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.

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.

AI/ML Overview

This document is a 510(k) summary for the Mindray Passport Series Patient Monitors (Passport 12m, Passport 17m, and T1). It focuses on establishing substantial equivalence to previously cleared predicate devices and does not contain a full study report with detailed acceptance criteria and performance data for a new AI/ML device.

Therefore, the following information, relevant to AI/ML device studies, cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: The document states that "functional and system level testing" was conducted and that the devices "continue to meet specifications and the performance of the device is equivalent to the predicate." However, it does not provide specific acceptance criteria values or detailed performance metrics.
Sample sized used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant as this is not a new AI/ML device being submitted for comparative effectiveness.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant as this is not a new AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary of available relevant information from the document:

This 510(k) submission is for modifications to existing patient monitors, not for a new AI/ML device. The changes include:

Wireless Module: Addition of a Laird (2.4GHz/5GHz) wireless module.
MPM Module: Addition of an MPM 3.0 module with similar functionality to the MPM 2.0 module.
Masimo SpO2 accessories: Support for new Masimo SpO2 accessories.
ECG accessories: Support for new ECG accessories (12-lead, defibrillation-proof).
CO2 accessories: Support for new DRYLINE PRIME and DRYLINE PRIME+ gas sampling lines and water traps.
Signal Cord Resistance: Improvements to SpO2/CO2/BIS signal cord resistance to damage.
NIBP Issue Correction: Correction of an issue where NIBP misreported "NIBP Excessive Motion" after 49 days.
Anesthetic Agent (AA) Numerics: Support for End tidal (Et) and Fraction of Inspired (Fi) numerics for anesthetic agent (AA).
Physiological Alarms: Support for specific physiological alarm behaviors (triggered only when parameter value is higher/lower than limits, re-alarming after reset, non-overlapping relationships of alarm limit setting).
Alarm Setup Menu: Support for password protection for accessing the Alarm Setup menu.
User Authorization: Support for user authorization via LDAP.
Patient Monitor Information: Support for Facility information, Room No. information, and Visit Number in patient demographics.
Printing: Support for printing arrhythmia settings in reports, changing factory default printer paper size, and QT report printing.
MAC Address Display: Support to display the MAC address of the patient monitor.
ST Values Display: Support for displaying ST values in the parameter tile.
Patient Private Information: Support for encryption of patient private information sent to the network.
ST Point Adjustment: Support for adjustment of the ST point on multiple displayed leads.
NIBP Measurement on Clock: Support for NIBP measurement on the clock.
Network Application Transmission Priority Setting: Support for network application transmission priority setting.
ECG Beat Annotation: Support for ECG beat annotation.
DNS for ADT and LDAP server address: Support for DNS for ADT and LDAP server address.
Bed No. Issue Correction: Correction of an issue where the Bed No. of the Passport 12m/17m is changed after T1 is pulled out of the monitors.

Performance Data:
Mindray conducted functional and system level testing to evaluate the performance of these modifications. The testing demonstrated that the devices "continue to meet specifications and the performance of the device is equivalent to the predicate." The devices also meet relevant consensus standards (listed in the document).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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:

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.

T1 Patient Monitor:

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.

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,Passport 17m and T1)
Submitter	Shenzhen Mindray Bio-medical Electronics Co., LTD.Mindray Building, Keji 12th Road South,Hi-tech Industrial Park, Nanshan,Shenzhen, 518057, P. R. ChinaTel: +86 755 8188 8998Fax: +86 755 2658 2680
Contact	Ms. Yanhong BaiManager Regulatory AffairsShenzhen Mindray Bio-medical Electronics Co., LTD.Mindray Building, Keji 12th Road South,High-tech Industrial Park, Nanshan, Shenzhen518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com
Date Prepared	December 31, 2018
Classification Regulation	21 CFR 870.1025, Class II, Arrhythmia detector and alarm(including ST-segment measurement and alarm)
Panel	Cardiovascular

