(28 days)
AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously 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.
Manual 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 flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Noninvasive Pacing is indicated for patients with symptomatic bradycardia or asystole.
12-Lead Electrocardiography is useful in the early detection and prompt treatment of patients with acute myocardial infarction.
Pulse Oximetry is used to check the saturation of oxygen in arterial blood. It is indicated for use in any patient who is at risk of developing hypoxemia.
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 post-defibrillation recovery analysis.
End-Tidal CO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy 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 is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using an invasive catheter system with a compatible transducer.
The LIFEPAK® 12 defibrillator/Monitor/Pacemaker is a complete acute response system, which consists of a battery or auxiliary powered cardiac response system (manual and automated), pacemaker, ECG monitor (3-lead, 5-lead, 5-lead and interpretive 12-Lead), pulse oximeter, noninvasive blood pressure monitor, end-tidal CO2 monitor, and invasive pressure monitor.
The modified LIFEPAK® 12 defibrillator/monitor/pacemaker provides the user with a new method of transmitting data from the LIFEPAK 12 defibrillator; the user can transmit data using either a data transfer cable or wirelessly via Bluetooth® wireless technology.
This 510(k) submission (K040775) is for a modification to the Medtronic Physio-Control LIFEPAK® 12 Defibrillator/Monitor/Pacemaker. The modification involves a new method of transmitting data (data transfer cable or wirelessly via Bluetooth®).
The submission explicitly states that "The features and functions of the LIFEPAK® 12 The reatures and rest/pacemaker are the same as those of the currently marketed LIFEPAK®12 defibrillator/monitor/pacemaker." and "The information in this 510(k) notification demonstrates that the modified LIFEPAK I he mormation in uns 316(tr) neasis substantially equivalent to the predicate device."
This indicates that the device's core functionality (defibrillation, monitoring, pacing, etc.) has not changed, and therefore, no new acceptance criteria, standalone study, or MRMC comparative effectiveness study was required or performed for this specific 510(k) submission. The submission is based on demonstrating substantial equivalence to a previously cleared device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, and ground truth for the modified device is not available in this document as it pertains to the original device's clearance. The current submission focuses solely on the data transmission modification and its substantial equivalence to the predicate.
§ 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.