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510(k) Data Aggregation
(247 days)
QMAPP® is intended for use by professional healthcare providers for physiological/hemodynamic monitoring. The system may be used to display and analyze surface ECG (Electrocardiogram), respiration, invasive pressures, pulse oximetry (SpO2), end tidal CO2 (EtCO2), fractional flow reserve (FFR), non-invasive blood pressure (NiBP), surface body temperature, cardiac output and intra-cardiac ECG.
QMAPP® is intended to be used on the patient population of adults. QMAPP® is not intended for neonatal/infant, pediatric and adolescent patients.
OMAPP® provides also clinical data acquisition, medical image/data processing and analytical assessment.
QMAPP® is intended for use in the areas of, but not limited to cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology.
OMAPP® can be used standalone and in networked environments. The system is intended for patient/procedural data management, such as documentation, logging, rending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or send to other devices, such as physiological monitoring system, information management systems, image acquisition/storage devices and other medical devices.
The QMAPP® system offers a complete physiological/hemodynamic monitoring and reporting system. The system is built from three units: an Amplifier, Live Monitoring CPU and Reporting CPU. The Amplifier Unit has various sensors connected with the patient, e.g. ECG, SpO2 and NiBP. The Amplifier Unit is connected to the Live Monitoring CPU via a dedicated Ethernet connection. The acquired patient information can be visualized on a Live Monitoring CPU, typically located in the technical room. A software application executed on the Live Monitoring CPU can visualize the patient information. Also the Amplifier Unit can be controlled, i.e. most importantly, set acquisition and filtering parameters for the different sensors, by the Live Monitoring CPU. Optionally the Monitoring unit can be connected via a dedicated Ethernet connection to a Reporting CPU, typically located in the technical room. On the Reporting CPU a database is installed which facilitates data storage and retrieval. A software application executed on the Reporting CPU serves as a patient data management system. It can be used for analysis, calculation and reporting in various representations of patient information.
The QMAPP® system, can operate standalone or it can be part of a typical hospital network infrastructure. The latter offers the possibility to send or receive information from and to other devices. The software has several communication modules, based on HL7 or DICOM protocols to interface with third party equipment/systems.
The QMAPP® system works with 3rd party 510(k) cleared devices: SpO2 module, (Covidien Nellcor, K083325), NiBP module (CAS Medical Systems, MAXNIBP ND+, e.g. CAS Medical Systems, 740 Select, K150620) and EtCO2 sensors, e.q. CLEO Patient Monitor, K142244.
The provided text describes the regulatory clearance of the QMAPP® system, a physiological/hemodynamic monitoring device. However, it does not contain specific acceptance criteria with reported device performance values or detailed study information typically found in a clinical study report.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and adherence to recognized performance standards. It mentions various non-clinical and usability tests, but doesn't provide specific numerical acceptance criteria or test results against those criteria.
Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided text.
Acceptance Criteria and Device Performance Study for QMAPP® System
The QMAPP® system underwent various non-clinical (bench) and usability testing, as well as validation against recognized performance standards to demonstrate its safety and effectiveness and establish substantial equivalence to predicate devices. The document does not explicitly state specific numerical acceptance criteria for each measurement type nor does it provide the exact reported device performance values against such criteria. Instead, the conclusion states that the system "meets the requirements of following performance Standards" and that "the non-clinical data support the safety of the device and the hardware and software verification and validation testing demonstrate that the QMAPP® system should perform as intended in the specified use conditions."
For the Non-Invasive Blood Pressure (NiBP) measurement, a clinical validation was carried out following IEC 81060-2:2009, which pertains to clinical validation of automated measurement type for non-invasive sphygmomanometers. However, the results of this clinical validation or specific acceptance criteria met are not detailed.