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ProductCode	RegulationNumber	Panel	Regulation description	Device Common Name
Primary
MHX	21 CFR870.1025	Cardiovascular	Arrhythmia detector andalarm (includingST-segment measurementand alarm)	monitor, physiological,patient(with arrhythmiadetection or alarms)
Secondary
ProductCode	RegulationNumber	Panel	Regulation description	Device Common Name
DSI	21 CFR870.1025	Cardiovascular	Arrhythmia detector andalarm (includingST-segment measurementand alarm)	detector and alarm,arrhythmia
MLD	21 CFR870.1025	Cardiovascular	Arrhythmia detector andalarm (includingST-segment measurementand alarm)	monitor, st segment withalarm
DRT	21 CFR870.2300	Cardiovascular	Cardiac Monitor(includingcardiotachometer and ratealarm)	monitor, cardiac (incl.cardiotachometer & ratealarm)
DXN	21 CFR870.1130	Cardiovascular	Noninvasive bloodpressure measurementsystem	system, measurement,blood-pressure,non-invasive
DSK	21 CFR870.1110	Cardiovascular	Blood pressure computer	computer, blood-pressure
FLL	21 CFR880.2910	Cardiovascular	Clinical electronicthermometer	thermometer, electronic,clinical
DQA	21 CFR870.2700	Cardiovascular	Oximeter	oximeter
DPZ	21 CFR870.2710	Cardiovascular	Ear oximeter	oximeter, ear
CCK	21 CFR868.1400	Anesthesiology	Carbon dioxide gasanalyzer	analyzer, gas,carbon-dioxide,gaseous-phase
CBQ	21 CFR868.1400	Anesthesiology	Enflurane gas analyzer	analyzer, gas, enflurane,

CBS	868.1500868.1620	21 CFR	Anesthesiology	Halothane gas analyzer	gaseous-phase (anesthetic concentration)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.

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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Device Description:

The subject Passport Series Patient Monitors includes three monitors:

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

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

Page 6 of 26

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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:3/5/12 lead ECG, NIBP, dual channel Temp, SpO2, dual channel IBP measurement	/	/	MPM 3.0 module is added, it support:3/5/12 lead ECG, NIBP, dual channel Temp, SpO2, dual channel IBP measurementWhen 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 MonitorsK170876, T1 Patient Monitor K152902)			Subject Devices
Feature	Passport 17m	Passport 12m	T1	Passport 17m	Passport 12m	T1
Respiration rate(Resp)	Uses the MPM (Multi Parameter Module) to measure the change in impedance measured across the thorax to determine the respiration rate.			Same
Temperature(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.Is compatible with the following 3 modules to measure oxygen saturation: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 SpO2Measurement range: 20 to 254 bpmAccuracy: ±3 bpm			PR from Mindray SpO2	Same
	PR from Masimo SpO2Measurement range: 25 to 240 bpmAccuracy: ±3 bpm (measured without motion)±5 bpm (measured with motion)			PR from Masimo SpO2	Same
Pulse rate (PR)	PR from Nellcor SpO2Measurement range: 20 to 300 bpmAccuracy: 20 to 250 bpm: ±3 bpm251 to 300 bpm, not specified			PR from Nellcor SpO2	Same
	PR from IBPMeasurement range: 25 to 350 bpmAccuracy:±1 bpm or ±1%, whichever is greater			PR from IBP	Same
	PR from NIBPMeasurement range: 40 to 240 bpmAccuracy: ±3 bpm or ±3%, whichever is greater			PR from NIBPMeasurement range: 30 to 300 bpmAccuracy: 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:Adult:Systolic: 40-270 mmHgDiastolic: 10-210 mmHgMean:20-230 mmHgPediatric:Systolic:40-200mmHgDiastolic:10-150mmHgMean:20-165mmHgNeonate:Systolic:40-135 mmHgDiastolic:10-100mmHgMean:20-110 mmHgAccuracy:Max mean error: ±5 mmHgMax standard deviation: 8 mmHg			Measurement range:Adult:Systolic: 25-290 mmHgDiastolic: 10-250 mmHgMean:15-260 mmHgPediatric:Systolic:25-240mmHgDiastolic:10-200mmHgMean:15-215mmHgNeonate:Systolic:25-140 mmHgDiastolic:10-115 mmHgMean:15-125 mmHg		Accuracy: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.					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
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.			Not supported	Same	Same
Continuous cardiac output (CCO)	CCO/SvO2 interface module is used to interface with Edwards Vigilance II monitor / Vigileo Monitor which measures continuous cardiac output (CCO), mixed venous oxygen saturation (SvO2) and central venous oxygen saturation (ScvO2).			Not supported	Same	Same
Central venous oxygen saturation (ScvO2)	ScvO2 module is used to measure central venous oxygen saturation (ScvO2).			Not supported	Same	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
Carbon dioxide (CO2)	Is compatible with the following 3 modules to measure carbon dioxide:Sidestream CO2 Module Microstream CO2 Module Mainstream CO2 Module CO2 monitoring is based on calculations from measuring the absorption of infrared (IR) light of specific wavelengths using a photodetector.			Sidestream CO2 2.0 module is added, the functionality and performance is same with Sidestream CO2 1.0 module.	The other modules and specifications remains the same.	Same
Anesthetic gas (AG)	Is compatible with the following 2 modules to measure Anesthetic gas:3-slot AG Module 2-slot AG Module The AG module analyzes gas samples from the patient and calculates CO2, O2, N2O and AA waves and related numerics, airway respiratory rate, and MAC (minimum alveolar concentration).Supports the 3-slot AG module.			Support Sample Gas Recycling feature for AG module	Not supported	Same
Feature	Predicate Device (Passport 12m and 17m Patient MonitorsK170876, T1 Patient Monitor K152902)			Subject Devices
	Passport 17m	Passport 12m	T1	Passport 17m	Passport 12m	T1
Impedancecardiograph (ICG)	Uses the ICG Module tomeasure a patient'shemodynamic statususing a non-invasivemethod based onthoracic electricalbioimpedance(TEB) technology.		Not supported	Same		Same
Bispectral index(BIS)	Measured parameters: EEG, BIS, BIS L,BIS R		Not supported	Same		Same
Respirationmechanics (RM)	Measures respirationmechanics foradults, pediatricsand infants.		Not supported	Same		Same
	Predicate Device (Passport 12m and 17m Patient MonitorsK170876, T1 Patient Monitor K152902)		Subject Devices
Feature	Passport 17m	Passport 12m	T1	Passport 17m	Passport 12m	T1
NMT	Uses the NMT module to monitor objective neuromuscular transmission.	It evaluates muscle relaxation of patients under neuromuscular block by measuring the strength of muscle reaction after electrically stimulating the dedicated motor nerve.	Not supported	Same	Same	Same
Feature	Passport 17m	Passport 12m	T1	Subject Devices	Passport 17m	Passport 12m	T1
cleaninganddisinfectingagents	List of agents:Sodium hypochlorite bleachHydrogen peroxideIsopropanolRely+On TMVirkon®1-PropanolPerform®			More agents are added:Metrex CaviCide1™Virex® II 256Virex® TBAlpet® D2 Surface Sanitizing WipesClorox Dispatch® Hospital Cleaner DisinfectantTowels with BleachClorox Healthcare® Bleach Germicidal WipesClorox HealthcareⓇ Hydrogen Peroxide CleanerDisinfectant WipesDiversey Oxivir® TB WipesMetrex CaviWipes™PDI Sani-Cloth® AF3 Germicidal Disposable WipePDI Sani-Cloth® Bleach Germicidal Disposable WipePDI Sani-Cloth® HB Germicidal Disposable WipePDI Sani-Cloth® Plus Germicidal Disposable ClothPDI Super Sani-Cloth® Germicidal Disposable WipeVIRAGUARD Hospital Surface Disinfectants





