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), and respiration mechanics (RM). 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/Scv02, and PAWP 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:

Passport 12m Patient Monitor ●
o 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

The provided text focuses on the substantial equivalence of the Passport Series Patient Monitors to predicate devices, rather than outlining specific acceptance criteria and a study demonstrating the device meets those criteria with detailed performance metrics. The information pertains to a 510(k) submission, which aims to show equivalence to a legally marketed device, not necessarily to prove it meets pre-defined acceptance criteria with a new, standalone study the way a PMA might.

However, I can extract information related to performance testing and changes from the provided text.

Here's an analysis based on the supplied document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds that the device must meet for specific clinical performance metrics. Instead, it describes "performance data" in the context of demonstrating substantial equivalence to a predicate device. The performance is assessed against the specifications of the predicate device and relevant consensus standards.

The table in the document (pages 7-8) compares the features and performance specifications of the subject devices to the predicate device (K143195). The relevant performance aspects are nested within the "Feature" column and include:

Feature/Parameter	Acceptance Criteria (Implicit - from Predicate or Standards)	Reported Device Performance (Subject Device)
Respiration Rate (Resp)	Measurement range: Adult: 0 to 120 rpm; Pediatric, neonate: 0 to 150 rpm. Accuracy: 7 to 150 rpm: ±2 rpm or ±2%, whichever is greater.	Same (Equivalent to predicate)
Temperature (Temp)	Measurement range: 0 to 50°C (32 to 122°F). Accuracy: ±0.1°C or ±0.2°F (without probe).	Same (Equivalent to predicate)
Pulse Oxygen Saturation (SpO2) - Mindray Module	Measurement range: 0 to 100%. Accuracy: 70 to 100%: ±2% (adult/pediatric mode); 70 to 100%: ±3% (neonate mode); 0% to 69%: Not specified.	Same (Equivalent to predicate)
Pulse Oxygen Saturation (SpO2) - Masimo Module	Measurement range: 1 to 100%. Accuracy: 70 to 100%: ±2% (without motion, adult/pediatric); 70 to 100%: ±3% (without motion, neonate); 70 to 100%: ±3% (with motion); 1% to 69%: Not specified.	Same (Equivalent to predicate)
Pulse Oxygen Saturation (SpO2) - Nellcor Module	Measurement range: 0 to 100%. Accuracy: 70 to 100%: ±2% (adult/pediatric); 70 to 100%: ±3% (neonate); 0% to 69%: Not specified.	Same (Equivalent to predicate)
Pulse Rate (PR) - from Mindray SpO2 Module	Measurement range: 20 to 254 bpm. Accuracy: ±3 bpm.	Same (Equivalent to predicate)
Pulse Rate (PR) - from Masimo SpO2 Module	Measurement range: 25 to 240 bpm. Accuracy: ±3 bpm (without motion); ±5 bpm (with motion).	Same (Equivalent to predicate)
Pulse Rate (PR) - from Nellcor SpO2 Module	Measurement range: 20 to 300 bpm. Accuracy: 20 to 250 bpm: ±3 bpm.	Same (Equivalent to predicate)
Pulse Rate (PR) - from IBP Module	Measurement range: 25 to 350 bpm. Accuracy: ±1 bpm or ±1%, whichever is greater.	Same (Equivalent to predicate)
Non-invasive Blood Pressure (NIBP) - Adult	Measurement range: Systolic: 40 to 270; Diastolic: 10 to 210; Mean: 20 to 230. Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg.	Same (Equivalent to predicate)
Non-invasive Blood Pressure (NIBP) - Pediatric	Measurement range: Systolic: 40 to 200; Diastolic: 10 to 150; Mean: 20 to 165. Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg.	Same (Equivalent to predicate)
Non-invasive Blood Pressure (NIBP) - Neonate	Measurement range: Systolic: 40 to 135; Diastolic: 10 to 100; Mean: 20 to 110. Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg.	Same (Equivalent to predicate)
Invasive Blood Pressure (IBP)	Measurement range: -50 to 300 mmHg. Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor).	Same (Equivalent to predicate)
Carbon Dioxide (CO2) - Sidestream Module	Measurement range: 0 to 99 mmHg. Accuracy: 0 to 40 mmHg: ±2 mmHg; 41 to 76 mmHg: ±5% of reading; 77 to 99 mmHg: ±10% of reading.	Same (Equivalent to predicate)
Carbon Dioxide (CO2) - Microstream Module	Measurement range: 0 to 99 mmHg. Accuracy: 0 to 38 mmHg: ±2 mmHg; 39 to 99 mmHg: ±5% of reading + 0.08% of (reading-38).	Same (Equivalent to predicate)
Carbon Dioxide (CO2) - Mainstream Module	Measurement range: 0 to 150 mmHg. Accuracy: 0 to 40 mmHg: ±2 mmHg; 41 to 70 mmHg: ±5% of reading; 71 to 100 mmHg: ±8% of reading; 101 to 150 mmHg: ±10% of reading.	Same (Equivalent to predicate)
Impedance Cardiograph (ICG)	Measurement range: SV: 5 to 250 ml; HR: 4 to 200 bpm; C.O.: 1.4 to 15 L/min. Accuracy: HR: ±2 bpm. (SV and C.O. not specified for accuracy).	Same (Equivalent to predicate)

