Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or related terms, and the description focuses on standard physiological parameter monitoring.

Therapeutic

No.
The device is a patient monitor intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters, not for treating conditions.

Diagnostic

Yes

Explanation: The device monitors, displays, and interprets various physiological parameters, including the interpretation of resting 12-lead ECG, which is a diagnostic function.

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," indicating the presence of hardware components in addition to software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device function: The BeneVision N Series Patient Monitors are described as devices for "monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters". These parameters are measured directly from the patient's body (e.g., ECG, blood pressure, temperature, SpO2).
No mention of sample analysis: The description does not mention the device analyzing any samples taken from the patient.

Therefore, the BeneVision N Series Patient Monitors are patient monitoring devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

BeneVision N12/N15/N17/N19/N22

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, and NMT monitoring, PNP, and PNC are intended for adult and pediatric 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.

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 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. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

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

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

Device Description

The subject BeneVision N Series Patient Monitors includes six monitors:

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

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

Adult, pediatric, and neonatal patients.
BIS, RM, CCO, SvO2/ScvO2, PAWP, NMT monitoring, PNP, and PNC are intended for adult and pediatric 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.

Intended User / Care Setting

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.

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)

Functional and system level testing was conducted and showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate. Software verification and validation testing was conducted. Electromagnetic Compatibility and Electrical Safety was assessed. Bench testing was conducted to validate the performance and showed that the subject device meets its accuracy specification and is substantially equivalent to the predicate device.

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.

K192972

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.

K200015

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

0

Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized eagle, and the FDA name is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

January 07, 2021

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China

Re: K202405

Trade/Device Name: BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX Dated: December 10, 2020 Received: December 11, 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.

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 (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 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.

for

Jennifer Shih Kozen Assistant Director 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

2

Indications for Use

510(k) Number (if known) K202405

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

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, and NMT monitoring, PNP, and PNC are intended for adult and pediatric 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 for N1 indications for Use)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Number (if known): K202405 Indications for Use (con't)

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 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. 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.

4

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-MEDICAL
ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
Shenzhen 518057, P.R. China
Tel: +86 755 81888998
Fax: +86 755 26582680 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Contact Person: Yanhong Bai
Title: Manager Regulatory Affairs
Phone: +86 755 81885635
Fax: +86 755 26582680
E-mail: baiyanhong@mindray.com |
| Date Prepared: | December 08, 2020 |
| 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 |

5

| 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 | 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- |

Table 1:

| 870.2910, II | DRG | Radiofrequency physiological signal
transmitter 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, preprogrammed
diagnostic 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 pressure
transducer. |
| 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) |

6

| Regulation
Number/Class | Product
Code | Regulation description | Device Common Name |
|----------------------------|-----------------|-----------------------------------------|-------------------------------------------------------------------|
| 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, gaseous
phase (anesthetic conc.) |
| 868.1720, II | CCL | Oxygen gas analyzer. | Analyzer, gas, oxygen, gaseous-phase |
| 868.2775, II | KOI | Electrical peripheral nerve stimulator. | Stimulator, nerve, peripheral, electric |
| 882.1400, II | OLW | Electroencephalograph. | Index-generating
electroencephalograph software |
| 882.1400, II | OLT | Electroencephalograph. | Non-normalizing quantitative
electroencephalograph software |
| 882.1400, II | OMC | Electroencephalograph. | Reduced-montage standard
electroencephalograph |
| 882.1400, II | ORT | Electroencephalograph | Burst suppression detection software
for electroencephalograph |
| 882.1320, II | GXY | Cutaneous electrode. | Electrode, cutaneous |

PREDICATE DEVICES 3.

. Predicate: K192972 – BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1)

REFERENCE DEVICES 4.

K200015 - ePM series Patient Monitors (ePM 10/ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M): provided a provided as reference devices for ECG algorithm supporting arrhythmia detection in neonate that has been added to the subject BeneVision N Series Patient Monitors.

DEVICE DESCRIPTION ನ.

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 ●

7

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

6. INTENDED USE/INDICATIONS FOR USE

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

The BeneVision N12/N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, OT 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;
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.

