Predicate Devices

Reference Devices

K161531, K131414, K180881, K210906, K193391, K182979

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms in the device description, intended use, or performance studies. The focus is on standard physiological parameter monitoring and analysis.

Therapeutic

No.
The device is described as a patient monitor intended for "monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters." It does not directly treat or diagnose a condition.

Diagnostic

Yes

Explanation: The device is intended for "monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters" and provides "interpretation of resting 12-lead ECG," which are functions of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the BeneVision N Series Patient Monitors provide a "flexible software and hardware platform" and lists multiple physical monitor models (N12, N15, N17, N19, N22, N1). The summary also details testing against hardware-related standards like IEC 60601-1 and includes parameters that require physical sensors and hardware for measurement (ECG, SpO2, NIBP, etc.).

IVD (In Vitro Diagnostic)

Based on the provided text, the BeneVision N Series Patient Monitors are not IVD (In Vitro Diagnostic) devices.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Function: The BeneVision N Series Patient Monitors directly monitor physiological parameters from the patient's body (ECG, SpO2, NIBP, etc.). They do not analyze samples taken from the patient.
Intended Use: The intended use describes monitoring, displaying, storing, alarming, and transferring physiological parameters. This aligns with patient monitoring, not in vitro testing.

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

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, 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.

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.

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

MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

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:

BIS, RM, CCO, SvO2/ScvO2, PAWP, NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only. CCO using FloTrac is intended for adult patients only;
C.O. monitoring and A-Fib are 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:

PAWP, PNP, and PNC are intended for adult and pediatric patients only;
A-Fib is intended for adult patients only;

Intended User / Care Setting

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 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment, whereas N1 configured with WMTS technology can be used inside the hospital only. 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.

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

Not Found

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

Not Found

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

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.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K202405

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Philips InterlliVue MX600, MX800 patient monitors (K161531), GE Carescape B850 patient monitor (K131414), Edwards HemoSphere Advanced Monitor (K180881), Philips InterlliVue MX850 patient monitors (K210906), Mindray BeneVision central monitoring system (K193391), Philips InterlliVue MX series patient monitors (K182979)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

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

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Summary

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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 12, 2022

Shenzhen Mindray Bio-medical Electronics Co., Ltd. Li Lei Manager Regulatory Affairs Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China

Re: K213799

Trade/Device Name: N Series Patient Monitors 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: June 9, 2022 Received: June 10, 2022

Dear Li Lei:

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.

1

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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 Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K213799

Device Name

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

Indications for Use (Describe)

The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, 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:

· BIS, RM, CCO, SvO2/ScvO2, PAWP, NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only. CCO using FloTrac is intended for adult patients only;
· C.O. monitoring and A-Fib are 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.

(Continue on next page N1 indications for use)

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

☒ 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): Indications for Use (con't)

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:

PAWP, PNP, and PNC are intended for adult and pediatric patients only;
A-Fib is intended for adult 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, whereas N1 configured with WMTS technology can be used inside the hospital only. 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.

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

SUBMITTER 1.

| Applicant: | SHENZHEN MINDRAY BIO-MEDICAL
ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
Shenzhen 518057, P.R. China
Tel: +86 755 81888998
Fax: +86 755 26582680 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Contact Person: Li Lei
Title: Manager Regulatory Affairs
Phone: +86 755 81885953
Fax: +86 755 26582680
E-mail: lilei.js@mindray.com |
| Date Prepared: | December 2, 2021 |
| 2.
DEVICE | |
| Device Trade Name: | BeneVision N Series Patient Monitors (Including
BeneVision N12, BeneVision N15, BeneVision N17,
BeneVision N19, BeneVision N22, BeneVision N1) |
| Device Common Name: | Patient Monitor |
| Classification Name: | 21 CFR 870.1025, Class II, Arrhythmia detector and
alarm (including ST-segment measurement and alarm) |
| Regulatory Class: | Class II |
| Primary Product Code: | MHX - Monitor, Physiological, Patient (with
arrhythmia detection or alarms) |
| Panel: | Cardiovascular |

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

Table 1: Secondary Product Codes

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PREDICATE DEVICES 3.

