(105 days)
The monitor monitors parameters such as ECG (3-lead or 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired C02.
The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient transport inside a healthcare facility. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
The Patient Monitor Models PM-2000A, PM-2000A+ & PM-2000A Pro can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models.
The Patient Monitor Models PM-2000A, PM-2000A+ & PM-2000A Pro can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, C02, IBP. The above is the maximum configuration; the user may select different monitoring parameters in according with specific requirements. The main difference between Patient Monitor models is the screen size as it is illustrated in the table below:
| Product models | Size (LxWxH) | Screen size | Monitoring features |
|---|---|---|---|
| PM-2000A | 10.1-Inch | ||
| PM-2000A+ | 320mmx150mmx265mm | 10.4-Inch | ECG/RESP.SPO2, NIBP, |
| TEMP, IBP, CO2 | |||
| PM-2000A Pro | 12.1-Inch |
The provided document is a 510(k) summary for patient monitors (PM-2000A, PM-2000A+, and PM-2000A Pro). It describes the device, its intended use, and its classification, but does not contain any information about acceptance criteria or a study proving performance against such criteria.
The document states:
- "Verification and Validation testing was done on the Patient Monitor."
- "This premarket notification submission demonstrates that the Patient Monitor Models PM-2000A, PM-2000A+ & PM-2000A Pro is substantially equivalent to the predicate device."
However, no details about the specific tests performed (e.g., performance metrics, acceptance thresholds, methodology, or results) are included in this summary. It lists general test categories like "Software Testing," "Hardware Testing," "Electrical Testing," and "Safety Testing" but provides no further specifics that would allow answering the prompt's questions about acceptance criteria or study details.
Therefore,Based on the provided information, I cannot answer your request as the document does not contain the necessary details regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, or study methodologies.
§ 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.