(159 days)
Without the SAED option, the PIC 2 is intended primarily for use by emergency responders, trained in advanced life support, cardiac care techniques, interpretation of ECG waveforms, and the use of the PIC 2. With the SAED option, the PIC 2 may be used by emergency responders, trained in basic life support, cardiac care techniques, and the use of the PIC 2. The usage may be in an ambulance or at the scene of an emergency. The PIC 2 is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. It is also intended to be used during the transport of patients between any of the locations mentioned above. The patient population will consist of adults and children (described below), and will consist of patients both with and without heart dysfunction. The PIC 2 will be used primarily on patients experiencing symptoms of cardiac arrest or in a post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. Indications for each of the specific functions are discussed below:
DEFIBRILLATOR FUNCTION:
The defibrillator function of the PIC 2 is used to treat: ventricular fibrillation and pulseless ventricular tachycardia. The biphasic waveform employed by the PIC 2 has not been clinically tested on pediatric patients The device has not been evaluated for cardioversion of atrial fibrillation or direct (internal) cardiac defibrillation. The semiautomatic mode should not be used on pediatric patients less than 8 years old.
ECG MONITOR FUNCTION:
The ECG monitor function of the PIC 2 is used to monitor and/or record ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The PIC 2 also provides output signals for the purpose of sending ECG waveforms to a remote monitor via direct connection, telephone, or radio transmission. Patients may range from neo-natal to adult.
EXTERNAL TRANSCUTANEOUS PACEMAKER FUNCTION:
The external transcutaneous pacing function of the PIC 2 is used for the emergency treatment of hemodynamically compromising bradycardia, bradycardia with escape rhythms that are unresponsive to pharmacologic therapy, refractory tachycardia (supraventricular or ventricular), and bradyasystolic cardiac arrest. Patients may range from pediatric to adult.
NON-INVASIVE BLOOD PRESSURE FUNCTION:
The non-invasive blood pressure function of the PIC 2 is used to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or (occasionally) leg. Patients may range from pediatric to adult.
TEMPERATURE MONITOR FUNCTION:
The temperature monitor function of the PIC 2 is used to make continuous measurements of rectal, esophageal, or surface temperature, and to alarm if the temperature is outside of the limits set by the user. It is used on patients ranging from neo-natal to adult.
PULSE OXIMETER FUNCTION:
The pulse oximeter function of the PIC 2 is used to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user. It is used on patients ranging from neo-natal to adult. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc. It is used on patients ranging from neo-natal to adult.
RESPIRATION RATE MONITOR FUNCTION:
The respiration rate monitor function of the PIC 2 is used to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. The patients range from neo-natal to adult. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. It is used on patients ranging from neo-natal to adult.
CO2 MONITOR FUNCTION
The respiration rate monitor function of the PIC 2 is used to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. It is used only as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis.
This CO2 monitor is intended for use with patients 3 years of age and older. This device is not recommended for patients with low tidal volume such as patients younger than 3 years of age or weighing less than 22 pounds, or patients with a respiration rate greater than or equal to 60 breaths per minute.
Not Found
This document is a 510(k) premarket notification approval letter for the Portable Intensive Care Unit (PIC2). It details the device's indications for use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
Therefore, I cannot provide the requested information based solely on this document. This letter is typically issued after the FDA has reviewed such studies and determined substantial equivalence, but the studies themselves are not part of this specific document.
§ 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.