BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1

K202405 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX · Jan 7, 2021 · Cardiovascular

Device Facts

• Record ID: K202405
• Device Name: BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: MHX · Cardiovascular
• Decision Date: Jan 7, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BeneVision N12/N15/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. 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.

Device Story

Multiparameter patient monitors (N1, N12, N15, N17, N19, N22) collect physiological signals via sensors (ECG leads, SpO2 probes, NIBP cuffs, IBP transducers, etc.). Data processed by internal modules (MPM 3.0, etc.) to calculate parameters, detect arrhythmias, and perform ST/QT analysis. Outputs displayed on integrated touchscreens; alarms triggered for abnormal values. Used in clinical settings by trained professionals; N1 supports transport. Provides real-time monitoring, trend analysis, and clinical decision support (EWS, SepsisSight, GCS). Benefits include continuous patient surveillance and early deterioration detection.

Clinical Evidence

Bench testing only. Functional and system-level testing validated performance against specifications and consensus standards (IEC 60601-1, IEC 60601-2-25/27/34, ISO 80601-2-61). Software verification and validation conducted per FDA guidance. No clinical data presented.

Technological Characteristics

Multiparameter monitors with modular architecture. Materials: non-patient contacting. Energy: AC/DC, Li-ion battery. Connectivity: Wi-Fi (MSD45N, SX-SDMAC-2832S+), wired network, pogo pin/infrared (N1). Algorithms: Mindray/Mortara ECG, oscillometric NIBP, infrared CO2, spectrophotometric ScvO2. Standards: ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-25/27/34, ISO 80601-2-61, ANSI IEEE C63.27, AAMI TIR69.

Indications for Use

Indicated for monitoring, displaying, storing, alarming, and transferring physiological parameters (ECG, Resp, Temp, SpO2, PR, NIBP, IBP, PAWP, C.O., CCO, SvO2/ScvO2, CO2, O2, AG, ICG, BIS, RM, NMT, EEG, rSO2) in adult, pediatric, and neonatal patients in healthcare facilities. Specific parameter exclusions apply based on patient age/size (e.g., A-Fib/C.O. for adults only).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BeneVision N Series Patient Monitors (K192972)

Reference Devices

• ePM series Patient Monitors (K200015)
• Edwards Vigilance II monitor (K043103)
• Vigileo monitor (K103094)
• EV1000 monitor (K160552)
• HemoSphere monitor (K163381)
• Masimo SpO2 module (K053269)

Submission Summary (Full Text)

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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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 ([e-mail]) or phone [phone] 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

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# 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)

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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.

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

### 1. SUBMITTER

| Applicant: | SHENZHEN MINDRAY BIO-MEDICAL<br>ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>Shenzhen 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone] |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Contact Person: Yanhong Bai<br>Title: Manager Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | December 08, 2020 |
| 2.<br>DEVICE | |
| Device Trade Name: | BeneVision N Series Patient Monitors (Including<br>BeneVision N12, BeneVision N15, BeneVision N17,<br>BeneVision N19, BeneVision N22, BeneVision N1) |
| Device Common Name: | Patient Monitor |
| Classification Name: | 21 CFR 870.1025, Class II, Arrhythmia detector and<br>alarm (including ST-segment measurement and alarm) |
| Regulatory Class: | Class II |
| Primary Product Code: | MHX - Monitor, Physiological, Patient (with<br>arrhythmia detection or alarms) |
| Panel | Cardiovascular |

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| Regulation<br>Number/Class | Product<br>Code | Regulation description | Device Common Name |
|----------------------------|-----------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------|
| 870.1025, II | DSI | Arrhythmia detector and alarm<br>(including ST-segment measurement<br>and alarm) | Detector and alarm, arrhythmia |
| 870.1025, II | MLD | Arrhythmia detector and alarm<br>(including ST-segment measurement<br>and alarm) | Monitor, st segment with alarm |
| 870.2300, II | DRT | Cardiac Monitor (including<br>cardiotachometer and rate<br>alarm) | Monitor, cardiac (incl.<br>cardiotachometer & rate alarm) |
| 870.1130, II | DXN | Noninvasive blood pressure<br>measurement system | System, measurement, blood-pressure<br>non-invasive |
| 870.1110, II | DSK | Blood pressure computer | Computer, blood-pressure |
| 880.2770, II | DSB | Impedance plethysmograph. | Plethysmograph, impedance |
| 880.2700, II | MUD | Oximeter | Oximeter, tissue saturation |
| 870.2340, II | MLC | Electrocardiograph | Monitor, st segment |
| 870.2370, II | KRC | Electrocardiograph surface electrode<br>tester. | Tester, electrode, surface,<br>electrocardiographic |
| 880.2910, II | FLL | Clinical electronic thermometer | Thermometer, electronic, clinical |
| 870.2700, II | DQA | Oximeter | Oximeter |
| 870.2300, II | MSX | Cardiac monitor (including<br>cardiotachometer and rate alarm). | System, network and communication,<br>physiological monitors |
| 870.2910, II | DRG | Radiofrequency physiological signal<br>transmitter and receiver. | Transmitters and receivers,<br>physiological signal, radiofrequency |
| 868.1400, II | CCK | Carbon dioxide gas analyzer | Analyzer, gas,<br>carbon-dioxide, gaseous-phase |
| 870.1435, II | DXG | Single-function, preprogrammed | Computer, diagnostic, pre- |

