The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-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), Bispectral Index (BIS), 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, BIS, 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, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment 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. Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.

AI/ML Overview

The provided text is a 510(k) Summary for the Mindray BeneVision N Series Patient Monitors. It mainly focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and specific performance metrics in the format requested.

The document discusses functional and system level testing and bench testing to validate performance and ensure specifications are met, but it does not provide a table of acceptance criteria alongside reported device performance data, nor does it detail the specifics of such a study.

Here's a breakdown of the requested information based on the provided text, highlighting what is not available:

A table of acceptance criteria and the reported device performance
- Not Available. The document states that "functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate" and "the subject device meets its accuracy specification." However, it does not provide the specific numerical acceptance criteria or the reported performance data in a table. It only lists measurement ranges and accuracies for various parameters (ECG, Respiration Rate, Temperature, SpO2, Pulse Rate, NIBP, IBP, C.O., CCO, SvO2/ScvO2, CO2, O2, AG, ICG, RM, NMT, EEG, rSO2) under the "Technological Comparison" tables (Table 2 and Table 3). These are presented as specifications rather than acceptance criteria for a study.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document mentions "functional and system level testing" and "bench testing" but provides no details on the sample size of data used for these tests, nor its provenance (country, retrospective/prospective nature).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Available. This device is a patient monitor, and its performance is assessed against established physical measurement standards and algorithms, not typically against expert interpretation of data for ground truth in the way an AI diagnostic algorithm might be (e.g., radiologists for medical images). The document does not mention any expert review process for determining ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. As mentioned above, the assessment appears to be against physical specifications and consensus standards, not an expert-adjudicated ground truth.
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
- No, not done. The document does not mention an MRMC study or any assessment of human reader improvement with AI assistance. This device is a patient monitor providing physiological parameters, not an AI-assisted diagnostic tool for human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A (Implicitly standalone for most parameters against physical standards). The performance evaluation described largely implies standalone testing against specifications and standards. For example, for ECG, SpO2, NIBP, etc., the device's internal algorithms process signals and provide readings, which are then assessed for accuracy. The "reporting" is of the device's ability to measure parameters correctly, not its ability to assist a human.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Physical Standards and Reference Devices/Methods. The ground truth for the measurements would be established by validated physical standards, calibrated equipment, and comparison to reference methods (e.g., for invasive blood pressure, cardiac output). The document implies validation against these types of established standards and specifications.
The sample size for the training set
- Not Applicable / Not Available. The document does not describe the development or training of AI algorithms that would require a "training set" in the context of machine learning. The patient monitor's algorithms are based on established physiological signal processing, not deep learning models.
How the ground truth for the training set was established
- Not Applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.

May 7, 2020

Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, China 518057

Re: K192972

Trade/Device Name: Patient Monitor 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 Dated: April 7, 2020 Received: April 8, 2020

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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192972

Device Name

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

Indications for Use (Describe) BeneVision N12/N15/N17/N19/N22

· 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.

(Continue on next page for N1 Indications for Use)

Type of Use (Select one or both, as applicable)

Transaction (For 21 CFR 801 Subpart D)	Own Use Compounding (21 CFR 801 Subpart C)
-------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Number (if known): K192972 Indications for Use (con't)

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

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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.

1. SUBMITTER

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:	October 22, 2019
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
-------------------------------------

Regulation Number/Class	Product Code	Regulation description	Device Common Name
870.1025, II	DSI	Arrhythmia detector and alarm (including ST-segment measurement and 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	CCL	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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3. PREDICATE DEVICES

Predicate: K182075 BeneVision N Series Patient Monitors (Including BeneVision N12, ● BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1)

REFERENCE DEVICES 4.

K190011 Passport 12m, Passport 17m, T1: provided as reference devices for ● the BIS module that has been added to the subject BeneVision N Series Patient Monitors.
K163381 Hemosphere Monitor: provided as a reference device in support the device ● integration functionality and PPV parameters.

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 ●

Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.

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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 transfering of multiple physiological parameters including ECG (3-lead, 5-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 (Sv02/Scv02), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), 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, BIS, 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/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

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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 BeneVision N12/N15/N17/N19/N22 has been modified to include the BIS parameter used on adult and pediatric patients. Although this feature is not present in the primary predicate devices, it is present in other cleared multiparameter patient monitors such as the Passport series Patient Monitors (K190011, Passport 17m. T1). The inclusion of BIS in the indications for use does not constitute a new fundamental intended use.

