Predicate Devices

Reference Devices

K171292, K131414, K130238, K053269, K170712, K082327, K162607, K043103, K103094, K160552

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard physiological monitoring and analysis techniques, such as arrhythmia detection and ST segment analysis, which are typically implemented using rule-based algorithms or signal processing, not necessarily AI/ML. There is no mention of AI, ML, deep learning, or any related terms in the provided text.

Therapeutic

No.
The device is described as a patient monitor intended for "monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters." It does not provide any therapy or treatment.

Diagnostic

Yes

Explanation: The device is intended for "monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters" and also provides "an interpretation of resting 12-lead ECG." The interpretation of physiological parameters and ECG, along with the ability to monitor a wide range of vital signs, supports clinical diagnosis, which aligns with the function of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the BeneVision N Series Patient Monitors are a "new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware". This indicates the device includes significant hardware components in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The BeneVision N Series Patient Monitors are designed to directly monitor physiological parameters on the patient's body (e.g., ECG, blood pressure, oxygen saturation, temperature). They do not analyze samples taken from the patient.
Intended Use: The intended use clearly states monitoring, displaying, reviewing, storing, and transferring of physiological parameters. It does not mention the analysis of biological specimens.

Therefore, the BeneVision N Series Patient Monitors fall under the category of patient monitoring devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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:

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.

Product codes (comma separated list FDA assigned to the subject device)

MHX, DSI, MLD, DRT, DXN, DSK, DSB, MUD, MLC, KRC, FLL, DQA, MSX, DRG, CCK, DXG, DSJ, DRS, CBQ, NHO, NHP, NHQ, CBS, CBR, CCI, KOI, OLW, OLT, OMC, ORT, GXY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult, pediatric, and neonatal patients.
Specific exclusions:

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.

Intended User / Care Setting

Healthcare facilities by clinical professionals or under their guidance. Users should have adequate training.
BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use.
BeneVision N1 monitor can be used in healthcare facilities and during patient transport inside and outside of the hospital environment, but not for home use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Mindray conducted functional and system level testing on the subject device. The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate device. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.

Mindray complies with the FDA Special Controls Document relevant to this device "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm Guidance for Industry and FDA (10/28/2003)"

Mindray has conducted testing to ensure the subject device meets relevant consensus standards.

Biocompatibility Testing

The N Series Patient Monitors are not patient contacting. There are no new patient contacting accessories of components, therefore biocompatibility testing is not applicable.

Software Verification and Validation Testing

Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification of the Bene Vision N Series Patient Monitors was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.

Electromagnetic Compatibility and Electrical Safety

The BeneVision N Series Patient Monitors were assessed for conformity with the relevant requirements of the following standards and found to comply:

ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) ● 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
. IEC 62133:2012 (Second Edition) Secondary cell and batteries containing alkaline or other non-acid electrolytes

Bench Testing

To establish the substantial equivalence of the BeneVision N Series Patient Monitors, Mindray conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets its accuracy specification, and is substantially equivalent to the predicate device.

In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.

. IEC 60601-1-6: 2010, AMD1:2013 Medical electrical equipment-part 1-6: general requirements for basic safety and essential performance- collateral standard: usability
IEC 60601-1-8:2006 + Am1:2012 Medical electrical equipment - part 1-8: general requirements for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
. IEC 60601-1-12:2014 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
IEC 60601-2-10:2012 Medical electrical equipment -- Part 2-10: Particular requirements for ● the basic safety and essential performance of nerve and muscle stimulators
IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
IEC 60601-2-26:2012 Medical electrical equipment Part 2-26: Particular requirements for ● the basic safety and essential performance of electroencephalographs
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 80601-2-30:2013 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
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 80601-2-55: 2011 Medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors
. 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
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
. EN 1789:2014 Medical vehicles and their equipment - Road ambulances
EN 13718-1:2008 Medical vehicles and their equipment Air ambulances Part 1: ● Requirements for medical devices used in air ambulances
AAMI / ANSI EC57:2012 Testing and reporting performance results of cardiac rhythm and . st-segment measurement algorithms
. MIL-STD-810G:2008 Department of defense test method standard - environmental engineering considerations and laboratory tests
MIL-STD-461F:2007 Department of interface standard - requirements for the control of electromagnetic interference characteristic of subsystems and equipment
IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
IEC 60068-2-64: 2008 Environmental testing Part 2-64: Tests Test Fh: Vibration, ● broadband random and guidance
. IEC 60068-2-6: 2008 Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal)
IEC 60068-2-29:1993 Basic environmental testing procedures -- part 2: tests test eb and . guidance: bump
IEC 61000-4-3: 2006+A1:2007+A2:2010 Electromagnetic compatibility (EMC) Part 4-3: ● Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-8:2009 Electromagnetic compatibility (EMC) Part 4-3: Testing and ● measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
IEC 60529:2013 Degrees of protection provided by enclosures (IP Code)

Clinical Data

Mindray provided the results of clinical testing to demonstrate that the Mindray and Nellcor SpO2 modules meet relevant consensus standards.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K152902, K161531, K170876

Reference Device(s)

K171292, K131414, K130238, K053269, K170712, K082327, K162607, K043103, K103094, K160552

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.

