(157 days)
The ePM 10/ePM 12/ePM 15/ePM 10M/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 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 document is a 510(k) Summary for the ePM Series Patient Monitors (K200015) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. This document describes the device, its intended use, and the data presented to the FDA to demonstrate substantial equivalence to predicate devices.
While the document details various performance specifications and mentions "functional and system level testing," and "bench testing," it does not provide explicit acceptance criteria in a table format, nor does it present detailed study results proving the device meets specific criteria for the entire suite of monitored parameters. It primarily focuses on demonstrating that the subject device's technological characteristics and performance are substantially equivalent to previously cleared predicate devices and meet relevant consensus standards.
However, based on the provided text, I can extract and infer information about performance and testing related to the ECG and Arrhythmia detection features, which are directly relevant to the regulation number 21 CFR 870.1025.
Here's an attempt to answer your questions based on the available information, with specific limitations noted where details are not provided:
Acceptance Criteria and Study Details for ePM Series Patient Monitors (K200015)
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as a separate, quantified target for each parameter, but rather lists "accuracy" or "measurement range" as performance specifications. The "reported device performance" is essentially implied to be within these stated specifications as a result of the conducted testing.
| Parameter | Acceptance Criteria (Implied / Stated Specification) | Reported Device Performance (Implied as meeting specification) |
|---|---|---|
| Arrhythmia Detection (ECG) | Referenced standards: IEC 60601-2-27:2011 (Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment) and AAMI / ANSI EC57:2012 (Testing and reporting performance results of cardiac rhythm and st-segment measurement algorithms). | |
| Specific arrhythmia types listed. | Performance demonstrated to meet relevant consensus standards (IEC 60601-2-27:2011, AAMI / ANSI EC57:2012). | |
| Supports detection of various arrythmias including 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. | ||
| ST Segment Analysis (ECG) | Referenced standards: As above (AAMI / ANSI EC57:2012). | Performance demonstrated to meet relevant consensus standards. J-point Auto detection included. |
| Heart Rate (HR) (ECG) | Referenced standards: As above (IEC 60601-2-27:2011, AAMI / ANSI EC57:2012). | Performance demonstrated to meet relevant consensus standards. |
| Respiration Rate (Resp) | Measurement range: Adult: 0-120 rpm; Pediatric, neonate: 0-150 rpm. | |
| Accuracy: 7-150 rpm: ±2 rpm or ±2%, whichever is greater; 0-6 rpm: Not specified. | Performance stated to meet these specifications. | |
| Temperature (Temp) | Measurement range: 0-50 °C (32-122 F). | |
| Accuracy: ±0.1 °C or ±0.2 F (without probe). | Performance stated to meet these specifications. | |
| Pulse Oxygen Saturation (SpO2) | Mindray SpO2: Range: 0-100%; Accuracy: 70-100%: ±2% (adult/pediatric), ±3% (neonate); 0-69%: Not specified. | |
| Masimo SpO2: Range: 1-100%; Accuracy: 70-100%: ±2% (adult/pediatric, no motion), ±3% (neonate, no motion), ±3% (with motion); 1-69%: Not specified. | ||
| Nellcor SpO2: Range: 0-100%; Accuracy: 70-100%: ±2% (adult/pediatric), ±3% (neonate); 0-69%: Not specified. | Performance stated to meet these specifications. | |
| Pulse Rate (PR) | Mindray SpO2 Module: Range: 20-254 bpm; Accuracy: ±3 bpm. | |
| Masimo SpO2 Module: Range: 25-240 bpm; Accuracy: ±3 bpm (no motion), ±5 bpm (with motion). | ||
| Nellcor SpO2 Module: Range: 20-300 bpm; Accuracy: 20-250 bpm: ±3 bpm; 251-300 bpm: Not specified. | Performance stated to meet these specifications. | |
| Non-invasive Blood Pressure (NIBP) | Adult: Systolic: 25-290, Diastolic: 10-250, Mean: 15-260. | |
| Pediatric: Systolic: 25-240, Diastolic: 10-200, Mean: 15-215. | ||
| Neonate: Systolic: 25-140, Diastolic: 10-115, Mean: 15-125. | ||
| Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg. | Performance stated to meet these specifications. | |
| Invasive Blood Pressure (IBP) | Measurement range: -50 to 300 mmHg. | |
| Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor). | Performance stated to meet these specifications. | |
| Cardiac Output (C.O.) | Measurement range: C.O: 0.1-20 L/min; TB: 23-43 °C; TI: 0-27 °C. | |
| Accuracy: C.O: ±5% or ±0.1 L/min, whichever is greater; TB, TI: ±0.1 °C (without sensor). | Performance stated to meet these specifications. | |
| Carbon Dioxide (CO2) | Sidestream CO2 2.0: Range: 0-150mmHg; Accuracy: 0-40 mmHg: ±2mmHg, 41-76 mmHg: ±5% of reading, 77-99 mmHg: ±10% of reading, 100-150mmHg: ±(3mmHg + 8% of reading). AwRR: |
§ 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.