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.

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.

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.

AI/ML Overview

The provided document is a 510(k) Summary for the Mindray BeneVision N Series Patient Monitors. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with statistical endpoints.

Therefore, many of the requested elements for a detailed study description (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with specific metrics, and ground truth establishment for training data) are not present in the provided text.

The document primarily highlights changes from predicate devices and states that functional and system-level testing, along with compliance with consensus standards, demonstrate equivalence.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically seen for a new device's efficacy study. Instead, it compares the specifications of the subject device with those of predicate devices, implicitly indicating that the subject device's performance meets or exceeds the predicate's established performance or relevant cleared standards.

Feature Area / Parameter	Acceptance Criteria (Implicitly, equivalent to/better than Predicate or standard)	Reported Device Performance (Subject BeneVision Devices)
Display	-	N22: 22" 16801050 pixelsN19: 19" 16801050 pixelsN17: 18.5" 19201080 pixelsN15: 15.6" 19201080 pixelsN12: 12.1" 1280800 pixelsN1: 5.5" 7201280 pixels
Wireless	2.4GHz/5GHz dual band module (Passport 12m)	2.4GHz/5GHz dual band module (All BeneVision N Series)
Data Storage	Compact Flash (Passport 17m)SD card (T1)	Solid State Hard Drive (SSD) (N22, N19)Embedded Multi Media Card (eMMC) (N17, N15, N12, N1)
Alarm System	Yellow/red alarm lamp (Predicate)	Cyan, yellow, or red alarm lamp; Supports Alarm Volume Escalation (Feature cleared in K161531)
ECG - 6-lead ECG	Not supported by predicate	Supported (Feature cleared in K162607)
ECG - Intelligent Arrhythmia Alarm	Not supported by predicate	Supported (Feature cleared in K161531)
ECG - ST Segment Analysis (Pediatric/Neonate)	Only adult (Predicate)	Pediatric and neonate supported (Feature cleared in K131414)
SpO2 - Masimo SpO2 module in MPM 3.0	Not supported by predicate	Supported (Feature cleared in K053269)
CO2 - Sidestream CO2 2.0 Module	Not supported by predicate (Type 1.0 supported)	Supported (Feature cleared in K170712)CO2 measurement range: 0-150mmHg (wider than predicate)AwRR measurement range: 0-150rpm (wider than predicate)AwRR accuracy improved
NMT Module	Not applicable (Predicate)	Supported (Feature cleared in K170876)
EEG Module	Not applicable (Predicate)	Supported (Feature cleared in K161531)
rSO2 Module	Not applicable (Predicate)	Supported (Feature cleared in K082327)
Gas Recycling (AG module)	Not supported by predicate	Supported (Feature cleared in K171292)
Early Warning Score (EWS)	Not applicable (Predicate)	Supported (Feature cleared in K170712)
Helicopter/ambulance transport (N1)	Not applicable (Predicate)	Supported for ECG, RESP, Temp, SpO2, PR, NIBP, IBP (Feature cleared in K161531)
NIBP Measurement Range	Adult: 40-270 (Systolic), 10-210 (Diastolic), 20-230 (Mean)Pediatric: 40-200 (Systolic), 10-150 (Diastolic), 20-165 (Mean)Neonate: 40-135 (Systolic), 10-100 (Diastolic), 20-110 (Mean)	Adult: 25-290 (Systolic), 10-250 (Diastolic), 15-260 (Mean)Pediatric: 25-240 (Systolic), 10-200 (Diastolic), 15-215 (Mean)Neonate: 25-140 (Systolic), 10-115 (Diastolic), 15-125 (Mean)
NIBP Accuracy	Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg (Predicate)	Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg (Same as Predicate)
IBP Measurement Range	-50 to 300 mmHg (Predicate)	-50 to 300 mmHg (Same as Predicate)
IBP Accuracy	±2% or ±1 mmHg, whichever is greater (without sensor) (Predicate)	±2% or ±1 mmHg, whichever is greater (without sensor) (Same as Predicate)
Cardiac Output Measurement Range	0.1 to 20 L/min (C.O.); 23 to 43 °C (TB); 0 to 27 °C (TI) (Predicate)	Same as Predicate
Cardiac Output Accuracy	±5% or ±0.1 L/min (C.O.); ±0.1 °C (TB, TI) (Predicate)	Same as Predicate

