BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)

K182075 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX · Dec 10, 2018 · Cardiovascular

Device Facts

• Record ID: K182075
• Device Name: BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: MHX · Cardiovascular
• Decision Date: Dec 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

BeneVision N12/N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: The arrhythmia detection, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only; C.O. monitoring is intended for adult patients only; ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg. rSO2 monitoring is intended for use in individuals greater than 2.5kg. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use. BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: The arrhythmia detection and PAWP is intended for adult and pediatric patients only. The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

Device Story

Multiparameter patient monitors (N12, N15, N17, N19, N22, N1) for healthcare facilities; input signals include ECG, SpO2, NIBP, IBP, CO2, EEG, NMT, rSO2, and others. Devices process physiological data to provide real-time monitoring, waveform display, alarm generation, and data storage. Features include arrhythmia detection, ST-segment analysis, and clinical assistive applications (EWS, GCS, SepsisSight, CPR Dashboard). Operated by trained clinical professionals. Output displayed on integrated touchscreens; supports external displays and central monitoring system connectivity. Assists clinicians in patient assessment and decision-making; provides continuous surveillance of vital signs to detect deterioration.

Clinical Evidence

Bench testing only. Functional and system-level testing validated performance against specifications and consensus standards (IEC 60601 series, ISO 80601 series). Clinical data provided specifically for Mindray and Nellcor SpO2 modules to demonstrate compliance with consensus standards.

Technological Characteristics

Multiparameter monitors with integrated touchscreens (12.1"-22"). Connectivity via 2.4GHz/5GHz wireless or wired network. Power: AC or Li-ion battery. Data storage: SSD or eMMC. Modules: MPM 2.0/3.0, IBP, CO2 (Sidestream/Microstream/Mainstream), AG, NMT, EEG, rSO2. Software: Rule-based arrhythmia/ST-segment analysis algorithms. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62366-1.

Indications for Use

Indicated for monitoring physiological parameters (ECG, Resp, Temp, SpO2, PR, NIBP, IBP, PAWP, C.O., CCO, SvO2/ScvO2, CO2, O2, AG, ICG, RM, NMT, EEG, rSO2) in adult, pediatric, and neonatal patients in healthcare facilities. Specific parameter limitations apply based on patient age/size (e.g., C.O. for adults only; rSO2 for >2.5kg). N1 model supports transport.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Passport Series Patient Monitors (K152902)
• Philips IntelliVue Patient Monitor MX800 (K161531)
• Passport Series Patient Monitors (K170876)

Reference Devices

• A7 Anesthesia System (K171292)
• CARESCAPE Monitor B850 (K131414)
• Nihon Kohden AE-918P Neuro Unit (K130238)
• Masimo SET Rad 8 Pulse Oximeter (K053269)
• Accutorr7/VS-900 Vital Signs Monitors (K170712)
• Philips IntelliVue Patient Monitor MX800 and MP2 (K161531)
• INVOS 5100C Cerebral/Somatic Oximeter System (K082327)
• BeneVision Central Monitoring System (K162607)
• Edwards Vigilance II monitor (K043103)
• Vigileo Monitor (K103094)
• EV1000 monitor (K160552)

Submission Summary (Full Text)

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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mindray BeneVision N Series Monitors is provided below.

#### SUBMITTER 1.

| Applicant: | SHENZHEN MINDRAY BIO-MEDICAL<br>ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>Shenzhen 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone] |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Contact Person: Yanhong Bai<br>Title: Manager Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | November 12, 2018 |
| 2.<br>DEVICE | |
| Device Trade Name: | BeneVision N Series Patient Monitors (Including<br>BeneVision N12, BeneVision N15, BeneVision N17,<br>BeneVision N19, BeneVision N22, BeneVision N1) |
| Device Common Name: | Patient Monitor |
| Classification Name: | 21 CFR 870.1025, Class II, Arrhythmia detector and<br>alarm (including ST-segment measurement and alarm) |
| Regulatory Class: | Class II |
| Primary Product Code: | MHX - Monitor, Physiological, Patient (with<br>arrhythmia detection or alarms) |

| Table 1: | Secondary Product Codes |
|----------|-------------------------|
|----------|-------------------------|

