(27 days)
The DINAMAP® ProCare Series 100N-400N 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 temperature and/or oxygen saturation (pulse oximetry). 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 step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.
The DINAMAP ProCare Series 100N-400N Monitor is a prescription device intended for use only by health care professionals. Four configurations of the monitor-all with integrated printer-will offer the following vital signs parameters:
- DPC 100N: Non-Invasive Blood Pressure and Pulse Rate .
- DPC 200N: Non-Invasive Blood Pressure and Pulse Rate, Temperature .
- DPC 300N: Non-invasive Blood Pressure and Pulse Rate, Pulse Oximetry .
- DPC 400N: Non-Invasive Blood Pressure and Pulse Rate. Pulse Oximetry . and Temperature.
This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery.
The provided document is a 510(k) summary for the DINAMAP® ProCare Series 100N-400N Monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study proving specific acceptance criteria in the manner requested (e.g., using a test set, ground truth experts, MRMC studies, or standalone algorithm performance).
The "Testing" section (I) states that "Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® ProCare Series 100N-400N Monitor." These studies are listed as:
- Electromagnetic Compatibility
- Electrical Safety
- Mechanical and Environmental
These types of studies typically involve engineering or regulatory compliance testing against pre-defined standards, not clinical performance evaluation with a test set of patient data, ground truth, or expert review as would be relevant for AI/software-as-a-medical-device (SaMD) clearances.
The document emphasizes that the device has the "same technological characteristics as the predicate device" and that "There are no new technologies used" (Section G). Specifically, for the key physiological parameters, it states:
- NIBP algorithm as implemented on the ProCare Series Monitor (predicate device)
- Alaris IVAC Turbo thermometry technology as implemented on the ProCare Series Monitor (predicate device)
- Wholly implemented Nellcor N-595 SpO2 technology (predicate device)
This indicates that the performance of these technologies relies on the clearance of the existing predicate devices rather than new performance studies for this specific submission.
Therefore, it is not possible to provide the requested information because the document does not describe the kind of study that would typically generate such data for a device with potentially new algorithms or performance claims. The submission is based on substantial equivalence to existing technologies and components.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).