(188 days)
No
The document describes a standard multi-parameter patient monitor and does not mention any AI or ML capabilities in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a patient monitor, intended for monitoring, displaying, reviewing, and transferring physiological parameters. It does not actively treat or intervene to improve a patient's health condition.
No
This device is described as a patient monitor intended for tracking and displaying various physiological parameters. While it collects and presents data that can be used by clinicians for diagnosis, its primary function is monitoring, not providing a diagnostic conclusion or interpretation that constitutes a diagnosis itself. It states it provides "interpretation of resting 12-lead ECG", which approaches a diagnostic function, but the overall context of monitoring multiple parameters suggests a supportive role in clinical assessment rather than a standalone diagnostic 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 physical 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.
- Device Function: The description clearly states that the Passport and T1 Patient Monitors are intended 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 by analyzing samples taken from the body.
- Lack of Sample Analysis: There is no mention of the device analyzing biological samples or performing laboratory-style tests.
Therefore, the function of these patient monitors falls under the category of patient monitoring devices, which are 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, reviewing, and transferring of multiple physiological parameters including ECG (3-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, OT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AC), impedance cardiograph (CCG), bispectral index (BIS), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). The equipment also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, PAWP monitoring and NMT monitoring are intended for adult and pediatric patients only;
· ST Segment analysis of Mindray algorithm is intended for adult patients only;
· C.O. monitoring is restricted to adult patients only;
• ICG monitoring is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
T1 Patient Monitor:
The T1 Patient Monitor is intended for monitoring, displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, QT analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arthythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients;
· ST Segment analysis of Mindray ECG algorithm is intended for adult patients only.
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
MHX, DQA, DRT, DSI, DSK, DXN, FLL, MLD, DPZ, CCK, CBQ, CBS, CBR, CCL, DSB, DXG, OLW, DSJ, KOI, GXY
Device Description
The subject Passport Series Patient Monitors includes three monitors:
- o Passport 12m Patient Monitor
- Passport 17m Patient Monitor
- o T1 Patient Monitor
All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, alarming, and transferring multiple physiological parameters. The Passport 12m and 17m Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor.
The T1 patient monitor is one of the available modules that can be plugged into the Passport 17m or 12m monitor. The T1 can also be used as a standalone monitor and when used as a standalone monitor, it provides a subset of the functions that are provided by Passport 17m and 12m.
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:
- Arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, PAWP monitoring and NMT monitoring are intended for adult and pediatric patients only.
- ST Segment analysis of Mindray algorithm is intended for adult patients only.
- C.O. monitoring is restricted to adult patients only.
- ICG monitoring is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
Intended User / Care Setting
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.
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 O (Passport 12m, Passport 17m and T1), Mindray conducted functional and system level testing on the subject devices. The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 152902, K170876
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 10, 2019
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, 518057, P.R. China
Re: K190011
Trade/Device Name: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, DQA, DRT, DSI, DSK, DXN, FLL, MLD, DPZ, CCK, CBQ, CBS, CBR, CCL, DSB, DXG, OLW, DSJ, KOI, GXY Dated: June 6, 2019 Received: June 10, 2019
Dear Yanhong Bai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Nicole Goodsell Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190011
Device Name
Passport Series Patient Monitors (including Passport 12m, Passport 17m and T1)
Indications for Use (Describe)
Passport 12m and 17m Patient Monitors:
The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, OT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AC), impedance cardiograph (CCG), bispectral index (BIS), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). The equipment also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, PAWP monitoring and NMT monitoring are intended for adult and pediatric patients only;
· ST Segment analysis of Mindray algorithm is intended for adult patients only;
· C.O. monitoring is restricted to adult patients only;
• ICG monitoring is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
T1 Patient Monitor:
The T1 Patient Monitor is intended for monitoring, displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, QT analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arthythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients;
· ST Segment analysis of Mindray ECG algorithm is intended for adult patients only.
