(130 days)
Not Found
Not Found
No
The summary describes a multi-functional physiological monitor and defibrillator with standard monitoring and therapeutic capabilities. There is no mention of AI or ML in the intended use or device description.
Yes
The device explicitly describes functions that treat medical conditions such as ventricular fibrillation, pulseless ventricular tachycardia, and hemodynamically compromising bradycardia.
Yes
The device explicitly describes functions such as ECG monitoring, non-invasive blood pressure measurement, temperature monitoring, pulse oximetry, and respiration rate monitoring, all of which are diagnostic in nature as they collect and display physiological data to assess a patient's condition.
No
The device description is not provided, but the intended use clearly describes functions that require hardware components (defibrillator, ECG monitor, external transcutaneous pacemaker, non-invasive blood pressure, temperature monitor, pulse oximeter, respiration rate monitor). These functions necessitate physical sensors, electrodes, cuffs, and other hardware to interact with the patient and perform the described measurements and therapies.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and functions described for the PIC (defibrillation, ECG monitoring, pacing, blood pressure, temperature, pulse oximetry, respiration rate) all involve direct interaction with the patient's body or monitoring physiological signals from the patient.
- There is no mention of analyzing biological samples. The text does not describe the device being used to test blood, urine, tissue, or any other sample taken from the patient.
The PIC is a multi-functional medical device used for monitoring and treating patients directly, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The PIC is intended primarily for use by trained emergency responders, trained in advanced life support, cardiac care techniques, interpretation of ECG waveforms, 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. Patients may range from neo-natal to adult.
DEFIBRILLATOR (INTERNAL PADDLE) FUNCTION:
With internal 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 adult.
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.
Product codes (comma separated list FDA assigned to the subject device)
74 DRO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neo-natal to adult, pediatric to adult, adults and children
Intended User / Care Setting
trained emergency responders, trained in advanced life support, cardiac care techniques, interpretation of ECG waveforms, 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.5550 External transcutaneous cardiac pacemaker (noninvasive).
(a)
Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.(b)
Classification. Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and
(2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joel Orlinsky Manager of QA & Regulatory Affairs Medical Research Laboratories, Inc. 1000 Asbury Drive Buffalo Grove, IL 60089
MAR - 2 1998
K974034 Re : Portable Intensive Care Unit Requlatory Class: III (three) Product Code: 74 DRO Dated: February 2, 1998 Received: February 3, 1998
Dear Mr. Orlinsky:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements
1
Page 2 - Mr. Joel Orlinsky
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Reqister, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small
2
Page 3 - Mr. Joel Orlinsky
Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
W. Sapuman
mo
lan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
. ·
3
510(k) Number (if Known): K97-4034
Device Name: PIC
Indications For Use:
The PIC is intended primarily for use by trained emergency responders, trained in advanced life support, cardiac care techniques, interpretation of ECG waveforms, 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. Patients may range from neo-natal to adult.
DEFIBRILLATOR (INTERNAL PADDLE) FUNCTION:
With internal 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 adult.
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)
Mr. Pugh
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number.
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
4
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.