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:

8

. 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. 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 N1/N12/N15/N17/N19/N22 has been modified to include support for arrhythmia detection in neonates when used with the MPM 3.0 module. Although this feature is not present in the primary predicate devices, it is present in other cleared multiparameter patient monitors such as the Mindray ePM series Patient Monitors (K200015, ePM 10/ePM 12/ePM 15/ePM 10M/ePM 15M). The inclusion of supporting arrhythmia detection in neonates in the indications for use does not constitute a new fundamental intended use.

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, K192972). The features in green are features which are different between the predicate devices and the subject devices.

9

Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
	Cleared in K192972					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.	Independent
control and
display.
Size: 21.5";
Model:2203
L.	Mirrored display.
Size: 21.5";
Model: 2203L.		No change	No change	No change	No change	No change
iView	Change the PC platform
Capacity of RAM: 8GB
Model of CPU: N4200
Windows 10			Not supported.		No change	No change	No change	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).
WiFi module: MSD45N					The 2.4G/5G module for connecting to a network wirelessly,
constructing a monitoring network with a central monitoring system
(CMS).
WiFi module: MSD45N and SX-SDMAC-2832S+
Module rack	Must be connected to the
main unit to provide up to
8 standard module slots.		Optional for the patient
monitors, adding 8 standard
module slots to extend the
measurement capabilities of
the system.	Not
supported.		No change	No change	No change	No change	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	No change	No change	No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
	Cleared in K192972					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 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
Connect with
Mindray
telemetry
monitors	Connect with the TM80 and the BP10 NIBP module to receive ECG,
SpO2, RESP, and NIBP waveforms and parameters.					Connect with the TM80/TM70 and the BP10 NIBP module to receive
ECG, SpO2, RESP, and NIBP waveforms and parameters.
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
			Cleared in K192972					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, and TM80: 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: 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 MPM 2.0 is intended for adult and pediatric patients only; The arrhythmia detection of Mindray algorithm in MPM 2.0 is intended for adult and pediatric patients only; The ST Segment analysis of Mindray algorithm in MPM 2.0 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: 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.
Pace detection enhancement
Expand the PVCs/min range: for adult mode is [0,300], For pediatric and neonate mode is [0,350]
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. Add arrhythmia detection for neonatal patients when used with the MPM 3.0 module.
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
			Cleared in K192972			Subject Device
Respiration rate
(Resp)		Measure the respiration waveforms and respiratory rate through transthoracic 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 oxygen
saturation (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 module
Measurement range: 0~100% Accuracy: 70%~100%: ±2% ABS (Adult/pediatric); 70%~~100%: ±3% ABS (neonate); 0~~69%: not specified.
Masimo SpO2 module
Measurement 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 module
Measurement 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.					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: 0~100% Accuracy: 70%~100%: ±2% ABS(Adult/pediatric); 70%~~100%: ±3% ABS (neonate); 0~~69%: not specified.
Masimo SpO2 module
Replace the Masimo SpO2 module(MS2040) in the MPM3.0 module to Masimo SpO2 module (MSX2040) (cleared in K053269)
Measurement 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.
Receives and displays SIQ waveforms from the Masimo module and allows enabling and disabling FastSat.

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |              |                |              |           |

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

10

Page 7 of 28

11

12

Page 9 of 28

13

Feature	N22	N19
	Cleared in K192972
	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 (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), T1 or N1 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), 25~140 mmHg (Neonate).
Diastolic: 10~~250 mmHg (Adult), 10~~200 mmHg (Pediatric), 10~115 mmHg (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.	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), 25~140 mmHg (Neonate).
Diastolic: 10~~250 mmHg (Adult), 10~~200 mmHg (Pediatric), 10~115 mmHg (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.
NIBP inflation pressure had been optimized for pediatric and neonatal patients.
Invasive blood	Uses the MPM (Multi Parameter Module), T1, N1 or the IBP Module to measure invasive blood pressure. The monitor can monitor up to 8	No change

14

Page 11 of 28

Feature	N22	N17	N12	N22
				Subject Device
pressure (IBP)		Cleared in K192972
	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.
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) / HemoSphere
monitor (cleared in K163381) which measures continuous cardiac output
(CCO).
This measurement can be used for adults and pediatrics.			No change
Mixed/central
venous oxygen
saturation		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			No change