Summary

0

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
ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
Shenzhen 518057, P.R. China
Tel: +86 755 81888998
Fax: +86 755 26582680 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Contact Person: Yanhong Bai
Title: Manager Regulatory Affairs
Phone: +86 755 81885635
Fax: +86 755 26582680
E-mail: baiyanhong@mindray.com |
| Date Prepared: | November 12, 2018 |
| 2.
DEVICE | |
| Device Trade Name: | BeneVision N Series Patient Monitors (Including
BeneVision N12, BeneVision N15, BeneVision N17,
BeneVision N19, BeneVision N22, BeneVision N1) |
| Device Common Name: | Patient Monitor |
| Classification Name: | 21 CFR 870.1025, Class II, Arrhythmia detector and
alarm (including ST-segment measurement and alarm) |
| Regulatory Class: | Class II |
| Primary Product Code: | MHX - Monitor, Physiological, Patient (with
arrhythmia detection or alarms) |

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

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

1

2

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.

3

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).

5

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
display and
touchscreen	17" 1280*1024
pixels.	12" 800*600
pixels.	22"
1680*1050
pixels.	19"
1680*1050
pixels.	18.5"
1920*1080 pixels.	15.6"
1920*1080
pixels.	12.1"
1280*800
Pixels.
Secondary
display	Independent
control and
display.	Mirrored
display.	Independent control and display.	Independent control and display.	Independent control and display.	Mirrored display.	Mirrored display.
iView	iView is an
isolated PC
platform that
allows the user
to run 3rd party
applications
using a limited
set of functions.	Not
supported.	iView is an isolated PC platform that
allows the user to run 3rd party
applications using a limited set of
functions.	iView is an isolated PC platform that
allows the user to run 3rd party
applications using a limited set of
functions.	iView is an isolated PC platform that
allows the user to run 3rd party
applications using a limited set of
functions.	Not supported.	Not supported.
Wireless	2.4GHz
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.	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
communication interface	Infrared communication interface.		Infrared communication interface.
Pogo pin communication interface.		Infrared communication interface.
Power supply	Battery or AC power.	Battery or AC power.	Battery or AC power.
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
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.
Allow parameter values, waveforms and alarms from 3rd party devices to be displayed, stored and printed.		Use Benelink Module to integrate 3rd party devices.
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
Alarm system	The alarm lamp is yellow, or red depending on alarm type.		The alarm lamp is cyan, yellow, or red depending on alarm type.
Supports Alarm Volume Escalation
Although the predicate device does not support an Alarm volume escalation functionality, the feature has been cleared in K161531.		The alarm lamp is yellow, or red depending on alarm type.
Support T1/N1
as a Module	Supports T1 as a module.		Supports T1/N1 as a module.		Supports T1/N1 as a module.
Supports
connecting
with Mindray
Telemetry
monitors,
TM80 and
BP10	No		Yes		No
Feature	Predicate Devices (K152902)		Subject BeneVision Devices
	Passport 17m	Passport 12m	N22	N19	N17	N15	N12
ECG	3-lead, 5-lead or 12-lead
selectable, arrhythmia detection,
ST segment analysis, QT
analysis, an interpretation of
resting 12-lead ECG, J-point
Auto detection, Dual Channel
Pace detection, adjustable QRS
threshold and heart rate (HR);

Arrhythmia detection is intended
for adult and pediatric.

ST segment analysis of Mindray
algorithm is intended for adult
patient. ST segment analysis of
Mortara algorithm is intended for
adult and pediatric patients.

Supports Mindray and Mortara
algorithm.

Only supports ECG function
from MPM 2.0 module | | 3-lead, 5-lead, 6-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, an interpretation of resting 12-lead ECG, J-point Auto detection, Dual Channel Pace detection, adjustable QRS threshold and heart rate (HR). Although the predicate device does not support a 6-lead ECG functionality, the feature has been cleared in K162607.

Arrhythmia detection is intended for adult and pediatric
Supports intelligent arrhythmia alarm.

Although the predicate device does not support an intelligent arrhythmia alarm functionality, the feature has been cleared in K161531 | | ST segment analysis is intended for adult, pediatric and
neonate.
Although the predicate device does not support ST segment analysis used for pediatric and neonate , the feature has been cleared in K131414.

