Search Results

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 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.

Semiautomatic Operation (AED): The Propaq MD products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the Propaq MD in the Semiautomatic mode for 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.

ECG Monitoring: The Propaq MD is intended for use to monitor and/or record 3, 5, 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.

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.

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.

SpO2 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.

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. 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 respiration 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.

12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data.

The ZOLL Propaq MD device (reviewed and cleared by the agency under application K100654) is being revised with additional software features. The Propaq MD is a light weight, portable device designed to be used by trained medical personnel who are familiar with basic monitoring, vital sign assessment and emergency cardiac care. As in its previous configuration, the Propaq MD combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, non-invasive blood pressure monitor, invasive pressure monitor, respiration rate monitor and temperature monitor. Functions are offered as options and functions can be configured to meet the needs of a particular application. Additionally, the proposed configuration adds the following features: Semi-automatic external defibrillation function (AED) Mode, Inovise Audicor 12-Lead ECG Interpretive Algorithm, ECG Life Threatening Alarms, Expanded Data Logging capabilities.

Here's an analysis of the acceptance criteria and the study information for the ZOLL Propaq MD, based on the provided text:

Important Note: The provided 510(k) summary (K112761) from 2012 focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results for the newly added features like the Inovise Audicor 12-Lead ECG Interpretive Algorithm. FDA 510(k) submissions for substantial equivalence often refer to the predicate device's performance for new features, or use a general statement about performance and safety testing. Therefore, the information directly addressing specific quantitative acceptance criteria and detailed study designs for the new features is limited in this document.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for substantial equivalence, specific quantitative acceptance criteria for the newly added features (e.g., specific sensitivity/specificity for the 12-Lead ECG Interpretation) are not explicitly stated in this document. Instead, the "acceptance criteria" are generally implied to be that the device performs as well as the predicate devices and meets its functional requirements and performance specifications.

The document claims:

• "Extensive performance testing ensures that the proposed ZOLL Propaq MD performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications."
• "Safety testing assures that the device complies with applicable sections of recognized industry and safety standards."

For the purpose of this analysis, I will infer the performance for the Inovise Audicor 12-Lead ECG Interpretive Algorithm feature by noting that the algorithm itself was a previously cleared device (K032145). In a typical 510(k) for an integrated component, the performance of the integrated component would usually be established in its own prior submission or validated against its established performance. The current K112761 document doesn't re-detail the specific performance of that algorithm in this submission.

Study Details for K112761:

1. Sample size used for the test set and the data provenance:

   • The document does not specify a separate "test set" for the newly added features of the ZOLL Propaq MD (K112761). The focus is on demonstrating substantial equivalence to predicate devices (K100654, K072923, and K032145).
   • For the Inovise Audicor 12-Lead ECG Interpretive Algorithm, its original 510(k) (K032145) would detail the specific test set and provenance used to establish its performance. This information is not present in the K112761 summary.
   • The document implies that "extensive performance testing" was conducted on the integrated device, but no specifics about sample size or data provenance (e.g., country of origin, retrospective/prospective) are provided for this new submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified within the K112761 document for the additional features. This information would typically be detailed in the original submission for the Inovise Audicor 12-Lead ECG Interpretive Algorithm (K032145) if expert review was part of its ground truth establishment.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified within the K112761 document. Again, this would be part of the performance evaluation for the underlying Inovise Audicor 12-Lead ECG Interpretive Algorithm (K032145) at the time of its original clearance.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study is mentioned for the new features in this 510(k) summary (K112761). The submission is based on substantial equivalence, not a clinical effectiveness study of human-AI collaboration.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • For the Inovise Audicor 12-Lead ECG Interpretive Algorithm, its performance was established as a standalone algorithm in its own original 510(k) (K032145). The current submission integrates this pre-cleared standalone algorithm. The K112761 document notes that the "interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data," indicating it's an assistive tool, not a diagnostic replacement.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not specified within the K112761 document for the new features. For the Inovise Audicor 12-Lead ECG Interpretive Algorithm, the ground truth would have been established during its original clearance (K032145), likely using expert cardiologists' consensus readings of ECGs, potentially correlated with clinical outcomes or other diagnostic tests depending on the specific conditions the algorithm interprets.

7. The sample size for the training set:

   • Not specified within the K112761 document. The training set size for the Inovise Audicor 12-Lead ECG Interpretive Algorithm would be found in its original 510(k) submission (K032145).

8. How the ground truth for the training set was established:

   • Not specified within the K112761 document. This information would have been part of the original submission for the Inovise Audicor 12-Lead ECG Interpretive Algorithm (K032145), likely involving expert review and annotation of ECGs.

Summary of Approach for K112761:

This 510(k) submission (K112761) demonstrates substantial equivalence by stating that the expanded ZOLL Propaq MD (with new features) is comparable to:

• The previous version of the Propaq MD (K100654) for most functions.
• The ZOLL E Series (K072923) for AED functionality.
• The Inovise Audicor 12-lead Interpretive algorithm (K032145) for the 12-Lead ECG interpretation feature.

For device modifications or integration of pre-cleared components like this, the focus of the 510(k) is often on ensuring that the integration does not negatively impact the performance, safety, or effectiveness established by the predicate devices. Detailed performance studies for the integrated algorithm are typically covered in its original 510(k) submission (K032145 in this case), not re-detailed in subsequent integrations unless significant modifications to the algorithm or its intended use are made. The current document asserts that "Extensive performance testing ensures that the proposed ZOLL Propaq MD performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications," but does not provide details of these tests.

Ask a specific question about this device

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

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.

Ask a specific question about this device

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:

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.

Ask a specific question about this device