The indications for use statement of the subject BeneVision N1 has not been changed.

In conclusion, the minor difference in the indications for use statement does not change the fundamental intended use of the N Series monitors as multiparameter monitors.

Technological Comparison

The tables below compare the key technological feature of the subject devices to the predicate device (N series Patient Monitors, K182075). The features in gray are features which are different between the predicate devices and the subject devices.

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Page 6 of 28

Table 2: Device Comparison Table (BeneVision 22/N19/N17/N15/N12)

Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
			Cleared in K182075					Subject Device
Primary displayand touchscreen	22"1680*1050pixels.	19"1680*1050pixels.	18.5"1920*1080pixels.	15.6"1920*1080pixels.	12.1"1280*800pixels.	Nochange	Nochange	No change	Nochange	Nochange
Secondarydisplay	Independent control anddisplay.	Independent control anddisplay.	Independentcontrol anddisplay.Size:18.5";Model:ET1919LM;	Mirrored display.Size:18.5";Model: ET1919LM;		No change	No change	Independentcontrol anddisplay.Size: 21.5";Model:2203L	Mirrored display.Size: 21.5";Model: 2203L;
iView	iView is an isolated PC platform that allowsthe user to run 3rd party applications using alimited set of functions. The iView system isnot intended to be used as a primary alarmdevice.Capacity of RAM: 4GBModel of CPU: J1900Windows 7			Not supported.		Change the PC platformCapacity of RAM: 8GBModel of CPU: N4200Windows 10		Change the PC platformCapacity of RAM: 8GBModel of CPU: N4200Windows 10	No change	No change
Wireless radiomodule	The 2.4G/5G module for connecting to a network wirelessly, constructing amonitoring network with a central monitoring system (CMS).						No change
Module rack	Must be connected to themain unit to provide up to8 standard module slots.	Must be connected to themain unit to provide up to8 standard module slots.	Optional for the patientmonitors, adding 8 standardmodule slots to extend themeasurement capabilities ofthe system.	Notsupported.	Notsupported.	No change
Power supply			One rechargeable Lithium-ion battery or AC power supply.			No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
			Cleared in K182075				Subject Device
Battery	Chargeable Lithium-Ion, 11.3 VDC, 5600 mAh.		Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh.			Chargeable Lithium-Ion, 10.8 VDC, 5600 mAh.		Chargeable Lithium-Ion, 10.95 VDC, 4500 mAh.
Data storage	Solid State Hard Drive (SDD)		Embedded Multi Media Card (eMMC).			No change
Data recorder	Supports the thermal recorder module, needs to be plugged into the SMR.		Supports the thermal recorder module and the built-in thermal recorder, but they cannot work at the same time.			No change
Speaker	Provides audible alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation.						No change
Alarm system	Supports alarm volume escalation. The alarm lamp will light cyan, yellow, or red depending on alarm type.						No change
Support T1/N1 as a Module	Support T1/N1 acting as a module.						No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
ECG	Cleared in K182075					Subject Device
	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, Multi-lead ECG synchronization analysis and heart rate (HR).Can be configured with either the Mindray or Mortara algorithm for ECG arrhythmia monitoring and arrhythmia detection. MPM 3.0, N1: supports Mindray Algorithm. T1, MPM 2.0, and TM80: support Mindray or Mortara algorithm Supports intelligent arrhythmia alarmsHR Measurement range: 15~~350 bpm (neonate, pediatric), 15~~300 bpm (adult); Accuracy: ±1 bpm or ±1%, whichever is greater.ST Measurement range: -2.0mV~+2.0mV; Accuracy: -0.8mV~+0.8mV, ±0.02mV or ±10%, whichever is greater, other range: not specified.QT Measurement range: 200~800ms; Accuracy: ±30ms.This measurement can be used for adults, pediatrics, and neonates, except that: The arrhythmia detection of MPM 3.0 is intended for adult and pediatric patients only; The arrhythmia detection and ST segment analysis of Mortara algorithm in T1, MPM 2.0, and TM80 (T1 is cleared in K190011, MPM 2.0 is cleared in K152902, and TM80 is cleared in K183238) are intended for adult and pediatric patients only; The arrhythmia detection of Mindray algorithm in T1, MPM 2.0, and TM80 is intended for adult and pediatric patients only; The ST Segment analysis of Mindray algorithm in T1, MPM 2.0, and TM80 is intended for adult patients only.	No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
Cleared in K182075					Subject Device
