(99 days)
The 740 SELECT is indicated for use as a bedside, portable device for use by health care professionals, clinicians and medically qualified personnel for spot checking, continuous monitoring and recording of adult, pediatric and neonatal patients. The Monitor features world class technology to facilitate the monitoring of non-invasive blood pressure, pulse rate, functional arterial oxygen saturation (Sp02) and body temperature in a variety of clinical environments.
The 740 SELECT Series Monitor is a portable and rugged non-invasive multi-parameter device used for spot checking, continuous monitoring, and recording of blood pressure, pulse rate, functional oxygen saturation (%Sp02), and predictive body temperature in a variety of clinical environments. The Monitor includes features that are optional or configurable. The 740 SELECT Series Monitor is compact and lightweight in design, allowing it to be easily carried and or configured for use with a mobile stand, wall mount or on a table top. A Lithium lon (Li-lon) rechargeable battery is provided for automatic switching to back-up power if an untended loss of AC power should occur as well as allow the monitor to be used for clinical applications when portable monitoring is required. The 740 SELECT Series Monitor is equipped with a color touchscreen which is the primary interface for the user to control and configure the Monitor (for patient type, alarms, settings and various clinical workflows). A dedicated message area provides patient alarm and technical messages. Date and time as well as the Monitor ID are displayed. A battery gauge provides approximate battery capacity when the monitor is operating on battery power. The Monitor supports both point-of-care and variable acuity monitoring. Spot vital signs measurements from multiple patients can be saved individually. The monitor can be used for continuous patient monitoring with full alarm support.when increased vigilance in necessary based on patient acuity. The Stand-By Mode provides enhanced bedside patient workflow and alarm management permitting sensor attachment, automatic alarm suspension and switch to active monitoring. The color coded Trends Display allows the user to recall all trended physiologic patient. measurement records. Trends can be recalled for saved snapshots as well as timed intervals. The Monitor provides a screen keyboard for entry of patient data (e.g., age, weight, height, gender, date of birth, patient name, and patient identification number). A serial data output is provided for connectivity to hospital EMR systems and external serial devices. An internal isolated relay switch is provided for nurse call systems. The monitor supports an optional externally connected thermal strip chart recorder which is directly powered from the serial port.
The provided text is a 510(k) Summary for the CASMED 740 SELECT physiological patient monitor. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (CAS 740 Series Monitor, K033048).
However, the document does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested. While it mentions "extensive performance, safety, electromagnetic, and environmental testing" and "clinical validation reports for the NIBP, pulse oximeter and the temperature function," it does not provide the specific metrics, actual performance data against thresholds, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, or other detailed study design elements you asked for.
The 510(k) Summary primarily states that:
- The device "has successfully undergone extensive clinical validation for the indicated use."
- "Clinical evaluation, safety testing, software and systems validation demonstrate the 740 SELECT is substantially equivalent to the predicate device."
It references clinical validation reports for NIBP, pulse oximeter, and temperature but does not provide the content of those reports. Therefore, I cannot extract the specific information requested in your numbered points from the provided text.
To answer your questions, I would need to see the actual clinical validation reports or other detailed performance testing documentation that would typically be submitted as part of a 510(k) application (but is often not included in the publicly available 510(k) Summary).
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).