Can be configured with either the Mindray or Mortara algorithm for ECG arrhythmia monitoring and arrhythmia detection. MPM 3.0: supports Mindray Algorithm. T1, MPM 2.0 and TM80: support Mindray or Mortara algorithm | | Supports ECG function from MPM 2.0 module and MPM 3.0
module. | |
| Arrhythmia
Analysis | Asystole, VFib/VTac, Vtac,
Vent. Brady, Extreme Tachy,
Extreme Brady, PVC, Couplet,
Bigeminy, Trigeminy, R on T,
Run PVCs, PVCs, Tachy, Brady,
Missed Beats, Vent. Rhythm,
Pacer Not Pacing, Pacer Not
Capture, Multif. PVC, Nonsus.
Vtac, Pause, Irr. Rhythm, Afib. | | | Asystole, V-Fib/V-Tach, V-Tach, Vent Brady, Extreme Tachy,
Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, R on T,
Run PVCs, PVCs/min, Tachy, Brady, Missed Beats, Vent
Rhythm, Pacer Not Pacing, Pacer Not Capture, Multiform
PVC, Nonsus V-Tach, Pause, Irr. Rhythm, A-Fib, Pauses/min.
Added Pauses/min;
Changed the names of: VFib/Vtac, Vtac, Vent.Brady,
Nonsus. Vtac, Vent.Rhythm, PVCs, Afib, and Multif.PVC | | | | |
| Respiration
rate (Resp) | Measurement range: Adult: 0 to
120 rpm; Pediatric, neonate: 0 to
150 rpm.
Accuracy: 7 to 150 rpm: ±2 rpm
or +2%, whichever is greater;
0 to 6 rpm: Not specified.

Only supports RESP function
from MPM 2.0 module | | | Measurement range: Adult: 0 to 120 rpm; Pediatric, neonate: 0
to 150 rpm.
Accuracy: 7 to 150 rpm: ±2 rpm or ±2%, whichever is greater;
0 to 6 rpm: Not specified.

Only supports Temperature
function from MPM 2.0 module. | | Measurement specifications are same.

Support Temperature function from MPM 2.0 module, MPM
3.0 module and Temperature module. | | | | | |
| Pulse oxygen
saturation
(SpO2) | Supports Mindray SpO2 function,
Masimo SpO2 function and
Nellcor SpO2 function from
MPM 2.0 module.

Supports a stand-alone Mindray
or a stand-alone Masimo SpO2
module.

Mindray SpO2 function
Measurement range: 0 to 100%;
Accuracy:70 to 100%: ±2%
(adult/pediatric mode);
70 to 100%: ±3% (neonate
mode);
0% to 69%: Not specified.

Masimo SpO2 function
Measurement range: 1 to 100%;
Accuracy:70 to 100%: ±2%
(measured without motion in
adult/pediatric mode);
70 to 100%: ±3% (measured
without motion in neonate
mode):
70 to 100%: ±3% (measured with
motion);
1% to 69%: Not specified.

Nellcor SpO2 function
Measurement range: 0 to 100%;
Accuracy:70 to 100%: ±2%
(adult/pediatric);
70 to 100%: ±3% (neonate);
0% to 69%: Not specified.

Note: The specifictions of the
various SpO2 functions provided
by each manufacturer are the
same across platforms. | | Supports Mindray SpO2 function, Masimo SpO2 function and
Nellcor SpO2 function from MPM 2.0 module.

Adds the option to use the MPM 3.0. The MPM 3.0 can be
configured with either a Mindray, Masimo, or Nellcor
SpO2 module.

Although the predicate device does not support Masimo SpO2
module in MPM 3.0 module, the feature has been cleared in
K053269.

Supports a stand-alone Mindray or a stand-alone Masimo SpO2
module.

Adds support for a stand-alone Nellcor SpO2 module.