Respiration rate(Resp)	Measure the respiration waveforms and respiratory rate through trans- thoracic impedance method.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.This measurement can be used for adults, pediatrics and neonates.					No change
Temperature(Temp)	Uses the MPM (Multi Parameter Module), T1, N1 or the Temperature Module to measure temperature using the thermal resistance method.Measurement range: 0 to 50°C (32 to 122°F).Accuracy: ±0.1°C or ±0.2°F (without probe).This measurement can be used for adults, pediatrics and neonates.					No change
Pulse oxygensaturation (SpO2)	Uses the MPM (Multi Parameter Module), T1, N1 or the SpO2 Module to measure Pulse oxygen saturation. N Series patient monitors are compatible with the following 3 types of modules to measure oxygen saturation:Mindray SpO2 moduleMeasurement range: 0~100 % Accuracy: 70%~~100%: ±2% ABS (Adult/pediatric); 70%~~100%: ±3% ABS (neonate); 0~~69%: not specified.Masimo SpO2 moduleMeasurement range: 1~~100 %, Accuracy: without motion 70%~~100%:±2% ABS (Adult/pediatric), 70%~~100%: ±3%ABS (neonate), 1~~69%: not specified; With motion 70%~~100%: ±3% ABS, 1~~69%: not specified.Nellcor SpO2 moduleMeasurement range: 0~~100 %, Accuracy: 70%~100% : ±2% ABS (Adult/pediatric); 70%~~100% : ±3% ABS (neonate); 0~~69%: not specified.This measurement can be used for adults, pediatrics and neonates.					No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
	Cleared in K182075					Subject Device
Pulse rate (PR)	Pulse rate may be obtained from all sources of SpO2, or the IBP module.Measurement range: 20~~254 bpm (Mindry SpO2), 25~~240 bpm (MasimoSpO2), 20~~300 bpm (Nellcor SpO2), 25~~350 bpm (IBP).Accuracy: ±3 bpm (Mindray SpO2), ±3 bpm without motion, ±5 bpm withmotion (Masimo SpO2); 20~~250 bpm ±3 bpm; 251~~300 bpm, not specified(Nellcor SpO2); ±1 bpm or ±1%, whichever is greater (IBP).This measurement can be used for adults, pediatrics and neonates.					No change
Non-invasiveblood pressure(NIBP)	Uses the MPM (Multi Parameter Module), T1 or N1 to measure NIBP. TheMPM uses the oscillometric method for measuring non-invasive bloodpressure (NIBP).Measurement range:Systolic: 25~~290 mmHg (Adult), 25~~240 mmHg (Pediatric), 25~~140mmHg (Neonate).Diastolic: 10~~250 mmHg (Adult), 10~~200 mmHg (Pediatric), 10~~115mmHg (Neonate).Mean: 15~~260 mmHg (Adult), 15~~215 mmHg (Pediatric), 15~~125 mmHg(Neonate).PR: 30~~300bpm.Accuracy:NIBP: Max mean error: ±5mmHg; Max standard deviation: 8mmHg.PR: ±3 bpm or ±3%, whichever is greater.This measurement can be used for adults, pediatrics and neonates.					No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
	Cleared in K182075					Subject Device
Invasive blood pressure (IBP)	Uses the MPM (Multi Parameter Module), T1, N1 or the 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.The IBP supports Pulse Pressure Variation (PPV) and Pulmonary Artery Wedge Pressure (PAWP) function.Measurement range: -50~300mmHg,Accuracy of module: ±2% or ±1mmHg, whichever is greater (without sensor)This measurement can be used for adults, pediatrics and neonates except that PAWP is not for neonates.					No change
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 can store up to 6 measurements.Measurement range:C.O.: 0.1~~20 L/min.TB: 23~~43°C, TI: 0~27°C.Accuracy:C.O.: ±5% or ±0.1L/min, whichever is greater.TB, TI: ±0.1°C (without sensor).This measurement can be used for adults.					No change
Continuous cardiac output (CCO)	The CCO/SvO2 interface module is used to interface with Edwards Vigilance II monitor (cleared in K043103) / Vigileo monitor (cleared in K103094)/ EV1000 monitor (cleared in K160552) which measures continuous cardiac output (CCO).This measurement can be used for adults and pediatrics.					The CCO/SvO2 interface module is used to interface with Edwards Vigilance II monitor (cleared in K043103)/ Vigileo monitor (cleared in K103094)/ EV1000 monitor (cleared in K160552) / HemoSphere monitor (cleared in K163381) which measures continuous cardiac output (CCO).This measurement can be used for adults and pediatrics.
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
		Cleared in K182075					Subject Device
Mixed/centralvenous oxygensaturation(SvO2/ScvO2)	The CCO/SvO2 interface module is used to interface with EdwardsVigilance II monitor (cleared in K043103) / Vigileo Monitor (cleared inK103094)/ EV1000 monitor (cleared in K160552) which measures mixedvenous oxygen saturation (SvO2) and central venous oxygen saturation(ScvO2).This measurement can be used for adults and pediatrics.					The CCO/SvO2 interface module is used to interface withEdwards Vigilance II monitor (cleared in K043103)/ Vigileomonitor (cleared in K103094)/ EV1000 monitor (cleared inK160552) / HemoSphere monitor (cleared in K163381)which measures mixed venous oxygen saturation (SvO2) andcentral venous oxygen saturation (ScvO2).This measurement can be used for adults and pediatrics.
