(90 days)
The SmartMonitor 2PS is intended for use in the continuous monitoring of respiration, heart rate and SpO2 levels of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.
The SmartMonitor 2PSL is intended for use in the continuous monitoring of respiration, and heart rate of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, and high or low breath rate. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.
The SmartMonitor 2PS is a microprocessor-based, software-controlled device intended for use as an infant apnea monitoring system or as an adult or pediatric vital signs monitoring system. The electromechanical design of the SmartMonitor 2PS is unchanged from the SmartMonitor 2PS (K032403) except that cleared ECG and oximetry sensor accessories have been selected for adult and pediatric use of the monitor.
The provided text describes a 510(k) summary for the SmartMonitor 2PS and 2PSL, primarily seeking to extend the existing claims to include adult and pediatric use. It does not contain specific acceptance criteria, a detailed study design with sample sizes, or the performance metrics typically associated with device efficacy.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Respironics SmartMonitor 2PS (K032403) and CAS Medical Systems 9303 Neonatal / Adult Vital Signs Monitor (K982776)) for the expanded patient population. The verification is based on design verification testing, safety standards (IEC 60601-1 and IEC 60601-1-2), and a Risk Traceability Matrix.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set information. This type of information is typically found in detailed clinical study reports or validation documents, which are not present in the provided 510(k) summary.
The document states:
- "The functionality of the design of the monitor was verified through the use of design verification testing."
- "The safety of the design was assured by the completion of IEC 60601-1 and IEC 60601-1-2 testing."
- "The Risk Traceability Matrix provided in the Risk Analysis assures that all hazards identified by the risk analysis are successfully mitigated."
These statements indicate that the device's design and safety were verified through standard engineering and safety testing, not through a clinical performance study with specific acceptance criteria as you've outlined. The submission seeks to extend existing claims, implying that the fundamental performance characteristics were established in the predicate device's clearance.
§ 868.2377 Apnea monitor.
(a)
Identification. An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA.”