Note: The specifications for various SpO2 functions provided
by each manufacturer for the new MPM 3.0 and Nellcor stand-
alone platforms are identical to those that were cleared in the
primary predicate device. | | | | | |
| Feature | Predicate Devices (K152902) | | | Subject BeneVision Devices | | | | |
| | Passport 17m | Passport 12m | N22 | N19 | N17 | N15 | N12 | |
| Pulse rate
(PR) | PR from Mindray SpO2 Module
Measurement range: 20 to 254
bpm;
Accuracy: ±3 bpm.
PR from Masimo SpO2 Module
Measurement range: 25 to 240
bpm;
Accuracy: ±3 bpm (measured
without motion);
±5 bpm (measured with motion).
PR from Nellcor SpO2 Module
Measurement range: 20 to 300
bpm;
Accuracy:20 to 250 bpm: ±3
bpm;
251 to 300 bpm, not specified. | | Same | | | | | |
| | PR from IBP Module
Measurement range: 25 to 350
bpm;
Accuracy: ±1 bpm or ±1%,
whichever is greater. | | | | | | | |
| Non-invasive
blood pressure
(NIBP) | Measurement range: | | | Measurement range: | | | | |
| | Adult | Pedia
tric | Neon
ate | Adult | Pedia
tric | Neona
te | | |
| | Syst
olic | 40-
270 | 40-
200 | 40-
135 | Systolic | 25-
290 | 25-
240 | 25-
140 |
| | Diast
olic | 10-
210 | 10-
150 | 10-
100 | Diastolic | 10-
250 | 10-
200 | 10-
115 |
| | Mea
n | 20-
230 | 20-
165 | 20-
110 | Mean | 15-
260 | 15-
215 | 15-
125 |
| | Accuracy:
Max mean error: ±5 mmHg;
Max standard deviation: 8
mmHg. | | | Accuracy:
Max mean error: ±5 mmHg;
Max standard deviation: 8 mmHg. | | | | |
| | Only supports NIBP function
from MPM 2.0 module. | | | Supports NIBP function from MPM 2.0 module and MPM 3.0
module. | | | | |
| | Predicate Devices (K152902) | | Subject BeneVision Devices | | | | | |
| Feature | Passport 17m | Passport 12m | N22 | N19 | N17 | N15 | N12 | |
| Invasive blood
pressure (IBP) | Uses the MPM 2.0 or the stand-alone IBP Module to measure invasive blood pressure. The monitor can monitor up to 8 invasive blood pressures and displays systolic, diastolic and mean pressures and a waveform for each pressure. Support PPV function.
Measurement range: -50 to 300 mmHg;
Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor). | Uses the MPM 2.0 or the stand-alone IBP Module to measure invasive blood pressure. The monitor can monitor up to 8 invasive blood pressures and displays systolic, diastolic and mean pressures and a waveform for each pressure. Support PPV function.
Measurement range: -50 to 300 mmHg;
Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor). | Uses MPM 2.0 and MPM 3.0 or the stand-alone IBP Module (cleared in K152902) to measure invasive blood pressure.
The measurement specifications are same. | Uses MPM 2.0 and MPM 3.0 or the stand-alone IBP Module (cleared in K152902) to measure invasive blood pressure.
The measurement specifications are same. | Uses MPM 2.0 and MPM 3.0 or the stand-alone IBP Module (cleared in K152902) to measure invasive blood pressure.
The measurement specifications are same. | Uses MPM 2.0 and MPM 3.0 or the stand-alone IBP Module (cleared in K152902) to measure invasive blood pressure.
The measurement specifications are same. | Uses MPM 2.0 and MPM 3.0 or the stand-alone IBP Module (cleared in K152902) to measure invasive blood pressure.
The measurement specifications are same. | |
| Cardiac output
(C.O.) | The cardiac output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using the right heart (atria) thermodilution method. The temperature change is displayed as a curve in the C.O. split screen, and the monitor calculates the C.O. value from this curve. The monitor is capable of storing 6 measurements.
Measurement range:
C.O: 0.1 to 20 L/min;
TB: 23 to 43 °C;
TI: 0 to 27 °C:
Accuracy:
C.O: ±5% or ±0.1 L /min, whichever is greater;
TB, TI: ±0.1 °C (without sensor). | The cardiac output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using the right heart (atria) thermodilution method. The temperature change is displayed as a curve in the C.O. split screen, and the monitor calculates the C.O. value from this curve. The monitor is capable of storing 6 measurements.
Measurement range:
C.O: 0.1 to 20 L/min;
TB: 23 to 43 °C;
TI: 0 to 27 °C:
Accuracy:
C.O: ±5% or ±0.1 L /min, whichever is greater;
TB, TI: ±0.1 °C (without sensor). | Same | Same | Same | Same | Same | |
| Continuous
Cardiac output
(CCO) | The CCO/SvO2 interface module provides an interface with Edwards Vigilance II monitor (cleared in K043103) and Vigileo Monitor (cleared in K103094), which measure continuous cardiac output (CCO). | The CCO/SvO2 interface module provides an interface with Edwards Vigilance II monitor (cleared in K043103) and Vigileo Monitor (cleared in K103094), which measure continuous cardiac output (CCO). | Provides an interface with Edwards Vigilance II monitor (cleared in K043103), Vigileo monitor (cleared in K103094), and EV1000 monitor (cleared in K160552) monitor which measure CCO. | Provides an interface with Edwards Vigilance II monitor (cleared in K043103), Vigileo monitor (cleared in K103094), and EV1000 monitor (cleared in K160552) monitor which measure CCO. | Provides an interface with Edwards Vigilance II monitor (cleared in K043103), Vigileo monitor (cleared in K103094), and EV1000 monitor (cleared in K160552) monitor which measure CCO. | Provides an interface with Edwards Vigilance II monitor (cleared in K043103), Vigileo monitor (cleared in K103094), and EV1000 monitor (cleared in K160552) monitor which measure CCO. | Provides an interface with Edwards Vigilance II monitor (cleared in K043103), Vigileo monitor (cleared in K103094), and EV1000 monitor (cleared in K160552) monitor which measure CCO. | |
| Feature | Predicate Devices (K152902) | | Subject BeneVision Devices | | | | | |
| Feature | Passport 17m | Passport 12m | N22 | N19 | N17 | N15 | N12 | |
| Mixed/central
venous oxygen
saturation
(SvO2/ScvO2) | Provides an interface with
monitors (Edwards Vigilance II
(cleared in K043103) and
Vigileo monitor (cleared in
K103094)) that measure mixed
venous oxygen saturation (SvO2)
and central venous oxygen
saturation (ScvO2). | Provides an interface with
monitors (Edwards Vigilance II
(cleared in K043103) and
Vigileo monitor (cleared in
K103094)) that measure mixed
venous oxygen saturation (SvO2)
and central venous oxygen
saturation (ScvO2). | Provides an interface with monitors (Edwards Vigilance II
(cleared in K043103), Vigileo (cleared in K103094), and
EV1000 (cleared in K160552)) that measures mixed venous
oxygen saturation (SvO2) and central venous oxygen saturation
(ScvO2). | | | | | |
| Central venous
oxygen
saturation
(ScvO2) | Central venous oxygen saturation
(ScvO2) is measured using
spectrophotometry.