Central venousoxygen saturation(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 used for adults and pediatrics.					No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
			Cleared in K182075					Subject Device
Carbon dioxide(CO2)	CO2 can be measured using the Mindray Sidestream CO2 module,Mindray AG module or third-party CO2 modules, Microstream module andMainstream module.Type: Sidestream CO2 module.Measurement range: CO2: 0~~150mmHg, awRR: 0~~150rpm.Accuracy: CO2: Full accuracy mode: 0~~40 mmHg: ±2mmHg, 41~~76mmHg: ±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: <60rpm, ±1rpm, 60~~150rpm, ±2rpmType: Microstream CO2 moduleMeasurement range: CO2: 0~~99mmHg, awRR: 0~~150rpmAccuracy: 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.Type: Mainstream CO2 module.Measurement range: CO2: 0~~150mmHg; awRR: 0~~150rpm.Accuracy: CO2: 0~~40mmHg: ±2mmHg, 41~~70mmHg: ±5% of the reading,71~~100mmHg: ±8% of the reading, 101~~150mmHg: ±10% of the reading;awRR: ±1rpmAG module:Measurement range: 0~30%;Accuracy: Full accuracy mode: 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,ISO mode: Add ±0.3% ABS.CO2 monitoring is based on calculations that come from measuring theabsorption of infrared (IR) light of specific wavelengths using aphotodetector.This measurement can be used for adults, pediatrics and neonates.			No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
			Cleared in K182075				Subject Device
Oxygen (O2)	Oxygen values are measured by the Sidestream CO2 module or the AGmodule using a paramagnetic method.Measurement range: 0~~100% (CO2 and AG),Accuracy: 0~~25%, $\pm$ 1%; 26~~80%, $\pm$ 2%; 81~~100%, $\pm$ 3% (CO2 and AG).This measurement can be used for adults, pediatrics and neonates.					No change
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 airwayrespiratory rate and MAC (minimum alveolar concentration).Measurement range:HAL, ENF, ISO, SEV, DES: 0~~30%,N2O: 0~~100%;awRR: 2~~100 rpmAccuracy:Full accuracy mode:N2O: 0~~20%REL: $\pm$ 2% ABS, 20~~100%REL: $\pm$ 3% ABS;HAL, ENF, ISO: 0~~1%REL: $\pm$ 0.15% ABS, 1~~5%REL: $\pm$ 0.2% ABS, >5%REL,not specified;SEV: 0~~1%REL: $\pm$ 0.15% ABS, 1~~5%REL: $\pm$ 0.2% ABS, 5~~8%REL: $\pm$ 0.4%ABS, >8%REL, not specified;DES : 0~~1%REL: $\pm$ 0.15% ABS, 1~~5%REL: $\pm$ 0.2% ABS, 5~~10%REL: $\pm$ 0.4% ABS,10~~15%REL: $\pm$ 0.6% ABS ,15~~18%REL: $\pm$ 1% ABS ,>18%REL, not specified;awRR:2~~60rpm, $\pm$ 1rpm, >60rpm, not specifiedThis measurement can be used for adults, pediatrics and neonates.					No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
	Cleared in K182075					Subject Device
Impedancecardiograph(ICG)	ICG measures a patient's hemodynamic status using a non-invasive methodbased on thoracic electrical bioimpedance (TEB) technology.		Measurement range:C.O.:1.4~~15L/min;SV:5~~250ml;HR: 44~185bpm.		Accuracy: HR: ±2bpm; other parameter: not specified.This measurement can be used for adults.	No change
Bispectral index(BIS)	Not supported					The BIS Module monitors the state of the brain by dataacquisition of EEG signals. Bispectral index (BIS) is aprocessed EEG variable that can be used as an aid inmonitoring the effects of certain anesthetic agents.Measurement range: BIS, BIS L, BIS R: 0~100.Accuracy: not specified.This measurement can be used for adults and pediatrics.
Respirationmechanics (RM)	The RM module measures respiration mechanics for adult and pediatricpatients.		Measurement range:		Accuracy:	No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
	Cleared in K182075					Subject Device
	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: 0.5 to 15 L/minCalculated Parameters:awRR:4~~120rpm;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;			FLOW:Adult/Pediatric: 1.2L/min or ±10%of reading, whichever is greater;Infant: 0.5 L/min or ±10% of thereading, whichever is greaterPAW: ±3% of reading;MVe/MVi: ±10% of reading;TVe/TVi:Adult/Pediatric: ±15ml or ±10% ofreading, whichever is greater;Infant: ±6 ml or ±10%×reading,whichever is greaterCalculated Parameters:awRR:4~~99rpm: ±1rpm,100~~120rpm, ±2rpm;I:E: not specified;FEV1.0: not specified;Pmean: ±10%;PEEP: not specified;PEF: ±10%;PIF: ±10%;PIP: ±10%;Pplat: not specified;Compl: not specified;RSBI: not specified;
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
			Cleared in K182075					Subject Device
