(216 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 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.
| Feature / Metric | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| General Device Performance | Performs as well as predicate devices and meets functional requirements and performance specifications. Compliance with safety standards. | "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." |
| Inovise Audicor 12-Lead ECG Interpretive Algorithm | Substantially equivalent to the performance demonstrated in K032145. | Integrated the previously cleared Inovise Audicor 12-Lead Interpretive algorithm (K032145), implying its prior demonstrated performance is maintained. |
| AED Mode Performance (Semi-automatic) | Substantially equivalent to the performance of predicate devices (ZOLL Propaq MD K100654, ZOLL E Series K072923) in delivering defibrillation in a semi-automatic manner. | Functions as an AED, requiring operator control for shock delivery, consistent with previously cleared devices. |
| ECG Life Threatening Alarms | Functional and reliable alarming as per industry standards and predicate devices. | Added as a feature; implicitly meets functional specifications. |
| Expanded Data Logging capabilities | Functional and reliable data logging. | Added as a feature; implicitly meets functional specifications. |
Study Details for K112761:
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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.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
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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.
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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.
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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.
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The sample size for the training set:
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How the ground truth for the training set was established:
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.
§ 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.