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510(k) Data Aggregation
(104 days)
PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
PMS8210A Model Code 500 is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Model Code 500 has certain features and functions.
The patient parameters that can be monitored by PMS8210A Model Code 500 are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2), Temperature (TEMP) and End-tidal CO2 (EtCO2) . Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.
The PMS8210A Model Code 500 is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.
The PMS8210A Model Code 500 is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
PMS8210A Model Code 500 Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG, respiration (RESP), Non-Invasive blood pressure (NIBP), Saturation of pulse oxygen (SPO2), Temperature (TEMP), End-tidal (etCO₂). The signals are converted into digital data and processed, examines the data for alarm conditions and displays the data. The monitor also provides operating control for the user. The submitted device is the same as the predicate with two differences. The new model has added an etCO2 function and the Temp module has been changed. The new Temp module is a previously FDA cleared device.
The provided text describes a 510(k) premarket notification for the PMS8210A (IRIS) Multi-Parameter Patient Monitor Model Code 500. This device is a multi-parameter patient monitor intended for use in healthcare facility settings.
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various standards and directives to which the device conforms, indicating these as the acceptance criteria. The device's performance is reported as meeting these standards, implying "Same" as the predicate device or conforming to the specified standards without providing specific numerical performance data within the summary itself.
| Category | Acceptance Criteria (Directives/Standards) | Reported Device Performance |
|---|---|---|
| NIBP | ISO 81060-2:2009 (Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers) | Conforms to ISO 81060-2:2009. |
| EN 865:1997 (Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type) | Conforms to EN 865:1997. | |
| SpO₂ | ISO 9919:2005 (Pulse oximeters, 5 SpO₂ Particular requirements) | Conforms to ISO 9919:2005. |
| IEC 80601-2-34 (Medical electrical equipment --- Part 2-34: Particular requirements for the basic safety and essential performance of pulse oximeters equipment for medical use) | Conforms to IEC 80601-2-34. | |
| Temperature | ASTM E1112:2000 (Electronic thermometer for intermittent determination of patient temperature) | Conforms to ASTM E1112:2000. |
| ASTM E1104-03 (Standard Specification for Clinical Thermometer Probe Covers and Sheaths) | Conforms to ASTM E1104-03. | |
| EN 12470-4:2000 (Clinical thermometers-Part 4: Performance of electrical thermometers for continuous measurement) | Conforms to EN 12470-4:2000. | |
| Respiratory Measurement | IEC 80601-2-55:2009 (Not fully described in table, but implied standard for respiratory measurement) | Conforms to relevant IEC standards. (Specific performance not detailed in available snippet) |
| ECG | Anti-polarized voltage: $\leq \pm 500$ mV; Baseline renewing time: |
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