# K983307: Modification to Portable Intensive Care Unit

- Pathway: 510(k) (Special)
- Applicant: Medical Research Laboratories, Inc.
- Decided: Nov 20, 1998 after 60 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Without the SAED option, the PIC 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. With the SAED option, the PIC may be used by emergency responders, frained in basic life support, cardiac care techniques, and the use of the PIC. The usage may be in an ambulance or at the scene of an emergency. The PIC 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. Itis 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 patieats both with and without heart dysfunction. The PIC will be used primarily on patients experiencing symptoms of cardiac afrest 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 is used to traat: ventricular fibrillation and pulseless ventricular tachycardia. In the manual mode, patients may range from neo-natal to adult. The semi-automatic mode should not be used on small (less than 8 years old) pediatric patients. DEFIBRILLATOR (INTERNAL PADDLE) FUNCTION: With intemal paddles, the defibrillator function of the PIC is used for the termination of ventricular fibrillation during cardiac surgery, with the paddles applied directly to the heart. Patients may range from neo-natal to aduit ECG MONITOR FUNCTION: The ECG monitor function of the PIC 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 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 TRANSCUTANEQUS PACEMAKER FUNCTION: The external transcutaneous pacing function of the PIC 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 aduilt. NON-INVASIVE BLOOD PRESSURE FUNCTION: The non-invasive blood pressure function of the PIC is used to make non-invasive measurements of arterial pressure and heatrt rate, and to alam 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 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 aduit. PULSE OXIMETER FUNCTION: The pulse oximeter function of the PIC is used to monitor pulse rate and oxygen saturation of arteriolar hemaglobin, 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 remate sites such as a finger, toe, ear lobe, bridge of nose, etc. 1t is used on patients ranging from neo-natal to adultt. RESPIRATION RATE MONITOR FUNCTION: The respiration rate monitor function of the PIC is used to continuously monitar 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 notf intended to be used as an apnea monitor. [t is used on patients ranging from neo-natal to adutt.

Source page: https://510kreport.com/device/K983307
Methodology: https://510kreport.com/methodology