(68 days)
The VSM 6000 Series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:
- noninvasive blood pressure.
- pulse rate,
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
- body temperature in normal and axillary modes.
The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.
The optional Masimo Rainbow SET® and accessories are indicated for the continuous noninvasive monitoring of total hemoglobin concentration of adult, pediatric, and neonatal patients turing both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
Optional compatible weight scales (e.g., Health o meter®) can be used for height, and BMI input.
The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.
This product is available for sale only upon the order of a physician or licensed health care professional.
The proposed modified Connex Vital Signs Monitor 6000 Series (CVSM) is the same device that was cleared under K110516; in particular, the indications for use for vital signs measuring/monitoring subsystem of the proposed device are the same as those cleared under K110516. In the modified device, the Welch Allyn Application Framework (Framework) - has been included as a separate subsystem. The Framework is general purpose software that allows medical device and non-medical device software applications to run on the Framework independently of, and isolated from, the CVSM's vital signs monitoring functionality.
The provided 510(k) summary for the Welch Allyn Connex® Vital Signs Monitor 6000 Series indicates that no clinical studies were utilized for the purpose of obtaining safety or effectiveness data.
Therefore, there is no information available in the provided text regarding acceptance criteria, reported device performance figures, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these typically stem from clinical performance evaluations.
The submission focuses on demonstrating substantial equivalence to a predicate device (Welch Allyn Vital Signs Monitor - CVSM 6000 Series, K110516) through non-clinical tests, primarily to verify:
- Expected performance of the CVSM 6000.
- That the addition of the "Framework" (a software platform) does not affect the functionality or performance of the CVSM's vital signs monitoring.
- That applications run on the Framework are isolated from and independent of CVSM vital signs monitoring functionality and do not control or otherwise affect the CVSM's performance.
The non-clinical tests involved verifying compliance with several IEC and ISO standards related to medical electrical equipment, electromagnetic compatibility, programmable electrical medical systems, alarm systems, sphygmomanometers, pulse oximeter equipment, and risk management. These standards inherently contain their own performance and safety criteria, which the device was tested against.
In summary, as no clinical performance data was provided or required for this 510(k) submission, the requested information regarding acceptance criteria and a study proving device performance against those criteria in a clinical context is not available in the given document.
§ 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).