(77 days)
The VS-800 Vital Signs Monitor is used to monitor physiologic parameters including SpO2, PR and NIBP, and to measure Temperature parameter on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for transport or home use.
The VS-800 Vital Signs Monitor is a prescription device intended for use by health care professionals. And the device is capable of operation from an external AC mains powers source or an internal battery including rechargeable lead-acid battery and lithium battery. The device uses the same or similar technology and materials as the predicate devices, see Legally Marketed Predicate Devices listed above.
The VS-800 Vital Signs Monitor is a configurable monitor with options selected by customer preference. Device's options including module configuration and language setting are configured at the time the monitor is manufactured. Options may be upgrade via upgrade port by the manufacturer. The monitor also provides customer with the convenient operating control and human-machine interface (HMI). All of the patient cable connections are located on the monitor. The LCD and LED display patient information and the menu provides single control operations of all main functions. Operator can adjust parameter alarm settings that give audible and visual indication when a violation occurs. The VS-800 provides oplion for printing information by a thermal recorder.
This monitor has the following parameters measurement functions:
- V SpO2 measurement: pulse oxygen saturation (SpO2), pulse rate (PR), and SpO2 plethysmogram.
-
NIBP measurement: systolic pressure (S), diastolic pressure (D), mean pressure (M), and pulse rate (PR).
- Rectal / oral / axillary TEMP measurement: temperature (TEMP). V
Here's an analysis of the provided text regarding the acceptance criteria and study details for the KOG3055 VS-800 Vital Signs Monitor:
Based on the provided 510(k) summary, Mindray is asserting substantial equivalence for the VS-800 Vital Signs Monitor. The key aspect of this submission is the addition of a Temperature (TEMP) parameter module to a previously cleared VS-800 monitor (K# 060281). Performance for SpO2, PR, and NIBP parameters are stated to remain unchanged from the previous clearance.
Therefore, the acceptance criteria and study specifically address the new TEMP parameter.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state specific quantitative acceptance criteria for the TEMP parameter. Instead, it relies on a comparative performance verification testing strategy against a predicate device.
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Temperature (TEMP) | Substantially equivalent to predicate device (DINAMAP PRO200 MONITOR, K# 992638) for Temp Parameter. | "The results show that the VS-800 Vital Signs Monitor is substantially equivalent to the predicate device named DINAMAP PRO200 MONITOR (K# 992638) for Temp Parameter." |
| SpO2, PR, NIBP | Unchanged from previously cleared VS-800 Vital Signs Monitor (K# 060281) and substantially equivalent to it. | "The SpO2, PR and NIBP Parameters specifications in this VS-800 Vital Signs Monitor remain unchanged as compared to the previously VS-800 Vital Signs Monitor (K# 060281)." "And This VS-800 Vital Signs Monitor is substantially equivalent to currently marketed VS-800 Vital Signs Monitor (K# 060281) for SpOz, PR and NIBP Parameters." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size used for the comparative performance verification testing of the TEMP parameter.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It generally refers to "clinical and laboratory testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the summary. The study appears to be a technical performance comparison against a predicate device, rather than one requiring extensive expert-established ground truth in the manner of diagnostic image analysis, for example.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a vital signs monitor, adjudication by multiple independent experts is typically not a primary method for establishing ground truth for objective physiological measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor would it be relevant for this type of medical device (vital signs monitor). This device is measuring objective physiological parameters; it is not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
For the SpO2, PR, and NIBP functions, it states that the specifications remain unchanged from a previously cleared device, implying the standalone performance was established in the prior submission.
For the new TEMP parameter, the testing described is "comparative Performance verification Testing" against a predicate device. This implies a standalone performance test of the device's temperature measurement accuracy and functionality, compared to a known, legally marketed equivalent.
7. The Type of Ground Truth Used
The ground truth for the TEMP parameter was effectively established by the performance of the predicate device (DINAMAP PRO200 MONITOR). The goal was to show that the new TEMP module's measurements were comparable to those of a device already deemed safe and effective. For SpO2, PR, and NIBP, a similar "ground truth" was established by the previously cleared VS-800 Vital Signs Monitor (K# 060281).
8. The Sample Size for the Training Set
This information is not applicable/not provided. Vital signs monitors typically do not use "training sets" in the machine learning sense. The device's algorithms are based on established physiological principles and signal processing, rather than being "trained" on large datasets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).