(16 days)
The CARESCAPE V100 Vital Signs Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature.
The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac stepdown. The CARESCAPE V100 Vital Signs Monitor can also be used in satellite areas, physicians' office, or alternate care settings.
The CARESCAPE V100 Vital Signs Monitor is a small, portable monitor for use in a sub-acute hospital and non-hospital settings. The CARESCAPE V100 is for use on adult, pediatric, or neonatal patients - one at a time. The battery operated monitor provides noninvasive determination of systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, oxygen saturation, and temperature.
The CARESCAPE V100 is a multi-parameter device that provides Sp02 monitoring for use in spot-checking or continuous monitoring. The CARESCAPE V100 also measures NIBP using the oscillometric method. There are no features of CARESCAPE V100 that can be controlled by the patient.
The CARESCAPE V100 monitor is available in four standard configurations with or without an integrated printer:
- CARESCAPE V100 with NIBP (Classic, Classic Auscultatory, or . SuperSTAT), Pulse
- CARESCAPE V100 with NIBP (Classic, Classic Auscultatory, or . SuperSTAT), Pulse, and Temperature
- . CARESCAPE V100 with NIBP (Classic, Classic Auscultatory, or SuperSTAT), Pulse, and Sp02 (Ohmeda TruSignal, Nellcor, or Masimo)
- . CARESCAPE V100 with NIBP (Classic, Classic Auscultatory, or SuperSTAT), Pulse, Temperature, and Sp02 (Ohmeda TruSignal, Nellcor, or Masimo)
The provided FDA 510(k) summary for the CARESCAPE V100 Vital Signs Monitor (K073203) describes the device and its intended use, but it does not contain information regarding specific acceptance criteria, study details (like sample sizes, ground truth establishment, or expert qualifications), device performance against those criteria, or multi-reader multi-case studies.
Instead, the document states: "The subject of this 510(k) is a design modification for the ProCare V1 Vital Signs Monitor. The CARESCAPE V100 Vital Signs Monitor complies with the voluntary standards as detailed in Section 4.2 of this submission. The following quality assurance measures were applied to the development of the CARESCAPE V100 Vital Signs Monitor: Risk Analysis, Requirements Reviews, Design Reviews, Subsystem Verification, Integration testing (System verification), Final acceptance testing (Validation), Performance testing, Safety testing, Environmental testing."
The conclusion provided is: "The results of these measurements demonstrated that the CARESCAPE V100 Vital Signs Monitor is as safe, as effective, and performs as well as the predicate device(s)," which is a general statement of substantial equivalence rather than a detailed report of performance against specific acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
The document refers to "voluntary standards as detailed in Section 4.2 of this submission," which would presumably contain the technical performance specifications and acceptance criteria, but Section 4.2 itself is not included in the provided text.
§ 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.