Predicate: K202405 BeneVision N Series Patient Monitors (Including BeneVision N12, . BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1)

4. REFERENCE DEVICES

Philips InterlliVue MX600, MX800 patient monitors (K161531): provided as reference devices for SVT and SVCs/min High, Artifact flag of ABP shields alarms function, and combined alarm function.
. GE Carescape B850 patient monitor (K131414) is provided as reference device for SVT and SVCs/min High and SVCs/min value.
. Edwards HemoSphere Advanced Monitor (K180881) is provided as reference device for the Flotrac CCO cable.
. Philips InterlliVue MX850 patient monitors (K210906) are provided as reference devices for the aEEG module.
Mindray BeneVision central monitoring system (K193391, including TM70 telemetry ● system) is provided as reference device for the WMTS module of TM70.
Philips InterlliVue MX series patient monitors (K182979) are provided as reference ● devices for the Alarm Threshold.

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DEVICE DESCRIPTION 5.

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.

INTENDED USE/INDICATIONS FOR USE 6.

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

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

BIS, RM, CCO, SvO2/ScvO2, PAWP, NMT monitoring, PNP, and PNC are intended ● for adult and pediatric patients only. CCO using FloTrac is intended for adult patients only:
C.O. monitoring and A-Fib are 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.

8

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, OT 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:

PAWP, PNP, and PNC are intended for adult and pediatric patients only;
A-Fib is intended for adult 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, whereas N1 configured with WMTS technology can be used inside the hospital only. 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 BeneVision N12/N15/N17/N19/N22 has been modified to include support for CCO using FloTrac in adult patients. Although this feature is not present in the primary predicate devices, it is present in HemoSphere Advanced Monitor (K180881, including Pressure Cable).

The indications for use statement of the subject BeneVision N1 has been modified to include WMTS technology for use inside the hospital only.

In conclusion, the minor difference in the indications for use statements do 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, K202405). The features in grey are features which are different between the predicate devices and the subject devices.

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

Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
	Cleared in K202405				Subject Device
Primary display and
touchscreen	22"
1680*1050
pixels.	19"
1680*1050
pixels.	18.5"
1920*1080
pixels.	15.6"
1920*1080
pixels.	12.1"
1280*800
pixels.	No change	No change	No change	No change	No change
Secondary display	Independent control and
display.		Independent
control and
display.
Size: 21.5"
Model:
ET2203LM.	Mirrored display.
Size: 21.5"
Model: ET2203LM.		No change	No change	No change	No change	No change
iView	iView is an isolated PC platform that
allows the user to run 3rd party
applications using a limited set of
functions. The iView system is not
intended to be used as a primary alarm
device.
Capacity of RAM: 8GB
Model of CPU: N4200
Windows 10			Not supported.		No change			No change
Wireless radio module	The 2.4G/5G module for connecting to a network wirelessly,
constructing a monitoring network with a central monitoring system
(CMS).					No change
Module rack	Must be connected to the
main unit to provide up
to 8 standard module
slots.		Optional for the patient
monitor, adding 8 standard
module slots to extend the
measurement capabilities of
the system.			Not
supported.	No change
Power supply	One rechargeable Lithium-ion battery or AC power supply.					No change
Battery	Chargeable Lithium-Ion,
10.8 VDC, 5600 mAh.		Chargeable Lithium-Ion, 10.95 VDC,
4500 mAh.			No change				No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
	Cleared in K202405					Subject Device
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 in 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.			Provides audible alarm tones (45 to 85 dB), key tones,
QRS tones; support PITCH TONE and multi-level
tone modulation.

