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/Scv02, and PAWP monitoring are intended for adult and pediatric patients only;
· ST Segment analysis of Mindray algorithm is intended for adult patients only;
· C.O. monitoring is restricted to adult patients only;
• ICG monitoring is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
T1 Patient Monitor:
The T1 Patient Monitor is intended for monitoring, displaying, reviewing, 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:
- 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.
The provided text focuses on the substantial equivalence of the Passport Series Patient Monitors to predicate devices, rather than outlining specific acceptance criteria and a study demonstrating the device meets those criteria with detailed performance metrics. The information pertains to a 510(k) submission, which aims to show equivalence to a legally marketed device, not necessarily to prove it meets pre-defined acceptance criteria with a new, standalone study the way a PMA might.
However, I can extract information related to performance testing and changes from the provided text.
Here's an analysis based on the supplied document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds that the device must meet for specific clinical performance metrics. Instead, it describes "performance data" in the context of demonstrating substantial equivalence to a predicate device. The performance is assessed against the specifications of the predicate device and relevant consensus standards.
The table in the document (pages 7-8) compares the features and performance specifications of the subject devices to the predicate device (K143195). The relevant performance aspects are nested within the "Feature" column and include:
| Feature/Parameter | Acceptance Criteria (Implicit - from Predicate or Standards) | Reported Device Performance (Subject Device) |
|---|---|---|
| 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. | Same (Equivalent to predicate) |
| Temperature (Temp) | Measurement range: 0 to 50°C (32 to 122°F). Accuracy: ±0.1°C or ±0.2°F (without probe). | Same (Equivalent to predicate) |
| Pulse Oxygen Saturation (SpO2) - Mindray 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. | Same (Equivalent to predicate) |
| Pulse Oxygen Saturation (SpO2) - Masimo Module | Measurement range: 1 to 100%. Accuracy: 70 to 100%: ±2% (without motion, adult/pediatric); 70 to 100%: ±3% (without motion, neonate); 70 to 100%: ±3% (with motion); 1% to 69%: Not specified. | Same (Equivalent to predicate) |
| Pulse Oxygen Saturation (SpO2) - Nellcor Module | Measurement range: 0 to 100%. Accuracy: 70 to 100%: ±2% (adult/pediatric); 70 to 100%: ±3% (neonate); 0% to 69%: Not specified. | Same (Equivalent to predicate) |
| Pulse Rate (PR) - from Mindray SpO2 Module | Measurement range: 20 to 254 bpm. Accuracy: ±3 bpm. | Same (Equivalent to predicate) |
| Pulse Rate (PR) - from Masimo SpO2 Module | Measurement range: 25 to 240 bpm. Accuracy: ±3 bpm (without motion); ±5 bpm (with motion). | Same (Equivalent to predicate) |
| Pulse Rate (PR) - from Nellcor SpO2 Module | Measurement range: 20 to 300 bpm. Accuracy: 20 to 250 bpm: ±3 bpm. | Same (Equivalent to predicate) |
| Pulse Rate (PR) - from IBP Module | Measurement range: 25 to 350 bpm. Accuracy: ±1 bpm or ±1%, whichever is greater. | Same (Equivalent to predicate) |
| Non-invasive Blood Pressure (NIBP) - Adult | Measurement range: Systolic: 40 to 270; Diastolic: 10 to 210; Mean: 20 to 230. Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg. | Same (Equivalent to predicate) |
| Non-invasive Blood Pressure (NIBP) - Pediatric | Measurement range: Systolic: 40 to 200; Diastolic: 10 to 150; Mean: 20 to 165. Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg. | Same (Equivalent to predicate) |
| Non-invasive Blood Pressure (NIBP) - Neonate | Measurement range: Systolic: 40 to 135; Diastolic: 10 to 100; Mean: 20 to 110. Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg. | Same (Equivalent to predicate) |
| Invasive Blood Pressure (IBP) | Measurement range: -50 to 300 mmHg. Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor). | Same (Equivalent to predicate) |
| Carbon Dioxide (CO2) - Sidestream Module | Measurement range: 0 to 99 mmHg. Accuracy: 0 to 40 mmHg: ±2 mmHg; 41 to 76 mmHg: ±5% of reading; 77 to 99 mmHg: ±10% of reading. | Same (Equivalent to predicate) |
| Carbon Dioxide (CO2) - Microstream Module | Measurement range: 0 to 99 mmHg. Accuracy: 0 to 38 mmHg: ±2 mmHg; 39 to 99 mmHg: ±5% of reading + 0.08% of (reading-38). | Same (Equivalent to predicate) |
| Carbon Dioxide (CO2) - Mainstream Module | Measurement range: 0 to 150 mmHg. Accuracy: 0 to 40 mmHg: ±2 mmHg; 41 to 70 mmHg: ±5% of reading; 71 to 100 mmHg: ±8% of reading; 101 to 150 mmHg: ±10% of reading. | Same (Equivalent to predicate) |
| Impedance Cardiograph (ICG) | Measurement range: SV: 5 to 250 ml; HR: 4 to 200 bpm; C.O.: 1.4 to 15 L/min. Accuracy: HR: ±2 bpm. (SV and C.O. not specified for accuracy). | Same (Equivalent to predicate) |
Note: For features like "QT analysis" (added to ECG Mindray Algorithm) and "AFib" (added to Arrhythmia Analysis Mindray Algorithm), and "Adjustable QRS Detection Threshold" (added), the document states "Added" or "Same" but does not provide specific performance metrics or acceptance criteria for these new or modified features in the provided text. It generally states that "The testing provided an evaluation of the performance of the device relevant to each of the modifications... 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."
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Mindray conducted functional and system level testing on the subject devices." It does not specify the sample size for this testing or the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be internal engineering and verification testing rather than a clinical trial with patient data.
3. Number of Experts and Qualifications
The document makes no mention of experts being used to establish ground truth for a test set. The validation described is based on engineering and system-level testing against specifications derived from the predicate device and consensus standards.
4. Adjudication Method
No adjudication method is mentioned, as there is no indication of expert review or clinical ground truth establishment in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a MRMC comparative effectiveness study, nor does it mention any effect size of human readers improving with or without AI assistance. This type of study would typically be conducted for diagnostic or interpretive algorithms, not necessarily for a multi-parameter patient monitor's basic physiological parameter measurements.
6. Standalone (Algorithm Only) Performance Study
The document generally refers to "functional and system level testing" and "conformance with applicable standards." While this implies algorithm performance was assessed as part of the overall device functionality, it does not specifically detail a standalone algorithm-only performance study with dedicated metrics like sensitivity, specificity, accuracy, etc., for a particular diagnostic output. The focus is on the device's ability to measure and present physiological parameters in a manner equivalent to the predicate.
7. Type of Ground Truth Used
Based on the provided text, the ground truth for the performance evaluations (e.g., accuracy of measurement ranges) would likely be established using calibrated test equipment, simulation, and potentially comparison to established reference methods or predicate device outputs during engineering and system-level testing. There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for this submission. The "ground truth" for showing equivalence seems to be alignment with predicate device specifications and recognized consensus standards.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This is a 510(k) submission for a patient monitor, not a machine learning or AI-driven diagnostic device that would typically involve a separate training set. While the device does have "arrhythmia detection" and "ST segment analysis" algorithms, the document focuses on their functional equivalence and adherence to standards rather than detailing the methodology of their development or independent training/testing.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned, this information is not provided.
§ 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.