Passport Series Patient Monitors(Passport 12m, Passport 17m)

K170876 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX · Aug 23, 2017 · Cardiovascular

Device Facts

• Record ID: K170876
• Device Name: Passport Series Patient Monitors(Passport 12m, Passport 17m)
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: MHX · Cardiovascular
• Decision Date: Aug 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, alarming, and transferring of multiple physiological parameters including ECG (3-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 (Sv02/Scv02), carbon dioxide (C02), Oxygen (02), anesthetic gas (AG), impedance cardiograph (ICC), bispectral index (BIS), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, PAWP monitoring and NMT monitoring are intended for adult and pediatric patients only; - · ST Segment analysis of Mindray algorithm is intended for adult patients only: · C.O. monitoring is restricted to adult patients only; • ICG monitoring is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg. The monitor is to be used in healthcare facilities 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 helicopter transport, hospital ambulance, or home use.

Device Story

Passport Series Patient Monitors (12m/17m) are multiparameter bedside monitors for healthcare facilities. They accept inputs from various physiological sensors (ECG leads, SpO2 probes, NIBP cuffs, IBP/C.O. catheters, gas analyzers, NMT sensors). The device processes these signals to display real-time waveforms and numerics, perform arrhythmia/ST-segment/QT analysis, and provide resting 12-lead ECG interpretation. Clinicians use the touchscreen interface to view data, set alarm thresholds, and manage patient monitoring. The device supports network connectivity to a Central Monitoring System (CMS). By providing continuous, multi-parameter physiological data and automated analysis, the monitor assists clinicians in patient assessment and clinical decision-making, potentially improving patient safety through early detection of physiological changes.

Clinical Evidence

Bench testing only. Functional and system-level testing was conducted to evaluate performance following modifications. Testing confirmed the devices meet specifications and are equivalent to the predicate. Compliance with consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-2-49, ISO 80601-2-55) was verified.

Technological Characteristics

Multiparameter patient monitor with integrated touchscreen (12" or 17"). Features modular design for physiological measurements (ECG, SpO2, NIBP, IBP, CO2, AG, ICG, BIS, RM, NMT). Connectivity via wireless modules (Laird/ASUS/Silex) to CMS. Power via AC or rechargeable Lithium-ion batteries. Software-based arrhythmia detection (Mindray and Mortara algorithms). Sterilization not applicable (reusable sensors/cables).

Indications for Use

Indicated for monitoring, displaying, and alarming physiological parameters (ECG, Resp, Temp, SpO2, PR, NIBP, IBP, PAWP, C.O., CCO, SvO2/ScvO2, CO2, O2, AG, ICG, BIS, RM, NMT) in adult, pediatric, and neonatal patients in healthcare facilities. Specific exclusions apply for certain parameters based on patient age/size.

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

• Passport Series Patient Monitors (Passport 12m, Passport 17m, and T1) (K152902)
• IntelliVue Patient Monitors (K161531)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol of three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 23, 2017

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

Re: K170876

Trade/Device Name: Passport Series Patient Monitors (Passport 12m, Passport 17m) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, DPZ, CCK, CBQ, CBS, CBR, CCL, DSB, DXG, OLW, DSJ, KOI, GXY Dated: July 14, 2017 Received: July 17, 2017

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

## Jessica E. Paulsen -S

for

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

Enclosure

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## Indications for Use

510(k) Number (if known) K170876

#### Device Name

Passport Series Patient Monitors (Passport 12m and Passport 17m)

#### Indications for Use (Describe)

The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, alarming, and transferring of multiple physiological parameters including ECG (3-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 (Sv02/Scv02), carbon dioxide (C02), Oxygen (02), anesthetic gas (AG), impedance cardiograph (ICC), bispectral index (BIS), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). The equipment also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, PAWP monitoring and NMT monitoring are intended for adult and pediatric patients only;

- · ST Segment analysis of Mindray algorithm is intended for adult patients only:
- · C.O. monitoring is restricted to adult patients only;

• ICG monitoring is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.