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for test sets. The testing mentioned is referred to as "functional and system level testing" and "bench testing." It also states Mindray conducted "clinical testing to demonstrate that the Mindray and Nellcor SpO2 modules meet relevant consensus standards."
There is no mention of data provenance (e.g., country of origin of data, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document does not describe the use of experts to establish ground truth for testing. The evaluation focused on meeting specifications and consensus standards, and demonstrating equivalence to predicate devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no mention of adjudication methods.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a patient monitor, not an AI-assisted diagnostic device, and no MRMC studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes performance in terms of functionality and adherence to technical specifications and consensus standards, not in terms of "algorithm-only" performance as would be relevant for an AI device. The tests performed are for the integrated device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The term "ground truth" is not used. The performance evaluation is based on meeting engineering specifications, comparing against predicate device performance, and compliance with recognized consensus standards (e.g., IEC, ISO, AAMI standards for physiological measurement accuracy).

8. The sample size for the training set

Not applicable. A "training set" is relevant for machine learning algorithms. This document describes a patient monitor, and no machine learning model training is discussed.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning model is mentioned.

Summary

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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-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680
Contact:	Contact Person: Yanhong BaiTitle: Manager Regulatory AffairsPhone: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com
Date Prepared:	November 12, 2018
2.DEVICE
Device Trade Name:	BeneVision N Series Patient Monitors (IncludingBeneVision 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 andalarm (including ST-segment measurement and alarm)
Regulatory Class:	Class II
Primary Product Code:	MHX - Monitor, Physiological, Patient (witharrhythmia detection or alarms)

Table 1:	Secondary Product Codes
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RegulationNumber/Class	ProductCode	Regulation description	Device Common Name
870.1025, II	DSI	Arrhythmia detector and alarm(including ST-segment measurementand alarm)	Detector and alarm, arrhythmia
RegulationNumber/Class	ProductCode	Regulation description	Device Common Name
870.1025, II	MLD	Arrhythmia detector and alarm(including ST-segment measurementand alarm)	Monitor, st segment with alarm
870.2300, II	DRT	Cardiac Monitor (includingcardiotachometer and ratealarm)	Monitor, cardiac (incl.cardiotachometer & rate alarm)
870.1130, II	DXN	Noninvasive blood pressuremeasurement system	System, measurement, blood-pressure,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 electrodetester.	Tester, electrode, surface,electrocardiographic
880.2910, II	FLL	Clinical electronic thermometer	Thermometer, electronic, clinical
870.2700, II	DQA	Oximeter	Oximeter
870.2300, II	MSX	Cardiac monitor (includingcardiotachometer and rate alarm).	System, network and communication,physiological monitors
870.2910, II	DRG	Radiofrequency physiological signaltransmitter and receiver.	Transmitters and receivers,physiological signal, radiofrequency
868.1400, II	CCK	Carbon dioxide gas analyzer	Analyzer, gas,carbon-dioxide, gaseous-phase
870.1435, II	DXG	Single-function, preprogrammeddiagnostic computer	Computer, diagnostic, pre-programmed, single-function
870.1100, II	DSJ	Blood pressure alarm	Alarm, blood-pressure
870.2850, II	DRS	Transducer, blood-pressure,extravascular	Extravascular blood pressuretransducer.
868.1500, II	CBQ	Enflurane gas analyzer.	Analyzer, gas, enflurane, gaseous-phase (anesthetic concentration)
868.1500, II	NHO	Enflurane gas analyzer.	Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)
868.1500, II	NHP	Enflurane gas analyzer.	Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
868.1500, II	NHQ	Enflurane gas analyzer.	Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)
868.1620, II	CBS	Halothane gas analyzer.	Analyzer, gas, halothane, gaseous-phase (anesthetic conc.)
868.1700, II	CBR	Nitrous oxide gas analyzer.	Analyzer, gas, nitrous-oxide, gaseousphase (anesthetic conc.)
868.1720, II	CCI	Oxygen gas analyzer	Analyzer, gas, oxygen, gaseous-phase
RegulationNumber/Class	ProductCode	Regulation description	Device Common Name
868.2775, II	KOI	Electrical peripheral nerve stimulator.	Stimulator, nerve, peripheral, electric
882.1400, II	OLW	Electroencephalograph.	Index-generatingelectroencephalograph software
882.1400, II	OLT	Electroencephalograph	Non-normalizing quantitativeelectroencephalograph software
882.1400, II	OMC	Electroencephalograph.	Reduced- montage standardelectroencephalograph
882.1400, II	ORT	Electroencephalograph	Burst suppression detection softwarefor 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

INTENDED USE/INDICATIONS FOR USE 6.

