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510(k) Data Aggregation
(146 days)
Accutorr 7/VS-900 Vital Signs Monitor
The Accutorr 7/VS-900 Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2), on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.
The Accutorr 7/VS-900 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. This patient monitor consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.
This document is a 510(k) Summary for the SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Accutorr 7/VS-900 Vital Signs Monitor. It outlines the device's indications for use, description, performance data, and a comparison to predicate devices to establish substantial equivalence.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria. Instead, it details various performance specifications for each physiological parameter (Temperature, SpO2, Pulse Rate, NIBP) found in the "Predicate Device (K132038)" column, and states that the "Subject Devices" (Accutorr 7/VS-900) generally have the "Same" performance characteristics. For CO2 monitoring, it references the characteristics of the reference predicate (K152902).
Here's a compilation of the performance specifications, which act as the de facto acceptance criteria based on established predicate device performance:
| Feature | Acceptance Criteria (Predicate Device K132038 / Reference Predicate K152902) | Reported Device Performance (Accutorr 7/VS-900) |
|---|---|---|
| WiFi | 2.4G band WiFi, compatible with 802.11 b/g/n | 2.4G/5G dual band WiFi compatible with IEEE 802.11 a/b/g/n |
| Temperature (Temp) | Technique: Thermal resistance | |
| Measurement range: Monitor mode: 25 to 44 °C (77 to 111.2 °F), Predictive mode: 35 to 43 °C (95 to 109.4 °F) | ||
| Resolution: 0.1°C | ||
| Accuracy (Monitor mode): 25 to 32°C (not include 32°C): ±0.2 °C; 32 to 44°C (include 32°C): ±0.1 °C (±0.2 °F) or 77 to 89.6 °F (not include 89.6°F): ±0.4 °F; 89.6 to 111.2 °F (include 89.6°F): ±0.2 °F | ||
| Response Time: Monitor mode: |
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