The Passport 17M and Passport 12M patient monitors are intended for monitoring. displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-mvasive 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 (Sy()//Scy(), 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, CCO. SvOz/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.

The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpOz), 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;

Device Description

The subject Passport Series Patient Monitors includes three monitors:

. Passport 12M Patient Monitor
Passport 17M Patient Monitor ●
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.

Each of the three monitors that are the subject of this 510(k) are modified versions of previously cleared Mindray devices. The Passport 17M and Passport 12M were previously cleared in K132075, on April 18, 2014 and the T1 was previously cleared in K123074 on July 3, 2013.

AI/ML Overview

The provided text is a 510(k) Summary for the Mindray Passport Series Patient Monitors (K143195). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a single study proving that the device meets those criteria.

The core of the submission is that the subject devices are modified versions of previously cleared Mindray devices (K132075 and K123074). The performance data cited refers to functional and system-level testing to evaluate the performance of the modifications and ensure continued adherence to specifications and relevant consensus standards. It does not contain information about a specific single study with acceptance criteria and results.

Given the nature of the K143195 submission as an amendment/modification to existing devices, the information provided focuses on the changes and how these changes do not alter the substantial equivalence to the predicate devices. Therefore, the requested information about acceptance criteria and a detailed study proving the device meets those criteria for the entire device as if it were a novel submission is not explicitly present in the provided text.

However, I can extract information related to the performance characteristics, which serve as implicit acceptance criteria based on the predicate device's performance and general recognized standards for patient monitors.

Here's an attempt to structure the answer based on the available information, noting where specific details are not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with corresponding performance results in a standalone "study summary" format. Instead, it compares the specifications of the subject devices to the predicate device. The "acceptance criteria" are implied to be the specifications of the predicate device and relevant industry standards. The "reported device performance" is generally stated as "Same" or that the new (modified) features "meet specifications" or "are equivalent to the predicate device."

Here's an illustrative table based on the provided "Device Comparison Table," highlighting areas that could be inferred as "acceptance criteria" and "performance":

Feature Category	Parameter	Implicit Acceptance Criteria (from Predicate Device K132075)	Reported Subject Device Performance (K143195)
General	Indications for Use	Monitoring, displaying, reviewing, alarming, and transferring multiple physiological parameters for adult, pediatric, and neonatal patients (with specific exceptions).	For Passport 12M/17M, "Same" as predicate device. For T1, Indications are a "subset" of the predicate. New feature: 12-lead ECG interpretation, noted as present in cleared Mindray V Series (K132026), implying equivalence.
Display	Integrated display and touchscreen (17M)	17", 1280*1024 pixels	Same
	Integrated display and touchscreen (12M)	12", 800*600 pixels	Same
	Integrated display and touchscreen (T1)	(Predicate K123074: 5", 480*272 pixels)	5", 480*272 pixels (same as K123074)
	Secondary display (Passport 12M/17M)	Independent control and display (17M), Linked to integrated display (12M)	Same
	Secondary display (T1)	N/A in predicate K132075	Independent display and control via a VGA port in the T1 docking station (new feature for T1)
Connectivity	Wireless module (Passport 17M)	ASUS module for network connection	Same
	Wireless module (Passport 12M)	ASUS module for network connection	Added support for Silex wireless module. "Mindray conducted Wireless functionality testing to ensure the performance of the new wireless modules meet specifications and are equivalent to the predicate device."
	Wireless module (T1)	N/A in predicate K132075	Added wireless function using the Cyberlink wireless module. "Mindray conducted Wireless functionality testing to ensure the performance of the new wireless modules meet specifications and are equivalent to the predicate device."
Physiological Params	ECG (features)	3-lead, 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, heart rate	Same
	12-lead ECG interpretation	Not supported (Predicate K132075)	Supported (All subject devices). Justified by equivalence to K132026. Performance not detailed here.
	ECG J-point auto detection	Supported	Same (17M, 12M). Added (T1). Performance not detailed.
	Respiration rate (Resp) Measurement & Accuracy	Adult: 0-120 rpm, Pediatric/Neonate: 0-150 rpm. Accuracy: 7-150 rpm: ±2 rpm or ±2%, whichever is greater; 0-6 rpm: Not specified.	Same
	Temperature (Temp) Measurement & Accuracy	0-50°C (32-122°F). Accuracy: ±0.1°C or ±0.2°F (without probe).	Same
	SpO2 Measurement & Accuracy (Mindray SpO2)	Range: 0-100%. Accuracy: 70-100%: ±2% (adult/pediatric), ±3% (neonate); 0-69%: Not specified.	Same
	SpO2 Measurement & Accuracy (Masimo SpO2)	Range: 1-100%. Accuracy: 70-100%: ±2% (no motion, adult/pediatric), ±3% (no motion, neonate), ±3% (with motion); 1-69%: Not specified.	Same
	SpO2 Measurement & Accuracy (Nellcor SpO2)	Range: 0-100%. Accuracy: 70-100%: ±2% (adult/pediatric), ±3% (neonate); 0-69%: Not specified.	Same
	Pulse rate (PR) from SpO2 Module	Mindray SpO2: 20-254 bpm, ±3 bpm. Masimo SpO2: 25-240 bpm, ±3 bpm (no motion), ±5 bpm (with motion). Nellcor SpO2: 20-300 bpm, 20-250 bpm: ±3 bpm.	Same
	Pulse rate (PR) from IBP Module	25-350 bpm, ±1 bpm or ±1%.	Same
	NIBP Measurement & Accuracy	Adult Systolic: 40-270 mmHg, Diastolic: 10-210 mmHg, Mean: 20-230 mmHg. Pediatric Systolic: 40-200 mmHg, Diastolic: 10-150 mmHg, Mean: 20-165 mmHg. Neonate Systolic: 40-135 mmHg, Diastolic: 10-100 mmHg, Mean: 20-110 mmHg. Accuracy: Max mean error: ±5 mmHg, Max standard deviation: 8 mmHg.	Same
	IBP Measurement & Accuracy	Range: -50 to 300 mmHg. Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor).	Same
	Pulse Pressure Variation (PPV)	Supported feature of IBP (Passport 12M/17M)	Same (17M, 12M). Added (T1).
	CO2 Measurement & Accuracy	Sidestream: 0-99 mmHg; Accuracy: 0-40 mmHg: ±2 mmHg, 41-76 mmHg: ±5%, 77-99 mmHg: ±10%. Microstream: 0-99 mmHg; Accuracy: 0-38 mmHg: ±2 mmHg, 39-99 mmHg: ±5% +0.08% of (reading-38). Mainstream: 0-150 mmHg; Accuracy: 0-40 mmHg: ±2 mmHg, 41-70 mmHg: ±5%, 71-100 mmHg: ±8%, 101-150 mmHg: ±10%.	Specifications unchanged. Modules repackaged to occupy a single slot. (All subject devices).
Other	3 Additional SpO2 Sensors	None (Predicate K132075)	Added LNCS NeoPt, LNCS Neo, LNCS Inf. Cleared in K132037 (implies their performance against specific standards is already established).
	4 New NIBP cuffs	None (Predicate K132075)	Added CM1306, CM1307, CM1506, CM1507. Substantial equivalent to NIBP cuffs cleared in K132075 and K092449 (implies their performance against specific standards is already established).

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

The document does not detail specific sample sizes for test sets for individual parameters or features. It states:

"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."
"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."
"Mindray conducted Wireless functionality testing to ensure the performance of the new wireless modules meet specifications and are equivalent to the predicate device."

There is no mention of data provenance (e.g., country of origin, retrospective/prospective). The studies appear to be internal V&V testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

There is no information provided regarding the number or qualifications of experts used to establish ground truth for any test sets. The testing referenced appears to be engineering/technical validation against specifications and standards rather than clinical studies requiring expert adjudication of data. For interpretations like 12-lead ECG, it is stated that the feature is equivalent to a previously cleared device (K132026), implying that its validation methods would have been established there.

4. Adjudication Method for the Test Set

No adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study is mentioned. This type of study is typically done for diagnostic imaging devices or algorithms where human interpretation is a key component and the AI is intended to assist, altering reader performance. For a patient monitor, the performance validation is typically against direct physiological measurements and established standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The entire device (the patient monitor) is a standalone system in the sense that its algorithms process physiological signals and present data and alarms. The performance data described ("functional and system level testing") would inherently be evaluating the algorithms and hardware in isolation from a human interpretation loop. For example, SpO2 accuracy is measured against a reference, not against a human's interpretation of SpO2. The 12-lead ECG interpretation, being an automated algorithm output, would be assessed for its accuracy as a standalone function.

7. The Type of Ground Truth Used

Based on the nature of the device (physiological monitor) and the parameters listed, the ground truth would typically be established by:

Reference standards/equipment: For parameters like NIBP, IBP, SpO2, Temperature, CO2, etc., the device's measurements are compared against highly accurate reference measurement equipment or simulators.
Known input signals: For features like arrhythmia detection, standardized ECG waveforms with known arrhythmias are often used.
Clinical data: For capabilities like 12-lead ECG interpretation, ground truth is usually established by highly experienced cardiologists' interpretations, though the document only refers to equivalence to a previously cleared device for this feature.
Specifications: The "acceptance criteria" are derived from the performance specifications of the predicate device and relevant international standards.

8. The Sample Size for the Training Set

The document does not describe the development or training of AI/ML algorithms. It is a 510(k) for hardware and software modifications to an existing patient monitor, rather than a novel AI/ML device. Therefore, no information on training set sample size is provided. The functions described (e.g., arrhythmia detection, ST segment analysis) typically rely on established signal processing algorithms, not necessarily machine learning requiring explicit "training sets" in the modern sense.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for AI/ML algorithms, this information is not applicable and not provided in the document.

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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

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

December 22, 2014

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

Re: K143195

Trade/Device Name: Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (With Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MHX Dated: Undated Received: November 6, 2014

Dear Ms. Yanhong Bai,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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,

Melissa A. Torres -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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K143195

Page 1

510(k) Number (if known): K143195

Device Name : Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)

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. SvOz/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.

T1 Patient Monitor:

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K143195

Page __ 2__ of __ 2__

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;

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

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510(K) SUMMARY 1.

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 (includingPassport 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:	November 4, 2014
Classification Regulation:	21 CFR 870.1025, Class II, Arrhythmia detectorand alarm (including ST-segment measurementand alarm)
Panel:	Cardiovascular

Classification Regulation, Classification Name and Product Codes:

ProductCode	RegulationNumber	Panel	Regulation Description	Device Common Name
Primary
ProductCode	RegulationNumber	Panel	Regulation Description	Device Common Name
MHX	21 CFR870.1025	Cardiovascular	Arrhythmia detector andalarm (includingST-segmentmeasurement and alarm)	monitor, physiological,patient (with arrhythmiadetection or alarms)
Secondary
DSI	21 CFR870.1025	Cardiovascular	Arrhythmia detector andalarm (includingST-segmentmeasurement and alarm)	detector and alarm,arrhythmia
MLD	21 CFR870.1025	Cardiovascular	Arrhythmia detector andalarm (includingST-segmentmeasurement and alarm)	monitor, st segment withalarm
DRT	21 CFR870.2300	Cardiovascular	Cardiac Monitor(includingcardiotachometer andrate alarm)	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 pressurecomputer	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)
ProductCode	RegulationNumber	Panel	Regulation Description	Device Common Name
CBS	21 CFR868.1620	Anesthesiology	Halothane gas analyzer	analyzer, gas, halothane,gaseous-phase (anestheticconc.)
CBR	21 CFR868.1700	Anesthesiology	Nitrous oxide gasanalyzer	analyzer, gas,nitrous-oxide, gaseousphase (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-generatingelectroencephalographsoftware

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Predicate Device:

K132075 - PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M), Mindray North America.

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 (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment 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:

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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:

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, 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;

Device Description:

The subject Passport Series Patient Monitors includes three monitors:

. Passport 12M Patient Monitor
Passport 17M Patient Monitor ●
T1 Patient Monitor

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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.

Performance Data:

. 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.
. The T1 has been modified to provide wireless functionality. The existing wireless functionality of Passport 12M Monitor has been modified to include a new wireless module. The wireless capabilities of the Passport 17M remain unchanged. Mindray conducted Wireless functionality testing to ensure the performance of the new wireless modules meet specifications and are equivalent to the predicate device.

Substantial Equivalence:

Comparison of Indications - Both the predicate device and the subject family of 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 T1 device are a subset of those for the predicate device, as the T1 device includes a subset of the functionality. The indications for use of the Passport 12M, Passport 17M and T1 also include the new feature of 12-lead ECG interpretation. Although this feature is not present in the predicate device, it is present in the cleared Mindray V Series Monitoring System (K132026), and thus does not constitute a new intended use for a multi-parameter monitor.

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 M K132075). The features in grey are the features that have been modified since their previous clearances and that are the subject of this 510(k).

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	Predicate Device (K132075)		Subject Devices
Feature	17M	12M	17M	12M	T1
Integrateddisplay andtouchscreen	17"1280*1024pixels	12" 800*600pixels	Same	Same	5", 480*272pixels(same asK123074)
Secondarydisplay	Independentcontrol anddisplay	Display islinked tointegrateddisplay	Same	Same	Independentdisplay andcontrol via aVGA port in theT1 dockingstation
Additionaldisplayfeatures	The minitrends diagram,OxyCRG diagram, othermonitor view, and calculationcan be viewed when using anexternal LCD screen		Same	Same	Added
Wirelessmodule(ASUS)	The ASUS module is used forconnecting to a networkwirelessly, constructing amonitoring network with acentral monitoring system(CMS).		Same	Added supportfor Silexwireless module	Added wirelessfunction usingthe Cyberlinkwirelessmodule
Module rack	Independent of the patientmonitor, provides 8 standardmodule slots to extend themeasurement capabilities ofthe system		Same	Same	Not supported
Power supply	TworechargeableLithium-ionbattery orAC powersupply	OnerechargeableLithium-ionbattery or ACpower supply	Same	Same	OnerechargeableLithium-ionbattery or DCpower supply orAC powersupply(same asK123074)
Feature	Predicate Device (K132075)		Subject Devices
	17M	12M	17M	12M	T1
Battery	Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh, 350 g	Same	Same	Same	Chargeable Lithium-Ion, 7.4 VDC, 2500 mAh (same as K123074)
External memory card	Compact Flash	Same	Same	Same	Secure Digital (same as K123074)
Data Recorder	The thermal recorder records patient information, measurement numerics, up to three waveforms, etc.	Same	Same	Same	Not supported
Speaker	Give alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation	Same	Same	Same	Same
ECG	3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, heart rate	Same	Same	Same	Same
12-lead ECG interpretation	Not supported	Supported	Supported	Supported	Supported
ECG J-point auto detection	Supported	Same	Same	Same	Added
Respiration rate (Resp)	Measurement range: Adult: 0 to 120 rpm; Pediatric, neonate: 0 to 150 rpm. Accuracy: 7 to 150 rpm: $\pm$ 2 rpm or $\pm$ 2%, whichever is greater; 0 to 6 rpm: Not specified.	Same	Same	Same	Same
Temperature (Temp)	Measurement range: 0 to 50°C (32 to 122°F) Accuracy: $\pm$ 0.1°C or $\pm$ 0.2°F (without probe)	Same	Same	Same	Same
Feature	Predicate Device (K132075)		Subject Devices
	17M	12M	17M	12M	T1
Pulse oxygensaturation(SpO2)	Mindray SpO2 ModuleMeasurement range: 0 to 100%Accuracy:70 to 100%: ±2%(adult/pediatric mode)70 to 100%: ±3% (neonatemode)0% to 69%: Not specified.Masimo SpO2 ModuleMeasurement range: 1 to 100%Accuracy:70 to 100%: ±2%(measured without motion inadult/pediatric mode)70 to 100%: ±3% (measuredwithout motion in neonatemode)70 to 100%: ±3% (measuredwith 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

Device Comparison Table

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K143195
Page 8 of 13

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	Predicate Device (K132075)		Subject Devices
Feature	17M	12M	17M	12M	T1
Pulse rate(PR)	PR from Mindray SpO2ModuleMeasurement range: 20 to 254 bpmAccuracy: $\pm$ 3 bpmPR from Masimo SpO2ModuleMeasurement range: 25 to 240 bpmAccuracy: $\pm$ 3 bpm (measured without motion)$\pm$ 5 bpm (measured with motion)PR from Nellcor SpO2ModuleMeasurement range: 20 to 300 bpmAccuracy:20 to 250 bpm: $\pm$ 3 bpm251 to 300 bpm, not specifiedPR from IBP ModuleMeasurement range: 25 to 350 bpmAccuracy: $\pm$ 1 bpm or $\pm$ 1%, whichever is greater"		Same	Same	Same
	Predicate Device (K132075)		Subject Devices
Feature	17M	12M	17M	12M	T1
Non-invasivebloodpressure(NIBP)	Measurement range:AdultPediatricSystolic: 40 to 270200Diastolic: 10 to 210150Mean: 20 to 230to 165Accuracy:Max mean error: ±5 mmHgMax standard deviation: 8mmHg	Measurement range:AdultPediatricNeonate40 to40 to 13510 to10 to 1002020 to 110	Same	Same	Same
Invasivebloodpressure(IBP)	Measurement range: -50 to300 mmHgAccuracy:±2% or ±1 mmHg,whichever is greater (withoutsensor)		Same	Same	Same
PulsePressureVariation(PPV)	Supported feature of IBP		Same	Same	Added
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 of storing 6measurements.		Same	Same	Not supported
Continuouscardiacoutput (CCO)	CCO/SvO2 interface moduleis used to interface withEdwards Vigilance II monitor/ Vigileo Monitor whichmeasures continuous cardiacoutput (CCO) and mixedvenous oxygen saturation(SvO2).		Same	Same	Not supported
Feature	Predicate Device (K132075)		Subject Devices
	17M	12M	17M	12M	T1
Mixed/centralvenousoxygensaturation(SvO2/ScvO2)	CCO/SvO2 interface moduleis used to interface withEdwards Vigilance II monitor/ Vigileo Monitor whichmeasures mixed venousoxygen saturation (SvO2) andcentral venous oxygensaturation (ScvO2).		Same	Same	Not supported
Carbondioxide (CO2)	Sidestream CO2 Module:Measurement range: 0 to 99mmHgAccuracy:0 to 40 mmHg: ±2 mmHg41 to 76 mmHg: ±5% of thereading77 to 99 mmHg: ±10% of thereading		SpecificationsunchangedModules havebeenrepackaged tooccupy a singleslot	SpecificationsunchangedModules havebeenrepackaged tooccupy a singleslot	SpecificationsunchangedModules havebeenrepackaged tooccupy a singleslot
	Microstream CO2 Module:Measurement range: 0 to 99mmHgAccuracy:0 to 38 mmHg: ±2 mmHg39 to 99 mmHg: ±5% of thereading ±5% of thereading+0.08% of (thereading-38)
	Mainstream CO2 Module:Measurement range: 0 to 150mmHgAccuracy:0 to 40 mmHg: ±2 mmHg41 to 70 mmHg: ±5% of thereading71 to 100 mmHg: ±8% of thereading101 to 150 mmHg: ±10% ofthe reading"
Feature	Predicate Device (K132075)		Subject Devices
	17M	12M	17M	12M	T1
Oxygen (O2)	Oxygen values are calculated based on user input and not directly measured.		Same	Same	Not supported
Anesthetic gas (AG)	The AG module can identify two anesthetic gases in a mixture automatically and distinguish between them according to their contributions to the MAC value for display as the primary and secondary anesthetic agents.		Same	Same	Not supported
Impedance cardiograph (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."		Same	Same	Not supported
Bispectral index (BIS)	Measured parameters: EEG, BIS, BIS L, BIS R		Same	Same	Not supported
Respiration mechanics (RM)	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;0 to 6 rpm: Not specified."		Same	Same	Not supported
3 Additional SpO2 Sensors	None		The model names of the three SPO2 sensors are LNCS NeoPt, LNCS Neo, LNCS Inf. These three SPO2 sensors are cleared in K132037.
4 New NIBP cuffs	None		The model names of the four NIBP cuffs are CM1306, CM1307, CM1506, CM1507. All this four NIBP cuffs are substantial equivalent to the NIBP cuffs which are cleared in K132075 and K092449.
Supports T1 as a module	Not supported		Supported	Supported	N/A

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Substantial Equivalence Conclusion:

Based on the detailed comparison of specifications for each of the modifications to the previously cleared Passport M Series devices, 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 device.

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.