(225 days)
The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 & 5 Lead ECG monitoring and 12 Lead ECG recording, impedance pneumography, non-invasive blood pressure (NIBP), end-tidal CO2 (ETCO2) and respiration rate, pulse oximetry (SpO2), contact temperature and invasive pressure.
The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
The device is indicated for adults, paediatrics and neonates.
The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz Small Parts / Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. These optional accessories are to be used in accordance with their Indications For Use.
The Tempus Pro is a multi-parameter vital signs monitor designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3&5 lead ECG monitoring, 12 lead ECG recording, pulse oximetry, non-invasive blood pressure, sidestream capnometry, contact temperature, impedance respiration, invasive pressure and user configurable alarms.
In addition, it provides the ability to transmit all vital signs data via wired or wireless connections to a software system (called i2i) expected to be based in a facility far from the user e.q. a response centre facility. In addition to sending all vital signs, the system can also send pictures or video via an integrated camera, geographic position by an integrated GPS receiver and voice via a wired or wireless headset.
This document is a 510(k) premarket notification for the Tempus Pro Patient Monitor with added accessories (ultrasound & video laryngoscope probe). It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific numerical acceptance criteria for the performance of the device (Tempus Pro with new accessories) in detecting particular conditions or making diagnoses. Instead, the acceptance criteria are generally framed around meeting relevant standards and demonstrating equivalence to predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary from Section 5.8) |
|---|---|
| Comparative Testing to Predicates: Performance of the device should be equivalent to the predicates. | "Comparative testing has been performed to demonstrate that the performance of the device is equivalent to the predicates." The specific predicates listed for the ultrasound features are K070907 Interson USB ultrasound probe system and K102153 MobiUS Ultrasound imaging system. |
| Software Compliance: Requirements of FDA Guidance for Premarket Submissions for Software and IEC 62304 should be applied. | "The requirements of the FDA document Guidance for the Content of Premarket Submissions for Software in Pre-Market Submissions has been applied. In addition, the requirements of IEC 62304 have been addressed." |
| Bench Testing (Parameter Specification): All parameters of the device operate to specification across their stated performance range and temperature range with the new accessories attached. | "All parameters of the device have been tested to confirm they operate to specification across their stated performance range and across their stated temperature range with the new accessories attached." This would involve tests for the display of ultrasound and video laryngoscope images. |
| Bench Testing (Data Transmission): All data is transmitted reliably and accurately. | "The product has been bench tested to confirm that all data is transmitted reliably and accurately." This refers to the telemedicine capabilities. |
| Usability: No degradation in user interaction or safety compared to the predicate Tempus Pro without the accessories. | "With respect to usability, no additional user validation was considered necessary, as the Tempus Pro used with these accessories is identical to the predicate Tempus Pro in terms of physical and interface features, including size and weight, user interface data layouts, button styles, menus, and layout of connectors, resulting the physical interaction with the device being unchanged." |
| Risk Management: Appropriate risk management processes have been carried out to determine the impact of new accessories and ensure appropriate verification/validation testing. (Implied by "design control procedures" which ensure this process.) | Not explicitly reported as a "performance" metric, but confirmed through adherence to design control procedures. |
Study Information & Details:
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Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a sample size for a test set in terms of patient data or images. The testing described is primarily bench testing and comparative testing to predicates at a system level, not a clinical study involving patients or diagnostic accuracy.
- Data Provenance: Not applicable in the context of clinical data for performance evaluation. The device is manufactured by Remote Diagnostic Technologies Ltd. in the United Kingdom.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No clinical test set requiring expert-established ground truth is described. The tests are focused on technical performance, software compliance, and equivalence to existing devices, not diagnostic accuracy based on expert consensus.
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Adjudication Method for the Test Set:
- Not applicable. No clinical data interpretation or diagnostic assessment by experts requiring adjudication is described.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. The document does not describe an MRMC study. The focus is on the device's technical ability to display images from the accessories and its equivalence to predicate devices, not on how human readers perform with or without AI assistance using the device. The device itself is a monitor, not an AI diagnostic tool.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a patient monitor displaying images from accessories. It does not contain an "algorithm" in the sense of an AI or diagnostic algorithm that would operate standalone or without human interpretation of the displayed image. The "algorithm" here would refer to the device's operating software and drivers for displaying the images.
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The Type of Ground Truth Used:
- For the bench testing of parameters, the ground truth would be based on engineering specifications, known input signals, and established standards (e.g., how accurately a known voltage signal is measured, or how faithfully a simulated ultrasound image is rendered).
- For the software compliance, the ground truth is adherence to the requirements outlined in the FDA Guidance for Software and IEC 62304.
- For comparative testing to predicates, the "ground truth" is the established performance and functionality of the cleared predicate devices.
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The Sample Size for the Training Set:
- Not applicable. This document describes a medical device, not a machine learning or AI model that requires a training set of data.
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How the Ground Truth for the Training Set was Established:
- Not applicable. As the device does not involve a machine learning model, there is no training set or associated ground truth establishment process for it.
In summary, this 510(k) focuses on demonstrating the technical and functional equivalence of adding new accessories to an existing cleared patient monitor, rather than presenting a clinical performance study with diagnostic accuracy metrics. The acceptance criteria and performance are reported in terms of compliance with regulatory standards, successful bench testing, and equivalence to predicate devices for displaying images and transmitting data.
§ 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).