| Regulation<br>Number/Class | Product<br>Code | Regulation description | Device Common Name |
|----------------------------|-----------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| 870.1025, II | DSI | Arrhythmia detector and alarm<br>(including ST-segment measurement<br>and alarm) | Detector and alarm, arrhythmia |
| Regulation<br>Number/Class | Product<br>Code | Regulation description | Device Common Name |
| 870.1025, II | MLD | Arrhythmia detector and alarm<br>(including ST-segment measurement<br>and alarm) | Monitor, st segment with alarm |
| 870.2300, II | DRT | Cardiac Monitor (including<br>cardiotachometer and rate<br>alarm) | Monitor, cardiac (incl.<br>cardiotachometer & rate alarm) |
| 870.1130, II | DXN | Noninvasive blood pressure<br>measurement system | System, measurement, blood-pressure,<br>non-invasive |
| 870.1110, II | DSK | Blood pressure computer | Computer, blood-pressure |
| 880.2770, II | DSB | Impedance plethysmograph. | Plethysmograph, impedance |
| 880.2700, II | MUD | Oximeter | Oximeter, tissue saturation |
| 870.2340, II | MLC | Electrocardiograph | Monitor, st segment |
| 870.2370, II | KRC | Electrocardiograph surface electrode<br>tester. | Tester, electrode, surface,<br>electrocardiographic |
| 880.2910, II | FLL | Clinical electronic thermometer | Thermometer, electronic, clinical |
| 870.2700, II | DQA | Oximeter | Oximeter |
| 870.2300, II | MSX | Cardiac monitor (including<br>cardiotachometer and rate alarm). | System, network and communication,<br>physiological monitors |
| 870.2910, II | DRG | Radiofrequency physiological signal<br>transmitter and receiver. | Transmitters and receivers,<br>physiological signal, radiofrequency |
| 868.1400, II | CCK | Carbon dioxide gas analyzer | Analyzer, gas,<br>carbon-dioxide, gaseous-phase |
| 870.1435, II | DXG | Single-function, preprogrammed<br>diagnostic computer | Computer, diagnostic, pre-<br>programmed, single-function |
| 870.1100, II | DSJ | Blood pressure alarm | Alarm, blood-pressure |
| 870.2850, II | DRS | Transducer, blood-pressure,<br>extravascular | Extravascular blood pressure<br>transducer. |
| 868.1500, II | CBQ | Enflurane gas analyzer. | Analyzer, gas, enflurane, gaseous-<br>phase (anesthetic concentration) |
| 868.1500, II | NHO | Enflurane gas analyzer. | Analyzer, gas, desflurane, gaseous-<br>phase (anesthetic concentration) |
| 868.1500, II | NHP | Enflurane gas analyzer. | Analyzer, gas, sevoflurane, gaseous-<br>phase (anesthetic concentration) |
| 868.1500, II | NHQ | Enflurane gas analyzer. | Analyzer, gas, isoflurane, gaseous-<br>phase (anesthetic concentration) |
| 868.1620, II | CBS | Halothane gas analyzer. | Analyzer, gas, halothane, gaseous-<br>phase (anesthetic conc.) |
| 868.1700, II | CBR | Nitrous oxide gas analyzer. | Analyzer, gas, nitrous-oxide, gaseous<br>phase (anesthetic conc.) |
| 868.1720, II | CCI | Oxygen gas analyzer | Analyzer, gas, oxygen, gaseous-phase |
| Regulation<br>Number/Class | Product<br>Code | Regulation description | Device Common Name |
| 868.2775, II | KOI | Electrical peripheral nerve stimulator. | Stimulator, nerve, peripheral, electric |
| 882.1400, II | OLW | Electroencephalograph. | Index-generating<br>electroencephalograph software |
| 882.1400, II | OLT | Electroencephalograph | Non-normalizing quantitative<br>electroencephalograph software |
| 882.1400, II | OMC | Electroencephalograph. | Reduced- montage standard<br>electroencephalograph |
| 882.1400, II | ORT | Electroencephalograph | Burst suppression detection software<br>for electroencephalograph |
| 882.1320, II | GXY | Cutaneous electrode. | Electrode, cutaneous |

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#### PREDICATE DEVICES 3.

