(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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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2017
Fysicon B.V. % Patsy Trisler JD, RAC, Consultant Qserve Group US Inc. 5600 Wisconsin Avenue Chevy Chase, Maryland 20815
Re: K170032
Trade/Device Name: QMAPP®, QMAPP® GO, QMAPP® AP and QMAPP® EP Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQK Dated: August 8. 2017 Received: August 9, 2017
Dear Patsy Trisler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
M.A. Willemsen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170032
Device Name
QMAPP, QMAPP® GO, QMAPP® AP and QMAPP® EP
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary – K170032
| Submitter Name:Submitter Address: | Fysicon B.V.Hoogheuvelstraat 114,5349 BA OssNetherlands |
|---|---|
| Phone Number: | +31 (0)412 653 333 |
| Fax Number: | +31 (0)412 653 330 |
| Contact Person: | C.W.A. (Eric) van Antwerpen |
| Date Prepared: | 30-Aug-2017 |
| Device TradeName: | QMAPP®, QMAPP® GO, QMAPP® AP and QMAPP® EP |
| Common Name: | Vital Signs Monitoring System |
| ClassificationName, Number &Product Code: | Programmable diagnostic computer, 21 CFR 870.1425 (DQK);Monitor, Physiological, Patient (Without Arrhythmia Detection OrAlarms), 21 CFR 870.2300 (MWI) |
| ClassificationPanel: | Cardiovascular |
| Primary PredicateDevice: | K131497, McKesson CardiologyTM Hemo, McKesson Israel Ltd. |
| SecondaryPredicate Device: | K130626, Mac-Lab, CardioLab, ComboLab, SpecialsLabRecording Systems v6.9.5, GE Healthcare (GE MedicalSystems Technologies, Inc.) |
| DeviceDescription: | The QMAPP® system offers a complete physiological/hemodynamic monitoring and reporting system. The system isbuilt from three units: an Amplifier, Live Monitoring CPU andReporting CPU. The Amplifier Unit has various sensorsconnected with the patient, e.g. ECG, SpO2 and NiBP. TheAmplifier Unit is connected to the Live Monitoring CPU via adedicated Ethernet connection. The acquired patient informationcan be visualized on a Live Monitoring CPU, typically located inthe technical room. A software application executed on the LiveMonitoring CPU can visualize the patient information. Also theAmplifier Unit can be controlled, i.e. most importantly, setacquisition and filtering parameters for the different sensors, bythe Live Monitoring CPU. Optionally the Monitoring unit can beconnected via a dedicated Ethernet connection to a Reporting |
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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.
Accessories intended for use with QMAPP®:
| Part# | Description |
|---|---|
| 01567031 | 10 Lead (IEC) ECG Trunk cable, (K120010) |
| 01567002 | 10 Lead (IEC) Lead wire set, (K120010) |
| 01567032 | 10 Lead (AHA) ECG Trunk cable, (K120010) |
| 01567033 | 10 Lead (AHA) Lead wire set, (K120010) |
| 01567056 | 5 Lead (IEC) ECG Trunk cable, (K120010) |
| 01567258 | 5 Lead (IEC) Lead wire set, (K120010) |
| 01567034 | Dual Pressure Adapter Cable, (K120010) |
| 01567022 | IBP Connection cable for BD/Argon (K120010) |
| 01567024 | IBP Connection cable for Medex/ACIST (K120010) |
| 01567023 | IBP Connection cable forNamic/Navilyst/Angiodynamics (K120010) |
| 01567020 | IBP Connection cable for Utah Medical (K120010) |
| 01567021 | IBP Connnection cable for Edwards/Baxter,(K120010) |
| 01567025 | SpO2 connection cable for Nellcor, (K120010) |
| 01567053 | Reusable Adult Silicone SpO2 finger sensor,(K120010) |
| 01567063 | Dual Temperature Adapter Cable, (K120010) |
| 01567029 | Reusable Central temperature probe - Adults,(K120010) |
| 01567027 | Reusable Skin temperature probe - Adults,(K120010) |
| 01567026 | Reusable Interconnection cable for disp. Probes(K120010) |
