(203 days)
The DINAMAP® Pro 1000 V2 Monitor is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, oxygen saturation (SpO2) by non-invasive pulse oximetry, and predictive temperature with an electronic thermometer in the adult, pediatric and neonate populations. An additional feature is the detection of three lethal arrhythmias- asystole, ventricular tachycardia (v-tach), and ventricular fibrillation (v-fib). The Pro 1000 V2 Monitor also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.
The DNAMAP® Pro 1000 V2 Monitor is intended to monitor a single patient's vital signs in the hospital, outpatient surgery and healthcare practitioner facilities. The patient populations include adult, pediatric, and neonatal. The device's networking capabilities include connection to a central station via VHF, 900 MHz or hardwire communication; host communications for use with other devices. In addition, the DINAMAP Pro 1000 V2 Monitor may be operated from internal batteries making the device portable and suitable for intra-hospital transport.
The provided text describes a 510(k) premarket notification for the DINAMAP® Pro 1000 V2 Monitor. It establishes substantial equivalence to a predicate device and mentions a software validation for an arrhythmia detection feature. However, it does not contain a study specifically detailing acceptance criteria and performance results in the manner requested.
Therefore, the following information is not available within the provided text:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set and data provenance for performance evaluation.
- Number of experts used to establish ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance evaluation.
- Sample size for the training set.
- How the ground truth for the training set was established.
Key information from the provided text regarding device validation:
- Device: DINAMAP® Pro 1000 V2 Monitor
- Intended Use: Monitoring oscillometric non-invasive blood pressure, heart/pulse rate, respiration rate, ECG, oxygen saturation (SpO2), and predictive temperature in adult, pediatric, and neonate populations. An additional feature is the detection of three lethal arrhythmias: asystole, ventricular tachycardia (v-tach), and ventricular fibrillation (v-fib).
- Predicate Device: DINAMAP® Pro 1000 Monitor (K002248) and the EkPro ECG algorithm in the DASH 3000/4000 Patient Monitor (K001359).
- Technological Characteristics: The DINAMAP® Pro 1000 V2 Monitor has the same technological characteristics as the predicate device. "There are no new technological characteristics. The Pro 1000 Monitor and the Pro 1000 V2 Monitor are both software-driven electronic devices that include the same monitoring parameters."
- Testing Mentioned: "A software validation was performed to demonstrate the implementation of the arrhythmia detection feature." This statement indicates that some testing was done specifically for the arrhythmia detection, but the details (acceptance criteria, results, methodology, sample sizes, etc.) are not provided.
- Conclusion: The device is deemed substantially equivalent to currently marketed predicate devices. This implies that the device is expected to perform at least as well as the predicate devices, but specific performance metrics are not detailed in this summary.
In summary, while the document confirms that a software validation was performed for the arrhythmia detection feature, it does not provide the detailed acceptance criteria and study data requested related to device performance. The focus of this 510(k) summary is on establishing substantial equivalence rather than presenting granular performance study results against specific criteria.
§ 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.