(143 days)
The Propaq MD is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the Propaq MD. The Propaq MD 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. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq MD will be used primarily on patients experiencing symptoms of cardiac arrest or in 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. The Propaq MD unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.
Manual Defibrillation: Use of the Propaq MD in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.
ECG Monitoring: The Propaq MD is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.
External Transcutaneous Pacing: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia, Pediatric pacing.
Non-Invasive Blood Pressure Monitoring: The Propaq MD is intended for use 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 leg.
Temperature Monitoring: The Propaq MD is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.
Sp02 Monitoring: The Propaq MD is intended for use 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. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc.
Respiration Monitoring: The Propaq MD is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. 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.
CO2 Monitoring: The Propaq MD is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate.
Invasive Pressure Monitoring: The Propaq MD is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply.
The ZOLL Propaq MD is a multi-parameter monitor / defibrillator / external transcutaneous pacer which include the following capabilities: 3, 5 and 12-Lead ECG, pulse oximetery, non-invasive blood pressure, invasive blood pressures. CO2. temperature, data recording and printing. Propag MD has been designed for use by trained medical personnel in both out-of-hospital and in-hospital applications. The design is light weight and easy to carry for transport situations.
This submission describes the ZOLL Propaq MD, a multi-parameter monitor/defibrillator/external transcutaneous pacer. The document focuses on demonstrating the device's substantial equivalence to existing predicate devices rather than providing a detailed study proving its performance against specific acceptance criteria. Therefore, the information requested for a study that explicitly proves device performance against acceptance criteria is largely not present in the provided text.
However, based on the information provided, we can infer some details and explicitly state what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria or quantitative performance metrics for the ZOLL Propaq MD. Instead, it states:
| Feature/Function | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Performance and Safety | Meets all functional requirements and performance specifications; complies with applicable sections of recognized industry and safety standards. | "Extensive performance testing ensures that Propaq MD performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures the device complies with applicable sections of recognized industry and safety standards." (No specific metrics or studies are detailed in the provided text). |
| Substantial Equivalence to Predicate Devices | Features and functions are substantially equivalent to predicate devices. | "Propaq MD utilizes the same features and functions to the indicated predicate units" (ZOLL R Series, Welch Allyn PIC50, Welch Allyn Propaq 200 Series, Welch Allyn Spot Ultra, and Oridion Capnostream20). "The information provided in this 510k demonstrates that the Propaq MD's features and functions are substantially equivalent to that of the indicated commercially distributed units with regard to performance, safety and effectiveness." (No specific metrics or comparative study results are provided). |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the text. The document refers to "extensive performance testing" but does not detail the sample size (e.g., number of patients, number of test cases) or the provenance (country of origin, retrospective/prospective nature) of the data used for this testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the text. There is no mention of expert involvement in establishing ground truth for any test set data.
4. Adjudication Method for the Test Set:
This information is not provided in the text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable/provided. The ZOLL Propaq MD is a multi-parameter monitor/defibrillator/pacer, not an AI-assisted diagnostic or interpretive device for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device type.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
This information is not explicitly provided in the context of an "algorithm only" performance study. The document states "extensive performance testing ensures that Propaq MD performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications." This implies testing of the device's integrated functionality, which may include internal algorithms, but it does not differentiate between "standalone" algorithm performance and overall device performance with human interaction.
7. The Type of Ground Truth Used:
This information is not explicitly provided in the text. Since the device monitors vital signs and performs defibrillation/pacing, the "ground truth" would implicitly be the actual physiological states (e.g., true heart rate, SpO2 levels, CO2 levels, presence of fibrillation, demand for pacing) as measured by reference standards or other validated methods during performance testing. However, the document does not specify these methods.
8. The Sample Size for the Training Set:
This information is not provided in the text. The device is a medical device, not a machine learning algorithm that typically requires a distinct "training set" in the way an AI diagnostic tool would. Development and validation would involve engineering verification and validation testing, but the concept of a "training set" as used in AI development is not directly applicable here or mentioned.
9. How the Ground Truth for the Training Set was Established:
This information is not provided in the text, as the concept of an AI "training set" and its ground truth is not discussed for this device.
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.