| On request | Disp. central temperature probe - Adults (24 pcs)(K120010) |
| On request | Disp. skin temperature probe - Adults (24 pcs)(K120010) |
| 01567065 | NiBP Hose 250 cm |
| 01593003 | UltraCheck® Reusable Cuff (18–26cm), Small adult,(K122365) |
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| K170032 | QMAPP®Premarket Notification: Traditional 510(k) | |
|---|---|---|
| Submitter:Fysicon BV | ||
| 01593004 | UltraCheck® Reusable Cuff (26–35cm), Adult,(K122365) | |
| 01593005 | UltraCheck® Reusable Cuff (29–38cm), Adult long,(K122365) | |
| 01593006 | UltraCheck® Reusable Cuff (32–42cm), Large Adult,(K122365) | |
| 01593007 | UltraCheck® Reusable Cuff (35–44cm), L Adult Long,(K122365) | |
| 01593008 | UltraCheck® Reusable Cuff (42–50cm), Thigh(K122365) | |
| 01567060 | CO Y-Cable(K012226) | |
| 01567029 | Reference probe (Central temperature probe)(K120010) | |
| Disposables and accessories (tranducers, cannulas andintubation devices) are not part of QMAPP®, but are supplied bythe end user facility as required. | ||
| PhysicalDescription: | QMAPP® Amplifier dimensions: 298 x 233 x 47 mm, Weight +/-2200g, Power External 24 VDC | |
| Intended Use/Indication for UseStatement: | QMAPP® is intended for use by professional healthcare providersfor physiological/hemodynamic monitoring. The system may beused to display and analyze surface ECG (Electrocardiogram),respiration, invasive pressures, pulse oximetry (SpO2), end tidalCO2 (EtCO2), fractional flow reserve (FFR), non-invasive bloodpressure (NiBP), surface body temperature, cardiac output andintra-cardiac ECG. | |
| QMAPP® is intended to be used on the patient population ofadults. QMAPP® is not intended for neonatal/infant, pediatric andadolescent patients. | ||
| QMAPP® provides also clinical data acquisition, medicalimage/data processing and analytical assessment. | ||
| QMAPP® is intended for use in the areas of, but not limited tocardiology, cardiac catheterization, electrophysiology, radiology,invasive radiology. | ||
| QMAPP® can be used standalone and in networkedenvironments. The system is intended for patient/procedural datamanagement, such as documentation, logging, reporting,trending, storing, reviewing, carrying out clinical calculations andexporting various representations of the acquired data. Data mayalso be acquired from and/or send to other devices, such asphysiological monitoring system, information managementsystems, image acquisition/storage devices and other medicaldevices. | ||
| Summary ofTechnologicalCharacteristics | The QMAPP® system offers vital signs measuring, visualization,monitoring and analysis. The QMAPP® Amplifier offers SurfaceECG (Electrocardiogram), respiration, invasive pressures, pulse |
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oximetry (SpO2), end tidal CO2 (EtCO2), Respiration effort, noninvasive blood pressure (NiBP), surface body temperature, cardiac output and intra-cardiac ECG measurements. Typically made in areas of, but not limited to cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology.
The vital signs data is transferred to a Live Monitoring CPU, which offers visualization of the vital sign information. The vital signs information can also be transferred to a Reporting CPU, which offers data storage, connection to Hospital Information Systems and PACS. The Reporting CPU also offers vital signs analysis and reports capabilities
The predicate devices have the same fundamental technological characteristics as the QMAPP® device. However, QMAPP® is considerably newer technology and the primary difference between the proposed and primary predicate is the primary predicate does not have the added feature of intra-cardiac monitoring using EP catheters, however, the secondary predicate includes that feature.