- Primary Predicate: K152902 Passport Series Patient Monitors ●
- . Secondary Predicate: K161531 - Philips IntelliVue Patient Monitor MX800: provided as a secondary predicate for the EEG module that has been added to the subject BeneVision N Series Patient.
- . Secondary Predicate: K170876 - Passport Series Patient Monitors: provided as a secondary predicate for the NMT module that has been added to the subject BeneVision N Series Patient Monitors

#### REFERENCE DEVICES 4.

- K171292 A7 Anesthesia System: provided as reference devices for the AG module that ● has been added to the subject BeneVision N Series Patient Monitors
- K131414 - CARESCAPE Monitor B850: provided as a reference device for expanding the indications for ST Segment analysis to include pediatric and neonatal patients and for the EEG module that has been added to the subject BeneVision N Series Patient Monitors.
- K130238 - Nihon Kohden AE-918P Neuro Unit: provided as a reference device for the EEG module that has been added to the subject BeneVision N Series Patient Monitors.
- K053269 - Masimo SET® Rad 8 Pulse Oximeter: provided as a reference device for the Masimo SpO2 module in MPM (Multi Parameter Module) 3.0 that has been added to the subject BeneVision N Series Patient Monitors.
- . K170712 - Accutorr7/VS-900 Vital Signs Monitors: provided as reference devices for the Sidestream CO2 2.0 module that has been added to the subject Bene Vision N Series Patient Monitors and for the Clinical Assistive Applications.

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- K161531 - Philips IntelliVue Patient Monitor MX800 and MP2: provided as a reference device for the patient transport function, Alarm Volume Escalation and intelligent arrhythmia alarm that has been added to the subject BeneVision N Series Patient Monitors
- K082327 - INVOS 5100C Cerebral/Somatic Oximeter System: provided as a reference device for the rSO2 module that has been added to the subject BeneVision N Series Patient Monitors
- K162607 - BeneVision Central Monitoring System: provided as a reference device for the 6-Lead ECG that has been added to the subject Bene Vision N Series Patient Monitors

#### 5. DEVICE DESCRIPTION

The subject BeneVision N Series Patient Monitors includes six monitors:

- BeneVision N12 Patient Monitor
- BeneVision N15 Patient Monitor
- BeneVision N17 Patient Monitor ●
- BeneVision N19 Patient Monitor ●
- BeneVision N22 Patient Monitor ●
- BeneVision N1 Patient Monitor

The BeneVision N Series Patient Monitors are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of monitoring.

#### INTENDED USE/INDICATIONS FOR USE 6.

### BeneVision N12/N15/N17/N19/N22 Patient Monitors:

The BeneVision N12/N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

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

- The arrhythmia detection, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only;
- C.O. monitoring is intended for adult patients only; ●
- ICG monitoring is intended for only adult patients who meet the following requirements: ● height: 122 to 229cm, weight: 30 to 155kg.
- rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use.

### BeneVision N1 Patient Monitor:

The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

- The arrhythmia detection and PAWP is intended for adult and pediatric patients only
The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

#### 7. SUBSTANTIAL EQUIVALENCE

### Comparison of Indications

Both the predicate devices and the subject devices are multiparameter patient monitors intended to be used under the direction of clinical professionals.

The indications for use statement of the subject devices have been modified to include ST Segment analysis used on pediatric and neonatal patients. It also includes the following new parameters: 6-lead ECG. NMT. EEG and rSO2 and the new patient transport function. Although these features are not present in the primary predicate devices, they are present in other cleared devices and do not constitute a new intended use:

- ST Segment analysis used on pediatric and neonatal patients is present in the cleared ● CARESCAPE Monitor B850 (cleared in K131414).

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- NMT is present in the Mindray Passport Series Monitors (Passport 12m and Passport 17m) (cleared in K170876).
- EEG is present in the Philips IntelliVue Patient Monitor MX800 (cleared in K161531) and the CARESCAPE Monitor B850 (cleared in K131414) and the Nihon Kohden AE-918P Neuro Unit (cleared in K130238)
- Patient transport is present in the Philips Intelli Vue Patient Monitor MP2 (cleared in K161531)
- . rSO2 is present in the INVOS 5100C Cerebral/Somatic Oximeter System (cleared in K082327).
- . 6-lead ECG functionality is present in the BeneVision Central Monitoring System (cleared in K162607)

In conclusion, the minor differences of the indications for use do not change the fundamental intended use of the BeneVision N series monitors as multiparameter monitors.