Replace the manufacturer of the speaker. | | | | | | |
| Main control board | CPU module: E3827
DDR3 capacity: 2GB | | CPU module: AM3358
DDR3 capacity: 1GB | | | CPU module: E3845
DD3 capacity: 4 GB
Modifications for
main control board.
Refer to | | | | | No change | |
| Alarm system | Supports alarm volume escalation. The alarm lamp will light cyan,
yellow, or red depending on alarm type. | | | | | Supports alarm volume escalation. The alarm lamp
will light cyan, yellow, or red depending on alarm
type.
Support combined alarm monitoring, optimized
auditory ALARM SIGNALS, Adjustment of
Default Alarm Threshold, alarm highlight.
Combined alarm monitoring. * Optimized auditory ALARM SIGNALS. * Adjustment of Default Alarm
Threshold. * Alarm highlight. | | | | | | |
| Support T1/N1 as a
Module | | Support T1/N1 acting as a module. | | | | No change | | | | | | |
| Connect with Mindray
telemetry monitors | | | Connect with the TM80/TM70 and the BP10 NIBP module to receive
ECG, SpO2, RESP, and NIBP waveforms and parameters. | | | No change | | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | | |
| | Cleared in K202405 | | | | | Subject Device | | | | | | |
| ECG | 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: supports Mindray Algorithm. MPM 2.0: support Mindray or Mortara algorithm Supports intelligent arrhythmia alarms
HR 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: 200800ms; Accuracy: ±30ms.
This measurement can be used for adults, pediatrics, and neonates,
except that:
The arrhythmia detection and ST segment analysis of
Mortara algorithm in MPM2.0 is intended for adult and pediatric
patients only; The arrhythmia detection of Mindray algorithm
inMPM2.0 is intended for adult and pediatric patients only; The ST Segment analysis of Mindray algorithm in
MPM2.0 is intended for adult patients only. | | | | | 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: supports Mindray Algorithm. MPM 2.0: support Mindray or Mortara algorithm Supports intelligent arrhythmia alarms
HR Measurement range: 15350 bpm (neonate,
pediatric), 15300 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: 200800ms; Accuracy:
±30ms.
Adjustment of QT calculation.
Support SVT and SVCs/min high arrhythmia
alarm.
Support SVCs/min Value
adult mode: 0300 pediatric and neonate mode: 0~350 Support Multi-lead ECG synchronization analysis. | | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | | |
| | | | Cleared in K202405 | | | | | 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: $\pm$ 2 rpm or $\pm$ 2%, whichever is greater;
0 to 6 rpm: Not specified.
This measurement can be used for adults, pediatrics and neonates. | | | This measurement can be used for adults, pediatrics, and neonates, except that:

The arrhythmia detection and ST segment analysis of Mortara algorithm in MPM2.0 is intended for adult and pediatric patients only;
The arrhythmia detection of Mindray algorithm in MPM2.0 is intended for adult and pediatric patients only;
The ST Segment analysis of Mindray algorithm in MPM2.0 is intended for adult patients only. | | | | | | |
| 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: $\pm$ 0.1°C or $\pm$ 0.2°F (without probe).
This measurement can be used for adults, pediatrics and neonates. | | | No change | | | | | | |
| Pulse oxygen
saturation (SpO2) | | | Uses the MPM (Multi Parameter Module) 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 module
Measurement range: 0100% Accuracy: 70%100%: $\pm$ 2% ABS(Adult/pediatric); 70%~~100%: $\pm$ 3% ABS (neonate); 0~~69%: not specified.
Masimo SpO2 module
Measurement range: 1100 % Accuracy: without motion | | | No change | | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | | |
| | Cleared in K202405 | | | | | Subject Device | | | | | | |
| | 70%100%: ±2% ABS (Adult/pediatric), 70%100%: ±3% ABS
(neonate), 169%: not specified; With motion 70%100%: ±3% ABS,
169%: not specified.
Nellcor SpO2 module
Measurement range: 0100 %, 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. | | | | | | | | | | | |
| Pulse rate (PR) | Pulse rate may be obtained from all sources of SpO2, or the IBP module.
Measurement range: 20254 bpm (Mindry SpO2), 25240 bpm
(Masimo SpO2), 20~~300 bpm (Nellcor SpO2), 25~~350 bpm (IBP).
Accuracy: ±3 bpm (Mindray SpO2), ±3 bpm without motion, ±5 bpm
with motion (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-invasive blood
pressure (NIBP) | Uses the MPM (Multi Parameter Module) to measure NIBP. The
MPM uses the oscillometric method for measuring non-invasive blood
pressure (NIBP).
Measurement range:
Systolic: 25~~290 mmHg (Adult), 25~~240 mmHg (Pediatric), 25140 mmHg (Neonate).
Diastolic: 10250 mmHg (Adult), 10~~200 mmHg (Pediatric), 10~~115 mmHg (Neonate).
Mean: 15~~260 mmHg (Adult), 15~~215 mmHg (Pediatric), 15125 mmHg (Neonate).
PR:30300bpm.
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 K202405 | | | | | 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: -50300mmHg,
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. | | | | | Uses the MPM (Multi Parameter Module) 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. Support Pulse Pressure Variation (PPV) and Pulmonary Artery Wedge Pressure (PAWP) function.
Measurement range: -50300mmHg,
Accuracy of module: ±2% or ±1mmHg, whichever is greater
This measurement can be used for adults, pediatrics and neonates except that PAWP is not for neonates.

