Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

K190011 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX · Jul 10, 2019 · Cardiovascular

Device Facts

• Record ID: K190011
• Device Name: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: MHX · Cardiovascular
• Decision Date: Jul 10, 2019
• 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, reviewing, 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 (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AC), impedance cardiograph (CCG), 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. The T1 Patient Monitor is intended for monitoring, displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-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), and carbon dioxide (CO2). 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 arthythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients; · ST Segment analysis of Mindray ECG algorithm is intended for adult patients only. 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

Multiparameter patient monitors (Passport 12m, 17m, T1) collect physiological signals via sensors (ECG leads, SpO2 probes, NIBP cuffs, etc.). Devices process inputs to display real-time waveforms, numerics, and alarms; provide arrhythmia/ST-segment analysis; and support data transfer to central monitoring systems. Used in clinical healthcare facilities by trained professionals. T1 functions as a standalone monitor or a module for 12m/17m units. Output assists clinicians in patient assessment and hemodynamic management. Benefits include continuous patient surveillance and timely detection of physiological abnormalities.

Clinical Evidence

Bench testing only. System-level functional testing and verification against consensus standards (e.g., IEC 60601-1, IEC 60601-2-27, ISO 80601-2-61) confirmed performance equivalence to predicates.

Technological Characteristics

Multiparameter monitors with integrated touchscreen displays. Connectivity via wireless modules (Laird 2.4GHz/5GHz). Power via rechargeable Li-ion batteries or AC/DC. Software-based signal processing for ECG, SpO2, NIBP, and gas analysis. Compliance with IEC 60601-1, 60601-2-25, 60601-2-27, 80601-2-61, 80601-2-30, 80601-2-56, 60601-2-34, 60601-2-49, and 80601-2-55.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in healthcare facilities for monitoring, displaying, and transferring physiological parameters (ECG, Resp, Temp, SpO2, PR, NIBP, IBP, PAWP, CO2, O2, AG, ICG, BIS, RM, NMT). Specific exclusions apply for certain advanced parameters (e.g., C.O., ICG, NMT) based on patient age or size. Not for home, ambulance, or helicopter use.

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 (K152902)
• Passport Series Patient Monitors (K170876)
• BeneVision N Series Patient Monitors (K182075)
• A7 Anesthesia System (K171292)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 10, 2019

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, 518057, P.R. China

Re: K190011

Trade/Device Name: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) 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, DQA, DRT, DSI, DSK, DXN, FLL, MLD, DPZ, CCK, CBQ, CBS, CBR, CCL, DSB, DXG, OLW, DSJ, KOI, GXY Dated: June 6, 2019 Received: June 10, 2019

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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Nicole Goodsell Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K190011

#### Device Name

Passport Series Patient Monitors (including Passport 12m, Passport 17m and T1)

#### Indications for Use (Describe)

Passport 12m and 17m Patient Monitors:

The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, reviewing, 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 (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AC), impedance cardiograph (CCG), 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.

#### T1 Patient Monitor:

The T1 Patient Monitor is intended for monitoring, displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-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), and carbon dioxide (CO2). 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 arthythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients;

· ST Segment analysis of Mindray ECG algorithm is intended for adult patients only.

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)

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.

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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>Passport 17m and T1) |
| 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 | December 31, 2018 |
| 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<br>alarm (including<br>ST-segment measurement<br>and alarm) | monitor, physiological,<br>patient(with arrhythmia<br>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<br>alarm (including<br>ST-segment measurement<br>and alarm) | detector and alarm,<br>arrhythmia | |
| MLD | 21 CFR<br>870.1025 | Cardiovascular | Arrhythmia detector and<br>alarm (including<br>ST-segment measurement<br>and alarm) | monitor, st segment with<br>alarm | |
| DRT | 21 CFR<br>870.2300 | Cardiovascular | Cardiac Monitor<br>(including<br>cardiotachometer and rate<br>alarm) | monitor, cardiac (incl.<br>cardiotachometer & rate<br>alarm) | |
| DXN | 21 CFR<br>870.1130 | Cardiovascular | Noninvasive blood<br>pressure measurement<br>system | system, measurement,<br>blood-pressure,<br>non-invasive | |
| DSK | 21 CFR<br>870.1110 | Cardiovascular | Blood pressure computer | computer, blood-pressure | |
| FLL | 21 CFR<br>880.2910 | Cardiovascular | Clinical electronic<br>thermometer | thermometer, electronic,<br>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<br>analyzer | analyzer, gas,<br>carbon-dioxide,<br>gaseous-phase | |
| CBQ | 21 CFR<br>868.1400 | Anesthesiology | Enflurane gas analyzer | analyzer, gas, enflurane, | |
| | | | | | |
| CBS | 868.1500<br>868.1620 | 21 CFR | Anesthesiology | Halothane gas analyzer | gaseous-phase (anesthetic concentration)<br>analyzer, gas, halothane, gaseous-phase (anesthetic conc.) |
| CBR | 868.1700 | 21 CFR | Anesthesiology | Nitrous oxide gas analyzer | analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.) |
| CCL | 868.1720 | 21 CFR | Anesthesiology | Oxygen gas analyzer | analyzer, gas, oxygen, gaseous-phase |
| DSB | 870.2770 | 21 CFR | Cardiovascular | Impedance plethysmograph | plethysmograph, impedance |
| DXG | 870.1435 | 21 CFR | Cardiovascular | Single-function, preprogrammed diagnostic computer | computer, diagnostic, pre-programmed, single-function |
| OLW | 882.1400 | 21 CFR | Neurology | Electroencephalograph | index-generating electroencephalograph software |
| DSJ | 870.1100 | 21 CFR | Cardiovascular | Blood pressure alarm | alarm, blood-pressure |
| KOI | 868.2775 | 21 CFR | Anesthesiology | Electrical peripheral nerve stimulator | stimulator, nerve, peripheral, electric |
| GXY | 870.1320 | 21 CFR | Neurology | Cutaneous electrode. | electrode, cutaneous |

