(31 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 Propag 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 Propag 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 was cleared by the agency under 510(k) application K100654 as a multi-parameter monitor / defibrillator / external transcutaneous pacer with the following capabilities: 3, 5 and 12-Lead ECG, pulse oximetery, non-invasive blood pressure, invasive blood pressures, CO2, temperature, data recording and printing. The device is designed for use by trained medical personnel in both out-of-hospital and inhospital applications. The proposed modification adds a filter (SmartCuf) to the existing NIBP algorithm that uses the existing ECG QRS detection to qualify the pressure pulses used in the device NIBP measurement.
The provided 510(k) summary for the ZOLL Propaq MD (K102468) describes a modification to an existing device (K100654), specifically the addition of a filter (SmartCuf) to the Non-Invasive Blood Pressure (NIBP) algorithm. The summary does not include detailed acceptance criteria or a specific study proving the device meets those criteria with numerical performance data. Instead, it relies on substantial equivalence and compliance with a recognized industry standard for the NIBP feature.
Here's an analysis based on the information given, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| NIBP (with SmartCuf filter) | Compliance with AAMI SP10 recognized industry standard. | "Extensive performance testing ensures that Propaq MD with the Smartcuf feature performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications. AAMI SP10 testing assures the device NIBP option with the SmartCuf feature continues to comply with the recognized industry standard." |
| ECG, Defibrillation, Pacing, etc. | "technological characteristics and meets the same specifications of the predicate Propaq MD (K100654)" | Implicitly meets the performance and functional requirements of the predicate device (K100654), as the SmartCuf modification only affects NIBP. |
Comments: The document states that the NIBP with SmartCuf feature continues to comply with AAMI SP10. It does not provide specific numerical criteria from AAMI SP10 (e.g., mean difference, standard deviation) or the actual measured performance data against those criteria. For other functionalities, the claim is substantial equivalence to the predicate, implying they meet the same (unspecified in this document) performance criteria as the predicate.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The general statement "Extensive performance testing" does not include details on sample size, data type (retrospective/prospective), or country of origin for any test data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given that the primary performance claim relates to an NIBP algorithm's compliance with a standard, it's less likely to involve expert reviewers in the same way an image analysis device would. The "ground truth" for NIBP standards typically involves direct arterial measurements.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically used when combining expert opinions, which is not indicated here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this document. This type of study is more common for diagnostic imaging AI, comparing human performance with and without AI assistance. The described modification is a filter for an NIBP algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The context of "AAMI SP10 testing" for an NIBP algorithm suggests a standalone evaluation of the algorithm's accuracy against a reference standard, without direct human-in-the-loop intervention during the measurement process. The SmartCuf filter modifies the NIBP algorithm itself.
7. The Type of Ground Truth Used
For the NIBP algorithm, the ground truth would typically be invasive arterial blood pressure measurements. While not explicitly stated as "invasive arterial measurements," compliance with AAMI SP10 for NIBP inherently requires comparison against such a gold standard. For predicate equivalence claims, the ground truth would be that established for the predicate device.
8. The Sample Size for the Training Set
This information is not provided in the document. As the SmartCuf is described as a "filter" added to an existing NIBP algorithm, it's unclear if "training data" in the machine learning sense was used, or if it's a rule-based or signal processing modification. If it's a rule-based filter, a distinct training set might not apply in the same way.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. If a training set was used, the method for establishing its ground truth (e.g., against invasive arterial measurements) is not detailed.
§ 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.