(52 days)
The Honeywell HomMed Sentry OTC Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, oral temperature and weight. Data from optional commercial stand-alone products extend the Sentry OTC Monitor's measurement capabilities. Data from the Sentry OTC Monitor can be transmitted via a communication module to a central viewing station for display. The Sentry OTC Monitor is not intended for emergency use or real-time monitoring.
The Honeywell HomMed Sentry OTC Monitor is a vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, oral temperature and weight. The Sentry OTC Monitor has six serial ports available for external options. The Sentry OTC Monitor acquires the vital signs data and displays it. The data can be transmitted via the communication module to a central viewing station.
The provided text is a 510(k) summary for the Honeywell HomMed Sentry OTC Monitor, which is a vital signs monitoring system. It leverages a predicate device (HomMed Sentry IIIB Patient Monitor System K040651) and highlights compliance with various voluntary standards.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for specific vital sign measurements (e.g., blood pressure accuracy in mmHg, pulse rate deviation). Instead, it uses a qualitative statement of compliance with standards and equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with EN 60601-1 (Medical Electrical Safety) | Demonstrated compliance |
| Compliance with IEC 601-1-2 (EMC Compliance) | Demonstrated compliance |
| Compliance with ISO 10993-5, 10-11 (Biocompatibility) | Demonstrated compliance |
| Performance consistent with FDA reviewer's guides for respiratory devices and electronic thermometers | "performs consistent with guidelines and standards" |
| Compliance with EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing | "demonstrate compliance with applicable standards" |
| Performance within specifications and functional requirements | "performed within its specifications and functional requirements" |
| As safe, as effective, and performs as well as the predicate device (HomMed Sentry IIIB Patient Monitor) | "results of these evaluations demonstrate the Sentry OTC Monitor is as safe, as effective and performs as well as the legally marketed predicate device" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" with a defined sample size for clinical validation focusing on vital sign accuracy. The "Test Summary" refers to engineering and quality assurance testing (EMC, electrical, mechanical durability, safety, temperature/humidity).
- Sample Size for Test Set: Not specified for clinical performance validation. The document focuses on regulatory compliance testing.
- Data Provenance (e.g., country of origin, retrospective or prospective): Not specified. The testing described appears to be laboratory-based engineering and quality assurance testing rather than a clinical trial with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that the testing described is primarily engineering and compliance-oriented, there is no mention of "experts" in the sense of clinical specialists establishing a "ground truth" for patient data. The ground truth for electrical, mechanical, and temperature/humidity tests would be established by reference standards and calibrated equipment.
4. Adjudication Method for the Test Set
Not applicable. The testing described does not involve a human-reader or diagnostic output that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a vital signs monitor, not an imaging or diagnostic device requiring human interpretation, so such a study would not be relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the testing described appears to be standalone performance of the device against engineering standards and compliance requirements. The statement "The Honeywell HomMed Sentry System (Sentry OTC and its predicate Sentry IIIB) utilized within the environments for which it is marketed performs consistent with guidelines and standards..." implies standalone performance evaluation. No human interpretation of the output is involved for the device's basic function of measuring vital signs.
7. Type of Ground Truth Used
The ground truth used for the reported tests would be:
- Reference Standards/Calibrated Equipment: For electrical, mechanical, EMC, temperature, and humidity testing.
- Regulatory Standards: For safety and biocompatibility.
- Predicate Device Performance: The primary "ground truth" for demonstrating substantial equivalence is the performance of the legally marketed predicate device, the HomMed Sentry IIIB Patient Monitor System (K040651). The device is stated to perform "as safe, as effective and performs as well as" the predicate.
8. Sample Size for the Training Set
Not applicable. This device is a vital signs monitor, not an AI/ML-based diagnostic algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).