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.

Device Description

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.

AI/ML Overview

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:

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.
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.
Adjudication Method for the Test Set:
- Not applicable. No clinical data interpretation or diagnostic assessment by experts requiring adjudication is described.
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.
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.
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.
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.
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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 12, 2014

Remote Diagnostic Technologies Ltd. Leigh Cornock Director Of Systems Engineering & Test The Old Coach House, The Avenue Farleigh Wallop, Basingstoke Hampshire, RG25 2HT UK

Re: K134014

Trade/Device Name: Tempus Pro Accessories (ultrasound & video laryngoscope probe) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, IYO, ITX Dated: June 25, 2014 Received: July 3, 2014

Dear Dr Leigh Cornock,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K134014

Device Name: Tempus Pro

Indications for Use:

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.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Date:
2014.08.12
13:23:06 -04'00'

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510(k) Summary of Safety and Effectiveness

5.1 Submitter's Information

The submitter of this special pre-market notification is:

Name:	Remote Diagnostic Technologies Limited
Address:	The Old Coach House, Farleigh Wallop, Basingstoke,RG25 2HT, United Kingdom
Company Phone No:	+44 (0) 1256 362 400
Company Fax No:	+44 (0) 1256 362 415
Contact Person:	Dr Leigh Cornock (Director of Systems Eng. & Test)
Date summary prepared:	23rd December, 2013

5.2 Device Identification

Device Trade Name:	Tempus Pro
Common Name:	Patient Monitor (without arrhythmia detection or alarms)
Class:	II
Classification Panel:	74
Product Code:	MWI
Secondary Product Codes:	IYO & ITX
Regulation Number:	870.2300

5.3 Device Description

5.4 Indications for Use

The following indications for use of the existing features of Tempus Pro Patient Monitor remain unchanged by addition of the option to used plug-in probes for displaying ultrasound and video laryngoscopy images on the monitor.

"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), endtidal 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.

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5.5 Comparison with Cleared Device

The intended use and indications for use, plus the fundamental technology used in the Tempus Pro device, remain essentially unchanged as a result of plugging in the optional accessories, the monitor may be used to display ultrasound and video laryngoscopy images.

5.6 Substantial Equivalence

The predicate for the Tempus Pro Patient Monitor with the specified accessories attached is the cleared Tempus Pro Patient Monitor (K130773).

The Predicate for the optional Ultrasound features are:

K070907 Interson USB ultrasound probe system ●
. K102153 – MobiUS Ultrasound imaging system

As the accessories are unmodified, claims for substantial equivalence relate to the display of images, using drivers supplied by the OEM (where appropriate) and additional RDT software to enable their display on the existing Tempus Pro screen.

5.8 Summary of Non-Clinical Testing

Addition of optional probes connected externally to Tempus Pro and changes to the associated software have been made under well-established design control procedures, which ensure that appropriate risk management processes have been carried out to determine their impact and ensure that appropriate verification/ validation testing is performed.

Area	Testing Performed
Comparative Testing topredicates	Comparative testing has been performed to demonstrate that theperformance of the device is equivalent to the predicates.
Software	The requirements of the FDA document Guidance for the Content ofPremarket Submissions for Software in Pre-Market Submissions hasbeen applied. In addition, the requirements of IEC 62304 have beenaddressed.
Bench testing	All parameters of the device have been tested to confirm they operateto specification across their stated performance range and across theirstated temperature range with the new accessories attached.
Bench testing	The product has been bench tested to confirm that all data istransmitted reliably and accurately.

The non-clinical testing carried out in relation to addition of the optional imaging probes described above is summarized in the following table:

In each case the results of this testing confirmed that acceptance criteria defined by the relevant standard, or other appropriate reference document had been met.

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. The way the accessories are used is un-changed as a result of using them with the Tempus Pro. .

5.8 Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this Premarket Notification, Remote Diagnostic Technologies Limited conclude that the Tempus Pro Patient Monitor when used with optional probes for ultrasound and video laryngoscopy is safe and effective, and substantially equivalent to the unmodified version of this device.

Regulation Number and Section

§ 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).