PORTABLE INTENSIVE CARE UNIT

K012766 · Medical Research Laboratories, Inc. · MKJ · Jan 23, 2002 · Cardiovascular

Device Facts

• Record ID: K012766
• Device Name: PORTABLE INTENSIVE CARE UNIT
• Applicant: Medical Research Laboratories, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Jan 23, 2002
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Indications for Use

Without the SAED option, the PIC 2 is intended primarily for use by emergency vitned the trained in advanced life support, cardiac care techniques, interpretation of recondores, 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.

Device Story

Portable Intensive Care Unit (PIC 2) provides multi-parameter monitoring and therapeutic intervention; used in ambulances, emergency scenes, and hospital settings (ER, ICU, CCU) by emergency responders, nurses, and physicians. Inputs include ECG leads, blood pressure cuffs, temperature probes, pulse oximetry sensors, and CO2 sampling lines. Device processes physiological signals to display waveforms/vitals and trigger alarms for out-of-limit conditions. Therapeutic functions include biphasic defibrillation and external transcutaneous pacing. Output allows clinicians to assess patient status, guide resuscitation, and monitor stability during transport. Benefits include rapid emergency intervention and continuous patient surveillance.

Clinical Evidence

No clinical data provided. The document notes the biphasic waveform has not been clinically tested on pediatric patients.

Technological Characteristics

Portable multi-parameter monitor/defibrillator. Features: biphasic defibrillation, external transcutaneous pacing, ECG monitoring, non-invasive blood pressure (cuff), temperature monitoring, pulse oximetry, respiration rate monitoring, and CO2 monitoring. Connectivity includes direct connection, telephone, or radio transmission for remote waveform monitoring.

Indications for Use

Indicated for adults and children experiencing cardiac arrest, post-trauma, or requiring monitoring of ECG, blood pressure, temperature, pulse oximetry, respiration, or CO2. Defibrillation indicated for ventricular fibrillation and pulseless ventricular tachycardia; contraindicated for pediatric patients <8 years in semiautomatic mode. Pacing indicated for hemodynamically compromising bradycardia, refractory tachycardia, and bradyasystolic cardiac arrest. CO2 monitoring indicated for patients ≥3 years and ≥22 lbs.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2002

Mr. Joel Orlinsky Medical Research Labs, Inc. 1000 Asbury Drive Buffalo Grove, IL 60089

Re: K012766

Portable Intensive Care Unit (Model PIC2) Regulation Number: 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: III (three) Product Code: 74 MKJ, LDD, MWI Dated: November 16, 2001 Received: November 19, 2001

Dear Mr. Orlinsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Joel Orlinsky

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast of advised that I Drivised in the your device complies with other requirements of the Act that I DA has made a actornmentlations administered by other Federal agencies. You must of any I cuch statutes and regarants ancluding, but not limited to: registration and listing (21 Comply with an the 11ct 31cc 31cc 801); good manufacturing practice requirements as set CI K Fart 607); adoming (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) roggless (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will and w you to organ maing of substantial equivalence of your device to a legally premailed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific acrise for in vitro diagnostic devices), please contact the Office of additionally 21 CFR Furt 007.10 10 m ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . Compinance at [phone]. Iffice of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Outler general information of the mational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ooth till
Bram D. Zuckerman, M.D.

ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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JAN 2 3 2002

012766 510(k) Number (if Known):

Device Name:_PIC 2

# Indications For Use:

Without the SAED option, the PIC 2 is intended primarily for use by emergency vitned the trained in advanced life support, cardiac care techniques, interpretation of recondores, 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.

Continued on Page

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Concurrence of CDRH, Office of Device Evaluation (ODR)

Doa Uortilh

Division of Cardiovascular & Respiratory Devices
510(k) Number K012766

Prescription Use
(Per 21 CFR 801.109

OR

Over-The-Counter Use_

(Optional Format 1-2-9

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# Attachment IV

# 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 actuall 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.

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### Attachment IV

# CO., MONITOR FUNCTION

The respiration rate monitor function of the PIC 2 is used to measure the concentration r no roopiration in a gas mixture to aid in determining the patient's ventilatory status. of ourben a only as an indicator of patient carbon dioxide concentration during expiration and is not intended as the sole basis for medical diagnosis.

This CO, 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.