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
Support new Masimo SpO2 accessories				Added:040-003378-00	RD SET MD 14-05, PC 5 ft
				040-003379-00	RD SET MD 14-12, Patient Cable 12 ft
				040-003310-00	8pin masimo Cable (RD SET)
				040-003426-00	LNCS to RD Adapter
				040-003381-00	RD to LNC Adapter Cable
				040-003376-00	RD SET DCI, Adult Reusable Sensor
	Not supported			040-003377-00	RD SET DCI, Pediatric Reusable Sensor
				040-003380-00	RD Set TC-I SpO2 Reusable Tip-Clip Ear Sensor, 3ft
				040-003382-00	RD SET Adhesive Sensor
				040-003383-00	RD SET PDT Adhesive Sensor
				040-003384-00	RD Set Infant Adhesive Sensor
				040-003385-00	RD Set Neo Adhesive Sensor
				040-003386-00	RD Set NeoPt Adhesive Sensor
				040-003387-00	RD Set NeoPt-500 Non-adhesive sensor
Support new ECG accessories	Not supported			Added:040-003528-00	ECG cable, defibrillation-proof, AHA	12-lead,
Feature	Passport 17m	Passport 12m	T1	Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) Subject Devices
Support new CO2 accessories	Not supported			Passport 17m	Passport 12m	T1
				Added:
				100-000138-00	DRYLINE PRIME Gas Sampling Line With Airway Adapter, Adult/Pediatric
				100-000139-00	DRYLINE PRIME Gas Sampling Line With Airway Adapter, Neonate
				100-000140-00	RYLINE PRIME+ Gas Sampling Line With Airway Adapter, Adult/Pediatric
				100-000141-00	DRYLINE PRIME+ Gas Sampling Line With Airway Adapter, Neonate
				100-000142-00	DRYLINE PRIME Nasal Gas Sampling Line, Adult
				100-000143-00	DRYLINE PRIME Nasal Gas Sampling Line, Pediatric
				100-000144-00	DRYLINE PRIME Nasal Gas Sampling Line, Neonate
				100-000145-00	DRYLINE PRIME+ Nasal Gas Sampling Line, Adult
				100-000146-00	DRYLINE PRIME+ Nasal Gas Sampling Line, Pediatric
				100-000147-00	DRYLINE PRIME+ Nasal Gas Sampling Line, Neonate
				100-000151-00	DRYLINE PRIME Water Trap Mini
	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
Improve the SpO2/CO2/BIS signal cord resistance to damage	Not supported			Supported		Note: T1 doesn't support BIS module
Corrected an issues where NIBP misreported "NIBP Excessive Motion" after 49 days of running	Not supported			Supported
Feature	Predicate Device (Passport 12m and 17m Patient MonitorsK170876, T1 Patient Monitor K152902)			Subject Devices
	Passport 17m	Passport 12m	T1	Passport 17m	Passport 12m	T1
The End tidal (Et) and Fraction ofInspired (Fi) numerics foranesthetic agent (AA)	Not supported			Supported		Same
Physiological alarms are trigged only when the monitored parameter value is higher than the high alarm limit or is lower than the low alarm limit	Not supported			Supported		Same
Extend the setting range of low alarm limit of EtO2	Not supported			Supported		Same