Neuromusculartransmissionmonitoring(NMT)	NMT evaluates muscle relaxation of patients under a neuromuscular blockby measuring the strength of muscle reaction after electrically stimulatingthe dedicated motor nerve.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 pediatrics.					No change
Electroencephalograph (EEG)	The EEG module measures the spontaneous, rhythmic electrical activity ofthe cortex. The EEG module can continuously monitor EEG signals fromup to 4 channels. It can also display Density Spectral Arrays (DSA) andCompressed Spectral Arrays (CSA).Frequency response: 0.5Hz~50Hz(-3dB)Input range: 4mVppDC offset: ±500 mVCMRR: ≥100 dB@51 kΩ and 60HzNoise level: ≤0.5 uVrms (1Hz to 30 HzDifferential input resistance: >15MΩ@10HzElectrode resistance: 0 to 90 kΩ, resolution: ±1 KΩ or 10%, whichever isthe greaterThis measurement is intended to be used for adults, pediatrics andneonates.					No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
	Cleared in K182075					Subject Device
Regional oxygensaturation (rSO2)	The rSO2 module provides noninvasive and continuous information ofchanges in regional oxygen saturation of blood. The measurement takesplace in real time, providing an immediate indication of a change in thecritical balance of regional oxygen delivery and oxygen consumption.Measurement range: rSO2: 15~95.This measurement can be used for adults, pediatrics and neonates.					No change
ECG 24hSummary	Provides an option to view a summary of a patient's ECG statistics from theprevious 24 hours, including HR statistics, ARR event statistics, max and minST statistics of each lead, QT/QTc measurement statistics, Pacer statistics (forpatients being paced), and typical ECG strips.					No change
Early WarningScore (EWS)	The EWS is a set of early warning scores that are intended to assist cliniciansin recognizing the early signs of deterioration in patients based on vital signsand clinical observations. The three types of EWS provided are Modified EarlyWarning Score (MEWS), National Early Warning Score (NEWS) and a userconfigurable Custom Score.					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), National Early Warning Score (NEWS),National Early Warning Score2 (NEWS2), and a userconfigurable Custom Score.Refer to Section 12.3.6
Glasgow ComaScale (GCS)	The GCS a well-established scoring system used to assess the state ofconsciousness based three sub-components: eye-opening response, verbalresponse, and limb movement.					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.
SepsisSight	The SepsisSight feature is intended to help clinicians recognize the earlysigns and symptoms of Sepsis based on recommendations from thepublished literature (Surviving Sepsis Campaign: InternationalGuidelines for Management of Severe Sepsis and Septic Shock: 2012and and The Third International Consensus Definition for Sepsis andSeptic Shock (Sepsis-3)).					The SepsisSight feature is intended to help cliniciansrecognize the early signs and symptoms of Sepsis based onrecommendations from the published literature (SurvivingSepsis Campaign: International Guidelines forManagement of Severe Sepsis and Septic Shock: 2016and and The Third International Consensus Definition forSepsis and Septic Shock (Sepsis-3))2.
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
	Cleared in K182075					Subject Device
Cardio-pulmonaryresuscitation(CPR) Dashboard		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 startcondition, rescue end condition).				No change
Deviceintegration	Support BeneLink Module to connect Anesthesia, Ventilator, Pump,TcGas Monitor Device, and Single Paramer Device.					Support BeneLink Module to connect Anesthesia,Ventilator, Pump, TcGas Monitor Device, and Single ParamerDevice.The types of the devices that can be connected are stillonly the five types listed above, but some types addednewly approved devices.
OxyCRGFunction		Support the function of oxygen cardio-respirogram (OxyCRG) whenthe patient type is neonate, and simultaneously provide real-timeOxyCRG interface and OxyCRG review interface to display parametertrends and waveforms				Support the function of oxygen cardio-respirogram(OxyCRG) when the patient type is neonate, andsimultaneously provide real-time OxyCRG interface andOxyCRG review interface to display parameter trends andwaveforms, and OxyCRG events.
Security ofPatientInformation	Support Mindray proprietary encryption algorithm (XOR algorithm)					Support AES128 encryption algorithm
Accessories	The accessories including ECG, SpO2, Temp, NIBP, IBP, C.O., ScvO2,ICG, CO2, AG, RM, EEG, BIS, NMT, rSO2, CCO/SvO2 accessories.					Add new ECG, Temp, C.O., and IBP accessories