The Artifact flag of Arterial Blood Pressure (ABP) shields alarms Monitoring Support | | | | | | |
| 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.: 0.120 L/min.
TB: 2343°C, TI: 027°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) / HemoSphere monitor (cleared in K163381) which measures continuous cardiac output (CCO).
This measurement can be used for adults and pediatrics. | | | | | No change | | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | | |
| | | | Cleared in K202405 | | | Subject Device | | | | | | |
| Continuous cardiac
output (FloTrac) | Not supported | | | | | Add Continuous cardiac output (FloTrac)
parameter.
FloTrac measures a patient's hemodynamic status
using a mini-invasive method based on pulse wave
analysis technology.
Measurement range:
CCO: 1.0-20.0L/min; Reproducibility: ±6% or 0.1
L/min, whichever is greater.
Resolution ratio: 0.1 L/min
CCI: 0.0-20.0 L/min/m2
SV: 0-300 mL
SVI: 0-200 mL/m2
SVR: 0-5000 DS/cm5
SVRI: 0-9950 DS-m2/cm5
SVV: 0-99%
PPV: 0-99%
PR:0220bpm, Arms ≤3bpm
Live pressure display range : -34 to 312 mmHg
MAP/DIA/SYS display range: 0-300 mmHg
Accuracy: ±4% or ±4 mmHg, whichever is
greater, in the range of -30 mmHg to 300 mmHg
This measurement is only indicated for adults. | | | | | | |
| Mixed/central venous
oxygen saturation
(SvO2/ScvO2) | | | 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 mixed venous oxygen
saturation (SvO2) and central venous oxygen saturation (ScvO2).
This measurement can be used for adults and pediatrics. | | | No change | | | | | | |
| Central venous oxygen
saturation (ScvO2) | | | Central venous oxygen saturation (ScvO2) is measured using
spectrophotometry.
Measurement range: 0 to 99%
Accuracy: 50% to 80%: ±3%, Other ranges: Not specified.
This measurement can be used for adults and pediatrics. | | | No change | | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | | |
| | Cleared in K202405 | | | | | 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 and Mainstream module.
Type: Sidestream CO2 module.
Measurement range: CO2: 0~~150mmHg, awRR: 0~~150rpm.
Accuracy: CO2: Full accuracy mode: 0~~40 mmHg: ±2mmHg, 41~~76 mmHg: ±5% of reading, 77~~99 mmHg: ±10% of reading, 100~~150mmHg: ±(3mmHg + 8% of reading),
ISO accuracy mode: Add ±2mmHg to the full accuracy mode.
awRR: 5%REL, not specified;
SEV: 0~~1%REL: ±0.15% ABS, 1~~5%REL: ±0.2% ABS, 58%REL: ±0.4% ABS, >8%REL, not specified;
DES : 01% 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:260rpm, ±1rpm, >60rpm, not specified
This measurement can be used for adults, pediatrics and neonates. | | | | | 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:
HAL, ENF, ISO, SEV, DES: 030 %,
N2O: 0100 %;
awRR: 2100 rpm
Accuracy:
Full accuracy mode:
N2O: 0~~20%REL: ±2% ABS, 20~~100%REL: ±3% ABS;
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,
58%REL: ±0.4% ABS, >8%REL, not specified;
DES: 01%REL: ±0.15% ABS, 15%REL: ±0.2% ABS,
510%REL: ±0.4% ABS, 1015%REL: ±0.6% ABS
,1518%REL: ±1% ABS ,>18%REL, not specified;
awRR:2~60rpm, ±1rpm, >60rpm, not specified
This measurement can be used for adults, pediatrics and neonates.
Internal electronic component changes for the AG module. | | | | | |
| Impedance cardiograph (ICG) | | | ICG measures a patient's hemodynamic status using a non-invasive method based on thoracic electrical bioimpedance (TEB) technology. | | | No change | | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | | |
| | Cleared in K202405 | | | | | Subject Device | | | | | | |
| | Measurement range:
C.O.:1.415L/min;
SV:5250ml;
HR: 44185bpm.
Accuracy: HR: ±2bpm; other parameter: not specified.
This measurement can be used for adults. | | | | | | | | | | | |
| Bispectral index (BIS) | The BIS Module monitors the state of the brain by data acquisition of EEG signals. Bispectral index (BIS) is a processed EEG variable that can be used as an aid in monitoring the effects of certain anesthetic agents.
Measurement range: BIS, BIS L, BIS R: 0100.
Accuracy: not specified.
This measurement can be used for adults and pediatrics. | | | | | No change | | | | | | |
| Respiration mechanics (RM) | | | The RM module measures respiration mechanics for adult and pediatric patients.