15

Page 12 of 28

Feature	N22	N19	N17	Cleared in K192972		N22	N19	N17	N15	N12
					Subject Device
(SvO2/ScvO2)	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
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, 5~8%REL: ±0.4%
ABS, >8%REL, not specified;
DES : 0~~1%REL: ±0.15% ABS, 1~~5%REL: ±0.2% ABS, 5~10%REL: ±0.4%
ABS, 10~~15%REL: ±0.6% ABS, 15~~18% REL: ±1% ABS,>18%REL, not					No change
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
Cleared in K192972					Subject Device
	specified;
awRR:2~60rpm, ±1rpm, >60rpm, not specified
This measurement can be used for adults, pediatrics and neonates.
Impedance
cardiograph
(ICG)	ICG measures a patient's hemodynamic status using a non-invasive
method based on thoracic electrical bioimpedance (TEB) technology.					No change
	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.
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: 0~100.
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.					No change
	Measurement range:			Accuracy:
Feature	N22	N19	N17	N15	N12	N22	N19	N17	N15	N12
	Cleared in K192972					Subject Device
	FLOW:
Adult/Pediatric: ±(2~120)L/min;
Infant: ± (0.5 to 30) L/min
PAW:-20~120 cmH2O;
MVe/MVi:
Adult/Pediatric: 2~60L/min;
Infant: 0.5 to 15 L/min
TVe/TVi:
Adult/Pediatric: 100~1500ml;
Infant: 0.5 to 15 L/min
Calculated 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 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 ±10%×reading,
whichever is greater
Calculated 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 K192972			Subject Device
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:0200%;
TOF-Count: 04;
TOF-Ratio: 5%160%;
TOF-T1%: 0200%;
PTC-Count:020;
DBS-Count:02;
DBS-Ratio:5%~160%

This measurement can be used for adults and pediatrics. | | | No change | | | | | |
| Electroencephalo
graph (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).

Frequency response: 0.5Hz~50Hz(-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. | | | No change | | | | | |
| 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 | | | No change | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| | | | | | Subject Device | | | | | | |
| | | | Cleared in K192972 | | | | | | | | |
| | | | critical balance of regional oxygen delivery and oxygen consumption. | | | | | | | | |
| | | | Measurement range: rSO2: 15~95. | | | | | | | | |
| | | | This measurement can be used for adults, pediatrics and neonates. | | | | | | | | |
| ECG 24h
Summary | | | | Provides an option to view a summary of a patient's ECG statistics from the previous 24 hours, including HR statistics, ARR event statistics, max and min ST statistics of each lead, QT/QTc measurement statistics, Pacer statistics (for patients being paced), and typical ECG strips. | No change | | | | | | |
| Dynamic
minitrend | | | | The Minitrend window is located to the left of the waveform area and shows the recent trend of a series of parameters. | The Minitrend window is located to the left of the waveform area and shows the recent trend of a series of parameters.

The Minitrend window is modified to enable users to hide, half display, or fully display the window by dragging the handle. | | | | | | |
| Early Warning
Score (EWS) | | | | The EWS is a set of early warning scores that are intended to assist clinicians in recognizing the early signs of deterioration in patients based on vital signs and clinical observations. The three types of EWS provided are Modified Early Warning Score (MEWS), National Early Warning Score (NEWS), National Early Warning Score2 (NEWS2), and a user configurable Custom Score. | The EWS is a set of early warning scores that are intended to assist clinicians in recognizing the early signs of deterioration in patients based on vital signs and clinical observations. The three types of EWS provided are Modified Early Warning Score (MEWS), National Early Warning Score (NEWS), National Early Warning Score2 (NEWS2), and a user configurable Custom Score.