The monitor is to be used in healthcare facilities 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 helicopter transport, hospital ambulance, or home use.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> × </div> |
|----------------------------------------------|-----------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |

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# 510(K) SUMMARY

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

| Device Common Name: | Patient Monitor |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | Passport Series Patient Monitors (Passport 12m<br>and Passport 17m) |
| Submitter: | Shenzhen Mindray Bio-medical Electronics Co., LTD.<br>Mindray Building, Keji 12th Road South,<br>Hi-tech Industrial Park, Nanshan,<br>Shenzhen, 518057, P. R. China<br>Tel: [phone]<br>Fax: [phone] |
| Contact: | Ms. Yanhong Bai<br>Manager Regulatory Affairs<br>Shenzhen Mindray Bio-medical Electronics Co., LTD.<br>Mindray Building, Keji 12th Road South,<br>High-tech Industrial Park, Nanshan, Shenzhen<br>518057, P.R. China<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | March 17, 2017 |
| Classification Regulation: | 21 CFR 870.1025, Class II, Arrhythmia detector and alarm<br>(including ST-segment measurement and alarm) |
| Panel: | Cardiovascular |

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| Product<br>Code | Regulation<br>Number | Panel | Regulation description | Device Common Name | |
|-----------------|----------------------|----------------|----------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------|
| Primary | | | | | |
| MHX | 21 CFR<br>870.1025 | Cardiovascular | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | monitor, physiological, patient(with arrhythmia detection or alarms) | |
| Secondary | | | | | |
| Product<br>Code | Regulation<br>Number | Panel | Regulation description | Device Common Name | |
| DSI | 21 CFR<br>870.1025 | Cardiovascular | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | detector and alarm, arrhythmia | |
| MLD | 21 CFR<br>870.1025 | Cardiovascular | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | monitor, st segment with alarm | |
| DRT | 21 CFR<br>870.2300 | Cardiovascular | Cardiac Monitor (including cardiotachometer and rate alarm) | monitor, cardiac (incl. cardiotachometer & rate alarm) | |
| DXN | 21 CFR<br>870.1130 | Cardiovascular | Noninvasive blood pressure measurement system | system, measurement, blood-pressure, non-invasive | |
| DSK | 21 CFR<br>870.1110 | Cardiovascular | Blood pressure computer | computer, blood-pressure | |
| FLL | 21 CFR<br>880.2910 | Cardiovascular | Clinical electronic thermometer | thermometer, electronic, clinical | |
| DQA | 21 CFR<br>870.2700 | Cardiovascular | Oximeter | oximeter | |
| DPZ | 21 CFR<br>870.2710 | Cardiovascular | Ear oximeter | oximeter, ear | |
| CCK | 21 CFR<br>868.1400 | Anesthesiology | Carbon dioxide gas analyzer | analyzer, gas, carbon-dioxide, gaseous-phase | |
| CBQ | 21 CFR<br>868.1500 | Anesthesiology | Enflurane gas analyzer | analyzer, gas, enflurane, gaseous-phase (anesthetic concentration) | |
| CBS | 21 | CFR | Anesthesiology | Halothane gas analyzer | analyzer, gas, halothane, gaseous-phase (anesthetic conc.) |
| CBR | 21 | CFR | Anesthesiology | Nitrous oxide gas analyzer | analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.) |
| CCL | 21 | CFR | Anesthesiology | Oxygen gas analyzer | analyzer, gas, oxygen, gaseous-phase |
| DSB | 21 | CFR | Cardiovascular | Impedance plethysmograph | plethysmograph, impedance |
| DXG | 21 | CFR | Cardiovascular | Single-function, preprogrammed diagnostic computer | computer, diagnostic, pre-programmed, single-function |
| OLW | 21 | CFR | Neurology | Electroencephalograph | index-generating electroencephalograph software |
| DSJ | 21 | CFR | Cardiovascular | Blood pressure alarm | alarm, blood-pressure |
| KOI | 21 | CFR | Anesthesiology | Electrical peripheral nerve stimulator | stimulator, nerve, peripheral, electric |
| GXY | 21 | CFR | Neurology | Cutaneous electrode. | electrode, cutaneous |
| | 868.1620 | | | | |
| | 868.1700 | | | | |
| | 868.1720 | | | | |
| | 870.2770 | | | | |
| | 870.1435 | | | | |
| | 882.1400 | | | | |
| | 870.1100 | | | | |
| | 868.2775 | | | | |
| | 870.1320 | | | | |