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

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

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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.

BeneVision N1 Patient Monitor:

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
Integrateddisplay andtouchscreen	17" 1280*1024pixels.	12" 800*600pixels.	22"1680*1050pixels.	19"1680*1050pixels.	18.5"1920*1080 pixels.	15.6"1920*1080pixels.	12.1"1280*800Pixels.
Secondarydisplay	Independentcontrol anddisplay.	Mirroreddisplay.	Independent control and display.	Independent control and display.	Independent control and display.	Mirrored display.	Mirrored display.
iView	iView is anisolated PCplatform thatallows the userto run 3rd partyapplicationsusing a limitedset of functions.	Notsupported.	iView is an isolated PC platform thatallows the user to run 3rd partyapplications using a limited set offunctions.	iView is an isolated PC platform thatallows the user to run 3rd partyapplications using a limited set offunctions.	iView is an isolated PC platform thatallows the user to run 3rd partyapplications using a limited set offunctions.	Not supported.	Not supported.
Wireless	2.4GHzmodule.	2.4GHz/5GHzdual bandmodule.	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
Modulecommunication 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.
Deviceintegration	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 EscalationAlthough 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/N1as a Module	Supports T1 as a module.		Supports T1/N1 as a module.		Supports T1/N1 as a module.
Supportsconnectingwith MindrayTelemetrymonitors,TM80 andBP10	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-leadselectable, arrhythmia detection,ST segment analysis, QTanalysis, an interpretation ofresting 12-lead ECG, J-pointAuto detection, Dual ChannelPace detection, adjustable QRSthreshold and heart rate (HR);Arrhythmia detection is intendedfor adult and pediatric.ST segment analysis of Mindrayalgorithm is intended for adultpatient. ST segment analysis ofMortara algorithm is intended foradult and pediatric patients.Supports Mindray and Mortaraalgorithm.Only supports ECG functionfrom 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 pediatricSupports 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.
ArrhythmiaAnalysis	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 NotCapture, 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, VentRhythm, Pacer Not Pacing, Pacer Not Capture, MultiformPVC, 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
Respirationrate (Resp)	Measurement range: Adult: 0 to120 rpm; Pediatric, neonate: 0 to150 rpm.Accuracy: 7 to 150 rpm: ±2 rpmor +2%, whichever is greater;0 to 6 rpm: Not specified.Only supports RESP functionfrom MPM 2.0 module			Measurement range: Adult: 0 to 120 rpm; Pediatric, neonate: 0to 150 rpm.Accuracy: 7 to 150 rpm: ±2 rpm or ±2%, whichever is greater;0 to 6 rpm: Not specified.Supports RESP 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
Temperature(Temp)	Measurement range: 0 to 50 °C(32 to 122 °F)Accuracy: ±0.1 °C or ±0.2 °F(without probe).Only supports Temperaturefunction from MPM 2.0 module.		Measurement specifications are same.Support Temperature function from MPM 2.0 module, MPM3.0 module and Temperature module.