| Feature | Subject Device | Primary Predicate | Secondary Predicate |
|---|---|---|---|
| 510(k) Number | K170032 | K131497 | K130626 |
| Trade name | QMAPP®, QMAPP®GO, QMAPP® AP andQMAPP® EP | McKessonCardiology™ Hemo | Mac-Lab, CardioLab,ComboLab,SpecialsLab RecordingSystems v6.9.5 |
| Manufacturer | Fysicon BV | McKesson Israel Ltd. | GE Healthcare |
| Regulation &Product Code | 21 CFR 870.1425,DQKProgrammablediagnostic computer21 CFR 870.2300,MWICardiac monitor | 21 CFR 870.1425,DQKProgrammablediagnostic computer21 CFR 870.2300,MWICardiac monitor | 21 CFR 870.1425,DQKProgrammablediagnostic computer |
| Intended Use(summary) | physiological/hemodynamic monitoring,recording andreporting system | same | same |
| MONITORSSURFACE ECG | Yes | Yes | Yes |
| MONITORSHEART RATE | Yes | Yes | Yes |
| MONITORSRESPIRATIONEFFORT | Yes | Yes | Yes |
| MONITORSNIBP | Yes | Yes | Yes |
| MONITORSOXYGENSATURATION | Yes | Yes | Yes |
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| MONITORSIBP | Yes | Yes | Yes |
|---|---|---|---|
| MONITORSSKINTEMPERATURE | Yes | Yes | Yes |
| MONITORSCARDIACOUTPUT | Yes | Yes | Yes |
| MONITORSEtCO2 | Yes | Yes | Yes |
| MONITORSIntra CardiacECG | Yes | No | Yes |
Non-Clinical Tests: Bench testing was carried out on the following characteristics:
- Electrocardiograph (EGG) ●
- Heart rate
- . SpO2
- NiBP
- . IBP
- Cardiac Output
- Intra cardiac ECG
- Skin Temperature
- ECG impedance for Rate of respiratory effort
- Measurement accuracy ●
- Electromagnetic compatibility (EMC)
- . Electrical safety testing
- Mechanical safety testing
- Software verification and validation testing ●
Usability Testing:
In addition to the above, usability testing was also conducted.
Referenced Standards and Performance Testing:
The QMAPP® system was tested and meets the requirements of following performance Standards.
- . IEC 60601-2-27:2011 Medical Electrical Equipment - Part 2-27: Particular Requirements for The Basic Safety and Essential Performance of Electrocardiographic Monitoring Equipment.
- . IEC 80601-2-30:2010 Medical Electrical Equipment - Part 2-30: Particular Requirements for The Basic Safety and Essential Performance of Automated Non-Invasive Sphygmomanometers.
- IEC 60601-2-34:2011 Medical Electrical Equipment - Part 2-34: Particular Requirements for The Basic Safety, Including Essential Performance, Of Invasive Blood Pressure Monitoring Equipment.
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| IEC 60601-2-49:2011 Medical electrical equipment -- Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment. ISO 80601-2-56:2009 Medical Electrical Equipment - Part 2-56: Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement. ISO 80601-2-61:2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. | |
|---|---|
| ClinicalPerformance Data: | Usability validation was presented in the Clinical PerformanceSection 20 of the 510(k). No clinical studies for safety andeffectiveness were required. |
| Clinical validation is carried out on the following characteristics: NIBP | |
| Referenced Standards and Performance Testing:The QMAPP system was tested and meets the requirements offollowing reference standard: IEC 81060-2:2009 Non-invasive sphygmomanometers –Part 2: Clinical validation of automated measurement type | |
| Conclusion: | The following comparison table shows the similarities anddifferences in technological characteristics. None of thedifferences raise new questions of safety and effectiveness.The non-clinical data support the safety of the device and thehardware and software verification and validation testingdemonstrate that the QMAPP® system should perform asintended in the specified use conditions. |
| Statement ofSubstantialEquivalence: | The intended use of the QMAPP® system is the same as both thePredicate and Reference devices, and the technologicalcharacteristics are similar. Per this information and the dataprovided, this 510(k) submission supports a substantialequivalence determination for the QMAPP® |
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).