(134 days)
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J. There are currently no clinical studies related to the use of SMART Biphasic waveform in pediatric applications.
Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronized defibrillation is indicated for termination of atrial fibrillation.
AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.
Non-Invasive External Pacing:
The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.
12-Lead ECG:
The 12-Lead ECG option is to be used where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms.
Non-Invasive Blood Pressure:
The NIBP option is intended for noninvasive measurement of arterial blood pressure for adult and pediatric patients.
Endtidal CO2:
The EtCO2 option is intended for noninvasive monitoring of exhaled carbon dioxide and to provide a respiration rate for adult, pediatric and neonatal patients.
Pulse Oximetry:
The SpO2 option is intended for use when it is beneficial to assess the oxygen saturation level for adult and pediatric patients.
The HeartStart MRx is a fully featured, external defibrillator/monitor intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or Basic Life Support, in a hospital or pre-hospital environment.
The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED).
In manual mode, the HeartStart MRx is a full-featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation allows users to select energy levels for external and internal defibrillation, perform synchronized cardioversion and provide non-invasive external pacing.
In AED mode, the HeartStart MRx, allows the provider who is trained in Basic Life Support (BLS) to provide defibrillation therapy. The device analyzes a patient's rhythm and advises the user to provide a shock. Voice prompts guide the user through the defibrillation process by providing instructions and patient information. The voice prompts are reinforced by messages that appear on the display.
In both modes of operation, the HeartStart MRx utilizes impedance compensating biphasic truncated exponential therapy waveform.
The HeartStart MRx can also be used for ECG monitoring of a patient using either 3 or 5 lead cables.
Additionally, the HeartStart MRx is offered with the following optional functionality:
Non-Invasive External Pacing:
The pacing option is intended for treating patients with symptomatic bradycardia. This parameter is used by ACLS trained clinicians typically performed in a hospital environment.
12-Lead ECG:
The 12-Lead ECG option is intended to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements. This parameter is used in both the hospital and pre-hospital environment by ACLS and BLS trained clinicians.
Non-Invasive Blood Pressure:
The NIBP option is intended for noninvasive measurement of a patient's arterial blood pressure. This parameter is used in both the hospital and pre-hospital environment by ACLS and BLS trained clinicians.
Endtidal CO2:
The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and also provides a respiration rate. This parameter is used by ACLS trained clinicians and performed in both the pre-hospital and hospital environments.
Pulse Oximetry:
The SpO2 option is intended for use when it is beneficial to assess a patient's arterial oxygen saturation level. This parameter is used by trained clinicians and performed in both the pre-hospital and hospital environments.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the HeartStart MRx device:
Acceptance Criteria and Device Performance
The submission focuses primarily on demonstrating substantial equivalence to predicate devices through technical comparisons and bench testing. It does not explicitly state numerical acceptance criteria in the format of sensitivity, specificity, or similar performance metrics. Instead, the "acceptance criteria" are implied to be meeting specifications through bench testing and being substantially equivalent to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets device specifications (hardware/software) | Bench testing demonstrated the performance of the device meets its specifications. |
| Substantially equivalent to predicate devices (Heartstream XL Defibrillator/Monitor and ZOLL M Series Defibrillator) | Technical comparison and bench testing concluded that the HeartStart MRx does not raise any different questions regarding safety or effectiveness compared to predicate devices. |
Note: The document states, "The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J." This refers to the predicate device's performance, which the HeartStart MRx is claiming equivalence to, rather than new performance data for the MRx itself.
Study Details
Based on the provided text, the study conducted for the HeartStart MRx was a bench testing study.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The study involved "bench testing" which typically refers to laboratory testing of the device hardware and software, rather than a clinical dataset of patient records.
- Data Provenance: Not applicable in the context of bench testing. The data would be generated directly from the device and test equipment in a lab setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a bench testing study. Ground truth in this context would likely be engineering specifications and validated test procedures.
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Adjudication method:
- Not applicable as this was a bench testing study.
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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:
- No MRMC study was done. The document explicitly states: "The tests used in the determination of substantial equivalence included only bench testing." The device is a defibrillator/monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance assessment was conducted in the form of "bench testing" which evaluates the device's hardware and software against specifications. While not an "algorithm-only" study in the modern AI sense, it assesses the device's inherent functionality.
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The type of ground truth used:
- Engineering specifications and design requirements. For example, the device would be tested to ensure its output waveform, energy delivery, ECG acquisition accuracy, and other parameters meet predefined technical standards.
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The sample size for the training set:
- Not applicable. This device is not described as utilizing a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such devices typically refers to the development and refinement of its internal logic and parameters based on engineering principles and established medical guidelines, rather than learning from a vast dataset.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 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.