Note: For features like "QT analysis" (added to ECG Mindray Algorithm) and "AFib" (added to Arrhythmia Analysis Mindray Algorithm), and "Adjustable QRS Detection Threshold" (added), the document states "Added" or "Same" but does not provide specific performance metrics or acceptance criteria for these new or modified features in the provided text. It generally states that "The testing provided an evaluation of the performance of the device relevant to each of the modifications... 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."

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Mindray conducted functional and system level testing on the subject devices." It does not specify the sample size for this testing or the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be internal engineering and verification testing rather than a clinical trial with patient data.

3. Number of Experts and Qualifications

The document makes no mention of experts being used to establish ground truth for a test set. The validation described is based on engineering and system-level testing against specifications derived from the predicate device and consensus standards.

4. Adjudication Method

No adjudication method is mentioned, as there is no indication of expert review or clinical ground truth establishment in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a MRMC comparative effectiveness study, nor does it mention any effect size of human readers improving with or without AI assistance. This type of study would typically be conducted for diagnostic or interpretive algorithms, not necessarily for a multi-parameter patient monitor's basic physiological parameter measurements.

6. Standalone (Algorithm Only) Performance Study

The document generally refers to "functional and system level testing" and "conformance with applicable standards." While this implies algorithm performance was assessed as part of the overall device functionality, it does not specifically detail a standalone algorithm-only performance study with dedicated metrics like sensitivity, specificity, accuracy, etc., for a particular diagnostic output. The focus is on the device's ability to measure and present physiological parameters in a manner equivalent to the predicate.

7. Type of Ground Truth Used

Based on the provided text, the ground truth for the performance evaluations (e.g., accuracy of measurement ranges) would likely be established using calibrated test equipment, simulation, and potentially comparison to established reference methods or predicate device outputs during engineering and system-level testing. There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for this submission. The "ground truth" for showing equivalence seems to be alignment with predicate device specifications and recognized consensus standards.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This is a 510(k) submission for a patient monitor, not a machine learning or AI-driven diagnostic device that would typically involve a separate training set. While the device does have "arrhythmia detection" and "ST segment analysis" algorithms, the document focuses on their functional equivalence and adherence to standards rather than detailing the methodology of their development or independent training/testing.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned, this information is not provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, representing health and human services.

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

February 18, 2016

Shenzhen Mindray Bio-medical Electronics Co., Ltd Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan Shenzhen. 518057 CN Re: K152902 Trade/Device Name: Passport Series Patient Monitors (Passport 12m, Passport 17m 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, DSI, MLD, DRT, DXN, DSK, FLL, DOA, DPZ, CCK, CBO, CBS, CBR, CCL, DSB, DXG, OLW Dated: February 4, 2016 Received: February 5, 2016

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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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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 at its toll-free number (800) 638-2041 or (301) 796-7100 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Kenneth J. Cavanaugh -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) K152902

Device Name

Passport Series Patient Monitors (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, and PAWP 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:

· 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 (including Passport 17m,Passport 12m and T1)
Submitter:	SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680
Contact:	Yanhong BaiManager Regulatory AffairsSHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, Nanshan518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com
Date Prepared:	September 30, 2015
Classification Regulation:	21 CFR 870.1025, Class II, Arrhythmia detector and alarm(including ST-segment measurement and alarm)
Panel:	Cardiovascular

Classification Regulation, Classification Name and Product Codes:

