(140 days)
No
The document does not mention AI, ML, or any related terms in the device description, intended use, or performance studies. The focus is on standard physiological parameter monitoring and analysis using established algorithms (Mortara, Mindray).
No
The device is a patient monitor intended for monitoring, displaying, alarming, and transferring physiological parameters. It does not provide any therapy or treatment.
No
The device is described as a "patient monitor" which is intended for "monitoring, displaying, alarming, and transferring of multiple physiological parameters." While it provides some "interpretation" (e.g., of resting 12-lead ECG), its primary function is continuous monitoring and display of vital signs, rather than diagnosing a disease or condition.
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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The Passport Series Patient Monitors are described as devices for "monitoring, displaying, alarming, 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.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the patient. Its function is to acquire and display real-time physiological data from the patient.
Therefore, the device falls under the category of patient monitoring equipment, which is distinct from In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Passport 12m and 17m Patient Monitors:
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/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, and transferring of multiple physiological parameters including ECG (3-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, QT analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arthythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients;
· ST Segment analysis of Mindray ECG algorithm is intended for adult patients only.
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
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.
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, 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
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.
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 ●
- 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.
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.
Restrictions:
- 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.
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)
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.
Mindray has also followed the FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm issues on October 28, 2003.
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.
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.
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
§ 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.
0
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
1
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
2
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:
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/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, and transferring of multiple physiological parameters including ECG (3-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, QT analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arthythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients;
· ST Segment analysis of Mindray ECG algorithm is intended for adult patients only.
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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-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: | 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:
| Product
Code | Regulation
Number | Panel | Regulation Description | Device Common Name |
|-----------------|----------------------|----------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Primary | | | | |
| 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 | | | | |
| Product
Code | Regulation
Number | Panel | Regulation Description | Device Common Name |
| 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) |
| 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 |
4
5
| 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.
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, 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
6
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.
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 ●
- 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.
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:
7
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 |
| Integrated | ||||||
| display and | ||||||
| touchscreen | 17" | |||||
| 1280*1024 | ||||||
| pixels | 12" | |||||
| 800*600 | ||||||
| pixels | 5", 480*272 pixels | Same | Same | Same | ||
| Secondary | ||||||
| display | Independent | |||||
| control and | ||||||
| display | Display is | |||||
| linked to | ||||||
| integrated | ||||||
| display | Independent | |||||
| display and | ||||||
| control via a VGA | ||||||
| port in the T1 | ||||||
| docking station | Same | Same | Same | |||
| Additional | ||||||
| display | ||||||
| features | The minitrends diagram, OxyCRG diagram, other | |||||
| monitor view, and calculation can be viewed | ||||||
| when using an external LCD screen | Same | Same | Same | Same | Same | |
| Wireless | ||||||
| module | The ASUS | |||||
| module is | ||||||
| used for | ||||||
| connecting | ||||||
| to a network | ||||||
| wirelessly. | ||||||
| constructing | ||||||
| a monitoring | ||||||
| network | ||||||
| with a | ||||||
| central | ||||||
| monitoring | ||||||
| system | ||||||
| (CMS). | Support | |||||
| wireless | ||||||
| function | ||||||
| using the | ||||||
| ASUS and | ||||||
| Silex | ||||||
| wireless | ||||||
| module. | Support wireless | |||||
| function using the | ||||||
| Cyberlink wireless | ||||||
| module | Same | Same | Same | |||
| Module rack | Independent of the patient | |||||
| monitor, provides 8 | ||||||
| standard module slots to | ||||||
| extend the measurement | ||||||
| capabilities of the system | Same | Not supported | Same | Same | Same | |
| Predicate Device (K143195) | Subject Devices | |||||
| Feature | 17m | 12m | T1 | 17m | 12m | T1 |
| Power supply | Two | |||||
| rechargeable | ||||||
| Lithium-ion | ||||||
| battery or | ||||||
| AC power | ||||||
| supply | One | |||||
| rechargeable | ||||||
| Lithium-ion | ||||||
| battery or | ||||||
| AC power | ||||||
| supply | One rechargeable | |||||
| Lithium-ion | ||||||
| battery or DC | ||||||
| power supply or | ||||||
| AC power supply | Same | Same | Same | |||
| Battery | Chargeable Lithium-Ion, | |||||
| 11.1 VDC, 4500 mAh, 350 g | Chargeable Lithium-Ion, | |||||
| 11.1 VDC, 4500 mAh, 350 g | Chargeable | |||||
| Lithium-Ion, 7.4 | ||||||
| VDC, 2500 mAh | Same | Same | Same | |||
| External | ||||||
| memory card | Compact Flash | Compact Flash | Secure Digital | Same | Same | Same |
| Data | ||||||
| Recorder | The thermal recorder | |||||
| records patient information, | ||||||
| measurement numerics, up | ||||||
| to three waveforms, etc. | Not supported | Same | Same | Same | ||
| Speaker | Give alarm tones (45 to 85 dB), key tones, QRS | |||||
| tones; support PITCH TONE and multi-level | ||||||
| tone modulation | Give alarm tones (45 to 85 dB), key tones, QRS | |||||
| tones; support PITCH TONE and multi-level | ||||||
| tone modulation | Same | Same | Same | |||
| Supports T1 | ||||||
| as a module | Supported | Supported | / | Same | Same | / |
| ECG | ||||||
| (Mindray | ||||||
| Algorithm) | 3-lead , 5-lead or 12-lead selectable, arrhythmia | |||||
| detection, ST segment analysis, an interpretation | ||||||
| of resting 12-lead ECG, J-point Auto detection, | ||||||
| Dual channel Pace detection and heart rate (HR) | Added QT analysis | |||||
| ECG | ||||||
| (Mortara | ||||||
| Algorithm) | 3-lead , 5-lead or 12-lead selectable, arrhythmia | |||||
| detection, ST segment analysis, J-point Auto | ||||||
| detection, and heart rate (HR) | Same | |||||
| Arrhythmia | ||||||
| Analysis | ||||||
| (Mindray | ||||||
| Algorithm) | 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 | |||||
| Arrhythmia | ||||||
| Analysis | ||||||
| (Mortara | ||||||
| Algorithm) | Asystole, Vfib, Vtac, Vent. Rhythm, Couplet, | |||||
| VT>2, Bigeminy, Trigeminy, R on T, Multif. | ||||||
| PVC, Irr. Rhythm, Tachy, Brady, Missed Beats, | ||||||
| PNP, PNC | Same | |||||
| Adjustable | ||||||
| QRS | ||||||
| Detection | ||||||
| Threshold | ||||||
| (Mindray | ||||||
| Algorithm) | Not supported | Not supported | Not supported | Added | ||
| 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; | 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; | 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 | 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 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 |
| Pulse rate
(PR) | PR from Mindray SpO2 Module
Measurement range: 20 to 254 bpm
Accuracy:±3 bpm
PR from Masimo SpO2 Module
Measurement range: 25 to 240 bpm
Accuracy:±3 bpm (measured without motion)
±5 bpm (measured with motion)
PR from Nellcor SpO2 Module
Measurement range: 20 to 300 bpm
Accuracy:20 to 250 bpm: ±3 bpm
251 to 300 bpm, not specified
PR from IBP Module
Measurement range: 25 to 350 bpmbpm
Accuracy:±1 bpm or ±1%, whichever is greater" | | | Same | Same | Same |
| Non-invasive
blood
pressure
(NIBP) | Measurement range:
Adult
Systolic: 40 to 270
Diastolic: 10 to 210
Mean: 20 to 230
Pediatric
Systolic: 40 to 200
Diastolic: 10 to 150
Mean: 20 to 165
Neonate
Systolic: 40 to 135
Diastolic: 10 to 100
Mean: 20 to 110
Accuracy:
Max mean error: ±5 mmHg
Max standard deviation: 8 mmHg | | | Same | Same | Same |
| | Predicate Device (K143195) | | | Subject Devices | | |
| Feature | 17m | 12m | T1 | 17m | 12m | T1 |
| Invasive
blood
pressure
(IBP) | Measurement range: -50 to 300 mmHg
Accuracy:±2% or ±1 mmHg, whichever is
greater (without sensor) | | | Same | Same | Same |
| Pulse
Pressure
Variation
(PPV) | Supported feature of IBP | | | Same | Same | Same |
| Cardiac
output (C.O.) | The temperature change is
displayed as a curve in the
C.O. split screen, and the
monitor calculates the C.O.
value from this curve. The
monitor is capable of
storing 6 measurements. | | Not supported | Same | Same | Same |
| Continuous
cardiac
output (CCO) | CCO/SvO2 interface
module is used to interface
with Edwards Vigilance II
monitor / Vigileo Monitor
which measures continuous
cardiac output (CCO) and
mixed venous oxygen
saturation (SvO2). | | Not supported | Same | Same | Same |
| Mixed/central
venous
oxygen
saturation
(SvO2/ScvO2) | CCO/SvO2 interface
module is used to interface
with Edwards Vigilance II
monitor / Vigileo Monitor
which measures mixed
venous oxygen saturation
(SvO2) and central venous
oxygen saturation (ScvO2). | | Not supported | Same | Same | Same |
| Carbon
dioxide
(CO2) | Sidestream CO2 Module:
Measurement range: 0 to 99 mmHg
Accuracy:
0 to 40 mmHg: ±2 mmHg
41 to 76 mmHg: ±5% of the reading
77 to 99 mmHg: ±10% of the reading
Microstream CO2 Module:
Measurement range: 0 to 99 mmHg
Accuracy:
0 to 38 mmHg: ±2 mmHg
39 to 99 mmHg: ±5% of the reading ±5% of the
reading+0.08% of (the reading-38)
Mainstream CO2 Module:
Measurement range: 0 to 150 mmHg
Accuracy:
0 to 40 mmHg: ±2 mmHg
41 to 70 mmHg: ±5% of the reading
71 to 100 mmHg: ±8% of the reading
101 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 are
calculated based on user
input and not directly
measured. | | Not supported | Same | Same | Same |
| 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. | | Not supported | Same | Same | Same |
| Impedance
cardiograph
(ICG) | Measurement range:
SV: 5 to 250 ml
HR: 44 to 2m
C.O. 1.4 to 15 L/min
Accuracy:
SV: Not specified.
HR: ±2 bpm
C.O. Not specified. | | Not supported | Same | Same | Same |
| Bispectral
index (BIS) | Measured parameters:
EEG, BIS, BIS L, BIS R | | Not supported | Same | Same | Same |
| 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." | | Not supported | Same | Same | Same |
| 2 New
neonatal pre-
wired
electrode | Not supported | | | Added | | |
Device Comparison Table
8
9
10
11
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.