to deliver defibrillation shocks. The electrodes are attached to the patient in the transthoriac position and connected to the device through a detachable cable. ECG rhythm analysis is initiated by the operator after verifying that the patient is unconscious, pulseless and not breathing. The shock advisory algorithm analyzes the electrical activity of the heart and determines if a shockable rhythm is present. If a shockable rhythm is present the defibrillator is automatically charged and a message is displayed on the CRT indicating that a shock is advised. The defibrillation shock is delivered when the operator depresses the discharge buttons on the defibrillator. The operator may repeat the analysis/defibrillation cycle by pressing the Analyze button to start a new analysis period.
The standard semi-automatic external defibrillator operation of the CodeMaster Shock Advisory Option follows the American Heart Association guidelines using 200 joules for
| l: 510(k) Summary of Safety and Effectiveness
| Notes of the consisted on the comments of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of th |
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2
the first two shocks, followed by 360 joules for the third shock. An alternative 2001, 300J, 360J energy sequence can be selected using setup mode.
The front panel of the predicate defibrillator device has been modified to enable an additional switch position already present on the energy select switch of the CodeMaster defibrillators to activate the shock advisory capability and a button to initiate analysis.
The CodeMaster Advisory Event Summary record contains information about the resuscitation attempt. ECG strips are automatically recorded for some events and the operator my record other events by pressing the MARK button. Advisory Event Summary information may be reviewed after the device has been turned off. The information in memory is cleared when the unit is powered on and a new advisory recording occurs. Advisory Event Summary is not present on the CodeMaster XL (Model M1723A/B).
At any time, if the energy select switch is moved from Advisory to a manual energy setting, the defibrillators will operate in standard manual defibrillator mode. In the manual mode the operator controls defibrillator charging, energy selection, and defibrillation delivery. The Shock Advisory capability is not operational in the manual defibrillator mode.
CodeMaster defibrillator/monitor features include recorder, optional noninvasive pacer, and optional pulse oximeter. They can be used with adult/pediatric external paddles, anterior/posterior paddles, external pads. or internal paddles. Energy selection ranges from 2 joules to 360 joules based on a 50 ohm load. Internal paddles are limited to 50 joules output. CodeMaster defibrillators will charge to the selected energy level in five seconds and will disarm itself if not discharged within 60 seconds. They may be used to defibrillate, cardiovert, pace, monitor ECG, and monitor oxygen saturation. The M1722A/B and M2475B provide an Event Summary of data in a format that facilitates code documentation.
Marketing History
The Shock Advisory Option for CodeMaster is not currently sold in the U.S. or foreign markets.
Adverse Effects of the Device on Health
Patients requiring treatment for ventricular fibrillation will die if a defibrillator is not used to restore an acceptable rhythm. If this device is used incorrectly, or fails to operate the result will also most likely be death or injury of the patient. This device provides ECG waveform information as well as high and low heart rate alarms.