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
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4
510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Passport Series Patient Monitors is provided below.
| Device Common Name: | Patient Monitor |
|---|---|
| Device Proprietary Name: | Passport Series Patient Monitors (Passport 12m, |
| Passport 17m and T1) | |
| Submitter | Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| Mindray Building, Keji 12th Road South, | |
| Hi-tech Industrial Park, Nanshan, | |
| Shenzhen, 518057, P. R. China | |
| Tel: +86 755 8188 8998 | |
| Fax: +86 755 2658 2680 | |
| Contact | Ms. Yanhong Bai |
| Manager Regulatory Affairs | |
| 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 | |
| E-mail: baiyanhong@mindray.com | |
| Date Prepared | December 31, 2018 |
| Classification Regulation | 21 CFR 870.1025, Class II, Arrhythmia detector and alarm |
| (including ST-segment measurement and alarm) | |
| Panel | Cardiovascular |
5
| 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
868.1400 | Anesthesiology | Enflurane gas analyzer | analyzer, gas, enflurane, | |
| | | | | | |
| CBS | 868.1500
868.1620 | 21 CFR | Anesthesiology | Halothane gas analyzer | gaseous-phase (anesthetic concentration)
analyzer, gas, halothane, gaseous-phase (anesthetic conc.) |
| CBR | 868.1700 | 21 CFR | Anesthesiology | Nitrous oxide gas analyzer | analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.) |
| CCL | 868.1720 | 21 CFR | Anesthesiology | Oxygen gas analyzer | analyzer, gas, oxygen, gaseous-phase |
| DSB | 870.2770 | 21 CFR | Cardiovascular | Impedance plethysmograph | plethysmograph, impedance |
| DXG | 870.1435 | 21 CFR | Cardiovascular | Single-function, preprogrammed diagnostic computer | computer, diagnostic, pre-programmed, single-function |
| OLW | 882.1400 | 21 CFR | Neurology | Electroencephalograph | index-generating electroencephalograph software |
| DSJ | 870.1100 | 21 CFR | Cardiovascular | Blood pressure alarm | alarm, blood-pressure |
| KOI | 868.2775 | 21 CFR | Anesthesiology | Electrical peripheral nerve stimulator | stimulator, nerve, peripheral, electric |
| GXY | 870.1320 | 21 CFR | Neurology | Cutaneous electrode. | electrode, cutaneous |
Classification Regulation, Classification Name and Product Codes:
6
Primary Predicate Device:
- K 152902 Passport Series Patient Monitors (Passport 12m, Passport 17m, and T1) Shenzhen Mindray Bio-Medical Electronics Co., Ltd
- K170876 Passport Series Patient Monitors (Passport 12m and Passport 17m) Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Secondary Predicate Device:
- K182075 -BeneVision N Series Patient Monitors Shenzhen Mindray Bio-Medical Electronics Co., Ltd K171292 - A7 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Indications for Use:
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Passport 12m and 17m Patient Monitors:
The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (Sv02/Scv02), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). The equipment also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
- The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, ● CCO, SvO2/ScvO2, PAWP monitoring and NMT monitoring are intended for adult and pediatric patients only;
- ST Segment analysis of Mindray algorithm is intended for adult patients only; ●
- C.O. monitoring is restricted to adult patients only; ●
- ICG monitoring is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
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, QT analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
- The arrhythmia detection, ST Segment analysis of Mortara algorithm, and ● PAWP monitoring are intended for adult and pediatric patients;
- ST Segment analysis of Mindray ECG algorithm is intended for adult patients ● only.
8
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:
- o Passport 12m Patient Monitor
- Passport 17m Patient Monitor ●
- o T1 Patient Monitor
All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, alarming, and transferring multiple physiological parameters. The Passport 12m and 17m Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor.
The T1 patient monitor is one of the available modules that can be plugged into the Passport 17m or 12m monitor. The T1 can also be used as a standalone monitor and when used as a standalone monitor, it provides a subset of the functions that are provided by Passport 17m and 12m.
Substantial Equivalence:
Comparison of Indications
The indications for use of the subject devices have not changed in this 510(K). Indications of the predicate device (Passport 12m and 17m Patient Monitors K170876,T1 Patient Monitor K152902) and the subject device (Passport 12m,Passport 17m and T1)) are the same.
Comparison of Technological Characteristics
The table below compares the key technological feature of the subject devices to the primary predicate device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902). The features in grey are the features that have been modified since their previous clearances and that are the subject of this 510(k).
Device Comparison Table (Compare with Passport 12m and 17m Patient Monitors K170876,T1 Patient Monitor K152902)
9
| Feature | Passport 17m | Passport 12m | T1 | Subject Devices |
|---|---|---|---|---|
| Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | ||||
| Integrated display and touchscreen | 17", 1280*1024 pixels | 12", 800*600 pixels | Same | Same |
| Secondary display | Independent display and display | Display is linked to integrated display | Independent control via a VGA port in the docking T1 station | Same |
| Additional display features | The minitrends diagram, OxyCRG diagram, other monitor view, and calculation can be viewed when using an external LCD screen | Same | Same | Same |
| Wireless module | The ASUS module is used for connecting to a network wirelessly, constructing a monitoring network with a central monitoring system (CMS). | The ASUS, Silex and Laird modules are used for connecting to a network wirelessly, constructing a monitoring network with a central monitoring system (CMS). | The Cyberlink modules is used for connecting to a network wirelessly, constructing a monitoring network with a central monitoring system (CMS). | Laird (2.4GHz/5GHz) wireless module is added |
Page 6 of 26
10
| Feature | Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | Subject Devices | |||||
|---|---|---|---|---|---|---|---|
| Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | ||
| Module rack | Independent of the patient monitor, provides 8 standard module slots to extend the measurement capabilities of the system | Not supported | Same | Same | Same | ||
| Power supply | Two rechargeable Lithium-ion battery or AC power supply | One rechargeable Lithium-ion battery or AC power supply | One rechargeable Lithium-ion battery or DC power supply or AC power supply | Same | Same | Same | |
| Battery | Chargeable Lithium-Ion, 11.1 VDC, 4500 mAh, 350 g | Chargeable Lithium-Ion, 7.4 VDC, 2500 mAh | Same | Same | Same | ||
| External memory card | Compact Flash | Secure Digital | Same | Same | Same | ||
| Data Recorder | The thermal recorder records patient information, measurement numerics, up to three waveforms, etc. | Not supported | Same | Same | Same | ||
| Speaker | Give alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation | Same | Same | Same | |||
| Supports T1 as a module | Supported | / | Same | Same | Same | ||
| Supports N1 as a module | Not supported | Not supported | Supported | Same | |||
| Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | Subject Devices | ||||||
| Feature | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | |
| MPM module | MPM 2.0 module, it support: | ||||||
| 3/5/12 lead ECG, NIBP, dual channel Temp, SpO2, dual channel IBP measurement | / | / | MPM 3.0 module is added, it support: | ||||
| 3/5/12 lead ECG, NIBP, dual channel Temp, SpO2, dual channel IBP measurement | |||||||
| When MPM 3.0 module is used with Passport 12m and 17m, the functionality and performance is same with MPM 2.0 module. | / | ||||||
| ECG | 3-lead, 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, heart rate (HR), an interpretation of resting 12-lead ECG, J-point Auto detection, Dual Channel Pace detection and Adjustable QRS Detection Threshold | Same | |||||
| Arrhythmia Analysis (Mindray Algorithm) | Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy, Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, R on T, Run PVCs, PVCs, Tachy, Brady, Missed Beats, Vent. Rhythm, PNP, PNC, Multif. PVC, Nonsus. Vtac, Pause, Irr. Rhythm, AFib | Same | |||||
| Arrhythmia Analysis (Mortara Algorithm) | Asystole, Vfib, Vtac, Vent. Rhythm, Couplet, Run PVCs, Bigeminy, Trigeminy, R on T, Multif. PVC, Irr. Rhythm, Tachy, Brady, Missed Beats, PNP, PNC, PVCs | Same | |||||
| Predicate Device (Passport 12m and 17m Patient Monitors | |||||||
| K170876, T1 Patient Monitor K152902) | Subject Devices | ||||||
| Feature | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | |
| Respiration rate | |||||||
| (Resp) | Uses the MPM (Multi Parameter Module) to measure the change in impedance measured across the thorax to determine the respiration rate. | Same | |||||
| Temperature | |||||||
| (Temp) | Uses the MPM (Multi Parameter Module) to measure core and skin temperature. The patient monitor can monitor two temperatures simultaneously using thermally sensitive resistors (thermistors). | Same | |||||
| Pulse oxygen saturation (SpO2) | Uses the MPM (Multi Parameter Module) or the SpO2 module to measure the amount of oxygenated haemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. | ||||||
| Is compatible with the following 3 modules to measure oxygen saturation: | |||||||
| Mindray SpO2 ModuleMasimo SpO2 ModuleNellcor SpO2 Module | Same | ||||||
| Feature | Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | Subject Devices | |||||
| Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | ||
| PR from Mindray SpO2 | |||||||
| Measurement range: 20 to 254 bpm | |||||||
| Accuracy: ±3 bpm | PR from Mindray SpO2 | Same | |||||
| PR from Masimo SpO2 | |||||||
| Measurement range: 25 to 240 bpm | |||||||
| Accuracy: ±3 bpm (measured without motion) | |||||||
| ±5 bpm (measured with motion) | PR from Masimo SpO2 | Same | |||||
| Pulse rate (PR) | PR from Nellcor SpO2 | ||||||
| Measurement range: 20 to 300 bpm | |||||||
| Accuracy: 20 to 250 bpm: ±3 bpm | |||||||
| 251 to 300 bpm, not specified | PR from Nellcor SpO2 | Same | |||||
| PR from IBP | |||||||
| Measurement range: 25 to 350 bpm | |||||||
| Accuracy:±1 bpm or ±1%, whichever is greater | PR from IBP | Same | |||||
| PR from NIBP | |||||||
| Measurement range: 40 to 240 bpm | |||||||
| Accuracy: ±3 bpm or ±3%, whichever is greater | PR from NIBP | ||||||
| Measurement range: 30 to 300 bpm | |||||||
| Accuracy: Same | |||||||
| Feature | Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | Subject Devices | |||||
| Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | ||
| Non-invasive blood pressure (NIBP) | Measurement range: | ||||||
| Adult: | |||||||
| Systolic: 40-270 mmHg | |||||||
| Diastolic: 10-210 mmHg | |||||||
| Mean:20-230 mmHg | |||||||
| Pediatric: | |||||||
| Systolic:40-200mmHg | |||||||
| Diastolic:10-150mmHg | |||||||
| Mean:20-165mmHg | |||||||
| Neonate: | |||||||
| Systolic:40-135 mmHg | |||||||
| Diastolic:10-100mmHg | |||||||
| Mean:20-110 mmHg | |||||||
| Accuracy: | |||||||
| Max mean error: ±5 mmHg | |||||||
| Max standard deviation: 8 mmHg | Measurement range: | ||||||
| Adult: | |||||||
| Systolic: 25-290 mmHg | |||||||
| Diastolic: 10-250 mmHg | |||||||
| Mean:15-260 mmHg | |||||||
| Pediatric: | |||||||
| Systolic:25-240mmHg | |||||||
| Diastolic:10-200mmHg | |||||||
| Mean:15-215mmHg | |||||||
| Neonate: | |||||||
| Systolic:25-140 mmHg | |||||||
| Diastolic:10-115 mmHg | |||||||
| Mean:15-125 mmHg | Accuracy: | ||||||
| Same | |||||||
| Invasive blood pressure (IBP) | Uses the MPM (Multi Parameter Module) or the IBP Module to measure invasive blood pressure. The monitor can monitor up to 8 invasive blood pressures and displays systolic, diastolic and mean pressures and a waveform for each pressure. Supports the PPV function. | Same | |||||
| Feature | Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | Subject Devices | |||||
| Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | ||
| Pulse Pressure Variation (PPV) | Supported feature of IBP | Same | |||||
| Cardiac output (C.O.) | The temperature change is displayed as a curve in the C.O. split screen, and the monitor calculates the C.O. value from this curve. The monitor is capable of storing 6 measurements. | Not supported | Same | Same | |||
| Continuous cardiac output (CCO) | CCO/SvO2 interface module is used to interface with Edwards Vigilance II monitor / Vigileo Monitor which measures continuous cardiac output (CCO), mixed venous oxygen saturation (SvO2) and central venous oxygen saturation (ScvO2). | Not supported | Same | Same | |||
| Central venous oxygen saturation (ScvO2) | ScvO2 module is used to measure central venous oxygen saturation (ScvO2). | Not supported | Same | Same | |||
| Feature | Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | Subject Devices | |||||
| Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | ||
| Carbon dioxide (CO2) | Is compatible with the following 3 modules to measure carbon dioxide: | ||||||
| Sidestream CO2 Module Microstream CO2 Module Mainstream CO2 Module CO2 monitoring is based on calculations from measuring the absorption of infrared (IR) light of specific wavelengths using a photodetector. | Sidestream CO2 2.0 module is added, the functionality and performance is same with Sidestream CO2 1.0 module. | The other modules and specifications remains the same. | Same | ||||
| Anesthetic gas (AG) | Is compatible with the following 2 modules to measure Anesthetic gas: | ||||||
| 3-slot AG Module 2-slot AG Module The AG module analyzes gas samples from the patient and calculates CO2, O2, N2O and AA waves and related numerics, airway respiratory rate, and MAC (minimum alveolar concentration). | |||||||
| Supports the 3-slot AG module. | Support Sample Gas Recycling feature for AG module | Not supported | Same | ||||
| Feature | Predicate Device (Passport 12m and 17m Patient Monitors | ||||||
| K170876, T1 Patient Monitor K152902) | Subject Devices | ||||||
| Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | ||
| Impedance | |||||||
| cardiograph (ICG) | Uses the ICG Module to | ||||||
| measure a patient's | |||||||
| hemodynamic status | |||||||
| using a non-invasive | |||||||
| method based on | |||||||
| thoracic electrical | |||||||
| bioimpedance | |||||||
| (TEB) technology. | Not supported | Same | Same | ||||
| Bispectral index | |||||||
| (BIS) | Measured parameters: EEG, BIS, BIS L, | ||||||
| BIS R | Not supported | Same | Same | ||||
| Respiration | |||||||
| mechanics (RM) | Measures respiration | ||||||
| mechanics for | |||||||
| adults, pediatrics | |||||||
| and infants. | Not supported | Same | Same | ||||
| Predicate Device (Passport 12m and 17m Patient Monitors | |||||||
| K170876, T1 Patient Monitor K152902) | Subject Devices | ||||||
| Feature | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | |
| NMT | Uses the NMT module to monitor objective neuromuscular transmission. | It evaluates muscle relaxation of patients under neuromuscular block by measuring the strength of muscle reaction after electrically stimulating the dedicated motor nerve. | Not supported | Same | Same | Same | |
| Feature | Passport 17m | Passport 12m | T1 | Subject Devices | Passport 17m | Passport 12m | T1 |
| cleaning | |||||||
| and | |||||||
| disinfecting | |||||||
| agents | List of agents: | ||||||
| Sodium hypochlorite bleach | |||||||
| Hydrogen peroxide | |||||||
| Isopropanol | |||||||
| Rely+On TMVirkon® | |||||||
| 1-Propanol | |||||||
| Perform® | More agents are added: | ||||||
| Metrex CaviCide1™ | |||||||
| Virex® II 256 | |||||||
| Virex® TB | |||||||
| Alpet® D2 Surface Sanitizing Wipes | |||||||
| Clorox Dispatch® Hospital Cleaner Disinfectant | |||||||
| Towels with Bleach | |||||||
| Clorox Healthcare® Bleach Germicidal Wipes | |||||||
| Clorox HealthcareⓇ Hydrogen Peroxide Cleaner | |||||||
| Disinfectant Wipes | |||||||
| Diversey Oxivir® TB Wipes | |||||||
| Metrex CaviWipes™ | |||||||
| PDI Sani-Cloth® AF3 Germicidal Disposable Wipe | |||||||
| PDI Sani-Cloth® Bleach Germicidal Disposable Wipe | |||||||
| PDI Sani-Cloth® HB Germicidal Disposable Wipe | |||||||
| PDI Sani-Cloth® Plus Germicidal Disposable Cloth | |||||||
| PDI Super Sani-Cloth® Germicidal Disposable Wipe | |||||||
| VIRAGUARD Hospital Surface Disinfectants | |||||||
| Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | Subject Devices | ||||||
| Feature | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | |
| Support new Masimo SpO2 accessories | Added: | ||||||
| 040-003378-00 | RD SET MD 14-05, PC 5 ft | ||||||
| 040-003379-00 | RD SET MD 14-12, Patient Cable 12 ft | ||||||
| 040-003310-00 | 8pin masimo Cable (RD SET) | ||||||
| 040-003426-00 | LNCS to RD Adapter | ||||||
| 040-003381-00 | RD to LNC Adapter Cable | ||||||
| 040-003376-00 | RD SET DCI, Adult Reusable Sensor | ||||||
| Not supported | 040-003377-00 | RD SET DCI, Pediatric Reusable Sensor | |||||
| 040-003380-00 | RD Set TC-I SpO2 Reusable Tip-Clip Ear Sensor, 3ft | ||||||
| 040-003382-00 | RD SET Adhesive Sensor | ||||||
| 040-003383-00 | RD SET PDT Adhesive Sensor | ||||||
| 040-003384-00 | RD Set Infant Adhesive Sensor | ||||||
| 040-003385-00 | RD Set Neo Adhesive Sensor | ||||||
| 040-003386-00 | RD Set NeoPt Adhesive Sensor | ||||||
| 040-003387-00 | RD Set NeoPt-500 Non-adhesive sensor | ||||||
| Support new ECG accessories | Not supported | Added: | |||||
| 040-003528-00 | ECG cable, defibrillation-proof, AHA | 12-lead, | |||||
| Feature | Passport 17m | Passport 12m | T1 | Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) Subject Devices | |||
| Support new CO2 accessories | Not supported | Passport 17m | Passport 12m | T1 | |||
| Added: | |||||||
| 100-000138-00 | DRYLINE PRIME Gas Sampling Line With Airway Adapter, Adult/Pediatric | ||||||
| 100-000139-00 | DRYLINE PRIME Gas Sampling Line With Airway Adapter, Neonate | ||||||
| 100-000140-00 | RYLINE PRIME+ Gas Sampling Line With Airway Adapter, Adult/Pediatric | ||||||
| 100-000141-00 | DRYLINE PRIME+ Gas Sampling Line With Airway Adapter, Neonate | ||||||
| 100-000142-00 | DRYLINE PRIME Nasal Gas Sampling Line, Adult | ||||||
| 100-000143-00 | DRYLINE PRIME Nasal Gas Sampling Line, Pediatric | ||||||
| 100-000144-00 | DRYLINE PRIME Nasal Gas Sampling Line, Neonate | ||||||
| 100-000145-00 | DRYLINE PRIME+ Nasal Gas Sampling Line, Adult | ||||||
| 100-000146-00 | DRYLINE PRIME+ Nasal Gas Sampling Line, Pediatric | ||||||
| 100-000147-00 | DRYLINE PRIME+ Nasal Gas Sampling Line, Neonate | ||||||
| 100-000151-00 | DRYLINE PRIME Water Trap Mini | ||||||
| Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | Subject Devices | ||||||
| Feature | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | |
| Improve the SpO2/CO2/BIS signal cord resistance to damage | Not supported | Supported | Note: T1 doesn't support BIS module | ||||
| Corrected an issues where NIBP misreported "NIBP Excessive Motion" after 49 days of running | Not supported | Supported | |||||
| Feature | Predicate Device (Passport 12m and 17m Patient Monitors | ||||||
| K170876, T1 Patient Monitor K152902) | Subject Devices | ||||||
| Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 | ||
| The End tidal (Et) and Fraction of | |||||||
| Inspired (Fi) numerics for | |||||||
| anesthetic agent (AA) | Not supported | Supported | Same | ||||
| Physiological alarms are trigged only when the monitored parameter value is higher than the high alarm limit or is lower than the low alarm limit | Not supported | Supported | Same | ||||
| Extend the setting range of low alarm limit of EtO2 | Not supported | Supported | Same |
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| Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | Subject Devices | |||||
|---|---|---|---|---|---|---|
| Feature | Passport 17m | Passport 12m | Passport 17m | Passport 12m | T1 | |
| Support the non-overlapping relationships of alarm limit setting of physiological alarms | Not supported | Supported | ||||
| Support re-alarming after a physiological alarm is reset | Not supported | Supported | ||||
| Support password protection for accessing the Alarm Setup menu | Not supported | Supported | ||||
| Support authorization of the user via the LDAP | Not supported | Supported | ||||
| Support the Facility information of patient monitor | Not supported | Supported | ||||
| Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | Subject Devices | |||||
| Feature | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 |
| Support the Room No. information of patient monitor | Not supported | Supported | ||||
| Support the Visit Number in the patient demographics | Not supported | Supported | ||||
| Support printing of the arrhythmia settings in reports | Not supported | Supported | ||||
| Change the factory default setting of printer paper size | Not supported | Supported | ||||
| Support to display the MAC address of patient monitor | Not supported | Supported | ||||
| Support the display mode of ST values in the parameter tile | Not supported | Supported | ||||
| Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | Subject Devices | |||||
| Feature | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 |
| Support encryption of patient private information sent to the network | Not supported | |||||
| Support Laird 2.4GHz/5GHz Wifi module | Supported | Not supported | Same | Supported | ||
| Support adjustment of the ST point on multiple displayed leads | Supported | Not supported | Same | Supported | ||
| Support QT report printing | Supported | Not supported | Same | Supported | ||
| Support NIBP measurement on clock | Supported | Not supported | Same | Supported | ||
| Support network application transmission priority setting | Supported | Not supported | Same | Supported | ||
| Support ECG beat annotation | Supported | Not supported | Same | Supported | ||
| Predicate Device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902) | Subject Devices | |||||
| Feature | Passport 17m | Passport 12m | T1 | Passport 17m | Passport 12m | T1 |
| Support DNS for ADT and LDAP server address | Not supported | Same | Supported | |||
| Corrected an issues where the Bed No. of the Passport 12m/17m is changed after T1 is pulled out of the monitors | Not supported | Same | Supported |
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Performance Data
- To establish the substantial equivalence of the Passport Series Patient Monitors O (Passport 12m, Passport 17m and T1), Mindray conducted functional and system level testing on the subject devices. The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.
O In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 :2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-25: 2011 (2nd edition) Particular requirements for the basic safety and essential performance of electrocardiographs
IEC 60601-2-27:2011 (3rd edition) Particular requirements for the safety, including essential performance of electrocardiographic monitoring equipment ISO 80601-2-61:2011 Particular requirements for the basic safety and essential performance of pulse oximeter equipment
IEC 80601-2-30:2009/AMD1:2013 Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers ISO 80601-2-56:2009 (First edition) Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement
IEC 60601-2-34 (Third Edition): 2011 Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
ISO 80601-2-55 First edition 2011-12-15 Medical electrical equipment - Part
29
2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Substantial Equivalence Conclusion:
Based on the detailed comparison of specifications for each of the modifications to the previously cleared Passport Series devices, Passport 12m and Passport 17m (K170876) and relevant reference predicates, T1 (K152902) and relevant reference predicates, the performance testing results and conformance with applicable standards show that the Passport Series Patient Monitors (including Passport 12m, Passport 17m and T1) can be found substantially equivalent to the predicate devices.