Measurement range:
FLOW:
Adult/Pediatric: ±(2120)L/min;
Infant: ± (0.5 to 30) L/min
PAW:-20120 cmH2O;
MVe/MVi:
Adult/Pediatric: 260L/min;
Infant: 0.5 to 15 L/min
TVe/TVi:
Adult/Pediatric: 1001500ml;
Infant: 0.5 to 15 L/min
Calculated Parameters:
awRR:4120rpm;
I:E:4:11:8; | Accuracy:
FLOW:
Adult/Pediatric: 1.2L/min or ±10% of reading, whichever is greater;
Infant: 0.5 L/min or ±10% of the reading, whichever is greater
PAW: ±3% of reading;
MVe/MVi: ±10% of reading;
TVe/TVi:
Adult/Pediatric: ±15ml or ±10% of reading, whichever is greater;
Infant: ±6 ml or | | No change | | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | | |
| | | | Cleared in K202405 | | | | | Subject Device | | | | |
| | Pmean:0120 cmH2O;
PEEP:0120 cmH2O;
PEF:2120L/min;
PIF:2120L/min;
PIP: 0120 cmH2O;
Pplat:0120 cmH2O;
Compl: 0200ml/ cmH2O;
RSBI:04095rpm/L; | | | ±10%×reading,
whichever is greater
Calculated Parameters:
awRR:499rpm: ±1rpm,
100120rpm, ±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; | | | | | | | | |
| Neuromuscular
transmission
monitoring (NMT) | | NMT evaluates muscle relaxation of patients under a neuromuscular
block by measuring the strength of muscle reaction after electrically
stimulating the dedicated motor nerve.
Measurement range:
ST-Ratio:0 ~ 200%;
TOF-Count: 04;
TOF-Ratio: 5%160%;
TOF-T1%:0200%;
PTC-Count:020;
DBS-Count:0~2;
DBS-Ratio:5%160%
This measurement can be used for adults and pediatrics. | | | | No change | | | | | | |
| Electroencephalograph
(EEG) | The EEG module measures the spontaneous, rhythmic electrical
activity of the cortex. The EEG module can continuously monitor
EEG signals from up to 4 channels. It can also display Density
Spectral Arrays (DSA) and Compressed Spectral Arrays (CSA). | | | | | | The EEG module and EEG-1 module measure the
spontaneous, rhythmic electrical activity of the cortex.
The EEG module can continuously monitor EEG
signals from up to 4 channels. It can also display | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | | |
| | Cleared in K202405 | | | | | Subject Device | | | | | | |
| | Frequency response: 0.5Hz50Hz(-3dB)
Input range: 4mVpp
DC offset: ±500 mV
CMRR: ≥100 dB@51 kΩ and 60Hz
Noise level: ≤0.5 uVrms (1Hz to 30 Hz
Differential input resistance: >15MΩ@10Hz
Electrode resistance: 0 to 90 KΩ, resolution: ±1 KΩ or 10%,
whichever is the greater
This measurement is intended to be used for adults, pediatrics and
neonates. | | | | | | Density Spectral Arrays (DSA) and Compressed Spectral Arrays (CSA). The aEEG module measures the electrical activity of the cortex to monitor the function of cerebral. The aEEG module can continuously monitor EEG signals from up to 4 channels.
N Series patient monitors are compatible with the following 3 types of modules to measure EEG:
EEG module:
Frequency response: 0.5Hz ~ 50 Hz (-3 dB)
Input range: 4 mVpp
DC offset: ±500 mV
CMRR: ≥ 100 dB @ 51 KΩ and 60 Hz
Noise level: ≤ 0.5 uV rms (1Hz to 30 Hz)
Differential input resistance: > 15 MΩ @ 10 Hz
Electrode resistance: 0 to 90 KΩ, resolution: ±1 KΩ or 10%, whichever is the greater
This measurement is intended to be used for adults, pediatrics, and neonates.
EEG-1 module:
Frequency response: 0.5Hz ~ 50 Hz (-3 dB)
Input range: 4 mVpp
DC offset: ±500 mV
CMRR: ≥ 100 dB @ 51 KΩ and 60 Hz
Noise level: ≤ 0.5 uV rms (1Hz to 30 Hz)
Differential input resistance: > 15 MΩ @ 10 Hz
Electrode resistance: 0 to 90 KΩ, resolution: ±1 KΩ or 10%, whichever is the greater
This measurement is intended to be used for adults, pediatrics, and neonates. | | | | | |