# Classification Regulation, Classification Name and Product Codes:

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#### Primary Predicate Device:

- K 152902 Passport Series Patient Monitors (Passport 12m, Passport 17m, and T1) Shenzhen Mindray Bio-Medical Electronics Co., Ltd
- K170876 Passport Series Patient Monitors (Passport 12m and Passport 17m) Shenzhen Mindray Bio-Medical Electronics Co., Ltd

#### Secondary Predicate Device:

- K182075 -BeneVision N Series Patient Monitors Shenzhen Mindray Bio-Medical Electronics Co., Ltd K171292 - A7 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd
## Indications for Use:

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# Passport 12m and 17m Patient Monitors:

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 (Sv02/Scv02), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), 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.

# T1 Patient Monitor:

The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, or 5-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), and carbon dioxide (CO2). 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, and ● PAWP monitoring are intended for adult and pediatric patients;
- ST Segment analysis of Mindray ECG algorithm is intended for adult patients ● only.

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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 three monitors:

- o Passport 12m Patient Monitor
- Passport 17m Patient Monitor ●
- o T1 Patient Monitor

All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, alarming, and transferring multiple physiological parameters. The Passport 12m and 17m Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor.

The T1 patient monitor is one of the available modules that can be plugged into the Passport 17m or 12m monitor. The T1 can also be used as a standalone monitor and when used as a standalone monitor, it provides a subset of the functions that are provided by Passport 17m and 12m.

# Substantial Equivalence:

## Comparison of Indications

The indications for use of the subject devices have not changed in this 510(K). Indications of the predicate device (Passport 12m and 17m Patient Monitors K170876,T1 Patient Monitor K152902) and the subject device (Passport 12m,Passport 17m and T1)) are the same.

## Comparison of Technological Characteristics

The table below compares the key technological feature of the subject devices to the primary predicate device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor 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).

Device Comparison Table (Compare with Passport 12m and 17m Patient Monitors K170876,T1 Patient Monitor K152902)

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| Feature | Passport 17m | Passport 12m | T1 | Subject Devices |
|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | | | | |
| Integrated display and touchscreen | 17", 1280*1024 pixels | 12", 800*600 pixels | Same | Same |
| Secondary display | Independent display and display | Display is linked to integrated display | Independent control via a VGA port in the docking T1 station | 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 | Same |
| Wireless module | The ASUS module is used for connecting to a network wirelessly, constructing a monitoring network with a central monitoring system (CMS). | The ASUS, Silex and Laird modules are used for connecting to a network wirelessly, constructing a monitoring network with a central monitoring system (CMS). | The Cyberlink modules is used for connecting to a network wirelessly, constructing a monitoring network with a central monitoring system (CMS). | Laird (2.4GHz/5GHz) wireless module is added |

