(37 days)
Conditions to be screened, monitored, treated or diagnosed.
Patient conditions indicated by abnormalities in various physiologic parameters,
including ECG waveform, respiratory effort, invasive and noninvasive blood
pressure measurements, temperature, cardiac output, and pulse oximeter (SpO₂)
readings.
Prescription use only.
Yes. Caution statement is provided in the introductory page of the Patient Care
Management System which includes the operating instructions for this Module.
Parts of body applied to.
Specific to the physiologic parameter being monitored, accessories may be applied
externally to the chest and limbs or invasively into the blood stream.
Frequency of use.
Frequency as directed by physician.
Physiological purpose.
In conjunction with clinical findings, a screening and diagnostic tool for use in:
assessing electrical activity of the heart in order to detect abnormal cardiac rhythms, including life threatening events such as high and low heart rates, asystole and ventricular fibrillation as well as, in adults, the detection of rhythms such as ventricular runs, tachycardia, and ST segment deviations; monitoring respiratory effort to detect abnormal respiration events such as high and low respiration rates and episodes of apnea; continuous monitoring of invasive pressure signals to detect abnormal events such as high and low pressure; episodic monitoring of noninvasive pressure signals to detect abnormal events such as high and low pressure; continuous monitoring of temperature signals to detect abnormal events such as high and low body temperature; monitoring of the patient's pumping ability of the heart and various hemodynamic values to detect abnormal flow volumes; and noninvasive, continuous monitoring of pulse oxygen saturation signals in order to detect desaturation due to abnormal pulmonary/circulatory functions.
The Spacelabs Medical Multiparameter Module 91496 with Option N is a slim, lightweight singular modular unit that, when used in conjunction with a ilght Care Medical Patient Care Management System (PCMS), provides the capability to acquire various common physiologic data in a clinical setting. The Module 91496 is the primary interface to the patient being monitored. The Module 91496 is capable of acquiring and processing ECG, respiration, invasive and noninvasive blood pressure, temperature, cardiac output and SpO2 parameters for a single patient. The Module 91496 accumulates the patient physiological data of interest and provides both waveform and digital data to a Spacelabs Medical PCMS monitor via SDLC communications. The PCMS monitor will provide the display capabilities for the care provider. Option N utilizes Nellcor Puritan Bennett OxiMax oximetry and sensors and OxiMax-compatible adapter cables.
The provided text describes a Special 510(k) for the Spacelabs Medical Multiparameter Module 91496 with Option N. However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in a quantitative way that would allow for a table of acceptance criteria and performance, or the other requested information (sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.).
The document focuses on:
- Identification of the device and submitter.
- Device description and intended use.
- Comparison to predicate devices (K972502 and K012891).
- A general statement about testing: "The Module 91496 was validated through rigorous testing that, in part, support the compliance of the Module 91496 to applicable standards. Additionally, the software for the Module 91496 was developed following a robust software development process and was fully specified and validated. Safety testing has been performed by third party agencies to ensure the device complies with applicable industry and safety standards."
- FDA's 510(k) clearance letter.
- Detailed indications for use.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or the other specific details about study design, ground truth, and sample sizes, because this information is not present in the provided text.
The document states that the device was "validated through rigorous testing that, in part, support the compliance of the Module 91496 to applicable standards," but it does not specify which standards, what the acceptance criteria within those standards were, or how the device performed against them. It also does not provide details about specific clinical studies or performance data.
§ 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.