## Classification Regulation, Classification Name and Product Codes:

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Primary Predicate Device: K152902 - Passport Series Patient Monitors (Passport 12m, Passport 17m, and T1); Shenzhen Mindray Bio-Medical Electronics Co., Ltd

#### Secondary Predicate Device:

K161531 - IntelliVue Patient Monitors (Philips Medizin Systeme Boeblingen GmbH)

#### Indications for Use:

The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, reviewing, 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), and

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respiration mechanics (RM), neuromuscular transmission monitoring(NMT). The equipment also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:

- The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, PAWP monitoring and NMT are intended for adult and pediatric patients only:
- ST Segment analysis of Mindray algorithm is intended for adult patients only;
- C.O. monitoring is restricted to adult patients only;
- ICG monitoring is only for use on adult patients who meet the following requirements: ■ height: 122 to 229cm, weight: 30 to 155kg.

The monitor is to be used in healthcare facilities 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 helicopter transport. hospital ambulance, or home use.

#### Device Description:

The subject Passport Series Patient Monitors includes two monitors:

- . Passport 12m Patient Monitor
- Passport 17m Patient Monitor ●

The Passport 12m and 17m Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor.

#### Performance Data:

- To establish the substantial equivalence of the Passport Series Patient Monitors (Passport 12m and Passport 17m), Mindray conducted functional and system level testing on the subject devices. The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. 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.
- In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
- IEC 60601-1:2005+A1:2012 Medical electrical equipment -- Part 1: General . requirements for basic safety and essential performance
- . IEC 60601-1-2:2007 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-10:2012 Medical electrical equipment Part 2-10: Particular . requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-2-49:2011 Medical electrical equipment Part 2-49: Particular ●

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requirements for the basic safety and essential performance of multifunction patient monitoring equipment

- . ISO 80601-2-55:2011 Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
#### Substantial Equivalence:

Comparison of Indications - Both the predicate device and the subject Passport 12m and Passport 17m devices are multiparameter patient monitors intended to be used in healthcare facilities under the direction of clinical professionals. The indications for use of the subject devices (Passport 12m and Passport 17m) have been modified to include the new module of NMT. Although this feature is not present in the predicate device, it is present in the cleared Philips (K161531), and thus does not constitute a new intended use for a multi-parameter monitor. In conclusion, the minor changes to the indications for use do not change the fundamental intended use of the Passport 12m and Passport 17m as multiparameter monitors.

Comparison of Technological Characteristics - The table below compares the key technological feature of the subject devices to the primary predicate device (Passport Series Patient Monitors K152902). The features in grey are the features that have been modified since their previous clearances and that are the subject of this 510(k).