Pulse oxygensaturation(SpO2)	Supports Mindray SpO2 function,Masimo SpO2 function andNellcor SpO2 function fromMPM 2.0 module.Supports a stand-alone Mindrayor a stand-alone Masimo SpO2module.Mindray SpO2 functionMeasurement range: 0 to 100%;Accuracy:70 to 100%: ±2%(adult/pediatric mode);70 to 100%: ±3% (neonatemode);0% to 69%: Not specified.Masimo SpO2 functionMeasurement range: 1 to 100%;Accuracy:70 to 100%: ±2%(measured without motion inadult/pediatric mode);70 to 100%: ±3% (measuredwithout motion in neonatemode):70 to 100%: ±3% (measured withmotion);1% to 69%: Not specified.Nellcor SpO2 functionMeasurement 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 thevarious SpO2 functions providedby each manufacturer are thesame across platforms.		Supports Mindray SpO2 function, Masimo SpO2 function andNellcor SpO2 function from MPM 2.0 module.Adds the option to use the MPM 3.0. The MPM 3.0 can beconfigured with either a Mindray, Masimo, or NellcorSpO2 module.Although the predicate device does not support Masimo SpO2module in MPM 3.0 module, the feature has been cleared inK053269.Supports a stand-alone Mindray or a stand-alone Masimo SpO2module.Adds support for a stand-alone Nellcor SpO2 module.Note: The specifications for various SpO2 functions providedby each manufacturer for the new MPM 3.0 and Nellcor stand-alone platforms are identical to those that were cleared in theprimary 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 ModuleMeasurement range: 20 to 254bpm;Accuracy: ±3 bpm.PR from Masimo SpO2 ModuleMeasurement range: 25 to 240bpm;Accuracy: ±3 bpm (measuredwithout motion);±5 bpm (measured with motion).PR from Nellcor SpO2 ModuleMeasurement range: 20 to 300bpm;Accuracy:20 to 250 bpm: ±3bpm;251 to 300 bpm, not specified.		Same
	PR from IBP ModuleMeasurement range: 25 to 350bpm;Accuracy: ±1 bpm or ±1%,whichever is greater.
Non-invasiveblood 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: 8mmHg.			Accuracy:Max mean error: ±5 mmHg;Max standard deviation: 8 mmHg.
	Only supports NIBP functionfrom MPM 2.0 module.			Supports NIBP function from MPM 2.0 module and MPM 3.0module.
	Predicate Devices (K152902)		Subject BeneVision Devices
Feature	Passport 17m	Passport 12m	N22	N19	N17	N15	N12
Invasive bloodpressure (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
ContinuousCardiac 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/centralvenous oxygensaturation(SvO2/ScvO2)	Provides an interface withmonitors (Edwards Vigilance II(cleared in K043103) andVigileo monitor (cleared inK103094)) that measure mixedvenous oxygen saturation (SvO2)and central venous oxygensaturation (ScvO2).	Provides an interface withmonitors (Edwards Vigilance II(cleared in K043103) andVigileo monitor (cleared inK103094)) that measure mixedvenous oxygen saturation (SvO2)and central venous oxygensaturation (ScvO2).	Provides an interface with monitors (Edwards Vigilance II(cleared in K043103), Vigileo (cleared in K103094), andEV1000 (cleared in K160552)) that measures mixed venousoxygen saturation (SvO2) and central venous oxygen saturation(ScvO2).
Central venousoxygensaturation(ScvO2)	Central venous oxygen saturation(ScvO2) is measured usingspectrophotometry.Measurement range: 0 to 99%Accuracy: 50% to 80%: ±3%,Other ranges: Not specified.This measurement can be usedfor adults and pediatrics.	Central venous oxygen saturation(ScvO2) is measured usingspectrophotometry.Measurement range: 0 to 99%Accuracy: 50% to 80%: ±3%,Other ranges: Not specified.This measurement can be usedfor adults and pediatrics.	Same	Same	Same	Same	Same