Table 1:

| 870.2910, II | DRG | Radiofrequency physiological signal<br>transmitter and receiver. | Transmitters and receivers,<br>physiological signal, radiofrequency |
|--------------|-----|------------------------------------------------------------------|--------------------------------------------------------------------------|
| 868.1400, II | CCK | Carbon dioxide gas analyzer | Analyzer, gas,<br>carbon-dioxide, gaseous-phase |
| 870.1435, II | DXG | Single-function, preprogrammed<br>diagnostic computer | Computer, diagnostic, pre-<br>programmed, single-function |
| 870.1100, II | DSJ | Blood pressure alarm | Alarm, blood-pressure |
| 870.2850, II | DRS | Transducer, blood-pressure,<br>extravascular | Extravascular blood pressure<br>transducer. |
| 868.1500, II | CBQ | Enflurane gas analyzer. | Analyzer, gas, enflurane, gaseous-<br>phase (anesthetic concentration) |
| 868.1500, II | NHO | Enflurane gas analyzer. | Analyzer, gas, desflurane, gaseous-<br>phase (anesthetic concentration) |
| 868.1500, II | NHP | Enflurane gas analyzer. | Analyzer, gas, sevoflurane, gaseous-<br>phase (anesthetic concentration) |
| 868.1500, II | NHQ | Enflurane gas analyzer. | Analyzer, gas, isoflurane, gaseous-<br>phase (anesthetic concentration) |

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| Regulation<br>Number/Class | Product<br>Code | Regulation description | Device Common Name |
|----------------------------|-----------------|-----------------------------------------|-------------------------------------------------------------------|
| 868.1620, II | CBS | Halothane gas analyzer. | Analyzer, gas, halothane, gaseous-<br>phase (anesthetic conc.) |
| 868.1700, II | CBR | Nitrous oxide gas analyzer. | Analyzer, gas, nitrous-oxide, gaseous<br>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<br>electroencephalograph software |
| 882.1400, II | OLT | Electroencephalograph. | Non-normalizing quantitative<br>electroencephalograph software |
| 882.1400, II | OMC | Electroencephalograph. | Reduced-montage standard<br>electroencephalograph |
| 882.1400, II | ORT | Electroencephalograph | Burst suppression detection software<br>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 ●

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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:

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- . 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.

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| Feature | N22 | N19 | N17 | N15 | N12 | N22 | N19 | N17 | N15 | N12 |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|----------------|--------------|-----------|
| | Cleared in K192972 | | | | | Subject Device | | | | |
| Primary display<br>and touchscreen | 22"<br>1680*1050<br>pixels. | 19"<br>1680*1050<br>pixels. | 18.5"<br>1920*1080<br>pixels. | 15.6"<br>1920*1080<br>pixels. | 12.1"<br>1280*800<br>pixels. | No<br>change | No<br>change | No change | No<br>change | No change |
| Secondary<br>display | Independent control and<br>display. | Independent control and<br>display. | Independent<br>control and<br>display.<br>Size: 21.5";<br>Model:2203<br>L. | Mirrored display.<br>Size: 21.5";<br>Model: 2203L. | | No change | No change | No change | No change | No change |
| iView | Change the PC platform<br>Capacity of RAM: 8GB<br>Model of CPU: N4200<br>Windows 10 | | | Not supported. | | No change | No change | No change | No change | No change |
| Wireless radio<br>module | The 2.4G/5G module for connecting to a network wirelessly,<br>constructing a monitoring network with a central monitoring system<br>(CMS).<br>WiFi module: MSD45N | | | | | The 2.4G/5G module for connecting to a network wirelessly,<br>constructing a monitoring network with a central monitoring system<br>(CMS).<br>WiFi module: MSD45N and SX-SDMAC-2832S+ | | | | |
| Module rack | Must be connected to the<br>main unit to provide up to<br>8 standard module slots. | | Optional for the patient<br>monitors, adding 8 standard<br>module slots to extend the<br>measurement capabilities of<br>the system. | Not<br>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,<br>10.8 VDC, 5600 mAh. | Chargeable Lithium-Ion, 10.95 VDC,<br>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<br>(SDD) | | | | Embedded Multi Media Card (eMMC). | No change | | | | |
| Data recorder | Supports the thermal<br>recorder module, needs to<br>be plugged into the SMR. | | Supports the thermal recorder module and<br>the built-in thermal recorder, but they<br>cannot work at the same time. | | | No change | | | | |
| Speaker | Provides audible alarm tones (45 to 85 dB), key tones, QRS tones;<br>support PITCH TONE and multi-level tone modulation. | | | | | No change…