| | Predicate Device (K152902) | | Subject Devices | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|----------------------------------------------------------------------------------------|
| Feature | Passport 17m | Passport 12m | Passport 17m | Passport 12m |
| Integrated display and touchscreen | 17" 1280*1024 pixels | 12" 800*600 pixels | Same | Same |
| Secondary display | Independent control and display | Display is linked to integrated display | Same | Same |
| Additional display features | The minitrends diagram, OxyCRG diagram, other monitor view, and calculation can be viewed when using an external LCD screen | | Same | Same |
| | Predicate Device (K152902) | | Subject Devices | |
| Feature | Passport 17m | Passport 12m | Passport 17m | Passport 12m |
| Wireless<br>module | The ASUS module is<br>used for connecting to a<br>network wirelessly,<br>constructing a monitoring<br>network with a central<br>monitoring system<br>(CMS). | The ASUS and Silex<br>modules are used for<br>connecting to a network<br>wirelessly, constructing a<br>monitoring network with a<br>central monitoring system<br>(CMS). | Same | Laird<br>(2.4G/5G)<br>wireless<br>module is<br>added. |
| Module rack | Independent of the patient monitor, provides 8 standard<br>module slots to extend the measurement capabilities of<br>the system | | Same | |
| Power supply | Two rechargeable Lithium-ion<br>battery or AC power supply | One rechargeable<br>Lithium-ion battery<br>or AC power supply | Same | Same |
| Battery | Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh, 350 g | | Same | |
| External<br>memory card | Compact Flash | | Same | |
| Data Recorder | The thermal recorder records patient information,<br>measurement numerics, up to three waveforms, etc. | | Same | |
| Speaker | Give alarm tones (45 to 85 dB), key tones, QRS tones;<br>support PITCH TONE and multi-level tone modulation | | Same | |
| Supports T1 as<br>a module | Supported | | Same | |
| ECG | 3-lead , 5-lead or 12-lead selectable, arrhythmia<br>detection, ST segment analysis, QT analysis, heart rate<br>(HR), an interpretation of resting 12-lead ECG, J-point<br>Auto detection, Dual Channel Pace detection and<br>Adjustable QRS Detection Threshold | | Same | |
| Arrhythmia<br>Analysis<br>(Mindray<br>Algorithm) | Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy,<br>Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, R<br>on T, Run PVCs, PVCs, Tachy, Brady, Missed Beats,<br>Vent. Rhythm, PNP, PNC, Multif. PVC, Nonsus. Vtac,<br>Pause, Irr. Rhythm, AFib | | Same | |
| Arrhythmia<br>Analysis<br>(Mortara<br>Algorithm) | Asystole, Vfib, Vtac, Vent. Rhythm, Couplet, Run PVCs,<br>Bigeminy, Trigeminy, R on T, Multif. PVC, Irr. Rhythm,<br>Tachy, Brady, Missed Beats, PNP, PNC, PVCs | | Same | |
| | Predicate Device (K152902) | | Subject Devices | |
| Feature | Passport 17m | Passport 12m | Passport 17m | Passport 12m |
| Respiration rate<br>(Resp) | Measurement range:<br>Adult: 0 to 120 rpm; Pediatric, neonate: 0 to 150 rpm.<br>Accuracy:<br>7 to 150 rpm: ±2 rpm or ±2%, whichever is greater;<br>0 to 6 rpm: Not specified. | | Same | |
| Temperature<br>(Temp) | Measurement range: 0 to 50°C (32 to 122°F)<br>Accuracy: ±0.1°C or ±0.2°F (without probe) | | Same | |
| Pulse oxygen<br>saturation<br>(SpO2) | Mindray SpO2 Module<br>Measurement range: 0 to 100%<br>Accuracy:70 to 100%: ±2% (adult/pediatric mode)<br>70 to 100%: ±3% (neonate mode)<br>0% to 69%: Not specified.<br>Masimo SpO2 Module<br>Measurement range: 1 to 100%<br>Accuracy:70 to 100%: ±2% (measured without motion in<br>adult/pediatric mode)<br>70 to 100%: ±3% (measured without motion in neonate<br>mode)<br>70 to 100%: ±3% (measured with motion)<br>1% to 69%: Not specified.<br>Nellcor SpO2 Module<br>Measurement range: 0 to 100%<br>Accuracy:70 to 100%: ±2% (adult/pediatric)<br>70 to 100%: ±3% (neonate)<br>0% to 69%: Not specified | | Same | |