Carbondioxide (CO2)	Compatible with the following 3modules to measure carbondioxide:Sidestream CO2 1.0 ModuleMicrostream CO2 ModuleMainstream CO2 Module		Compatible with the following 3 modules to measure carbondioxide:Sidestream CO2 Module, 1.0 and 2.0Microstream CO2 ModuleMainstream CO2 Module	Compatible with the following 3 modules to measure carbondioxide:Sidestream CO2 Module, 1.0 and 2.0Microstream CO2 ModuleMainstream CO2 Module	Compatible with the following 3 modules to measure carbondioxide:Sidestream CO2 Module, 1.0 and 2.0Microstream CO2 ModuleMainstream CO2 Module	Compatible with the following 3 modules to measure carbondioxide:Sidestream CO2 Module, 1.0 and 2.0Microstream CO2 ModuleMainstream CO2 Module	Compatible with the following 3 modules to measure carbondioxide: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 forISO accuracy mode.AwRR measurement:range: 0 to 120rpm;accuracy: ±2rpm.		Type: Sidestream CO2 Module (CO2 2.0):Measurement range: 0~~150mmHgAccuracy: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 modeAwRR measurement:awRR measurement range: 0 to 150rpm;awRR: <60rpm, ±1rpm, 60~~150rpm, ±2rpm.The CO2 measurement range of subject devices is wider than the predicate devices.The AwRR measurement range of subject devices is wider than the predicate devices. The Accuracy of AwRR is also improved.The SideStream CO2 1.0 module has been cleared in K152902.The SideStream CO2 2.0 module has been cleared in K170712.
		Type: Microstream CO2 ModuleMeasurement range:CO2: 0~~99mmHg;awRR: 0~~150rpm;Accuracy:CO2: 0~~38mmHg: ±2mmHg;39~~99mmHg: ±5% of thereading+0.08% of (the reading-38).awRR: 0~~70rpm: ±1rpm,71~~120rpm:±2rpm,121~150rpm: ±3rpm.	Same
	Predicate Devices (K152902)		Subject BeneVision Devices
Feature	Passport 17m	Passport 12m	N22	N19	N17	N15	N12
	Type: Mainstream CO2 ModuleMeasurement range:CO2: 0~~150mmHg;awRR: 0~~150rpm;Accuracy:CO2: 0~~40mmHg: ±2mmHg,41~~70mmHg: ±5% of thereading, 71~~100mmHg: ±8% ofthe reading, 101~~150mmHg:±10% of the reading;awRR: ±1rpm.		Same
Oxygen (O2)	Oxygen values are measured bythe AG module using aparamagnetic method.Measurement range: 0~~100%(CO2 and AG),Accuracy: 0~~25%, ±1%;26~~80%, ±2%; 81~~100%, ±3%(CO2 and AG).			Oxygen values are measured by the Sidestream CO2 2.0module or the AG module using a paramagnetic method.Measurement specifications are the same.
	Predicate Devices (K152902)		Subject BeneVision Devices
Feature	Passport 17m	Passport 12m	N22	N19	N17	N15	N12
Anesthetic gas (AG)	The AG module analyzes gas samples from the patient and calculates CO2, O2, N2O, and AA waveforms and related numerics that include airway respiratory rate and MAC (minimum alveolar concentration).Measurement range:CO2, HAL, ENF, ISO, SEV, DES: 0~~30 %;O2, N2O: 0~~100 %;awRR: 2~~100 rpm.Accuracy:Full accuracy mode:CO2:0%≤CO2≤1%, ±0.1%ABS,1%<CO2≤5%, ±0.2% ABS, 5%<CO2≤7%, ±0.3% ABS, 7%<CO2≤10%, ±0.5% ABS, 10%<CO2 not specified;N2O: 0~~20%REL: ±2% ABS,20~~100%REL: ±3% ABS;O2 0~~25%, ±1%; 26~~80%, ±2%;81~~100%, ±3%;HAL, ENF, ISO: 0~~1%REL:±0.15% ABS, 1~~5%REL: ±0.2% ABS, >5%REL, not specified;SEV: 0~~1%REL: ±0.15% ABS,1~~5%REL: ±0.2% ABS, 5~~8%REL:±0.4% ABS, >8%REL, not specified;DES : 0~~1%REL: ±0.15% ABS,1~~5%REL: ±0.2% ABS, 5~~10%REL:±0.4% ABS, 10~~15%REL: ±0.6% ABS ,15~~18%REL: ±1% ABS ,>18%REL, not specified;awRR:2~60rpm,±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
Impedancecardiograph(ICG)	Measurement range:C.O.:1.4~~15L/min;SV:5~~250ml;HR:44~185bpm.Accuracy: HR: ±2bpm; anotherparameter: not specified.		Same
