(193 days)
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.
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 transthoracic 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 200J, 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.
Here's an analysis of the provided text to extract the acceptance criteria and study information:
Key Takeaways:
- This 510(k) summary is for the Shock Advisory Option for CodeMaster, a software modification for existing defibrillators.
- The primary function is to automatically analyze ECG rhythms and advise on defibrillation (semi-automatic external defibrillation).
- The comparison is to a legally marketed predicate device: Physio Control Likfepak 9 and 9A with Shock Advisory capability (K#892005).
- The document does not contain the specific detailed acceptance criteria or a study section describing the performance of this specific device against those criteria. It primarily focuses on the device description, indications for use, and a comparison to the predicate device in terms of intended use. The provided text details the predicate device's substantial equivalence but doesn't present a new study for the CodeMaster's Shock Advisory Option.
Analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific numerical acceptance criteria (e.g., sensitivity, specificity thresholds) for the CodeMaster Shock Advisory Option, nor does it present a tabular summary of its performance against such criteria. The document is a 510(k) summary focusing on substantial equivalence to a predicate device, rather than a detailed clinical study report for the new device.
The closest to "acceptance criteria" for this device, as implied by the substantial equivalence argument, would be that its performance is at least as safe and effective as the predicate device. However, the specific metrics and targets for this are not detailed within this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given 510(k) summary. There is no description of a specific test set or study conducted for the CodeMaster Shock Advisory Option's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there is no description of a specific test set or ground truth establishment process for the CodeMaster Shock Advisory Option in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no description of a specific test set or adjudication process for the CodeMaster Shock Advisory Option in this summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not mentioned or described in the provided text. The device is a "Shock Advisory Option," implying it assists the human operator, but a formal MRMC study demonstrating improvement with AI assistance (though it's an algorithm, not explicitly "AI" in modern terms) is not presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation (algorithm only) is not explicitly described in the text. The device operates in a "semi-automatic external defibrillation" mode where the algorithm analyzes but the operator delivers the shock. While the algorithm's performance (identifying shockable rhythms) is critical, a dedicated "standalone performance study" on the algorithm in isolation isn't detailed here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth is not specified as there is no description of a study for the CodeMaster Shock Advisory Option's performance in this summary. For this type of device, ground truth would typically involve expert cardiologists confirming ECG rhythms.
8. The sample size for the training set
This information is not provided. The document describes a software modification to an existing platform and focuses on substantial equivalence, not the development or training of a new algorithm.
9. How the ground truth for the training set was established
This information is not provided.
Summary of Missing Information:
The provided 510(k) summary (Attachment I) primarily serves to establish "substantial equivalence" of the CodeMaster Shock Advisory Option to a previously cleared predicate device (Physio Control Likfepak 9 and 9A with Shock Advisory capability, K#892005).
It clearly states that "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." This approach relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a cleared device, rather than presenting new, detailed performance study data against explicit acceptance criteria.
Therefore, the specific details regarding acceptance criteria, study design (sample size, provenance, experts, adjudication), and training set information are not present within this particular 510(k) summary document. Such details would typically be found in more extensive technical documentation or internal company reports, not always in the publicly available 510(k) summary.
§ 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.