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria and reported performance values are not explicitly provided in the document, the table reflects the types of tests conducted and the standards met, rather than direct numerical comparisons.
| Feature/Measurement Point | General Acceptance Criteria (as implied by standards compliance) | Reported Device Performance (as implied by successful testing) |
|---|---|---|
| Electrocardiograph (ECG) | Compliance with IEC 60601-2-27 (Basic Safety and Essential Performance of Electrocardiographic Monitoring Equipment) | Met the requirements of IEC 60601-2-27. |
| Heart Rate | Compliance with IEC 60601-2-27 | Met the requirements of IEC 60601-2-27. |
| SpO2 | Compliance with ISO 80601-2-61 (Basic Safety and Essential Performance of Pulse Oximeter Equipment) | Met the requirements of ISO 80601-2-61. |
| NiBP | Compliance with IEC 80601-2-30 (Basic Safety and Essential Performance of Automated Non-Invasive Sphygmomanometers) and IEC 81060-2 (Clinical Validation of Automated Measurement Type) | Met the requirements of IEC 80601-2-30 and successfully completed clinical validation per IEC 81060-2. |
| IBP (Invasive Pressure) | Compliance with IEC 60601-2-34 (Basic Safety and Essential Performance of Invasive Blood Pressure Monitoring Equipment) | Met the requirements of IEC 60601-2-34. |
| Cardiac Output | Performance as intended for physiological/hemodynamic monitoring capabilities. | Bench testing conducted; device performs as intended. |
| Intra-cardiac ECG | Performance as intended for physiological/hemodynamic monitoring capabilities. | Bench testing conducted; device performs as intended. |
| Skin Temperature | Compliance with ISO 80601-2-56 (Basic Safety and Essential Performance of Clinical Thermometers) | Met the requirements of ISO 80601-2-56. |
| ECG impedance for Rate of Respiratory Effort | Performance as intended for physiological/hemodynamic monitoring capabilities. | Bench testing conducted; device performs as intended. |
| Measurement Accuracy | General accuracy requirements for each monitored parameter based on relevant standards. | Bench testing conducted; implied to be within acceptable limits as per standards. |
| EMC (Electromagnetic Compatibility) | Compliance with relevant EMC standards. | Bench testing conducted; meets EMC requirements. |
| Electrical Safety | Compliance with relevant electrical safety standards. | Bench testing conducted; meets electrical safety requirements. |
| Mechanical Safety | Compliance with relevant mechanical safety standards. | Bench testing conducted; meets mechanical safety requirements. |
| Software Verification and Validation | Ensures software functions as intended and meets specifications. | Verification and validation testing demonstrates the system performs as intended. |
| Usability | Demonstrated safe and effective use by professional healthcare providers. | Usability testing conducted and validated in Section 20 of the 510(k). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a sample size for the bench tests or the usability testing. For the NiBP clinical validation, no specific sample size is mentioned, only that clinical validation was carried out.
- Data Provenance: The document does not specify the country of origin of the data for any of the tests. It also does not explicitly state if the data was retrospective or prospective. Given the nature of bench and usability testing, these would typically be prospective tests conducted in a controlled environment. The NIBP clinical validation, by its nature, would involve prospective patient data.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: The document does not specify the number of experts used for any part of the testing or for establishing ground truth, and it does not mention the use of experts to establish 'ground truth' in the context of diagnostic accuracy.
- Qualifications of Experts: Since no experts are explicitly mentioned in this context, their qualifications are not provided.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth as it focuses on physiological monitoring, which typically relies on direct measurement validation against reference standards rather than expert reader interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not mentioned or implied in the provided text. The device is a physiological/hemodynamic monitor, not an AI-assisted diagnostic tool designed to improve human reader performance. Therefore, there is no discussion of human readers improving with AI assistance.
6. Standalone (Algorithm Only) Performance
The testing described (bench testing, compliance with performance standards, software verification) essentially validates the standalone performance of the QMAPP® system in its capacity as a physiological/hemodynamic monitor. The document confirms that "the QMAPP® system should perform as intended in the specified use conditions," indicating standalone functionality and accuracy.
7. Type of Ground Truth Used
- For ECG, SpO2, IBP, Temperature, Heart Rate, Respiratory Effort, Cardiac Output: The ground truth would typically be established by comparing the device's measurements against calibrated reference instruments or established measurement methods in a laboratory or clinical setting (bench testing).
- For NiBP: The ground truth for the clinical validation would have been established through a reference measurement method as defined by the IEC 81060-2 standard (e.g., auscultatory method with a trained observer using a mercury sphygmomanometer or an equivalent validated reference device).
- For Software: Ground truth is established by functional and performance specifications that the software is designed to meet.
8. Sample Size for the Training Set
The document does not mention a training set size because it is not describing a machine learning or AI algorithm that requires a training phase. The QMAPP® system is a monitor, and its functionality is validated through traditional engineering and clinical performance testing, not via model training.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set for a machine learning model, this question is not applicable.
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