Respirationmechanics	Measurement range:FLOW:Adult/Pediatric: ±(2~~120)L/min;Infant: ±(0.5 to 30) L/minPAW: -20~~120 cmH2O;MVe/MVi:Adult/Pediatric: 2~~60L/min;Infant: 0.5 to 15 L/minTVe/TVi:Adult/Pediatric: 100~~1500ml;Infant:20 to 500 mlawRR:4~~120rpm;Calculated Parameters:I:E: 4:1~~1:8;FEV1.0: 0~~100%;Pmean:0~~120 cmH2O;PEEP:0~~120 cmH2O;PEF:2~~120L/min;PIF:2~~120L/min;PIP: 0~~120 cmH2O;Pplat:0~~120 cmH2O;Compl: 0~~200ml/ cmH2O;RSBI:0~4095rpm/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 thereading, whichever is greaterPAW: $\pm$ 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 greaterawRR:4~~99rpm: $\pm$ 1rpm,100~~120rpm, $\pm$ 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 transmissionmonitoring(NMT)	Not applicable		NMT evaluates muscle relaxation of patients under aneuromuscular block by measuring the strength of musclereaction after electrically stimulating the dedicated motornerve.Measurement range:ST-Ratio:0 ~ 200%;TOF-Count: 0~~4;TOF-Ratio: 5%~~160%;TOF-T1%: 0~~200%;PTC-Count:0~~20;DBS-Count:0~2;DBS-Ratio:5%~160%.This measurement can be used for adults and pediatricsAlthough the predicate device does not support NMT module,the feature has been cleared in K170876, which has anidentical intended use, measurement range and patient
	Predicate Devices (K152902)		Subject BeneVision Devices
Feature	Passport 17m	Passport 12m	N22	N19	N17	N15	N12
Electroencephalograph(EEG)	Not applicable		The EEG module measures the spontaneous, rhythmicelectrical activity of the cortex. The EEG module cancontinuously monitor EEG signals from up to 4 channels. Itcan also display Density Spectral Arrays (DSA) andCompressed Spectral Arrays (CSA).Measurement range:Input range: 4mVppDC offset voltage: ±500 mVCMRR: ≥100 dB@51 kΩ and 60HzDifferential input resistance: >15MΩ@10HzElectrode resistance: 0 to 90 kΩ, accuracy: ±1 kΩ or 10%,whichever is the greater.Although the predicate device does not support EEG, thefeature has been cleared in K161531.
Regionaloxygensaturation(rSO2)	Not applicable		The rSO2 module provides non-invasive and continuousinformation of changes in regional oxygen saturation of blood.The measurement takes place in real time, providing animmediate indication of a change in the critical balance ofregional oxygen delivery and oxygen consumption.Measurement range: rSO2: 15~95This measurement can be used for adults, pediatrics andneonates.Although the predicate device does not support a rSO2 module,the feature has been cleared in K082327.
Wirelessfunction	The Wirelessradio module(ASUS) is usedfor connectingto a wirelessmonitoringnetwork with acentralmonitoringsystem (CMS).	The Wirelessradio module(Laird) is usedfor connectingto a wirelessmonitoringnetwork witha centralmonitoringsystem(CMS).	Same as Passport 12m
ECG 24hSummary	Not applicable		Provides the function to statistical results of heart rate changesand cardiac arrhythmia of patients within 24 hours, includingHR statistics, ARR statistics, ST statistics, QT/QTc statisticsand 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 toassist clinicians in recognizing the early signs of deteriorationin patients based on vital signs and clinical observations. Thethree types of EWS provided are Modified Early WarningScore (MEWS, cleared in the Accutorr 7), National EarlyWarning Score (NEWS) and Custom Scoring.Although the predicate device does not support a EWSfunctionality, the feature has been cleared in K170712.
GlasgowComa Scale(GCS)	Not applicable	Not applicable	The GCS a well-established scoring system used to assess thestate of consciousness based three sub-components: eye-opening response, verbal response, and limb movement.
SepsisSightCompanion(SSC)	Not applicable	Not applicable	The SSC feature is intended to help clinicians recognize theearly signs and symptoms of Sepsis based on recommendationsfrom the published literature.
Cardio-pulmonaryresuscitation(CPR)Dashboard	Not applicable	Not applicable	Records all operations during rescue.The rescue operations recorded can be customized and includetreatment (rescue drug input, rescue treatment input, start/endrescue, rescue start condition, rescue end condition).