| | Predicate Device (K152902) | | Subject Devices | |
| Feature | Passport 17m | Passport 12m | Passport 17m | Passport 12m |
| Pulse rate (PR) | PR from Mindray SpO2 Module<br>Measurement range: 20 to 254 bpm<br>Accuracy: ±3 bpm<br><br>PR from Masimo SpO2 Module<br>Measurement range: 25 to 240 bpm<br>Accuracy: ±3 bpm (measured without motion)<br>±5 bpm (measured with motion)<br><br>PR from Nellcor SpO2 Module<br>Measurement range: 20 to 300 bpm<br>Accuracy:20 to 250 bpm: ±3 bpm<br>251 to 300 bpm, not specified<br><br>PR from IBP Module<br>Measurement range: 25 to 350 bpm<br>Accuracy:±1 bpm or ±1%, whichever is greater" | | Same | |
| Non-invasive blood pressure (NIBP) | Measurement range:<br>Adult<br>Neonate<br>Systolic: 40 to 270<br>Diastolic: 10 to 210<br>Mean: 20 to 230<br><br>Accuracy:<br>Max mean error: ±5 mmHg<br>Max standard deviation: 8 mmHg | Pediatric<br>Neonate<br>Systolic: 40 to 200<br>Diastolic: 10 to 150<br>Mean: 20 to 165 | Same | Pediatric<br>Neonate<br>Systolic: 40 to 135<br>Diastolic: 10 to 100<br>Mean: 20 to 110 |
| Invasive blood pressure (IBP) | Measurement range: -50 to 300 mmHg<br>Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor) | | Same | |
| Pulse Pressure Variation (PPV) | Supported feature of IBP | | Same | |
| Cardiac output (C.O.) | The temperature change is displayed as a curve in the C.O. split screen, and the monitor calculates the C.O. value from this curve. The monitor is capable of storing 6 measurements. | | Same | |
| | Predicate Device (K152902) | | Subject Devices | |
| Feature | Passport 17m | Passport 12m | Passport 17m | Passport 12m |
| Continuous<br>cardiac output<br>(CCO) | CCO/SvO2 interface module is used to interface<br>with Edwards Vigilance II monitor / Vigileo<br>Monitor which measures continuous cardiac<br>output (CCO), mixed venous oxygen saturation<br>(SvO2) and central venous oxygen saturation<br>(ScvO2). | | Same | |
| Central venous<br>oxygen<br>saturation<br>(ScvO2) | ScvO2 module is used to measure central venous oxygen<br>saturation (ScvO2). | | Same | |
| Carbon dioxide<br>(CO2) | Sidestream CO2 Module:<br>Measurement range: 0 to 99 mmHg<br>Accuracy:<br>0 to 40 mmHg: ±2 mmHg<br>41 to 76 mmHg: ±5% of the reading<br>77 to 99 mmHg: ±10% of the reading<br>Microstream CO2 Module:<br>Measurement range: 0 to 99 mmHg<br>Accuracy:<br>0 to 38 mmHg: ±2 mmHg<br>39 to 99 mmHg: ±5% of the reading ±5% of the<br>reading+0.08% of (the reading-38)<br>Mainstream CO2 Module:<br>Measurement range: 0 to 150 mmHg<br>Accuracy:<br>0 to 40 mmHg: ±2 mmHg<br>41 to 70 mmHg: ±5% of the reading<br>71 to 100 mmHg: ±8% of the reading<br>101 to 150 mmHg: ±10% of the reading | | Same | |
| Anesthetic gas<br>(AG) | The AG module analyzes gas samples from the patient<br>and calculates CO2, O2, N2O and AA waves and related<br>numerics, airway respiratory rate, and MAC (minimum<br>alveolar concentration).<br>Supports the 3-slot AG module. | | Added support for the<br>2-slot AG module | |
| | Predicate Device (K152902) | | Subject Devices | |
| Feature | Passport 17m | Passport 12m | Passport<br>17m | Passport<br>12m |
| Impedance<br>cardiograph<br>(ICG) | Measurement range:<br>SV: 5 to 250 ml<br>HR: 44 to 2m<br>C.O. 1.4 to 15 L/min<br>Accuracy:<br>SV: Not specified.<br>HR: ±2 bpm<br>C.O. Not specified. | | Same | |
| Bispectral index<br>(BIS) | Measured parameters: EEG, BIS, BIS L, BIS R | | Same | |
| Respiration<br>mechanics<br>(RM) | Measurement range: Adult: 0 to 120 rpm; Pediatric: 0 to<br>150 rpm.<br>Accuracy: 7 to 150 rpm:±2 rpm or ±2%, whichever is<br>greater;<br>0 to 6 rpm: Not specified." | | Same | |
| NMT | Not supported | | Added | |