The EWS window is modified to enable users to hide, half display, or fully display the window by dragging the handle. | | | | | | |
| Glasgow Coma
Scale (GCS) | | | | The GCS a well-established scoring system used to assess the state of consciousness based three sub-components: eye-opening response, verbal response, and limb movement. | No change | | | | | | |
| SepsisSight | | | | The SepsisSight feature is intended to help clinicians recognize the early signs and symptoms of Sepsis based on recommendations from the published literature (Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2016 and The Third International Consensus Definition for Sepsis and Septic Shock (Sepsis-3)). | No change | | | | | | |
| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 | |
| | | | Cleared in K192972 | | | | | Subject Device | | | |
| Cardio-
pulmonary
resuscitation
(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 start
condition, rescue end condition). | | | | | No change | | | | | |
| Device
integration | Support BeneLink Module to connect Anesthesia, Ventilator, Pump,
TcGas Monitor Device, and Single Parameter Device.
The types of the devices that can be connected are still only the five
types listed above, but some types added newly approved devices. | | | | | No change | | | | | |
| OxyCRG
Function | Support the function of oxygen cardio-respirogram (OxyCRG) when the
patient type is neonate, and simultaneously provide real-time OxyCRG
interface and OxyCRG review interface to display parameter trends and
waveforms, and OxyCRG events. | | | | | No change | | | | | |
| Accessories | The accessories including ECG, SpO2, Temp, NIBP, IBP, C.O., ScvO2,
ICG, BIS, CO2, AG, RM, EEG, BIS, NMT, rSO2, CCO/SvO2
accessories. | | | | | Add new C.O. accessories | | | | | |

16

Page 13 of 28

17

Page 14 of 28

18

Page 15 of 28

19

Page 16 of 28

20

21

Page 18 of 28

Table 3: Device Comparison Table – BeneVision N1

Feature	N1	N1
	Cleared in K192972	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

22

Feature	N1	N1
	Cleared in K192972	Subject Device
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.	No change
Communication
on Interface when
N1 is working as
a module	Infrared communication interface.
Pogo pin communication interface.	No change
Feature	N1	N1
	Cleared in K192972	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)
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,
other range: not specified;
QT: ±30ms;
HR: ±1 bpm or ±1%, whichever is greater.
This measurement can be used for adults, pediatrics and neonates
except for the arrhythmia detection. The arrhythmia detection is
intended for adult and pediatric 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)
Supports intelligent arrhythmia alarm.
Pace detection enhancement
Expand the PVCs/min range: for adult mode is [0,300], For
pediatric and neonate mode is [0,350]
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,
other range: not specified;
QT: ±30ms;
HR: ±1 bpm or ±1%, whichever is greater.
This measurement can be used for adults, pediatrics and neonates.
Add arrhythmia detection for neonatal patients.
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
Feature	N1	N1
	Cleared in K192972	Subject Device
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: SpO2:0~100 %,
Accuracy: 70%~100%: ±2% ABS (Adult/pediatric); 70%~100%:
±3% ABS (neonate); 0~69%: not specified.
Masimo SpO2 module board
Measurement 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 module board
Measurement 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.	Integrates one of the 3 kinds of SpO2 modules:
Mindray SpO2 module board
Measurement range: SpO2:0~100 %.
Accuracy: 70%~100%: ±2% ABS(Adult/pediatric); 70%~100%:
±3% ABS(neonate); 0~69%: not specified.
Masimo SpO2 module board
Replace the Masimo SpO2 module(MS2040) in the MPM3.0
module to Masimo SpO2 module (MSX2040) (cleared in
K053269)
Measurement 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.
Receives and displays SIQ waveforms from the Masimo module
and allows enabling and disabling FastSat.
Nellcor SpO2 module board
Measurement 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.
Feature	N1	N1
	Cleared in K192972	Subject Device
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
Non-invasive
blood pressure
(NIBP)	The N1 uses the oscillometric method for measuring non-
invasive blood pressure (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: ±5mmHg; Max standard deviation: 8mmHg;
PR: ±3 bpm or ±3%, whichever is greater.
This measurement can be used for adults, pediatrics, and
neonates.	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),
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: ±5mmHg; Max standard deviation: 8mmHg;
PR: ±3 bpm or ±3%, whichever is greater.
NIBP inflation pressure had been optimized for pediatric and
neonatal patients.
Feature	N1	N1
	Cleared in K192972	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.

The monitor added stand-alone IBP module in this 510(k).

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. |
| Feature | N1 | N1 |
| | Cleared in K192972 | 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, 77~~99 mmHg: ±10% of reading, 100~~150mmHg: ±(3mmHg + 8% of reading), ISO accuracy mode: Add ±2mmHg to the full accuracy mode
awRR: