Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard physiological monitoring and analysis algorithms (like arrhythmia detection and ST segment analysis) but does not mention AI or ML. The performance studies focus on functional equivalence and meeting standards, not AI/ML model performance.

Therapeutic

No

The device is described as a "patient monitor" which is explicitly intended for "monitoring, displaying, reviewing, and transferring of multiple physiological parameters." It provides information about the patient's physiological state but does not perform any therapeutic or treatment functions.

Diagnostic

Yes

The device is a patient monitor that collects, displays, and interprets various physiological parameters (e.g., ECG, SpO2, blood pressure, CO2). It also provides an "interpretation of resting 12-lead ECG," which indicates a diagnostic function for medical professionals.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the devices are "multiparameter monitors" and mentions "user selected modules that are plugged into the main monitor," indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for medical conditions.
Device Function: The Passport Series Patient Monitors are described as devices for "monitoring, displaying, reviewing, and transferring of multiple physiological parameters". These parameters (ECG, respiration, temperature, SpO2, NIBP, IBP, etc.) are measured directly from the patient's body using sensors and electrodes, not from samples taken from the body.
Intended Use: The intended use clearly states the device is for monitoring patients in healthcare facilities. It does not mention any analysis of biological samples.

Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Passport 12M and 17M Patient Monitors: The Passport 17M and Passport 12M patient monitors are intended for monitoring. displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-lead , 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()/Scv()), 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.

T1 Patient Monitor: 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; 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.

Product codes (comma separated list FDA assigned to the subject device)

MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, DPZ, CCK, CBQ, CBS, CBR, CCL, DSB, DXG, OLW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult, pediatric, and neonatal patients. Specific exceptions include:

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.

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K132075

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K132026, K123074, K132037, K092449

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

1

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 :

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.

T1 Patient Monitor:

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.

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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;

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.

(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

OR

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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 (including
Passport 17M, Passport 12M and T1)
Submitter:	SHENZHEN MINDRAY BIO-MEDICAL
ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
Shenzhen 518057, P.R. China
Tel: +86 755 81885635
Fax: +86 755 26582680
Contact:	Yanhong Bai
Manager Regulatory Affairs
SHENZHEN MINDRAY BIO-MEDICAL
ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
518057, P.R. China
Tel: +86 755 81885635
Fax: +86 755 26582680
E-mail: baiyanhong@mindray.com
Date Prepared:	November 4, 2014
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:

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

5

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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.

The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

T1 Patient Monitor:

The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, 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;

The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

Device Description:

The subject Passport Series Patient Monitors includes three monitors:

. 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

8

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.

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
Integrated
display and
touchscreen	17"
1280*1024
pixels	12" 800*600
pixels	Same	Same	5", 480*272
pixels
(same as
K123074)
Secondary
display	Independent
control and
display	Display is
linked to
integrated
display	Same	Same	Independent
display and
control via a
VGA port in the
T1 docking
station
Additional
display
features	The minitrends diagram,
OxyCRG diagram, other
monitor view, and calculation
can be viewed when using an
external LCD screen		Same	Same	Added
Wireless
module
(ASUS)	The ASUS module is used for
connecting to a network
wirelessly, constructing a
monitoring network with a
central monitoring system
(CMS).		Same	Added support
for Silex
wireless module	Added wireless
function using
the Cyberlink
wireless
module
Module rack	Independent of the patient
monitor, provides 8 standard
module slots to extend the
measurement capabilities of
the system		Same	Same	Not supported
Power supply	Two
rechargeable
Lithium-ion
battery or
AC power
supply	One
rechargeable
Lithium-ion
battery or AC
power supply	Same	Same	One
rechargeable
Lithium-ion
battery or DC
power supply or
AC power
supply
(same as
K123074)
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 oxygen
saturation
(SpO2)	Mindray SpO2 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.
Masimo SpO2 Module
Measurement range: 1 to 100%
Accuracy:70 to 100%: ±2%
(measured without motion in
adult/pediatric mode)
70 to 100%: ±3% (measured
without motion in neonate
mode)
70 to 100%: ±3% (measured
with motion)
1% to 69%: Not specified.
Nellcor SpO2 Module
Measurement 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

12

	Predicate Device (K132075)		Subject Devices
Feature	17M	12M	17M	12M	T1
Pulse rate
(PR)	PR from Mindray SpO2
Module
Measurement range: 20 to 254 bpm
Accuracy: $\pm$ 3 bpm

PR from Masimo SpO2
Module
Measurement range: 25 to 240 bpm
Accuracy: $\pm$ 3 bpm (measured without motion)
$\pm$ 5 bpm (measured with motion)

PR from Nellcor SpO2
Module
Measurement range: 20 to 300 bpm
Accuracy:20 to 250 bpm: $\pm$ 3 bpm
251 to 300 bpm, not specified

Modules have
been
repackaged to
occupy a single
slot | Specifications
unchanged

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14

15

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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.