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Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
			Cleared in K202405			Subject Device
						aEEG module:
Frequency response: 0.5Hz ~ 50 Hz (-3 dB)
Input range: 4 mVpp
DC offset: ±500 mV
CMRR: ≥ 100 dB @ 51 kΩ and 60 Hz
Noise level: ≤ 0.5 uV rms (1Hz to 30 Hz)
Differential input resistance: > 15 MΩ @ 10 Hz
Electrode resistance: 0 to 90 kΩ, resolution: ±1 kΩ
or 10%, whichever is the greater.
This measurement is intended to be used for
adults, pediatrics, and neonates.
Added EEG-1 module.
Added aEEG module.
Regional oxygen
saturation (rSO2)		The rSO2 module provides noninvasive and continuous information
of changes in regional oxygen saturation of blood. The measurement
takes place in real time, providing an immediate indication of a
change in the critical balance of regional oxygen delivery and oxygen
consumption.		Measurement range: rSO2: 15~95.	This measurement can be used for adults, pediatrics and neonates.	No change
Device integration		Support BeneLink Module to connect Anesthesia, Ventilator, Pump,
TcGas Monitor Device, and Single Paramer Device.				No change
A-Fib overview		Not supported				* The A-Fib overview function only collects atrial
fibrillation, atrial fibrillation with rapid
ventricular rate, atrial fibrillation with R-R long
interval and other related events, and the A-Fib
overview screen displays the A-Fib specifications.
Accessories		The accessories including ECG, SpO2, Temp, NIBP, IBP, C.O.,
ScvO2, ICG, BIS, CO2, AG, RM, EEG, BIS, NMT, rSO2				* Add new EEG cable
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
	Cleared in K202405					Subject Device
	CCO/SvO2 accessories.

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Table 3: Device Comparison Table – BeneVision N1

Feature	N1	N1
Cleared in K202405	Subject Device
Primary display
and touchscreen	5.5", 720*1280 pixels.	No change
External display	Allows the display of mirrored or independent data when
connected to an external 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 7.2VDC, 2500mAh.	No change
Data storage	Embedded Multi Media Card (eMMC)	No change
Speaker	Gives 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.	Supports alarm volume escalation. The alarm lamp will light cyan,
yellow, or red depending on alarm type.
Support combined alarm monitoring, optimized auditory alarm
signals, Adjustment of Default Alarm Threshold, alarm highlight.
Combined alarm monitoring.