ProductCode	RegulationNumber	Panel	Regulation Description	Device Common Name
Primary
MHX	21 CFR870.1025	Cardiovascular	Arrhythmia detector andalarm (including ST-segment measurement andalarm)	monitor, physiological, patient(with arrhythmia detection oralarms)
Secondary
ProductCode	RegulationNumber	Panel	Regulation Description	Device Common Name
DSI	21 CFR870.1025	Cardiovascular	Arrhythmia detector andalarm (including ST-segment measurement andalarm)	detector and alarm, arrhythmia
MLD	21 CFR870.1025	Cardiovascular	Arrhythmia detector andalarm (including ST-segment measurement andalarm)	monitor, st segment with alarm
DRT	21 CFR870.2300	Cardiovascular	Cardiac Monitor(includingcardiotachometer and ratealarm)	monitor, cardiac (incl.cardiotachometer & rate alarm)
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 CFR868.1500	Anesthesiology	Enflurane gas analyzer	analyzer, gas, enflurane,gaseous-phase (anestheticconcentration)
CBS	21 CFR868.1620	Anesthesiology	Halothane gas analyzer	analyzer, gas, halothane,gaseous-phase (anesthetic conc.)
CBR	21 CFR868.1700	Anesthesiology	Nitrous oxide gasanalyzer	analyzer, gas, nitrous-oxide,gaseous phase (anesthetic conc.)
CCL	21 CFR868.1720	Anesthesiology	Oxygen gas analyzer	analyzer, gas, oxygen, gaseous-phase
DSB	21 CFR870.2770	Cardiovascular	Impedanceplethysmograph	plethysmograph, impedance
DXG	21 CFR870.1435	Cardiovascular	Single-function,preprogrammeddiagnostic computer	computer, diagnostic, pre-programmed, single-function
OLW	21 CFR882.1400	Neurology	Electroencephalograph	index-generatingelectroencephalograph software

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Primary Predicate Device:	K143195 - Passport Series Patient Monitors (Including Passport 17M, Passport 12m, and T1); Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Reference Predicates:	K101521 - Philips ST/AR ST and Arrhythmia Software Model; Philips Medical Systems
	K150352 - V Series Monitoring System; Shenzhen Mindray Bio-Medical Electronics Co., Ltd
	K150632 - Hypervisor IX Monitoring System; Shenzhen Mindray Bio-Medical Electronics Co., Ltd

Indications for Use:

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 (3lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, OT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), and respiration mechanics (RM). 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, o CCO, SvO2/ScvO2, and PAWP 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, storing, alarming, 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

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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 Mindrav ECG algorithm is intended for adult patients ● only.

Device Description:

The subject Passport Series Patient Monitors includes three monitors:

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

Performance Data:

o To establish the substantial equivalence of the Passport Series Patient Monitors (including 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.
In addition. Mindray has conducted testing to ensure the subject devices meet relevant ● consensus standards.
- Mindray has also followed the FDA Class II Special Controls Guidance Document: ● Arrhythmia Detector and Alarm issues on October 28, 2003.

Substantial Equivalence:

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Comparison of Indications - Both the predicate device and the subject Passport 12m, Passport 17m and T1 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 have been modified to include the new feature of QT analysis. Although this feature is not present in the predicate device, it is present in the cleared Philips ST/AR ST and Arrhythmia software (K101521), 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. Passport 17m and T1 as multiparameter monitors.

