QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP

K170032 · Fysicon BV · MWI · Sep 8, 2017 · Cardiovascular

Device Facts

• Record ID: K170032
• Device Name: QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP
• Applicant: Fysicon BV
• Product Code: MWI · Cardiovascular
• Decision Date: Sep 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Indications for Use

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.

Device Story

System comprises Amplifier Unit, Live Monitoring CPU, and Reporting CPU; Amplifier connects to patient sensors (ECG, SpO2, NiBP, IBP, temperature, CO2, FFR, intra-cardiac ECG). Amplifier transmits data via Ethernet to Live Monitoring CPU for real-time visualization and parameter control. Reporting CPU provides database for storage, retrieval, clinical calculations, and reporting. Used in cardiology, cath lab, EP, and radiology by professional healthcare providers. Integrates with hospital networks via HL7/DICOM for data exchange with third-party systems. Supports clinical decision-making through real-time monitoring, trending, and data analysis. Benefits include centralized patient data management and comprehensive hemodynamic assessment.

Clinical Evidence

No clinical studies for safety and effectiveness were required. Bench testing performed for ECG, heart rate, SpO2, NiBP, IBP, cardiac output, intra-cardiac ECG, skin temperature, and respiration. Usability validation presented. NIBP clinical validation conducted per IEC 81060-2:2009.

Technological Characteristics

System includes Amplifier (298x233x47mm, 2200g, 24VDC), Live Monitoring CPU, and Reporting CPU. Connectivity via Ethernet, HL7, and DICOM. Complies with IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-34, IEC 60601-2-49, ISO 80601-2-56, and ISO 80601-2-61. Software-based analysis and data management.

Indications for Use

Indicated for adult patients requiring physiological/hemodynamic monitoring in clinical settings including cardiology, cardiac catheterization, electrophysiology, and radiology. Not indicated for neonatal, infant, pediatric, or adolescent patients.

Regulatory Classification

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.

Predicate Devices

• McKesson Cardiology™ Hemo (K131497)
• Mac-Lab, CardioLab, ComboLab, SpecialsLab Recording Systems v6.9.5 (K130626)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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) | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary – K170032

| Submitter Name:<br>Submitter Address: | Fysicon B.V.<br>Hoogheuvelstraat 114,<br>5349 BA Oss<br>Netherlands |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | C.W.A. (Eric) van Antwerpen |
| Date Prepared: | 30-Aug-2017 |
| Device Trade<br>Name: | QMAPP®, QMAPP® GO, QMAPP® AP and QMAPP® EP |
| Common Name: | Vital Signs Monitoring System |
| Classification<br>Name, Number &<br>Product Code: | Programmable diagnostic computer, 21 CFR 870.1425 (DQK);<br>Monitor, Physiological, Patient (Without Arrhythmia Detection Or<br>Alarms), 21 CFR 870.2300 (MWI) |
| Classification<br>Panel: | Cardiovascular |
| Primary Predicate<br>Device: | K131497, McKesson CardiologyTM Hemo, McKesson Israel Ltd. |
| Secondary<br>Predicate Device: | K130626, Mac-Lab, CardioLab, ComboLab, SpecialsLab<br>Recording Systems v6.9.5, GE Healthcare (GE Medical<br>Systems Technologies, Inc.) |
| Device<br>Description: | The QMAPP® system offers a complete physiological/<br>hemodynamic monitoring and reporting system. The system is<br>built from three units: an Amplifier, Live Monitoring CPU and<br>Reporting CPU. The Amplifier Unit has various sensors<br>connected with the patient, e.g. ECG, SpO2 and NiBP. The<br>Amplifier Unit is connected to the Live Monitoring CPU via a<br>dedicated Ethernet connection. The acquired patient information<br>can be visualized on a Live Monitoring CPU, typically located in<br>the technical room. A software application executed on the Live<br>Monitoring CPU can visualize the patient information. Also the<br>Amplifier Unit can be controlled, i.e. most importantly, set<br>acquisition and filtering parameters for the different sensors, by<br>the Live Monitoring CPU. Optionally the Monitoring unit can be<br>connected via a dedicated Ethernet connection to a Reporting |

{4}------------------------------------------------

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 for<br>Namic/Navilyst/Angiodynamics (K120010) |
| 01567020 | IBP Connection cable for Utah Medical (K120010) |
| 01567021 | IBP Connnection cable for Edwards/Baxter,<br>(K120010) |
| 01567025 | SpO2 connection cable for Nellcor, (K120010) |
| 01567053 | Reusable Adult Silicone SpO2 finger sensor,<br>(K120010) |
| 01567063 | Dual Temperature Adapter Cable, (K120010) |
| 01567029 | Reusable Central temperature probe - Adults,<br>(K120010) |
| 01567027 | Reusable Skin temperature probe - Adults,<br>(K120010) |
| 01567026 | Reusable Interconnection cable for disp. Probes<br>(K120010) |
| On request | Disp. central temperature probe - Adults (24 pcs)<br>(K120010) |
| On request | Disp. skin temperature probe - Adults (24 pcs)<br>(K120010) |
| 01567065 | NiBP Hose 250 cm |
| 01593003 | UltraCheck® Reusable Cuff (18–26cm), Small adult,<br>(K122365) |