Measurement range: 0 to 99%
Accuracy: 50% to 80%: ±3%,
Other ranges: Not specified.

This measurement can be used
for adults and pediatrics. | Central venous oxygen saturation
(ScvO2) is measured using
spectrophotometry.

Measurement range: 0 to 99%
Accuracy: 50% to 80%: ±3%,
Other ranges: Not specified.

This measurement can be used
for adults and pediatrics. | Same | Same | Same | Same | Same | |
| Carbon
dioxide (CO2) | Compatible with the following 3
modules to measure carbon
dioxide:
Sidestream CO2 1.0 ModuleMicrostream CO2 ModuleMainstream CO2 Module | | Compatible with the following 3 modules to measure carbon
dioxide:
Sidestream CO2 Module, 1.0 and 2.0Microstream CO2 ModuleMainstream CO2 Module | Compatible with the following 3 modules to measure carbon
dioxide:
Sidestream CO2 Module, 1.0 and 2.0Microstream CO2 ModuleMainstream CO2 Module | Compatible with the following 3 modules to measure carbon
dioxide:
Sidestream CO2 Module, 1.0 and 2.0Microstream CO2 ModuleMainstream CO2 Module | Compatible with the following 3 modules to measure carbon
dioxide:
Sidestream CO2 Module, 1.0 and 2.0Microstream CO2 ModuleMainstream CO2 Module | Compatible with the following 3 modules to measure carbon
dioxide:
Sidestream CO2 Module, 1.0 and 2.0Microstream CO2 ModuleMainstream CO2 Module | |
| Feature | Predicate Devices (K152902) | | Subject BeneVision Devices | | | | | |
| | Passport 17m | Passport 12m | N22 | N19 | N17 | N15 | N12 | |
| | Type: Sidestream CO2Module (CO2 1.0)
0-5%: ±0.26% abs,
5-10%: ±5% of the reading,
10-13%: ±10% of the reading;
±0.3%ABS increase in error for
ISO accuracy mode.
AwRR measurement:
range: 0 to 120rpm;
accuracy: ±2rpm. | | Type: Sidestream CO2 Module (CO2 2.0):
Measurement range: 0150mmHg
Accuracy:
040 mmHg: ±2mmHg,
4176 mmHg: ±5% of reading,
7799 mmHg: ±10% of reading,
100150mmHg: ±(3mmHg + 8% of reading),
ISO accuracy mode: Add ±2mmHg to the full accuracy mode
AwRR measurement:
awRR measurement range: 0 to 150rpm;
awRR: 5%REL, not specified;
SEV: 01%REL: ±0.15% ABS,
1~~5%REL: ±0.2% ABS, 5~~8%REL:
±0.4% ABS, >8%REL, not specified;
DES : 01%REL: ±0.15% ABS,
15%REL: ±0.2% ABS, 510%REL:
±0.4% ABS, 1015%REL: ±0.6% ABS ,1518%REL: ±1% ABS ,>18%REL, not specified;
awRR:260rpm,
±1rpm, >60rpm, not specified.
This measurement can be used for adults, pediatrics and neonates. | | The new AG module has the same measurement specifications and patient population is the same.
Includes new Gas recycling feature.
Although the predicate device does not support gas recycling feature, the feature (including the module and accessories) has been cleared in K171292. | | | | | |
| Feature | Predicate Devices (K152902) | | Subject BeneVision Devices | | | | | |
| | Passport 17m | Passport 12m | N22 | N19 | N17 | N15 | N12 | |
| Impedance
cardiograph
(ICG) | Measurement range:
C.O.:1.415L/min;
SV:5250ml;
HR:44~185bpm.

