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.
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.
This document is a 510(k) summary for the Mindray Passport Series Patient Monitors (Passport 12m, Passport 17m, and T1). It focuses on establishing substantial equivalence to previously cleared predicate devices and does not contain a full study report with detailed acceptance criteria and performance data for a new AI/ML device.
Therefore, the following information, relevant to AI/ML device studies, cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: The document states that "functional and system level testing" was conducted and that the devices "continue to meet specifications and the performance of the device is equivalent to the predicate." However, it does not provide specific acceptance criteria values or detailed performance metrics.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant as this is not a new AI/ML device being submitted for comparative effectiveness.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant as this is not a new AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Summary of available relevant information from the document:
This 510(k) submission is for modifications to existing patient monitors, not for a new AI/ML device. The changes include:
- Wireless Module: Addition of a Laird (2.4GHz/5GHz) wireless module.
- MPM Module: Addition of an MPM 3.0 module with similar functionality to the MPM 2.0 module.
- Masimo SpO2 accessories: Support for new Masimo SpO2 accessories.
- ECG accessories: Support for new ECG accessories (12-lead, defibrillation-proof).
- CO2 accessories: Support for new DRYLINE PRIME and DRYLINE PRIME+ gas sampling lines and water traps.
- Signal Cord Resistance: Improvements to SpO2/CO2/BIS signal cord resistance to damage.
- NIBP Issue Correction: Correction of an issue where NIBP misreported "NIBP Excessive Motion" after 49 days.
- Anesthetic Agent (AA) Numerics: Support for End tidal (Et) and Fraction of Inspired (Fi) numerics for anesthetic agent (AA).
- Physiological Alarms: Support for specific physiological alarm behaviors (triggered only when parameter value is higher/lower than limits, re-alarming after reset, non-overlapping relationships of alarm limit setting).
- Alarm Setup Menu: Support for password protection for accessing the Alarm Setup menu.
- User Authorization: Support for user authorization via LDAP.
- Patient Monitor Information: Support for Facility information, Room No. information, and Visit Number in patient demographics.
- Printing: Support for printing arrhythmia settings in reports, changing factory default printer paper size, and QT report printing.
- MAC Address Display: Support to display the MAC address of the patient monitor.
- ST Values Display: Support for displaying ST values in the parameter tile.
- Patient Private Information: Support for encryption of patient private information sent to the network.
- ST Point Adjustment: Support for adjustment of the ST point on multiple displayed leads.
- NIBP Measurement on Clock: Support for NIBP measurement on the clock.
- Network Application Transmission Priority Setting: Support for network application transmission priority setting.
- ECG Beat Annotation: Support for ECG beat annotation.
- DNS for ADT and LDAP server address: Support for DNS for ADT and LDAP server address.
- Bed No. Issue Correction: Correction of an issue where the Bed No. of the Passport 12m/17m is changed after T1 is pulled out of the monitors.
Performance Data:
Mindray conducted functional and system level testing to evaluate the performance of these modifications. The testing demonstrated that the devices "continue to meet specifications and the performance of the device is equivalent to the predicate." The devices also meet relevant consensus standards (listed in the document).
§ 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.