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

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Table 3:	Device Comparison Table - N1
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	Predicate Device (K152902)	Subject Device
Feature	T1	BeneVision N1
Primary display andtouchscreen	5", 480*272 pixels	5.5", 720*1280 pixels.
External display	Allows the display of independent datawhen connected to an external monitorthrough the VGA connector provided bythe Dock.	Allows the display of mirrored orindependent data when connected to anexternal monitor through the VGAconnector provided by the Dock.The mirrored function in the N1 isidentical to the Passport 17m/12mmirrored function (K152902).
Power supply	One rechargeable Lithium-ion battery, orDC-in power supply.	Two rechargeable Lithium-ion batteries(without built-in CO2 module), onerechargeable Lithium-ion battery (withbuilt-in CO2 module), or DC-in powersupply.
	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).
Communicationinterface when workingas a module	Infrared communication interface,	Infrared communication interface.Pogo pin communication interface.
Speaker	Audible alarm tones (45 to 85 dB), keytones, QRS tones; support PITCH TONEand 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 reddepending on alarm type.Supports Alarm Volume EscalationAlthough the predicate device does notsupport an Alarm volume escalationfunctionality, the feature has been clearedin K161531.
ECG	3-lead, 5-lead, or 12-lead selectable,arrhythmia detection, ST segmentanalysis, QT analysis, an interpretation ofresting 12-lead ECG, J-point Auto	3-lead, 5-lead, 6-lead or 12-leadselectable, arrhythmia detection, STsegment analysis, QT analysis, aninterpretation of resting 12-lead ECG, J-pointAuto detection, Dual Channel Pacedetection, adjustable QRS threshold, andheart rate (HR).Although the predicate device does notsupport a 6-lead ECG functionality, thefeature has been cleared in K162607.Arrhythmia detection is intended for adultand pediatric.Supports intelligent arrhythmia alarm.Although the predicate device does notsupport an intelligent arrhythmia alarmfunctionality, the feature has been clearedin K161531.ST segment analysis is intended for adult,pediatric and neonate.Although the predicate device does notsupport ST segment analysis used forpediatric and neonate, the feature hasbeen cleared in K131414.The ECG function comes from MPM 3.0module.
	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, MissedBeats, Vent. Rhythm, Pacer Not Pacing,Pacer Not Capture, Multif. PVC, Nonsus.Vtac, Pause, Irr. Rhythm, Afib.	Asystole, V-Fib/V-Tach, V-Tach, VentBrady, Extreme Tachy, Extreme Brady,PVC, Couplet, Bigeminy, Trigeminy, R onT, Run PVCs, PVCs/min, Tachy, Brady,Missed Beats, Vent Rhythm, Pacer NotPacing, Pacer Not Capture, MultiformPVC, Nonsus V-Tach, Pause, Irr. Rhythm,A-Fib, Pauses/minAdded: Pauses/min;Changed the name of: VFib/Vtac, Vtac,Vent.Brady, Nonsus.Vtac,Vent.Rhythm, PVCs, Afib, andMultif.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 MPM2.0module.	Measurement specifications are the same.The RESP function comes from MPM 3.0module.
Temperature (Temp)	Measurement range: 0 to 50 °C (32 to122 °F);Accuracy: ±0.1 °C or ±0.2 °F (withoutprobe).The TEMP function comes from MPM 2.0module.	Measurement specifications are same.The TEMP function comes from MPM3.0 module.
	Predicate Device (K152902)	Subject Device
Feature	T1	BeneVision N1
Pulse oxygen saturation(SpO2)	Mindray SpO2 functionMeasurement 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 functionMeasurement range: 1 to 100%Accuracy:70 to 100%: ±2% (measuredwithout motion in adult/pediatric mode)70 to 100%: ±3% (measured withoutmotion in neonate mode)70 to 100%: ±3% (measured with motion)1% to 69%: Not specified.Nellcor SpO2 functionMeasurement 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, MasimoSpO2 function and Nellcor SpO2 functioncome from MPM 2.0 module.	Measurement specifications are same.The Mindray SpO2 function, MasimoSpO2 function and Nellcor SpO2 functioncome from MPM 3.0 module.Although the predicate device does notsupport Masimo SpO2 module in MPM3.0 module, the feature has been cleared inK053269.
Pulse rate (PR)	PR from Mindray SpO2 ModuleMeasurement range: 20 to 254 bpmAccuracy: ±3 bpm.PR from Masimo SpO2 ModuleMeasurement range: 25 to 240 bpmAccuracy: ±3 bpm (measured withoutmotion)±5 bpm (measured with motion).PR from Nellcor SpO2 ModuleMeasurement range: 20 to 300 bpmAccuracy:20 to 250 bpm: ±3 bpm251 to 300 bpm, not specified.PR from IBP ModuleMeasurement range: 25 to 350 bpmAccuracy: ±1 bpm or ±1%, whichever isgreater.	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
	Systolic40-270	40-200	40-135	Systolic25-290	25-240	25-140
	Diastolic10-210	10-150	10-100	Diastolic10-250	10-200	10-115
	Mean20-230	20-165	20-110	Mean15-260	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: -50~300mmHgAccuracy: ±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) Module0-5%: ±0.26% abs;5-10%: ±5% of the reading;10-13%: ±10% of the reading;±0.3% ABS increase in error for ISOaccuracy mode.AwRR measurement:range: 0 to 120rpm;accuracy: ±2rpm.	Type: Sidestream CO2 Module (CO2 2.0)Measurement range: 0~~150mmHgAccuracy:0~~40 mmHg: ±2mmHg,41~~76 mmHg: ±5% of reading,77~~99 mmHg: ±10% of reading,100~~150mmHg: ±(3mmHg + 8% ofreading),ISO accuracy mode: Add ±2mmHg to thefull accuracy mode.AwRR measurement:awRR measurement range: 0 to 150rpm;awRR: <60rpm, accuracy: ±1rpm;60~~150rpm, accuracy: ±2rpm.The CO2 measurement range of subjectdevices is wider than the predicatedevicesThe AwRR measurement range ofsubject devices is wider than thepredicate devices. The Accuracy ofAwRR is also improved.The SideStream CO2 1.0 module has beencleared in K152902.The SideStream CO2 2.0 module has beencleared in K170712.
	Type: Microstream CO2 ModuleMeasurement range:CO2: 0~~99mmHg, awRR: 0~~150rpm.Accuracy:CO2: 0~~38mmHg: ±2mmHg;39~~99mmHg: ±5% of the reading+0.08%of (the reading-38).awRR: 0~~70rpm: ±1rpm, 71~~120rpm:±2rpm,121~150rpm: ±3rpm.	Same

