PORTABLE INTENSIVE CARE UNIT

K012030 · Medical Research Laboratories, Inc. · MKJ · Sep 24, 2001 · Cardiovascular

Device Facts

• Record ID: K012030
• Device Name: PORTABLE INTENSIVE CARE UNIT
• Applicant: Medical Research Laboratories, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Sep 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended 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, trained 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. 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 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) provides multi-parameter monitoring and therapeutic intervention; used by emergency responders, nurses, and physicians in ambulances, ERs, ICUs, and during transport. Inputs include ECG leads, blood pressure cuffs, temperature probes, pulse oximetry sensors, respiration effort sensors, CO2 sampling lines, and invasive pressure transducers. Device processes physiological signals to display waveforms and numerical data; provides audible/visual alarms for user-defined limits. Therapeutic functions include defibrillation (biphasic waveform) and external transcutaneous pacing. Output enables clinicians to assess patient status, perform life-saving interventions, and transmit data to remote monitors. Benefits include rapid stabilization and continuous monitoring of critically ill or trauma patients.

Clinical Evidence

No clinical data provided. The document indicates that the biphasic waveform used for defibrillation has not been clinically tested on pediatric patients.

Technological Characteristics

Multi-parameter monitor/defibrillator. Features: ECG, non-invasive/invasive blood pressure, temperature, pulse oximetry, respiration, CO2 monitoring, and external transcutaneous pacing. Energy source: electrical. Connectivity: direct connection, telephone, or radio transmission for remote monitoring. Form factor: portable unit. Software: includes alarm management and signal processing for physiological parameters.

Indications for Use

Indicated for adults and children (neonatal to adult, depending on function) experiencing cardiac arrest, post-trauma, or requiring monitoring of ECG, heart rate, blood pressure, temperature, pulse oximetry, respiration, CO2, or invasive pressure. Defibrillation indicated for ventricular fibrillation and pulseless ventricular tachycardia. Pacing indicated for hemodynamically compromising bradycardia, bradycardia with escape rhythms, refractory tachycardia, and bradyasystolic cardiac arrest. Contraindications: Biphasic waveform not tested on pediatric patients; semi-automatic mode contraindicated for pediatric patients <8 years; CO2 monitor contraindicated for patients <3 years, <22 lbs, or respiratory rate ≥60 bpm.

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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, forming a symbolic representation of people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2001

Mr. Joel Orlinsky Director of Q. A. and Regulatory Affairs Medical Research Laboratories, Inc. 1000 Asbury Drive Buffalo Grove, Illinois 60089

Re: K012030

Trade Name: Portable Intensive Care Unit (PIC) Regulation Number: 21 CFR 870.1025 Regulation Name: Defibrillator, Automatic, External Regulatory Class: Class III (three) Product Code: MKJ Dated: June 25, 2001 Received: June 28, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office 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 Division of Small Manufacturers, International 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,

K. Dillard III

James B. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Attachment III

K012030 .510(k) Number (if Known):____________________________________________________________________________________________________________________________________________________

p. 1/3

Device Name: PIC

### 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, trained 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. 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 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 is used to treat: ventricular fibrillation and pulseless ventricular tachycardia. The bibhasic waveform employed by the PIC has not been clinically tested on pediatric patients The semi-automatic mode should not be used on pediatric patients less than 8 years old.

Continued on Page 2

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODR)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012030

Prescription Use
(Per 21 CFR 801.109

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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# 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 TRANSCUTANEOUS 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 adult.

# 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 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 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 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 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.

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#### KO12030 Attachment III

### CO., MONITOR FUNCTION

The respiration rate monitor function of the PIC is used to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. This device is intended 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.

# INVASIVE PRESSURE MONITOR FUNCTION

The invasive pressure monitor function of the PIC is used to display the measurements made by any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous blood pressure, and intracranial pressure. Patients may range from neo-natal to adult. Any contra-indications of the particular transducer selected by the user shall apply.