Accuracy: HR: ±2bpm; another
parameter: not specified. | | Same | | | | | |
| Respiration
mechanics | Measurement range:
FLOW:
Adult/Pediatric: ±(2120)L/min;
Infant: ±(0.5 to 30) L/min
PAW: -20120 cmH2O;
MVe/MVi:
Adult/Pediatric: 260L/min;
Infant: 0.5 to 15 L/min
TVe/TVi:
Adult/Pediatric: 1001500ml;
Infant:20 to 500 ml
awRR:4~120rpm;

Calculated Parameters:
I:E: 4:11:8;
FEV1.0: 0100%;
Pmean:0120 cmH2O;
PEEP:0120 cmH2O;
PEF:2120L/min;
PIF:2120L/min;
PIP: 0120 cmH2O;
Pplat:0120 cmH2O;
Compl: 0200ml/ cmH2O;
RSBI:04095rpm/L. | | Same | | | | | |
| | Predicate Devices (K152902) | | Subject BeneVision Devices | | | | | |
| Feature | Passport 17m | Passport 12m | N22 | N19 | N17 | N15 | N12 | |
| | Accuracy:
FLOW:
Adult/Pediatric: 1.2L/min or
$\pm$ 10% of reading, whichever is | | Same | | | | | |
| | greater;
Infant: 0.5 L/min or $\pm$ 10% of the
reading, whichever is greater
PAW: $\pm$ 3% of reading;
MVe/MVi: $\pm$ 10% of reading;
TVe/TVi:
Adult/Pediatric: $\pm$ 15ml or $\pm$ 10%
of reading, whichever is greater;
Infant: $\pm$ 6 ml or $\pm$ 10% $\times$ reading,
whichever is greater
awRR:499rpm: $\pm$ 1rpm,
100120rpm, $\pm$ 2rpm;
I:E: not specified;
FEV1.0: not specified;
Pmean: $\pm$ 10%;
PEEP: not specified;
PEF: $\pm$ 10%;
PIF: $\pm$ 10%;
PIP: $\pm$ 10%;
Pplat: not specified; | | | | | | | |
| | Compl: not specified;
RSBI: not specified. | | | | | | | |
| Neuromuscular transmission
monitoring
(NMT) | Not applicable | | NMT evaluates muscle relaxation of patients under a
neuromuscular block by measuring the strength of muscle
reaction after electrically stimulating the dedicated motor
nerve.
Measurement range:
ST-Ratio:0 ~ 200%;
TOF-Count: 04;
TOF-Ratio: 5%160%;
TOF-T1%: 0200%;
PTC-Count:020;
DBS-Count:0~2;
DBS-Ratio:5%~160%.
This measurement can be used for adults and pediatrics
Although the predicate device does not support NMT module,
the feature has been cleared in K170876, which has an
identical intended use, measurement range and patient | | | | | |
| | Predicate Devices (K152902) | | Subject BeneVision Devices | | | | | |
| Feature | Passport 17m | Passport 12m | N22 | N19 | N17 | N15 | N12 | |
| Electroenceph
alograph
(EEG) | Not applicable | | The EEG module measures the spontaneous, rhythmic
electrical activity of the cortex. The EEG module can
continuously monitor EEG signals from up to 4 channels. It
can also display Density Spectral Arrays (DSA) and
Compressed Spectral Arrays (CSA).

Measurement range:
Input range: 4mVpp
DC offset voltage: ±500 mV
CMRR: ≥100 dB@51 kΩ and 60Hz
Differential input resistance: >15MΩ@10Hz
Electrode resistance: 0 to 90 kΩ, accuracy: ±1 kΩ or 10%,
whichever is the greater.

Although the predicate device does not support EEG, the
feature has been cleared in K161531. | | | | | |
| Regional
oxygen
saturation
(rSO2) | Not applicable | | The rSO2 module provides non-invasive and continuous
information of changes in regional oxygen saturation of blood.
The measurement takes place in real time, providing an
immediate indication of a change in the critical balance of
regional oxygen delivery and oxygen consumption.

Measurement range: rSO2: 15~95

This measurement can be used for adults, pediatrics and
neonates.

Although the predicate device does not support a rSO2 module,
the feature has been cleared in K082327. | | | | | |
| Wireless
function | The Wireless
radio module
(ASUS) is used
for connecting
to a wireless
monitoring
network with a
central
monitoring
system (CMS). | The Wireless
radio module
(Laird) is used
for connecting
to a wireless
monitoring
network with
a central
monitoring
system
(CMS). | Same as Passport 12m | | | | | |
| ECG 24h
Summary | Not applicable | | Provides the function to statistical results of heart rate changes
and cardiac arrhythmia of patients within 24 hours, including
HR statistics, ARR statistics, ST statistics, QT/QTc statistics
and Pace statistics. | | | | | |
| | Predicate Devices (K152902) | | Subject BeneVision Devices | | | | | |
| Feature | Passport 17m | Passport 12m | N22 | N19 | N17 | N15 | N12 | |
| EWS | Not applicable | Not applicable | The EWS is a set of early warning scores that are intended to
assist clinicians in recognizing the early signs of deterioration
in patients based on vital signs and clinical observations. The
three types of EWS provided are Modified Early Warning
Score (MEWS, cleared in the Accutorr 7), National Early
Warning Score (NEWS) and Custom Scoring.