### Technological Comparison

The table below compares the key technological feature of the subject devices to the predicate device (the Mindray Passport Series Patient Monitors K152902). The features in grey are the features that are different from the predicate device and that are the subject of this 510(k).

| Feature | Predicate Devices (K152902) | | Subject BeneVision Devices | | | | | |
|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Passport 17m | Passport 12m | N22 | N19 | N17 | N15 | N12 | |
| Integrated<br>display and<br>touchscreen | 17" 1280*1024<br>pixels. | 12" 800*600<br>pixels. | 22"<br>1680*1050<br>pixels. | 19"<br>1680*1050<br>pixels. | 18.5"<br>1920*1080 pixels. | 15.6"<br>1920*1080<br>pixels. | 12.1"<br>1280*800<br>Pixels. | |
| Secondary<br>display | Independent<br>control and<br>display. | Mirrored<br>display. | Independent control and display. | Independent control and display. | Independent control and display. | Mirrored display. | Mirrored display. | |
| iView | iView is an<br>isolated PC<br>platform that<br>allows the user<br>to run 3rd party<br>applications<br>using a limited<br>set of functions. | Not<br>supported. | iView is an isolated PC platform that<br>allows the user to run 3rd party<br>applications using a limited set of<br>functions. | iView is an isolated PC platform that<br>allows the user to run 3rd party<br>applications using a limited set of<br>functions. | iView is an isolated PC platform that<br>allows the user to run 3rd party<br>applications using a limited set of<br>functions. | Not supported. | Not supported. | |
| Wireless | 2.4GHz<br>module. | 2.4GHz/5GHz<br>dual band<br>module. | 2.4GHz/5GHz dual band module. | 2.4GHz/5GHz dual band module. | 2.4GHz/5GHz dual band module. | 2.4GHz/5GHz dual band module. | 2.4GHz/5GHz dual band module. | |
| | Predicate Devices (K152902) | | Subject BeneVision Devices | | | | | |
| Feature | Passport 17m | Passport 12m | N22 | N19 | N17 | N15 | N12 | |
| Module rack | Independent of the patient monitor, provides 8 standard module slots to extend the measurement capabilities of the system. | | Must be connected to the main unit to provide at least 8 standard module slots. | | Independent of the patient monitor, provides 8 standard module slots to extend the measurement capabilities of the system. | | Not supported | |
| Module<br>communication interface | Infrared communication interface. | | Infrared communication interface.<br>Pogo pin communication interface. | | Infrared communication interface. | | | |
| Power supply | Battery or AC power. | Battery or AC power. | Battery or AC power.<br>Battery is only intended as a back-up power supply. | Battery or AC power. | Battery or AC power. | | | |
| Battery | Rechargeable Lithium-Ion, 11.1 VDC, 4500 mAh. | | Rechargeable Lithium-Ion, 11.3 VDC, 5600 mAh | | Rechargeable Lithium-Ion, 11.1 VDC, 4500 mAh. | | | |
| Data storage | Compact Flash. | | Solid State Hard Drive (SSD). | | Embedded Multi Media Card (eMMC). | | | |
| Data Recorder | Only supports internal thermal recorder. | | Only supports external thermal recorder. | | Supports internal and external thermal recorders. But they cannot be used at same time. | | | |
| Device<br>integration | Use Benelink Module to integrate 3rd party devices. Allow parameter values and alarms from 3rd party devices to be displayed, stored and printed. | | Use Benelink Module to integrate 3rd party devices.<br>Allow parameter values, waveforms and alarms from 3rd party devices to be displayed, stored and printed. | | Use Benelink Module to integrate 3rd party devices.<br>Allow parameter values, waveforms and alarms from 3rd party devices to be displayed, stored and printed. | | | |
| Speaker | Give alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation. | | Same | | Same…