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Table 3: Device Comparison Table – N1

Feature	N1	N1
	Cleared in K182075	Subject Device
Primary displayand touchscreen	5.5", 720*1280 pixels.	No change

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Feature	N1	N1
	Cleared in K182075	Subject Device
External display	Allows the display of mirrored or independent data when connected to anexternal monitor through the video connector provided by the Dock.	No change
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.	No change
Battery	Chargeable Lithium-ion 7.56VDC, 2500mAh.	Chargeable Lithium-ion 7.2VDC, 2500mAh.
Data storage	Embedded Multi Media Card (eMMC)	No change
Speaker	Gives alarm tones (45 to 85 dB), key tones, QRS tones; support PITCHTONE and multi-level tone modulation.	No change
Alarm system	Supports Alarm Volume Escalation.The alarm lamp will light cyan, yellow, or red depending on alarm type.	No change
Communicationon Interface whenN1 is working asa module	Infrared communication interface.Pogo pin communication interface.	No change
Feature	N1	N1
	Cleared in K182075	Subject Device
ECG	3-lead, 5-lead, 6-lead, or 12-lead selectable, arrhythmia detection, STsegment analysis, QT analysis, an interpretation of resting 12-lead ECG,J-point auto detection, Dual channel pace detection, adjustable QRSthreshold, Multi-lead ECG synchronization analysis and heart rate (HR)Supports intelligent arrhythmia alarm.Measurement range:ST: -2.0mV~+2.0mV;QT: 200~~800ms;HR: 15~~350bpm (neonate, pediatric), 15~~300bpm (adult).Accuracy:ST: -0.8mV~~+0.8mV, ±0.02mV or ±10%, whichever is greater, otherrange: not specified;QT: ±30ms;HR: ±1 bpm or ±1%, whichever is greater.This measurement can be used for adults, pediatrics and neonates exceptfor the arrhythmia detection. The arrhythmia detection is intended foradult and pediatric patients only.	No change
Respiration rate(Resp)	Measure the respiration waveforms and respiratory rate through trans-thoracic impedance method.Measurement range: Adult: 0 to 120 rpm; Pediatric, neonate: 0 to 150rpm.Accuracy: 7 to 150 rpm: ±2 rpm or ±2%, whichever is greater;0 to 6 rpm: Not specified.This measurement can be used for adults, pediatrics and neonates.	No change
Temperature(Temp)	Measures temperature using the thermal resistance method.Measurement range: 0 to 50℃ (32 to 122°F).Accuracy: ±0.1℃ or ±0.2 °F (without probe).This measurement can be used for adults, pediatrics and neonates.	No change
Feature	N1	N1
	Cleared in K182075	Subject Device
Pulse oxygen saturation (SpO2)	Integrates one of the 3 kinds of SpO2 modules:Mindray SpO2 module boardMeasurement range: SpO2:0~100 %,Accuracy: 70%~~100%: ±2% ABS (Adult/pediatric); 70%~~100%: ±3% ABS (neonate); 0~~69%: not specified.Masimo SpO2 module boardMeasurement range: 1~~100 %,Accuracy: without motion 70%~~100%: ±2% ABS (Adult/pediatric),70%~~100%: ±3% ABS (neonate), 1~~69%: not specified; With motion70%~~100%: ±3% ABS, 1~~69%: not specified.Nellcor SpO2 module boardMeasurement range: SpO2:0~~100 %,Accuracy: SpO2:70%~100%: ±2% ABS (Adult/pediatric); 70%~~100%: ±3% ABS (neonate); 0~~69%: not specified.This measurement can be used for adults, pediatrics and neonates.	No change
Pulse rate (PR)	Obtains pulse rate from SpO2 or IBP.Measurement range: 20~~254bpm (Mindray SpO2), 25~~240bpm (Masimo SpO2), 20~~300bpm (Nellcor SpO2), 25~~350bpm (IBP).Accuracy: ±3 bpm (Mindray SpO2), ±3 bpm without motion, ±5 bpm with motion (Masimo SpO2); 20~~250bpm ±3 bpm; 251~~300bpm, not specified (Nellcor SpO2); ±1 bpm or ±1%, whichever is greater (IBP).This measurement can be used for adults, pediatrics and neonates.	No change