Although the predicate device does not support a EWS
functionality, the feature has been cleared in K170712. | | | | | |
| Glasgow
Coma Scale
(GCS) | Not applicable | Not applicable | The GCS a well-established scoring system used to assess the
state of consciousness based three sub-components: eye-
opening response, verbal response, and limb movement. | | | | | |
| SepsisSight
Companion
(SSC) | Not applicable | Not applicable | The SSC feature is intended to help clinicians recognize the
early signs and symptoms of Sepsis based on recommendations
from the published literature. | | | | | |
| Cardio-
pulmonary
resuscitation
(CPR)
Dashboard | Not applicable | Not applicable | Records all operations during rescue.
The rescue operations recorded can be customized and include
treatment (rescue drug input, rescue treatment input, start/end
rescue, rescue start condition, rescue end condition). | | | | | |

Table 2: Device Comparison Table - N22/N19/N17/N15/N12

6

7

8

9

10

11

12

13

14

15

16

17

18

Table 3:	Device Comparison Table - N1
----------	------------------------------	--

	Predicate Device (K152902)	Subject Device
Feature	T1	BeneVision N1
Primary display and
touchscreen	5", 480*272 pixels	5.5", 720*1280 pixels.
External display	Allows the display of independent data
when connected to an external monitor
through the VGA connector provided by
the Dock.	Allows the display of mirrored or
independent data when connected to an
external monitor through the VGA
connector provided by the Dock.
The mirrored function in the N1 is
identical to the Passport 17m/12m
mirrored function (K152902).
Power supply	One rechargeable Lithium-ion battery, or
DC-in power supply.	Two rechargeable Lithium-ion batteries
(without built-in CO2 module), one
rechargeable Lithium-ion battery (with
built-in CO2 module), or DC-in power
supply.
	Predicate Device (K152902)	Subject Device
Feature	T1	BeneVision N1
Battery	Chargeable Lithium-ion 7.4VDC,
2500mAh (hard package).	Chargeable Lithium-ion 7.56VDC,
2500mAh (soft package).
Data storage	Secure Digital Memory Card (SD card).	Embedded Multi Media Card (eMMC).
Communication
interface when working
as a module	Infrared communication interface,	Infrared communication interface.
Pogo pin communication interface.
Speaker	Audible alarm tones (45 to 85 dB), key
tones, QRS tones; support PITCH TONE
and multi-level tone modulation.	Same
Alarm system	The alarm lamp is yellow or red,
depending on the alarm type.	The alarm lamp is cyan, yellow, or red
depending on alarm type.
Supports Alarm Volume Escalation
Although the predicate device does not
support an Alarm volume escalation
functionality, the feature has been cleared
in K161531.
ECG	3-lead, 5-lead, or 12-lead selectable,
arrhythmia detection, ST segment
analysis, QT analysis, an interpretation of
resting 12-lead ECG, J-point Auto

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | 3-lead, 5-lead, 6-lead or 12-lead