Comparison of Technological Characteristics - The table below compares the key technological feature of the subject devices to the primary predicate device (the Mindray Passport Series Patient Monitors K143195). 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 (K143195)			Subject Devices
Feature	17m	12m	T1	17m	12m	T1
Integrateddisplay andtouchscreen	17"1280*1024pixels	12"800*600pixels	5", 480*272 pixels	Same	Same	Same
Secondarydisplay	Independentcontrol anddisplay	Display islinked tointegrateddisplay	Independentdisplay andcontrol via a VGAport in the T1docking station	Same	Same	Same
Additionaldisplayfeatures	The minitrends diagram, OxyCRG diagram, othermonitor view, and calculation can be viewedwhen using an external LCD screen	Same	Same	Same	Same	Same
Wirelessmodule	The ASUSmodule isused forconnectingto a networkwirelessly.constructinga monitoringnetworkwith acentralmonitoringsystem(CMS).	Supportwirelessfunctionusing theASUS andSilexwirelessmodule.	Support wirelessfunction using theCyberlink wirelessmodule	Same	Same	Same
Module rack	Independent of the patientmonitor, provides 8standard module slots toextend the measurementcapabilities of the system	Same	Not supported	Same	Same	Same
	Predicate Device (K143195)			Subject Devices
Feature	17m	12m	T1	17m	12m	T1
Power supply	TworechargeableLithium-ionbattery orAC powersupply	OnerechargeableLithium-ionbattery orAC powersupply	One rechargeableLithium-ionbattery or DCpower supply orAC power supply	Same	Same	Same
Battery	Chargeable Lithium-Ion,11.1 VDC, 4500 mAh, 350 g	Chargeable Lithium-Ion,11.1 VDC, 4500 mAh, 350 g	ChargeableLithium-Ion, 7.4VDC, 2500 mAh	Same	Same	Same
Externalmemory card	Compact Flash	Compact Flash	Secure Digital	Same	Same	Same
DataRecorder	The thermal recorderrecords patient information,measurement numerics, upto three waveforms, etc.		Not supported	Same	Same	Same
Speaker	Give alarm tones (45 to 85 dB), key tones, QRStones; support PITCH TONE and multi-leveltone modulation		Give alarm tones (45 to 85 dB), key tones, QRStones; support PITCH TONE and multi-leveltone modulation	Same	Same	Same
Supports T1as a module	Supported	Supported	/	Same	Same	/
ECG(MindrayAlgorithm)	3-lead , 5-lead or 12-lead selectable, arrhythmiadetection, ST segment analysis, an interpretationof resting 12-lead ECG, J-point Auto detection,Dual channel Pace detection and heart rate (HR)			Added QT analysis
ECG(MortaraAlgorithm)	3-lead , 5-lead or 12-lead selectable, arrhythmiadetection, ST segment analysis, J-point Autodetection, and heart rate (HR)			Same
ArrhythmiaAnalysis(MindrayAlgorithm)	Asystole, VFib/VTac, Vtac, Vent. Brady,Extreme Tachy, Extreme Brady, PVC, Couplet,Bigeminy, Trigeminy, R on T, VT>2, PVCs,Tachy, Brady, Missed Beats, Vent. Rhythm,PNP, PNC, Multif. PVC,Nonsus. Vtac, Pause, Irr. Rhythm			Added AFib
ArrhythmiaAnalysis(MortaraAlgorithm)	Asystole, Vfib, Vtac, Vent. Rhythm, Couplet,VT>2, Bigeminy, Trigeminy, R on T, Multif.PVC, Irr. Rhythm, Tachy, Brady, Missed Beats,PNP, PNC			Same
AdjustableQRSDetectionThreshold(MindrayAlgorithm)	Not supported	Not supported	Not supported	Added
Respirationrate (Resp)	Measurement range:Adult: 0 to 120 rpm; Pediatric, neonate: 0 to 150 rpm.Accuracy:7 to 150 rpm: ±2 rpm or ±2%, whichever isgreater;	Measurement range:Adult: 0 to 120 rpm; Pediatric, neonate: 0 to 150 rpm.Accuracy:7 to 150 rpm: ±2 rpm or ±2%, whichever isgreater;	Measurement range:Adult: 0 to 120 rpm; Pediatric, neonate: 0 to 150 rpm.Accuracy:7 to 150 rpm: ±2 rpm or ±2%, whichever isgreater;	Same	Same	Same
	Predicate Device (K143195)			Subject Devices
Feature	17m	12m	T1	17m	12m	T1
Temperature(Temp)	Measurement range: 0 to 50°C (32 to 122°F)Accuracy: ±0.1°C or ±0.2°F (without probe)			Same	Same	Same