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Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902)			Subject Devices
Feature	Passport 17m	Passport 12m	Passport 17m	Passport 12m	T1
Support the non-overlapping relationships of alarm limit setting of physiological alarms	Not supported		Supported
Support re-alarming after a physiological alarm is reset	Not supported		Supported
Support password protection for accessing the Alarm Setup menu	Not supported		Supported
Support authorization of the user via the LDAP	Not supported		Supported
Support the Facility information of patient monitor	Not supported		Supported
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
Support the Room No. information of patient monitor	Not supported			Supported
Support the Visit Number in the patient demographics	Not supported			Supported
Support printing of the arrhythmia settings in reports	Not supported			Supported
Change the factory default setting of printer paper size	Not supported			Supported
Support to display the MAC address of patient monitor	Not supported			Supported
Support the display mode of ST values in the parameter tile	Not supported			Supported
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
Support encryption of patient private information sent to the network	Not supported
Support Laird 2.4GHz/5GHz Wifi module	Supported		Not supported	Same		Supported
Support adjustment of the ST point on multiple displayed leads	Supported		Not supported	Same		Supported
Support QT report printing	Supported		Not supported	Same		Supported
Support NIBP measurement on clock	Supported		Not supported	Same		Supported
Support network application transmission priority setting	Supported		Not supported	Same		Supported
Support ECG beat annotation	Supported		Not supported	Same		Supported
	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
Support DNS for ADT and LDAP server address	Not supported			Same		Supported
Corrected an issues where the Bed No. of the Passport 12m/17m is changed after T1 is pulled out of the monitors	Not supported			Same		Supported

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Performance Data

To establish the substantial equivalence of the Passport Series Patient Monitors O (Passport 12m, Passport 17m and T1), 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.
O In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.

ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2 :2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-2-25: 2011 (2nd edition) Particular requirements for the basic safety and essential performance of electrocardiographs

IEC 60601-2-27:2011 (3rd edition) Particular requirements for the safety, including essential performance of electrocardiographic monitoring equipment ISO 80601-2-61:2011 Particular requirements for the basic safety and essential performance of pulse oximeter equipment

IEC 80601-2-30:2009/AMD1:2013 Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers ISO 80601-2-56:2009 (First edition) Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement

IEC 60601-2-34 (Third Edition): 2011 Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

ISO 80601-2-55 First edition 2011-12-15 Medical electrical equipment - Part

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2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

Substantial Equivalence Conclusion:

Based on the detailed comparison of specifications for each of the modifications to the previously cleared Passport Series devices, Passport 12m and Passport 17m (K170876) and relevant reference predicates, T1 (K152902) and relevant reference predicates, the performance testing results and conformance with applicable standards show that the Passport Series Patient Monitors (including Passport 12m, Passport 17m and T1) can be found substantially equivalent to the predicate devices.

Regulation Number and Section

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

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