Device Comparison Table (Compare with Passport 12m/17m (K152902))

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| Feature | Secondary Predicate Device<br>NMT (K152902) | Subject Mindray NMT in this<br>510(k) | Comparison<br>System |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Composition | Module and accessory cable | Module and accessory cable | Same |
| Intended use | The IntelliVue NMT<br>Module is intended to be<br>used as an objective<br>neuromuscular transmission<br>monitor, using<br>accelerometry for<br>measuring the muscle<br>contraction following an<br>electrical stimulation of a<br>peripheral nerve. The NMT<br>Module is intended to be<br>used with adult and<br>pediatric patients. | The neuromuscular<br>transmission (NMT) module<br>is intended to be used as an<br>objective neuromuscular<br>transmission monitor, using<br>accelerometry for measuring<br>the muscle contraction<br>following an electrical<br>stimulation of a peripheral<br>nerve. The NMT module is<br>intended to be used with adult<br>and pediatric patients. | Same |
| Principle of<br>measurement | Neuro Muscular<br>Transmission (NMT) and<br>its measurement enables the<br>evaluation of muscle<br>relaxation of patients under<br>Neuromuscular Block by<br>measuring the strength of<br>muscle reaction after<br>electrically stimulating the<br>dedicated motor nerve.<br>The NMT Monitor<br>electrodes are placed on the<br>patient's skin over the ulnar<br>nerve, a controllable current<br>source delivers stimulation<br>pulses to two skin surface<br>electrodes for the nerve<br>stimulation, the muscle<br>response is measured with<br>an acceleration sensor. | Neuromuscular Transmission<br>(NMT) module evaluates<br>muscle relaxation of patients<br>under neuromuscular block by<br>measuring the strength of<br>muscle reaction after<br>electrically stimulating the<br>dedicated motor nerve.<br>The electrodes are placed on<br>the patient's skin over ulnar<br>nerve, a controllable current<br>source delivers stimulation<br>pulses to two skin surface<br>electrodes for the nerve<br>stimulation, and the muscle<br>response is measured with an<br>acceleration sensor. | Same |
| Feature | Secondary Predicate Device<br>NMT (K152902) | Subject Mindray NMT in this<br>510(k) | Comparison<br>System |
| Stimulation<br>Output | Current pulse: 100, 200, or<br>300μs; monophasic<br>rectangle pulse | Current Pulse: 100, 200 or<br>300μs; monophasic rectangle<br>pulse;<br>Pulse width Accuracy: ±10% | Same |
| | Current Range: 5 to 60 mA<br>in increments of 5 mA | Current Range:0 - 60 mA in<br>increments of 5 mA | the actual output<br>current of the<br>two sides are<br>both 5 to 60 mA<br>Same |
| | Current Accuracy: ± 5% or<br>± 2 mA, whichever is<br>greater | Current Accuracy: ± 5% or ±<br>2 mA, whichever is greater | Same |
| | Max. Skin Resistance: 3<br>kOhm | Max. Skin Impedance: 3kohm | Same |
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