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Feature	N1	N1
	Cleared in K182075	Subject Device
Non-invasiveblood pressure(NIBP)	The N1 uses the oscillometric method for measuring non-invasive bloodpressure (NIBP).Measurement range:Systolic: 25~~290mmHg (Adult), 25~~240mmHg (Pediatric),25~~140mmHg (Neonate);Diastolic: 10~~250mmHg (Adult), 10~~200mmHg (Pediatric),10~~115mmHg (Neonate);Mean: 15~~260mmHg (Adult), 15~~215mmHg (Pediatric), 15~~125mmHg(Neonate);PR:30~~300bpm.Accuracy:Max mean error: $\pm$ 5mmHg; Max standard deviation: 8mmHg;PR: $\pm$ 3 bpm or $\pm$ 3%, whichever is greater.This measurement can be used for adults, pediatrics, and neonates.	No change
Invasive bloodpressure (IBP)	The monitor can monitor up to 2 invasive blood pressures and displaysthe systolic, diastolic, and mean pressures and a waveform for eachpressure.The IBP supports Pulse Pressure Variation (PPV) and Pulmonary ArteryWedge Pressure (PAWP) function.Measurement range: -50~300mmHg.Accuracy: $\pm$ 2% or $\pm$ 1mmHg, whichever is greater (without sensor).This measurement can be used for adults, pediatrics and neonates exceptthat PAWP is not for neonates.	No change
Feature	N1Cleared in K182075	N1Subject Device
Carbon dioxide(CO2)	CO2 can be measured using a built-in Sidestream CO2 2.0 module, or itcan also connect to an external Sidestream CO2 2.0 module (when usedwith a rack). Alternatively, third-party CO2 modules, Microstreammodule and Mainstream module, can be used.Type: Sidestream CO2 moduleMeasurement range:CO2 :0~~150mmHg, awRR: 0~~150rpm.Accuracy:CO2: Full accuracy mode: 0~~40 mmHg: $\pm$ 2mmHg, 41~~76 mmHg: $\pm$ 5%of reading, 77~~99 mmHg: $\pm$ 10% of reading, 100~~150mmHg: $\pm$ (3mmHg+ 8% of reading), ISO accuracy mode: Add $\pm$ 2mmHg to the full accuracymodeawRR: <60rpm, $\pm$ 1rpm, 60~~150rpm, $\pm$ 2rpm.Type: Microstream CO2 moduleMeasurement range:CO2 :0~~99mmHg, awRR: 0~~150rpm.Accuracy:CO2: 0~~38mmHg: $\pm$ 2mmHg; 39~~99mmHg: $\pm$ 5% of the reading+0.08%of (the reading-38).awRR: 0~~70rpm: $\pm$ 1rpm, 71~~120rpm: $\pm$ 2rpm, 121~~150rpm: $\pm$ 3rpm.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 thereading;awRR: $\pm$ 1rpm.CO2 monitoring is based on calculations that come from measuring theabsorption of infrared (IR) light of specific wavelengths using aphotodetectorThis measurement can be used for adults, pediatrics and neonates.	No change
Feature	N1	N1
	Cleared in K182075	Subject Device
Oxygen (O2)	Oxygen values are measured by the Sidestream CO2 (only for externalSidestream CO2 2.0 module) module using a paramagnetic method.Measurement range: O2: 0~~100%Accuracy: 0~~25%, ±1%; 26~~80%, ±2%; 81~~100%, ±3%.This measurement can be used for adults, pediatrics and neonates.	No change
Dock, Rack andTransport Dock	The Dock is used to connect either the N1 without a Rack or the N1docked inside a Rack, in order to extend ports such as USB, VGA, orwired network.The Rack can connect an external parameter module, such as CO2, toN1.The Transport Dock is used to provide DC voltage to N1 when N1 isused for out-of-hospital transportation on the ambulance vehicle oraircraft. The Transport Dock is fixed on the ambulance vehicle or aircraftand converts an AC input to DC output.	No change