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Feature	Predicate Device (K152902)T1	Subject DeviceBeneVision N1
	Type: Mainstream CO2 ModuleMeasurement range: CO2: 0~~150mmHg;awRR: 0~~150rpm;Accuracy: CO2: 0~~40mmHg: $\pm$ 2mmHg,41~~70mmHg: $\pm$ 5% of the reading,71~~100mmHg: $\pm$ 8% of the reading,101~~150mmHg: $\pm$ 10% of the reading;awRR: $\pm$ 1rpm.	Same
Oxygen (O2)	Not Applicable	Oxygen values are measured by theSidestream CO2 (only for externalSidestream CO2 2.0 module) module usinga paramagnetic method.Measurement range: O2: 0~~100%;Accuracy:0~~25%, $\pm$ 1%; 26~~80%, $\pm$ 2%;81~~100%, $\pm$ 3%.
Wireless radio Module	The Wireless radio module (Laird) is usedfor connecting to a wireless monitoringnetwork with a central monitoring system(CMS).	Same
Helicopter andambulance transport	Not Applicable	Only ECG, RESP, Temp, SpO2, PR,NIBP, and IBP can be used in helicoptersand ambulances. CO2 and O2 cannot beused in helicopters or ambulances.Although the predicate device does notsupport a Helicopter and ambulancetransport functionality, the feature hasbeen cleared in K161531.
EWS	Not Applicable	The EWS is a set of early warning scoresthat are intended to assist clinicians inrecognizing the early signs of deteriorationin patients based on vital signs and clinicalobservations. The three types of EWSprovided are Modified Early WarningScore (MEWS, cleared in the Accutorr 7),National Early Warning Score (NEWS)and Custom Scoring.Although the predicate device does notsupport a EWS functionality, the feature hasbeen cleared in K170712.
Glasgow Coma Scale(GCS)	Not Applicable	The GCS a well-established scoringsystem used to assess the state ofconsciousness based three sub-components: eye-opening response, verbalresponse, and limb movement.

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	Predicate Device (K152902)	Subject Device
Feature	T1	BeneVision N1
Cardio-pulmonaryresuscitation (CPR)Dashboard	Not Applicable	Records all operations during rescue.The rescue operations recorded can becustomized and include treatment (rescuedrug input, rescue treatment input,start/end rescue, rescue start condition,rescue end condition).

In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness.

8. PERFORMANCE DATA

To establish the substantial equivalence of the BeneVision N Series Patient Monitors, 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:

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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

{27}------------------------------------------------

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

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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.

CONCLUSION 9.

Based on the detailed comparison of specifications for each of the modifications to the previously cleared Passport Series devices (K152902), the performance testing and conformance with applicable standards, the BeneVision N Series Patient Monitors (including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1) can be found substantially equivalent to the predicate devices.

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Image /page/30/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 10, 2018

Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen 518057, P.R. China

Re: K182075

Trade/Device Name: BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, MUD, MLC, DSB, KRC, MSX, DRG, CCK, DXG, DSJ, DRS, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, KOI, OLW, OLT, OMC, ORT, GXY Dated: November 12, 2018 Received: November 13, 2018

Dear Yanhong Bai:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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.