Pulse oxygensaturation(SpO2)	Mindray SpO2 ModuleMeasurement range: 0 to 100%Accuracy:70 to 100%: ±2% (adult/pediatricmode)70 to 100%: ±3% (neonate mode)0% to 69%: Not specified.Masimo SpO2 ModuleMeasurement range: 1 to 100%Accuracy:70 to 100%: ±2% (measured withoutmotion in adult/pediatric mode)70 to 100%: ±3% (measured without motion inneonate mode)70 to 100%: ±3% (measured with motion)1% to 69%: Not specified.Nellcor SpO2 ModuleMeasurement range: 0 to 100%Accuracy:70 to 100%: ±2% (adult/pediatric)70 to 100%: ±3% (neonate)0% to 69%: Not specified.			Same	Same	Same
Pulse rate(PR)	PR from Mindray SpO2 ModuleMeasurement range: 20 to 254 bpmAccuracy:±3 bpmPR from Masimo SpO2 ModuleMeasurement range: 25 to 240 bpmAccuracy:±3 bpm (measured without motion)±5 bpm (measured with motion)PR from Nellcor SpO2 ModuleMeasurement range: 20 to 300 bpmAccuracy:20 to 250 bpm: ±3 bpm251 to 300 bpm, not specifiedPR from IBP ModuleMeasurement range: 25 to 350 bpmbpmAccuracy:±1 bpm or ±1%, whichever is greater"			Same	Same	Same
Non-invasivebloodpressure(NIBP)	Measurement range:AdultSystolic: 40 to 270Diastolic: 10 to 210Mean: 20 to 230PediatricSystolic: 40 to 200Diastolic: 10 to 150Mean: 20 to 165NeonateSystolic: 40 to 135Diastolic: 10 to 100Mean: 20 to 110Accuracy:Max mean error: ±5 mmHgMax standard deviation: 8 mmHg			Same	Same	Same
	Predicate Device (K143195)			Subject Devices
Feature	17m	12m	T1	17m	12m	T1
Invasivebloodpressure(IBP)	Measurement range: -50 to 300 mmHgAccuracy:±2% or ±1 mmHg, whichever isgreater (without sensor)			Same	Same	Same
PulsePressureVariation(PPV)	Supported feature of IBP			Same	Same	Same
Cardiacoutput (C.O.)	The temperature change isdisplayed as a curve in theC.O. split screen, and themonitor calculates the C.O.value from this curve. Themonitor is capable ofstoring 6 measurements.		Not supported	Same	Same	Same
Continuouscardiacoutput (CCO)	CCO/SvO2 interfacemodule is used to interfacewith Edwards Vigilance IImonitor / Vigileo Monitorwhich measures continuouscardiac output (CCO) andmixed venous oxygensaturation (SvO2).		Not supported	Same	Same	Same
Mixed/centralvenousoxygensaturation(SvO2/ScvO2)	CCO/SvO2 interfacemodule is used to interfacewith Edwards Vigilance IImonitor / Vigileo Monitorwhich measures mixedvenous oxygen saturation(SvO2) and central venousoxygen saturation (ScvO2).		Not supported	Same	Same	Same
Carbondioxide(CO2)	Sidestream CO2 Module:Measurement range: 0 to 99 mmHgAccuracy:0 to 40 mmHg: ±2 mmHg41 to 76 mmHg: ±5% of the reading77 to 99 mmHg: ±10% of the readingMicrostream CO2 Module:Measurement range: 0 to 99 mmHgAccuracy:0 to 38 mmHg: ±2 mmHg39 to 99 mmHg: ±5% of the reading ±5% of thereading+0.08% of (the reading-38)Mainstream CO2 Module:Measurement range: 0 to 150 mmHgAccuracy:0 to 40 mmHg: ±2 mmHg41 to 70 mmHg: ±5% of the reading71 to 100 mmHg: ±8% of the reading101 to 150 mmHg: ±10% of the reading			Same	Same	Same
Feature	Predicate Device (K143195)			Subject Devices
	17m	12m	T1	17m	12m	T1
Oxygen (O2)	Oxygen values arecalculated based on userinput and not directlymeasured.		Not supported	Same	Same	Same
Anestheticgas (AG)	The AG module canidentify two anestheticgases in a mixtureautomatically anddistinguish between themaccording to theircontributions to the MACvalue for display as theprimary and secondaryanesthetic agents.		Not supported	Same	Same	Same
Impedancecardiograph(ICG)	Measurement range:SV: 5 to 250 mlHR: 44 to 2mC.O. 1.4 to 15 L/minAccuracy:SV: Not specified.HR: ±2 bpmC.O. Not specified.		Not supported	Same	Same	Same
Bispectralindex (BIS)	Measured parameters:EEG, BIS, BIS L, BIS R		Not supported	Same	Same	Same
Respirationmechanics(RM)	Measurement range: Adult:0 to 120 rpm; Pediatric,neonate: 0 to 150 rpm.Accuracy: 7 to 150 rpm:±2rpm or ±2%, whichever isgreater;0 to 6 rpm: Not specified."		Not supported	Same	Same	Same
2 Newneonatal pre-wiredelectrode	Not supported			Added

Device Comparison Table

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Substantial Equivalence Conclusion:

Based on the detailed comparison of specifications for each of the modifications to the previously cleared Passport Series devices (K143195), the performance testing and conformance with applicable standards, 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.