selectable, arrhythmia detection, ST
segment analysis, QT analysis, an
interpretation of resting 12-lead ECG, J-point
Auto detection, Dual Channel Pace
detection, adjustable QRS threshold, and
heart rate (HR).
Although the predicate device does not
support a 6-lead ECG functionality, the
feature has been cleared in K162607.
Arrhythmia detection is intended for adult
and pediatric.
Supports intelligent arrhythmia alarm.
Although the predicate device does not
support an intelligent arrhythmia alarm
functionality, the feature has been cleared
in K161531.
ST segment analysis is intended for adult,
pediatric and neonate.
Although the predicate device does not
support ST segment analysis used for
pediatric and neonate, the feature has
been cleared in K131414.
The ECG function comes from MPM 3.0
module. |
| | Predicate Device (K152902) | Subject Device |
| Feature | T1 | BeneVision N1 |
| Arrhythmia Analysis | Asystole, VFib/VTac, Vtac, Vent. Brady,
Extreme Tachy, Extreme Brady, PVC,
Couplet, Bigeminy, Trigeminy, R on T,
Run PVCs, PVCs, Tachy, Brady, Missed
Beats, Vent. Rhythm, Pacer Not Pacing,
Pacer Not Capture, Multif. PVC, Nonsus.
Vtac, Pause, Irr. Rhythm, Afib. | Asystole, V-Fib/V-Tach, V-Tach, Vent
Brady, Extreme Tachy, Extreme Brady,
PVC, Couplet, Bigeminy, Trigeminy, R on
T, Run PVCs, PVCs/min, Tachy, Brady,
Missed Beats, Vent Rhythm, Pacer Not
Pacing, Pacer Not Capture, Multiform
PVC, Nonsus V-Tach, Pause, Irr. Rhythm,
A-Fib, Pauses/min
Added: Pauses/min;
Changed the name of: VFib/Vtac, Vtac,
Vent.Brady, Nonsus.Vtac,
Vent.Rhythm, PVCs, Afib, and
Multif.PVC. |
| Respiration rate (Resp) | Measurement range: Adult: 0 to 120 rpm;
Pediatric, neonate: 0 to 150 rpm.
Accuracy: 7 to 150 rpm: ±2 rpm or ±2%,
whichever is greater;
0 to 6 rpm: Not specified.
The RESP function comes from MPM2.0
module. | Measurement specifications are the same.
The RESP function comes from MPM 3.0
module. |
| Temperature (Temp) | Measurement range: 0 to 50 °C (32 to
122 °F);
Accuracy: ±0.1 °C or ±0.2 °F (without
probe).
The TEMP function comes from MPM 2.0
module. | Measurement specifications are same.
The TEMP function comes from MPM
3.0 module. |
| | Predicate Device (K152902) | Subject Device |
| Feature | T1 | BeneVision N1 |
| Pulse oxygen saturation
(SpO2) | Mindray SpO2 function
Measurement range: 0 to 100%
Accuracy:70 to 100%: ±2%
(adult/pediatric mode)
70 to 100%: ±3% (neonate mode)
0% to 69%: Not specified.
Masimo SpO2 function
Measurement range: 1 to 100%
Accuracy:70 to 100%: ±2% (measured
without motion in adult/pediatric mode)
70 to 100%: ±3% (measured without
motion in neonate mode)
70 to 100%: ±3% (measured with motion)
1% to 69%: Not specified.
Nellcor SpO2 function
Measurement range: 0 to 100%
Accuracy:70 to 100%: ±2%
(adult/pediatric)
70 to 100%: ±3% (neonate)
0% to 69%: Not specified.
The Mindray SpO2 function, Masimo
SpO2 function and Nellcor SpO2 function
come from MPM 2.0 module. | Measurement specifications are same.
The Mindray SpO2 function, Masimo
SpO2 function and Nellcor SpO2 function
come from MPM 3.0 module.
Although the predicate device does not
support Masimo SpO2 module in MPM
3.0 module, the feature has been cleared in
K053269. |
| Pulse rate (PR) | PR from Mindray SpO2 Module
Measurement range: 20 to 254 bpm
Accuracy: ±3 bpm.
PR from Masimo SpO2 Module
Measurement range: 25 to 240 bpm
Accuracy: ±3 bpm (measured without
motion)
±5 bpm (measured with motion).
PR from Nellcor SpO2 Module
Measurement range: 20 to 300 bpm
Accuracy:20 to 250 bpm: ±3 bpm
251 to 300 bpm, not specified.
PR from IBP Module
Measurement range: 25 to 350 bpm
Accuracy: ±1 bpm or ±1%, whichever is
greater. | Same |

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Feature	Predicate Device (K152902)			Subject Device
	T1			BeneVision N1
Non-invasive blood pressure (NIBP)	Measurement range:			Measurement range:
	Adult	Pediatric	Neonate	Adult	Pediatric	Neonate
	Systolic
40-270	40-200	40-135	Systolic
25-290	25-240	25-140
	Diastolic
10-210	10-150	10-100	Diastolic
10-250	10-200	10-115
	Mean
20-230	20-165	20-110	Mean
15-260	15-215	15-125
	Accuracy:
Max mean error: ±5 mmHg.
Max standard deviation: 8 mmHg.
The NIBP function comes from MPM 2.0 module.			Accuracy:
Max mean error: ±5 mmHg.
Max standard deviation: 8 mmHg.
The NIBP function comes from MPM 3.0 module.
Invasive blood pressure (IBP)	The monitor can monitor up to 2 invasive blood pressures and displays the systolic, diastolic, and mean pressures and a waveform for each pressure.
The IBP supports Pulse Pressure Variation (PPV) and Pulmonary Artery Wedge Pressure (PAWP) function.
Measurement range: -50~300mmHg
Accuracy: ±2% or ±1mmHg, whichever is greater (without sensor).
The IBP function comes from MPM 2.0 module.			Measurement specifications are the same.
The IBP function comes from MPM 3.0 module.
Carbon dioxide (CO2)	Is compatible with the following 3 modules to measure carbon dioxide:
• Sidestream CO2 1.0 Module
• Microstream CO2 Module
• Mainstream CO2 Module			Is compatible with the following 3 modules to measure carbon dioxide:
• Sidestream CO2 Module, 1.0 and 2.0
• Microstream CO2 Module
• Mainstream CO2 Module

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Feature	Predicate Device (K152902)	Subject Device
	T1	BeneVision N1
	Type: Sidestream CO2 (CO2 1.0) Module
0-5%: ±0.26% abs;
5-10%: ±5% of the reading;
10-13%: ±10% of the reading;
±0.3% ABS increase in error for ISO
accuracy mode.
AwRR measurement:
range: 0 to 120rpm;
accuracy: ±2rpm.	Type: Sidestream CO2 Module (CO2 2.0)
Measurement range: 0~150mmHg
Accuracy:
0~40 mmHg: ±2mmHg,
41~76 mmHg: ±5% of reading,
77~99 mmHg: ±10% of reading,
100~150mmHg: ±(3mmHg + 8% of
reading),
ISO accuracy mode: Add ±2mmHg to the
full accuracy mode.
AwRR measurement:
awRR measurement range: 0 to 150rpm;
awRR: