(122 days)
The ePM 10/ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M patient monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2), Oxygen (O2) and Anesthetic Gas (AG). The system also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
• The arrhythmia detection and PAWP monitoring is intended for adult and pediatric patients only;
• C.O. monitoring is intended for adult patients only;
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The ePM 12/ePM 15/ePM 10M/ePM 12M/ePM 15M monitors are not intended for helicopter transport, hospital ambulance, or home use.
The subject ePM Series Patient Monitors includes six monitors:
• ePM 10 Patient Monitor
• ePM 12 Patient Monitor
• ePM 15 Patient Monitor
• ePM 10M Patient Monitor
• ePM 12M Patient Monitor
• ePM 15M Patient Monitor
The ePM Series Patient Monitors are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of monitoring.
The provided text describes a 510(k) premarket notification for the ePM Series Patient Monitors, arguing their substantial equivalence to a predicate device (BeneVision N Series Patient Monitors). The document outlines various performance characteristics and how they compare to the predicate, along with general statements about testing performed.
There is no specific study detailed that "proves the device meets the acceptance criteria" in terms of clinical performance or a comparative effectiveness study with human readers. The document primarily focuses on demonstrating that the new device's technological characteristics and performance specifications are equivalent to the predicate device. The information details bench testing and compliance with consensus standards to show that the device meets its accuracy specifications and does not raise new questions of safety and effectiveness.
Therefore, the requested information elements related to a specific study, such as sample size, expert adjudication, MRMC studies, or standalone algorithm performance, cannot be extracted from this document as such a study is not described. The document discusses performance specifications and claims that bench testing validates these specifications and shows substantial equivalence.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the predicate device's specifications and compliance with relevant standards. The reported device performance is presented as being "the same" or having "minor circuit board layout differences" but maintaining the same specifications as the predicate. The document doesn't provide a direct table of acceptance criteria with reported performance, but rather a comparison table of features and specifications between the subject device and the predicate.
Below is a summary derived from the "Technological Comparison" table (Table 2) and subsequent explanatory text, focusing on the measurement parameters where performance specifications are explicitly mentioned or affirmed as "same":
| Feature | Predicate Devices (K182075) Performance/Specifications (Acceptance Criteria) | Subject ePM Devices Reported Performance/Specifications |
|---|---|---|
| ECG | 3-, 5-, 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, interpretation of resting 12-lead ECG, J-point Auto detection, Dual Channel Pace detection, adjustable QRS threshold, HR. Arrhythmia for adult/pediatric, ST for adult/pediatric/neonate, intelligent arrhythmia alarm. | Same as predicate, with 6-lead option added. |
| Arrhythmia Analysis | Asystole, VFib/Vtac, Vtac, Vent.Brady, Extreme Tachy, Extreme Brady, PVCs, Couplet, Bigeminy, Trigeminy, R on T, Run PVCs, PVCs/min, Tachy, Brady, Missed Beats, Vent Rhythm, Pacer Not Pacing, Pacer Not Capture, Multif.PVC, Nonsus.Vtac, Pause, Vent.Rhythm, Afib, Pauses/min. | Same as predicate. |
| Respiration Rate (Resp) | Range: Adult: 0-120 rpm; Pediatric, neonate: 0-150 rpm. Accuracy: 7-150 rpm: ±2 rpm or ±2% (greater); 0-6 rpm: Not specified. | Measurement specifications are the same. Minor circuit board layout differences. |
| Temperature (Temp) | Range: 0-50°C (32-122°F). Accuracy: ±0.1°C or ±0.2ºF (without probe). | Measurement specifications are the same. Minor circuit board layout differences. |
| Pulse Oxygen Saturation (SpO2) (Mindray) | Range: 0-100%. Accuracy: 70-100%: ±2% (adult/pediatric); 70-100%: ±3% (neonate); 0-69%: Not specified. | Same specifications. Minor circuit board layout differences in internal module. |
| Pulse Oxygen Saturation (SpO2) (Masimo) | Range: 1-100%. Accuracy: 70-100%: ±2% (without motion in adult/pediatric); 70-100%: ±3% (without motion in neonate); 70-100%: ±3% (with motion); 1-69%: Not specified. | Same specifications. Internal module identical to predicate's. |
| Pulse Oxygen Saturation (SpO2) (Nellcor) | Range: 0-100%. Accuracy: 70-100%: ±2% (adult/pediatric); 70-100%: ±3% (neonate); 0-69%: Not specified. | Same specifications. Internal module identical to predicate's. |
| Pulse Rate (PR) (from Mindray SpO2) | Range: 20-254 bpm. Accuracy: ±3 bpm. | Same as predicate. |
| Pulse Rate (PR) (from Masimo SpO2) | Range: 25-240 bpm. Accuracy: ±3 bpm (without motion); ±5 bpm (with motion). | Same as predicate. |
| Pulse Rate (PR) (from Nellcor SpO2) | Range: 20-300 bpm. Accuracy: 20-250 bpm: ±3 bpm; 251-300 bpm: Not specified. | Same as predicate. |
| Non-invasive Blood Pressure (NIBP) | Range: Systolic adult 25-290, pedi 25-240, neon 25-140; Diastolic adult 10-250, pedi 10-200, neon 10-115; Mean adult 15-260, pedi 15-215, neon 15-125. Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg. | Measurement specifications are the same. Minor circuit board layout and overpressure protection channel differences. |
| Invasive Blood Pressure (IBP) | Range: -50 to 300 mmHg. Accuracy: ±2% or ±1 mmHg (greater, without sensor). | Measurement specifications are the same. Minor circuit board layout differences. |
| Cardiac Output (C.O.) | Range: C.O: 0.1 to 20 L/min; TB: 23 to 43°C; TI: 0 to 27°C. Accuracy: C.O: ±5% or ±0.1 L/min (greater); TB, TI: ±0.1°C (without sensor). | Internal C.O. module is identical to external C.O. module in predicate. |
| Carbon Dioxide (CO2) (Sidestream 2.0) | Range: 0-150 mmHg. Accuracy: 0-40 mmHg: ±2mmHg; 41-76 mmHg: ±5% of reading; 77-99 mmHg: ±10% of reading; 100-150mmHg: ±(3mmHg + 8% of reading). awRR Range: 0-150 rpm. awRR Acc: |
§ 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.