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| Feature | Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | | | Subject Devices | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------|----|
| | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | |
| Module rack | Independent of the patient monitor, provides 8 standard module slots to extend the measurement capabilities of the system | | Not supported | Same | Same | Same | |
| Power supply | Two rechargeable Lithium-ion battery or AC power supply | One rechargeable Lithium-ion battery or AC power supply | One rechargeable Lithium-ion battery or DC power supply or AC power supply | Same | Same | Same | |
| Battery | Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh, 350 g | | Chargeable Lithium-Ion, 7.4 VDC, 2500 mAh | Same | Same | Same | |
| External memory card | Compact Flash | | Secure Digital | Same | Same | Same | |
| Data Recorder | The thermal recorder records patient information, measurement numerics, up to three waveforms, etc. | | Not supported | Same | Same | Same | |
| Speaker | Give alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation | | | Same | Same | Same | |
| Supports T1 as a module | Supported | | / | Same | Same | Same | |
| Supports N1 as a module | Not supported | | Not supported | Supported | | Same | |
| | Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | | | Subject Devices | | | |
| Feature | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | |
| MPM module | MPM 2.0 module, it support:<br>3/5/12 lead ECG, NIBP, dual channel Temp, SpO2, dual channel IBP measurement | / | / | MPM 3.0 module is added, it support:<br>3/5/12 lead ECG, NIBP, dual channel Temp, SpO2, dual channel IBP measurement<br>When MPM 3.0 module is used with Passport 12m and 17m, the functionality and performance is same with MPM 2.0 module. | | / | |
| ECG | 3-lead, 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, heart rate (HR), an interpretation of resting 12-lead ECG, J-point Auto detection, Dual Channel Pace detection and Adjustable QRS Detection Threshold | | | Same | | | |
| Arrhythmia Analysis (Mindray Algorithm) | Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy, Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, R on T, Run PVCs, PVCs, Tachy, Brady, Missed Beats, Vent. Rhythm, PNP, PNC, Multif. PVC, Nonsus. Vtac, Pause, Irr. Rhythm, AFib | | | Same | | | |
| Arrhythmia Analysis (Mortara Algorithm) | Asystole, Vfib, Vtac, Vent. Rhythm, Couplet, Run PVCs, Bigeminy, Trigeminy, R on T, Multif. PVC, Irr. Rhythm, Tachy, Brady, Missed Beats, PNP, PNC, PVCs | | | Same | | | |
| Predicate Device (Passport 12m and 17m Patient Monitors<br>K170876, T1 Patient Monitor K152902) | | | Subject Devices | | | | |
| Feature | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | |
| Respiration rate<br>(Resp) | Uses the MPM (Multi Parameter Module) to measure the change in impedance measured across the thorax to determine the respiration rate. | | | Same | | | |
| Temperature<br>(Temp) | Uses the MPM (Multi Parameter Module) to measure core and skin temperature. The patient monitor can monitor two temperatures simultaneously using thermally sensitive resistors (thermistors). | | | Same | | | |
| Pulse oxygen saturation (SpO2) | Uses the MPM (Multi Parameter Module) or the SpO2 module to measure the amount of oxygenated haemoglobin and pulse rate by measuring the absorption of selected wavelengths of light.<br>Is compatible with the following 3 modules to measure oxygen saturation:<br>Mindray SpO2 ModuleMasimo SpO2 ModuleNellcor SpO2 Module | | | Same | | | |
| Feature | Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | | | Subject Devices | | | |
| | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | |
| | PR from Mindray SpO2<br>Measurement range: 20 to 254 bpm<br>Accuracy: ±3 bpm | | | PR from Mindray SpO2 | Same | | |
| | PR from Masimo SpO2<br>Measurement range: 25 to 240 bpm<br>Accuracy: ±3 bpm (measured without motion)<br>±5 bpm (measured with motion) | | | PR from Masimo SpO2 | Same | | |
| Pulse rate (PR) | PR from Nellcor SpO2<br>Measurement range: 20 to 300 bpm<br>Accuracy: 20 to 250 bpm: ±3 bpm<br>251 to 300 bpm, not specified | | | PR from Nellcor SpO2 | Same | | |
| | PR from IBP<br>Measurement range: 25 to 350 bpm<br>Accuracy:±1 bpm or ±1%, whichever is greater | | | PR from IBP | Same | | |
| | PR from NIBP<br>Measurement range: 40 to 240 bpm<br>Accuracy: ±3 bpm or ±3%, whichever is greater | | | PR from NIBP<br>Measurement range: 30 to 300 bpm<br>Accuracy: Same | | | |
| Feature | Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | | | Subject Devices | | | |
| | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | |
| Non-invasive blood pressure (NIBP) | Measurement range:<br>Adult:<br>Systolic: 40-270 mmHg<br>Diastolic: 10-210 mmHg<br>Mean:20-230 mmHg<br>Pediatric:<br>Systolic:40-200mmHg<br>Diastolic:10-150mmHg<br>Mean:20-165mmHg<br>Neonate:<br>Systolic:40-135 mmHg<br>Diastolic:10-100mmHg<br>Mean:20-110 mmHg<br>Accuracy:<br>Max mean error: ±5 mmHg<br>Max standard deviation: 8 mmHg | | | Measurement range:<br>Adult:<br>Systolic: 25-290 mmHg<br>Diastolic: 10-250 mmHg<br>Mean:15-260 mmHg<br>Pediatric:<br>Systolic:25-240mmHg<br>Diastolic:10-200mmHg<br>Mean:15-215mmHg<br>Neonate:<br>Systolic:25-140 mmHg<br>Diastolic:10-115 mmHg<br>Mean:15-125 mmHg | | Accuracy:<br>Same | |
| Invasive blood pressure (IBP) | Uses the MPM (Multi Parameter Module) or the IBP Module to measure invasive blood pressure. The monitor can monitor up to 8 invasive blood pressures and displays systolic, diastolic and mean pressures and a waveform for each pressure. Supports the PPV function. | | | |…