(67 days)
The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2.
The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
The Spacelabs Medical mCARE 300 Vital Signs Monitor, Model 91220, is a portable patient monitoring device intended to be used by clinicians and medically qualified personnel for monitoring physiological parameters; ECG, respiration, noninvasive and invasive blood pressure, body temperature, Sp02, or End tidal C02 or ETC02; in neonatal, of pediatric and adult patients.
This device is designed to be used in all general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Spacelabs Medical mCARE 300 Vital Signs Monitor. It does not contain the specific acceptance criteria, reported device performance data, or details of a study that would allow for a complete answer to your request.
The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to special controls and standards. It mentions that the device "successfully underwent testing to demonstrate conformance to the Special Controls established for 21CFR 807.1025, 'Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm'" and "was validated through rigorous testing that, in part, support the compliance... to the Standards mentioned in Section 9.0 of this submission." However, it does not provide the results of these tests or the acceptance criteria used.
Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text.
Here's what I can infer or state based on the given information:
- Device Type: Vital Signs Monitor (ECG, respiration, noninvasive and invasive blood pressure, body temperature, SpO2, EtCO2).
- Classification: Class II, with special controls: "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm."
- Intended Use: Adult, pediatric, and neonate patient populations in all areas of a healthcare facility, for monitoring the listed physiological parameters.
- Regulatory Pathway: 510(k) Premarket Notification, establishing substantial equivalence to predicate devices.
Missing Information:
The document lacks critical details such as:
- Specific numerical acceptance criteria for any of the physiological parameters.
- Detailed performance data (e.g., accuracy, precision, sensitivity, specificity) against those criteria.
- The specifics of any clinical or bench studies conducted (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, details of training sets, etc.).
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
To answer your questions fully, you would typically need to consult the full 510(k) submission and associated test reports, which are not included in this summary.
§ 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.