(106 days)
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients.
Automated external defibrillation mode is intended for use on patients eight years of age and older.
Indications for Use:
Manual Defibrillation:
Indications
Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy 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 15 monitor/defibrillator 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 ST-elevation myocardial infarction (STEMI).
Pulse Oximetry
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SpO2 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions.
Noninvasive Blood Pressure Monitoring:
Indications
Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance.
End-Tidal CO2 monitoring:
Indications
EtCO2 monitoring is used to detect 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.
Invasive Pressure Monitoring:
Indications
Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis.
Temperature Monitoring:
Indications
Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.
The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LIFEPAK 15 monitor/defibrillator was designed for use in a variety of hospital and pre-hospital settings including emergency rooms, catheterization laboratories, electrophysiology laboratories, crash carts, operating rooms, and ground ambulances.
Features of the LIFEPAK 15 monitor/defibrillator include manual and automated external defibrillation, noninyasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry (SpO2, SpCO. and SpMet), synchronized cardioversion, noninvasive blood pressure monitoring, end-tidal CO2 monitoring and invasive pressure monitoring. The existing LIFEPAK 15 monitor/defibrillator is powered by rechargeable lithium-ion batteries.
The proposed LIFEPAK 15 monitor/defibrillator includes all of the same features and functions as the predicate device plus 2 new features: 1) temperature monitoring and 2) auxiliary power. The temperature monitoring feature allows continuous monitoring of body temperature with the use of temperature probes. The temperature reading can be trended and displayed on the LIFEPAK 15 monitor/defibrillator screen. The temperature trend graph can also be printed or saved and transmitted to the Physio-Control CODE-STAT" software for post event review.
The new auxiliary power feature gives users an additional option for powering the LIFEPAK 15 monitor/defibrillator. In addition to the existing rechargeable lithium-ion batteries, users will have the option to operate their device from AC power sources via an AC power adapter or from DC power sources via a DC power adapter. The LIFEPAK 15 monitor/defibrillator charges installed batteries when connected to auxiliary power.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria for the new features (temperature monitoring and auxiliary power). Instead, it states: "The information in this 510(k) notification demonstrates that the LIFEPAK 15 monitor/defibrillator is substantially equivalent to the predicate LIFEPAK 15 device with respect to safety, effectiveness, and performance." This implies that the new features are considered substantially equivalent to existing, cleared technologies and thus a comprehensive study with acceptance criteria might not have been performed or documented in this summary.
Here's a breakdown of what can be inferred and what is missing, based on your requested information:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document primarily focuses on describing the device, its intended use, and its equivalence to a predicate device.
2. Sample size used for the test set and the data provenance:
This information is not provided. As no specific study proving the device meets acceptance criteria for the new features is detailed, there's no mention of a test set, its sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This is not applicable as the device is a monitor/defibrillator adding temperature monitoring and auxiliary power, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is a medical monitoring and intervention device, not an algorithm being tested in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided.
8. The sample size for the training set:
This information is not provided.
9. How the ground truth for the training set was established:
This information is not provided.
Summary of available information regarding acceptance criteria and studies:
The document concludes with: "The information in this 510(k) notification demonstrates that the LIFEPAK 15 monitor/defibrillator is substantially equivalent to the predicate LIFEPAK 15 device with respect to safety, effectiveness, and performance." This statement suggests that the new features (temperature monitoring and auxiliary power) were likely evaluated against established standards for vital sign monitoring and power supply systems, rather than requiring a new, extensive clinical study with specific acceptance criteria outlined in this summary. The "substantial equivalence" argument is the primary method used to demonstrate that the device with these new features is safe and effective.
§ 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.