(159 days)
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No
The summary describes a multi-function physiological monitor and defibrillator with standard monitoring capabilities (ECG, NIBP, SpO2, Temp, Respiration, CO2) and defibrillation/pacing functions. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic parameter monitoring and alarming.
Yes
The device is described with multiple functions including defibrillation, external transcutaneous pacing, and monitoring of vital signs, all of which are used in the treatment and management of patients with various medical conditions.
Yes
The "Intended Use / Indications for Use" section explicitly describes various monitoring functions (ECG, Non-Invasive Blood Pressure, Temperature, Pulse Oximeter, Respiration Rate, CO2) which are used to measure and analyze physiological parameters to provide information about a patient's health status, fitting the definition of a diagnostic device. While it also has therapeutic functions like defibrillation and pacing, its diagnostic capabilities are clearly stated.
No
The device description is not available, but the intended use clearly describes functions like defibrillation, external transcutaneous pacing, non-invasive blood pressure measurement using an inflatable cuff, temperature monitoring, pulse oximetry using non-invasive measurements at remote sites, and respiration rate monitoring. These functions inherently require hardware components to interact with the patient and perform the described measurements and therapies. Therefore, it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PIC 2 is a multi-functional medical device that performs various physiological monitoring and therapeutic functions directly on the patient's body (e.g., ECG monitoring, defibrillation, pacing, blood pressure, temperature, pulse oximetry, respiration rate, CO2 monitoring).
- Lack of Sample Analysis: The text describes measurements and interventions performed in vivo (on the living patient), not in vitro (on samples outside the body).
Therefore, the PIC 2 falls under the category of a medical device used for patient monitoring and treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
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.
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.
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.
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.
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.
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. 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.
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.
Product codes
74 MKJ, LDD, MWI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
DEFIBRILLATOR FUNCTION: pediatric patients less than 8 years old (semiautomatic mode should not be used).
ECG MONITOR FUNCTION: Patients may range from neo-natal to adult.
EXTERNAL TRANSCUTANEOUS PACEMAKER FUNCTION: Patients may range from pediatric to adult.
NON-INVASIVE BLOOD PRESSURE FUNCTION: Patients may range from pediatric to adult.
TEMPERATURE MONITOR FUNCTION: patients ranging from neo-natal to adult.
PULSE OXIMETER FUNCTION: patients ranging from neo-natal to adult.
RESPIRATION RATE MONITOR FUNCTION: patients range from neo-natal to adult.
CO., MONITOR FUNCTION: 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.
Intended User / Care Setting
emergency responders trained in advanced life support, cardiac care techniques, interpretation of recondores, and the use of the PIC 2.
emergency responders, trained in basic life support, cardiac care techniques, and the use of the PIC 2.
ambulance or at the scene of an emergency.
(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.
during the transport of patients between any of the locations mentioned above.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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 (301) 594-1010. Iffice of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
2
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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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
3
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.
4
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.