(77 days)
Manual Defibrillation:
Indications
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications
AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Noninvasive Pacing
Indications
Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
12-lead Electrocardiography:
Indications
The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction.
Pulse Oximetry
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
Noninvasive Blood Pressure Monitoring:
Indications
Noninvasive blood pressure monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for postdefibrillation recovery analysis.
End-Tidal CO2 monitoring:
Indications
EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully. It is intended for use on adult and pediatric patients.
Invasive Pressure Monitoring:
Indications
The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system with a compatible transducer. It may be used on the adult or pediatric patient.
The LIFEPAK 12 defibrillator/monitor was designed for use in a variety of hospital and pre-hospital settings including emergency departments. critical care areas, and air and ground ambulances. The LIFEPAK 12 defibrillator/monitor is powered by either AC power or battery power. LIFEPAK 12 defibrillator/monitor features include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry, synchronized cardioversion, noninvasive blood pressure monitoring, end-tidal CO2 monitoring, and invasive pressure monitoring.
The proposed LIFEPAK 12 defibrillator/monitor has the same features and functions as the predicate LIFEPAK 12 defibrillator/monitor and includes an additional battery option; a rechargeable lithium-ion battery. Use of the proposed lithium-ion battery in the LIFEPAK 12 defibrillator/monitor provides an increase in the available operating time and an increase in the number of 360-Joule discharges available while on battery power as compared to using the existing batteries.
The provided document is a 510(k) Premarket Notification for the Physio-Control Inc. LIFEPAK 12 defibrillator/monitor. It focuses on demonstrating substantial equivalence to a predicate device due to the addition of a new battery option (rechargeable lithium-ion battery).
However, the document does not contain acceptance criteria or a study proving the device meets specific performance criteria in the way medical device AI submissions typically do. This submission is for a hardware modification (battery) to an existing device, not a new or modified AI algorithm.
Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truthing, sample sizes for test and training sets, and MRMC studies is not applicable or cannot be extracted from this document.
Here's what can be gathered, and an explanation of why other points are not present:
1. Table of Acceptance Criteria and Reported Device Performance:
Not provided in the document. The submission focuses on substantial equivalence based on a hardware change (battery) where the core functionalities (defibrillation waveform, ECG analysis, monitoring, and defibrillation features) remain unchanged from the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. There isn't a "test set" in the context of evaluating an AI algorithm's performance against ground truth. The testing mentioned would have been related to the safety and performance of the new battery option within the existing device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. There is no AI algorithm being evaluated against a ground truth established by experts.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size:
Not applicable. This document does not describe the evaluation of an AI algorithm's impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no standalone AI algorithm being evaluated.
7. The Type of Ground Truth Used:
Not applicable.
8. The Sample Size for the Training Set:
Not applicable. There is no AI algorithm being trained.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
Summary of what the document does state:
- Device: LIFEPAK 12 defibrillator/monitor with a new rechargeable lithium-ion battery option.
- Change: The only difference is an additional rechargeable lithium-ion battery.
- Impact of Change: The new battery provides an increase in available operating time and an increase in the number of 360-Joule discharges compared to existing batteries.
- Unchanged Features: The defibrillation waveform, ECG analysis system, and monitoring and defibrillation features of the proposed device are unchanged from the previously cleared predicate LIFEPAK 12 defibrillator/monitor.
- Conclusion: The submission demonstrates that the LIFEPAK 12 defibrillator/monitor with the new battery is "substantially equivalent to the predicate LIFEPAK 12 device with respect to safety, effectiveness, and performance." This substantial equivalence is the primary "acceptance criterion" for a 510(k) submission, and the "study" is the documentation proving this equivalence through testing relevant to the battery's performance and safety within the device, although specific details of those tests are not in this 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.