{5}------------------------------------------------

| K170032 | | QMAPP®<br>Premarket Notification: Traditional 510(k) |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter:<br>Fysicon BV | | |
| | 01593004 | UltraCheck® Reusable Cuff (26–35cm), Adult,<br>(K122365) |
| | 01593005 | UltraCheck® Reusable Cuff (29–38cm), Adult long,<br>(K122365) |
| | 01593006 | UltraCheck® Reusable Cuff (32–42cm), Large Adult,<br>(K122365) |
| | 01593007 | UltraCheck® Reusable Cuff (35–44cm), L Adult Long,<br>(K122365) |
| | 01593008 | UltraCheck® Reusable Cuff (42–50cm), Thigh<br>(K122365) |
| | 01567060 | CO Y-Cable<br>(K012226) |
| | 01567029 | Reference probe (Central temperature probe)<br>(K120010) |
| | | Disposables and accessories (tranducers, cannulas and<br>intubation devices) are not part of QMAPP®, but are supplied by<br>the end user facility as required. |
| Physical<br>Description: | QMAPP® Amplifier dimensions: 298 x 233 x 47 mm, Weight +/-<br>2200g, Power External 24 VDC | |
| Intended Use/<br>Indication for Use<br>Statement: | QMAPP® is intended for use by professional healthcare providers<br>for physiological/hemodynamic monitoring. The system may be<br>used to display and analyze surface ECG (Electrocardiogram),<br>respiration, invasive pressures, pulse oximetry (SpO2), end tidal<br>CO2 (EtCO2), fractional flow reserve (FFR), non-invasive blood<br>pressure (NiBP), surface body temperature, cardiac output and<br>intra-cardiac ECG. | |
| | QMAPP® is intended to be used on the patient population of<br>adults. QMAPP® is not intended for neonatal/infant, pediatric and<br>adolescent patients. | |
| | QMAPP® provides also clinical data acquisition, medical<br>image/data processing and analytical assessment. | |
| | QMAPP® is intended for use in the areas of, but not limited to<br>cardiology, cardiac catheterization, electrophysiology, radiology,<br>invasive radiology. | |
| | QMAPP® can be used standalone and in networked<br>environments. The system is intended for patient/procedural data<br>management, such as documentation, logging, reporting,<br>trending, storing, reviewing, carrying out clinical calculations and<br>exporting various representations of the acquired data. Data may<br>also be acquired from and/or send to other devices, such as<br>physiological monitoring system, information management<br>systems, image acquisition/storage devices and other medical<br>devices. | |
| Summary of<br>Technological<br>Characteristics | The QMAPP® system offers vital signs measuring, visualization,<br>monitoring and analysis. The QMAPP® Amplifier offers Surface<br>ECG (Electrocardiogram), respiration, invasive pressures, pulse | |

{6}------------------------------------------------

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®<br>GO, QMAPP® AP and<br>QMAPP® EP | McKesson<br>Cardiology™ Hemo | Mac-Lab, CardioLab,<br>ComboLab,<br>SpecialsLab Recording<br>Systems v6.9.5 |
| Manufacturer | Fysicon BV | McKesson Israel Ltd. | GE Healthcare |
| Regulation &<br>Product Code | 21 CFR 870.1425,<br>DQK<br>Programmable<br>diagnostic computer<br>21 CFR 870.2300,<br>MWI<br>Cardiac monitor | 21 CFR 870.1425,<br>DQK<br>Programmable<br>diagnostic computer<br>21 CFR 870.2300,<br>MWI<br>Cardiac monitor | 21 CFR 870.1425,<br>DQK<br>Programmable<br>diagnostic computer |
| Intended Use<br>(summary) | physiological/hemody<br>namic monitoring,<br>recording and<br>reporting system | same | same |
| MONITORS<br>SURFACE ECG | Yes | Yes | Yes |
| MONITORS<br>HEART RATE | Yes | Yes | Yes |
| MONITORS<br>RESPIRATION<br>EFFORT | Yes | Yes | Yes |
| MONITORS<br>NIBP | Yes | Yes | Yes |
| MONITORS<br>OXYGEN<br>SATURATION | Yes | Yes | Yes |

{7}------------------------------------------------

| MONITORS<br>IBP | Yes | Yes | Yes |
|----------------------------------|-----|-----|-----|
| MONITORS<br>SKIN<br>TEMPERATURE | Yes | Yes | Yes |
| MONITORS<br>CARDIAC<br>OUTPUT | Yes | Yes | Yes |
| MONITORS<br>EtCO2 | Yes | Yes | Yes |
| MONITORS<br>Intra Cardiac<br>ECG | 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.

{8}------------------------------------------------

| 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. | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical<br>Performance Data: | Usability validation was presented in the Clinical Performance<br>Section 20 of the 510(k). No clinical studies for safety and<br>effectiveness were required. |
| Clinical validation is carried out on the following characteristics: NIBP | |
| Referenced Standards and Performance Testing:<br>The QMAPP system was tested and meets the requirements of<br>following reference standard: IEC 81060-2:2009 Non-invasive sphygmomanometers –<br>Part 2: Clinical validation of automated measurement type | |
| Conclusion: | The following comparison table shows the similarities and<br>differences in technological characteristics. None of the<br>differences raise new questions of safety and effectiveness.<br><br>The non-clinical data support the safety of the device and the<br>hardware and software verification and validation testing<br>demonstrate that the QMAPP® system should perform as<br>intended in the specified use conditions. |
| Statement of<br>Substantial<br>Equivalence: | The intended use of the QMAPP® system is the same as both the<br>Predicate and Reference devices, and the technological<br>characteristics are similar. Per this information and the data<br>provided, this 510(k) submission supports a substantial<br>equivalence determination for the QMAPP® |