(140 days)
The VS-800 Vital Signs Monitor is used to monitor physiological parameters, including Sp02, PR and NIBP on adults, pediatric and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
The device is not intended for transport or home use.
The VS-800 Vital Signs Monitor is battery or line-powered monitor used on human patient. The Vital Signs Monitor acquires the physiological signals non-invasive blood pressure (NIBP) and pulse oxygen saturation of the blood (SpO2). These physiological signals are converted into digital data and processed. The VS-800 Vital Signs Monitor examines the data for alarm conditions and presents them on the front panel. The Vital Signs Monitor also provides user with the convenient operating control and human-machine interface (HMI),
The optional built-in recorder provides hard copies of all digital data and waveforms as well as Tabular and Graphic Trend Information, and storage the previous monitoring data information when power off accidentally.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on establishing substantial equivalence to a predicate device and adherence to various safety and performance standards rather than reporting specific quantitative performance metrics against pre-defined acceptance criteria.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Safety and Efficacy | Be as safe, as effective, and perform as well as or better than the legally marketed predicate device (PM-8000 Patient Monitor K#043348). | Demonstrated through laboratory testing, hazard analysis, and compliance with numerous industry and safety standards to be substantially equivalent and perform at least as well as the predicate device. |
| SpO2 Accuracy | Similar to predicate device (PM-8000), comply with relevant ANSI/AAMI, IEC, EN, and ISO standards (e.g., EN865). Specific numerical criteria not provided. | "Parameters' specification of the VS-800 Vital Signs Monitor, including SpO2... is similar to the predicate PM-8000 Patient Monitor." Compliance with EN865 is stated. |
| Pulse Rate (PR) Accuracy | Similar to predicate device (PM-8000), comply with relevant ANSI/AAMI, IEC, EN, and ISO standards. Specific numerical criteria not provided. | "Parameters' specification of the VS-800 Vital Signs Monitor, including... PR... is similar to the predicate PM-8000 Patient Monitor." |
| Non-Invasive Blood Pressure (NIBP) Accuracy | Similar to predicate device (PM-8000), comply with relevant ANSI/AAMI, IEC, EN, and ISO standards, specifically ANSI/AAMI Standards SP10. Specific numerical criteria not provided. | "Parameters' specification of the VS-800 Vital Signs Monitor, including... NIBP... is similar to the predicate PM-8000 Patient Monitor." Testing conducted according to ANSI/AAMI Standards SP10. |
| Electrical Safety | Meet requirements of IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4. Prevent excessive electrical leakage current. | Testing performed by third-party agencies to ensure compliance with applicable industry and safety standards, including IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4. |
| Software Functionality & Data Accuracy (Misdiagnosis Prevention) | Software design and signal processing should not lead to inaccurate diagnostic data. | Hazard analysis of the system and its software was performed, and testing was conducted to validate the systems overall operation to address the risk of misdiagnosis due to inadequate design. |
| Alarm Functionality | Adequate design for audible and visual indicators to prevent inadequate response to the patient's condition. | Hazard analysis addressed the risk of inadequate design of the system's ability to alert users. |
| Environmental Performance | Meet all environmental testing identified in FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. | Laboratory testing was conducted to validate and verify that the VS-800 Vital Signs Monitor met all design specifications, including environmental testing. |
| Risk Management | Comply with ISO 14971. Address risks like electrical shock and misdiagnosis. | Testing assured compliance with ISO14971. Hazard analysis performed for electrical shock and misdiagnosis. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified. The document mentions "laboratory testing" and "third-party agencies" for safety testing, but the number of patients or samples used for these tests is not provided.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing described is "laboratory testing" and appears to be internal validation and verification, potentially involving some human subjects for performance against standards like SP10, but details are lacking. The country of origin for the testing itself is not explicitly stated, but the submitter is from Shenzhen, P. R. China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not specified. The document describes engineering and standards compliance testing, not a clinical study where expert ground truth would typically be established for diagnostic accuracy. The testing for NIBP (ANSI/AAMI SP10) would involve comparison against a reference method, but this is a technical standard, not a subjective expert assessment. The "misdiagnosis" risk area implies the accuracy of "diagnostic data" is critical, but how its ground truth was established for testing purposes is not detailed beyond "inadequate design of the signal processing and measurement circuitry or program can lead generation of inaccurate diagnostic data."
4. Adjudication Method for the Test Set:
- Not applicable/Not specified. As mentioned above, the testing described is not a clinical study involving subjective interpretation from experts requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study was not performed. This device is a vital signs monitor, not an image interpretation or diagnostic aid that would typically involve multiple human readers. The study focuses on the device's technical performance and safety.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The entire testing described ("Laboratory testing," "hazard analysis," "system validation," "safety testing by third party agencies," testing "according to the requirements outlined in the ANSI/AAMI Standards SP10") focuses on the performance of the device itself (the "algorithm only" in the context of a simple monitor) rather than its impact on human reader performance. The device provides "digital data" and "processed" signals, implying standalone functionality.
7. The Type of Ground Truth Used:
- Reference Standards/Predicate Device Comparison:
- For NIBP, the ground truth is established by the requirements and reference measurements outlined in ANSI/AAMI Standards SP10.
- For SpO2 and PR, the implied ground truth is the performance "similar to the predicate PM-8000 Patient Monitor" and compliance with EN865 and other general standards.
- For safety, the ground truth is defined by IEC 60601-1 series, ISO 14971, and other applicable safety standards.
8. The Sample Size for the Training Set:
- Not applicable/Not specified. This device is a vital signs monitor, not a machine learning or AI-driven diagnostic system that typically involves a distinct "training set" in the modern sense. Its development would involve traditional embedded systems engineering and calibration, not machine learning model training.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As a traditional vital signs monitor, there isn't a "training set" in the context of supervised learning. The device's internal algorithms and calibrations would be developed based on engineering principles, physiological models, and empirical testing against reference instruments and standards.
§ 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.