Wireless radiomodule	The Wireless radio module is used for connecting to a wirelessmonitoring network with a central monitoring system (CMS).	No change
Helicopter andambulancetransport	ECG, RESP, Temp, SpO2, PR, NIBP, and IBP can be monitored inhelicopters and ambulances.	No change
Early WarningScore (EWS)	The EWS is a set of early warning scores that are intended to assistclinicians in recognizing the early signs of deterioration in patients basedon vital signs and clinical observations. The three types of EWS providedare Modified Early Warning Score (MEWS), National Early WarningScore (NEWS) and a user configurable Custom Score.	The EWS is a set of early warning scores that areintended to assist clinicians in recognizing the earlysigns of deterioration in patients based on vital signs andclinical observations. The three types of EWS providedare Modified Early Warning Score (MEWS), NationalEarly Warning Score (NEWS), National EarlyWarning Score2 (NEWS2), and a user configurableCustom Score.
Glasgow ComaScale (GCS)	The GCS is a well-established scoring system used to assess the state ofconsciousness based three sub-components: eye-opening response, verbalresponse, and limb movement.	No change
Feature	N1	N1
	Cleared in K182075	Subject Device
Cardio-pulmonaryresuscitation(CPR) Dashboard	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 startcondition, rescue end condition).	No change
OxyCRGFunction	Support the function of oxygen cardio-respirogram (OxyCRG) when thepatient type is neonate, and simultaneously provide real-time OxyCRGinterface and OxyCRG review interface to display parameter trends andwaveforms	Support the function of oxygen cardio-respirogram(OxyCRG) when the patient type is neonate, andsimultaneously provide real-time OxyCRG interfaceand OxyCRG review interface to display parametertrends and waveforms, and OxyCRG events.
Security ofPatientInformation	Support Mindray proprietary encryption algorithm (XOR algorithm)	Support AES128 encryption algorithm
Accessories	The accessories including ECG, SpO2, Temp, NIBP, IBP, C.O., ScvO2,ICG, CO2, AG, RM, EEG, BIS, NMT, rSO2, CCO/SvO2 accessories.	Add new ECG, Temp, C.O., and IBP accessories

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

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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:

. ANSVAAMI 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 62133-2:2017 Secondary cell and batteries containing alkaline or other non-acid electrolytes - safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: lithium systems.

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

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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 60601-2-26:2012 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

CONCLUSION 9.

Based on the detailed comparison of specifications for each of the modifications to the previously cleared BeneVision N Series Patient Monitors (K182075), 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.

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.