(30 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: 12 Lead ECG recording with interpretation: real-time arrhythmia detection / alarming: QT measurement / alarming and ST measurements / alarming; impedance pneumography; non-invasive blood pressure (NIBP); end-tidal CO2 (ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (SpCO), methaemoglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) The monitor is intended to be used as a stand-alone monitor or as a telemedicine system measurements. (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 monitoring system designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3 & 5 lead ECG recording, real-time arrhythmia detection & alarming, QT interval measurement & alarming, ST segment & alarming, impedance respiration, pulse oximetry (including Masimo Rainbow® co-oximetry measurements i.e. SpOC, SpHb, SpMet, SpCO, PVI and Pl), non-invasive blood pressure, sidestream capnometry, contact temperature, invasive pressure, and user configurable alarms. Third-party video laryngoscopes and ultrasound probes may also be connected to the device. In addition, it provides the ability to transmit all vital signs data via wired or wireless connections to a telemedicine software system expected to be based in a facility far from the user e.g. 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 submission is to notify the FDA of our intent to market the Tempus Pro modified by the addition of an optional thermal printer, which enables the user of a Tempus Pro to print medical records on-demand. Additionally, compatible external devices may also print medical records on the Tempus Pro's optional thermal printer when paired to the Tempus Pro via a secure 1-to-1 data link called Tempus Data Link (TDL).
The provided text describes a 510(k) submission for the Tempus Pro Patient Monitor. However, this submission (K173768) is specifically for a modification to the existing Tempus Pro device, which is the addition of an optional thermal printer. The document explicitly states: "This submission is to notify the FDA of our intent to market the Tempus Pro modified by the addition of an optional thermal printer..." and "No changes have been made to the device's indications for use, intended use, or fundamental scientific technology as a result of the modification that has prompted this submission."
Therefore, the provided text does not contain the acceptance criteria or study details for the core functionalities of the Tempus Pro Patient Monitor (e.g., ECG monitoring, arrhythmia detection, NIBP, SpO2 measurements). It only discusses the non-clinical evidence related to the addition of the thermal printer.
Here's a breakdown of what can be extracted from the provided text regarding this specific modification:
1. A table of acceptance criteria and the reported device performance:
The document states: "Non-clinical testing has been performed to demonstrate that the safety and efficacy of the device remains substantially equivalent to its predicate." However, it does not provide specific acceptance criteria (e.g., print speed, resolution, accuracy of printed data) or performance data (e.g., results of specific tests for thermal printer quality).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document for the thermal printer | Not specified in this document for the thermal printer |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified for the thermal printer.
- Data Provenance: The testing was "non-clinical testing," but further details (e.g., country of origin, retrospective/prospective) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This was non-clinical testing related to a printer, not diagnostic accuracy requiring expert interpretation of medical images or signals.
4. Adjudication method for the test set:
- Not applicable/Not specified. This was non-clinical testing related to a printer, not diagnostic accuracy requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case study was not mentioned. The device modification is a thermal printer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not specified. This is a hardware modification (thermal printer), not an algorithm.
7. The type of ground truth used:
- Not applicable/Not specified. For the thermal printer, the "ground truth" would likely relate to the ability of the printer to accurately reproduce data the device generates, rather than a medical ground truth (like pathology). The document only mentions "safety and efficacy."
8. The sample size for the training set:
- Not applicable/Not specified, as this submission is for a hardware modification (thermal printer) and not an algorithmic device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned for this modification.
In summary: The provided document is a 510(k) summary for an administrative change and a modification to the Tempus Pro Patient Monitor (addition of a thermal printer). It states that non-clinical testing was performed for this modification to ensure substantial equivalence regarding safety and efficacy, but it does not provide specific acceptance criteria, performance data, sample sizes, expert details, or ground truth methodologies for the thermal printer functionality, nor for the original device's performance. The original Tempus Pro Patient Monitor (K170567) would have contained this information for its core functionalities.
§ 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.