Optimized auditory alarm signals.
Adjustment of Default Alarm Threshold.
Alarm highlight. |
| Feature | N1 | N1 |
| | Cleared in K202405 | Subject Device |
| Communication
on Interface when
N1 is working as
a module | Infrared communication interface.
Pogo pin communication interface. | No change |
| ECG | 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)
Supports intelligent arrhythmia alarm.
Measurement range:
ST: -2.0mV~+2.0mV;
QT: 200800ms;
HR: 15350bpm (neonate, pediatric), 15300bpm (adult).
Accuracy:
ST: -0.8mV+0.8mV, ±0.02mV or ±10%, whichever is greater,
other range: not specified;
QT: ±30ms;
HR: ±1 bpm or ±1%, whichever is greater.
This measurement can be used for adults, pediatrics and
neonates. | 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)
Supports intelligent arrhythmia alarm.
Measurement range:
ST: -2.0mV~+2.0mV;
QT: 200800ms;
HR: 15350bpm (neonate, pediatric), 15300bpm(adult).
Accuracy:
ST: -0.8mV+0.8mV, ±0.02mV or ±10%, whichever is greater,
other range: not specified;
QT: ±30ms;
HR: ±1 bpm or ±1%, whichever is greater.
Adjustment of QT calculation.
Support SVT, SVCs/min high arrhythmia alarm.
Support SVCs/min Value
• adult mode :0300
• pediatric and neonate mode:0350
Support Multi-lead ECG synchronization analysis. |
| Feature | N1 | N1 |
| | Cleared in K202405 | 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) | Measures 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 oxygen
saturation (SpO2) | Integrates one of the 3 kinds of SpO2 modules:
Mindray SpO2 module board
Measurement range: SpO2:0100 %,
Accuracy: 70%100%: ±2% ABS(Adult/pediatric); 70%100%:
±3% ABS (neonate); 069%: not specified.
Measurement range: 1100 %,
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 module board
Measurement range: SpO2:0100 %,
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 |
| Feature | N1 | N1 |
| | Cleared in K202405 | Subject Device |
| Pulse rate (PR) | Obtains pulse rate from SpO2 or IBP.
Measurement range: 20254 bpm (Mindray SpO2), 25240 bpm (Masimo SpO2), 20~~300 bpm (Nellcor SpO2), 25~~350 bpm (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 |
| Non-invasive blood pressure (NIBP) | The N1 uses the oscillometric method for measuring non-invasive blood pressure (NIBP). This measurement can be used for adults, pediatrics, and neonates.
Measurement range:
Systolic: 25~~290mmHg (Adult), 25~~240mmHg (Pediatric), 25140mmHg (Neonate);
Diastolic: 10250mmHg (Adult), 10~~200mmHg (Pediatric), 10~~115mmHg (Neonate);
Mean: 15~~260mmHg (Adult), 15~~215mmHg (Pediatric), 15125mmHg (Neonate);
PR:30300bpm.
Accuracy:
Max mean error: ±5mmHg; Max standard deviation: 8mmHg;
PR: ±3 bpm or ±3%, whichever is greater. | No change |

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Feature	N1	N1
	Cleared in K202405	Subject Device
Invasive blood
pressure (IBP)	The monitor can monitor up to 2 invasive blood pressures and
displays the systolic, diastolic, and mean pressures and a
waveform for each pressure.

The IBP supports Pulse Pressure Variation (PPV) and Pulmonary
Artery Wedge Pressure (PAWP) function.

Measurement range: -50~300mmHg.

Accuracy: $±2%$ or $±1mmHg$ , whichever is greater (without
sensor).

This measurement can be used for adults, pediatrics and neonates
except that PAWP is not for neonates. | The monitor can monitor up to 4 invasive blood pressures and
displays the systolic, diastolic, and mean pressures and a waveform
for each pressure.

The IBP supports Pulse Pressure Variation (PPV) and Pulmonary
Artery Wedge Pressure (PAWP) function.

Measurement range: -50~300mmHg.

Accuracy: $±2%$ or $±1mmHg$ , whichever is greater (without sensor).

This measurement can be used for adults, pediatrics and neonates
except that PAWP is not for neonates.

The Artifact flag of Arterial Blood Pressure (ABP) shields
alarms Monitoring Support. |
| Feature | N1 | N1 |
| | Cleared in K202405 | Subject Device |
| Carbon dioxide
(CO2) | CO2 can be measured using a built-in Sidestream CO2 2.0
module, or it can also connect to an external Sidestream CO2 2.0
module (when used with a rack). Alternatively, third-party CO2
modules, Microstream module and Mainstream module, can be
used.
Type: Sidestream CO2 module
Measurement range:
CO2 :0~~150mmHg, awRR: 0~~150rpm.
Accuracy:
CO2: Full accuracy mode: 0~~40 mmHg: ±2mmHg, 41~~76
mmHg: ±5% of reading, 7799 mmHg: ±10% of reading,
100150mmHg: ±(3mmHg + 8% of reading), ISO accuracy
mode: Add ±2mmHg to the full accuracy mode
awRR: