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 with interpretation, impedance pneumography, non-invasive blood pressure (NIBP), endtidal CO2 (ETCO2), respiration rate, pulse oximetry (SpO2), contact temperature, invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (SpCO), metheglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) measurements.

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, pediatrics and neonates.

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.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 GP$ receiver and voice via a wired or wireless headset.

AI/ML Overview

Here's an analysis of the Tempus Pro (EF) medical device submission based on the provided document, focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes non-clinical testing to ensure the device meets safety and performance standards. It does not contain specific quantitative "acceptance criteria" and "reported performance" like sensitivity/specificity for a diagnostic AI model. Instead, the acceptance criteria are implicit: successful completion of tests according to relevant international standards and equivalence to predicate devices.

Area	Acceptance Criteria (Implicit from Testing Performed)	Reported Device Performance
Safety	Compliance with IEC60601-1.	"The device has been tested to IEC60601-1." "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."
Defibrillation and Electrosurgical Protection	Compliance with IEC60601-1 (and relevant particular standards) for operation with a defibrillator and electro-surgical unit.	"The device has been tested for operation with a defibrillator and operation with an electro-surgical unit according to IEC60601-1 (and relevant particular standards)." "In each case the results of this testing confirmed that acceptance criteria... had been met."
Environmental	Compliance with RTCA DO-160, MIL810, EN1789, EN13718-1, EN60068 for temperature, altitude, humidity, vibration, shock.	"The device has been tested to a range of environmental (temperature, altitude, humidity, vibration, shock) tests according to RTCA DO-160, MIL810, EN1789, EN13718-1, EN60068." "In each case the results of this testing confirmed that acceptance criteria... had been met."
Ingress Protection	Compliance with IEC 60529 for solid and water ingress.	"The device has been tested to IEC 60529 for solid and water ingress." "In each case the results of this testing confirmed that acceptance criteria... had been met."
EMC	Compliance with IEC 60601-1-2 for emissions and immunity, and RTCA DO-160 for radiated emissions (including immunity at 20 V/m).	"The device has been tested to IEC 60601-1-2 for emissions and immunity and RTCA DO-160 for radiated emissions (including immunity at 20 V/m)." "In each case the results of this testing confirmed that acceptance criteria... had been met."
Invasive Pressure	Compliance with IEC 60601-2-34.	"The device has been tested to IEC 60601-2-34." "In each case the results of this testing confirmed that acceptance criteria... had been met."
Pulse Oximeter	Compliance with IEC 9919.	"The device has been tested to IEC 9919." "In each case the results of this testing confirmed that acceptance criteria... had been met."
Comparative Testing to Predicates	Performance equivalent to predicate devices (K110028, K130773, K083749).	"Comparative testing has been performed to demonstrate that the performance of the device is equivalent to the predicates." "In each case the results of this testing confirmed that acceptance criteria... had been met."
Software	Compliance with FDA Guidance for the Content of Premarket Submissions for Software in Pre-Market Submissions and IEC 62304.	"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." "In each case the results of this testing confirmed that acceptance criteria... had been met."
Bench Testing (Parameter Specification)	Operation to specification across stated performance and temperature ranges for all parameters.	"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." "In each case the results of this testing confirmed that acceptance criteria... had been met."
Bench Testing (Data Transmission)	Reliable and accurate transmission of all data.	"The product has been bench tested to confirm that all data is transmitted reliably and accurately." "In each case the results of this testing confirmed that acceptance criteria... had been met."
Wireless Co-existence Testing (Thermometer)	Reliable operation in the presence of other wireless fields, as per FDA Guidance for Radio-Frequency Wireless Technology in Medical Devices.	"The thermometer has been tested to confirm it operates reliably in the presence of other wireless fields as per the FDA Guidance for Radio-Frequency Wireless Technology in Medical Devices." "In each case the results of this testing confirmed that acceptance criteria... had been met."
Usability	No significant changes to physical interaction or user interface compared to predicate device.	"no additional user validation was considered necessary, as the Tempus Pro (EF) is almost 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."

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical engineering and bench testing, not a clinical study with a "test set" in the sense of a dataset for an AI algorithm. Therefore, no specific sample sizes for a test set are mentioned, nor is there data provenance in terms of country of origin or retrospective/prospective for a clinical dataset. The testing primarily involved the device itself and its components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since this is a submission for a vital signs monitor and not an AI-driven diagnostic device requiring expert interpretation of outputs, there were no experts used to establish ground truth for a test set in the typical sense. Expertise was likely involved in setting the testing standards and interpreting the results of the engineering tests (e.g., verifying compliance with IEC standards), but this is not specified as "ground truth establishment."

4. Adjudication Method for the Test Set

As there is no diagnostic "test set" with subjective interpretations, no adjudication method (like 2+1 or 3+1) was used or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done or reported. The device is a vital signs monitor, and the submission focuses on verifying its technical performance and substantial equivalence to predicate devices, not on the improvement of human reader performance with AI assistance. The "AI" component mentioned is the "interpretation output" of the mymisys32.dll for 12-Lead ECG, but this is presented as a pre-existing component from a cleared device (QRS Diagnostic CardioView K083749) that is now being displayed, rather than a new AI requiring an MRMC study for effectiveness.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The 12-Lead ECG interpretation (part of the mymisys32.dll) is an algorithmic function. The submission indicates that "the interpretation output of the ■ mymisys32.dll, which is already an integral part of the cleared Tempus Pro, but the interpretation output is not currently displayed to the user." It further states that this dll is part of a previously cleared software package (QRS Diagnostic CardioView K083749).

This means the algorithm for ECG interpretation has been evaluated in standalone fashion as part of its original clearance (K083749). For this specific submission, the focus is on the safety and effectiveness of displaying this pre-existing interpretation, rather than re-evaluating the algorithm itself. Yes, a standalone evaluation of this ECG interpretation algorithm would have been done for its original clearance, and the current submission relies on that prior clearance.

7. The Type of Ground Truth Used

For the engineering and bench testing, the "ground truth" was established by objective technical specifications and compliance with international standards (e.g., IEC60601-1, IEC 9919, RTCA DO-160). For the ECG interpretation component (mymisys32.dll), its original clearance (K083749) would have relied on expert consensus or clinically validated ECG databases to establish ground truth for its interpretive accuracy, though this is not detailed in the provided document.

8. The Sample Size for the Training Set

This document does not describe the development or training of a de novo AI algorithm. The components added (Masimo SET Rainbow module, Medlab IBP module, QRS Diagnostic CardioView dll) are all from established, previously cleared predicate devices. Therefore, no sample size for a training set for the Tempus Pro (EF) itself is mentioned. Any training data for the individual components (like the ECG interpretation algorithm) would have been part of their original development and clearance, which is not detailed here.

9. How the Ground Truth for the Training Set Was Established

Given that no de novo AI algorithm training is described for the Tempus Pro (EF) in this submission, the establishment of ground truth for a training set is not applicable to this document. For the pre-existing components (e.g., the ECG interpretation algorithm), ground truth for their training would have been established during their original development, likely through expert cardiologist consensus on annotated ECG waveforms or through comparison with established diagnostic methods.

Summary

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K133988 Page 1 of 4

RDT Abbreviated 510(k) Submission - Tempus Pro (EF)

5. 510(k) Summary of Safety and Effectiveness

MAY 1 6 2014

5.1 Submitter's Information

The submitter of this abbreviated pre-market notification is:

Name:	Remote Diagnostic Technologies Limited
Address:	The Old Coach House, Farleigh Wallop, Basingstoke, RG252HT, 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:	10th April, 2014

5.2 Device Identification

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

Secondary FDA product code	Regulation Number
Cardiac Monitor (DRT)	870.2300
Electrocardiograph (DPS)	870.2340
Impedance Plethysmograph (DSB)	870.2770
Non Invasive Blood Pressure Measurement System (DXN)	870.2770
Carbon Dioxide Gas Analyzer (CCK)	868.1400
Breathing frequency monitor (MNR)	868.2375
Oximeter (DQA)	870.2700
Clinical electronic thermometer (FLL)	880.2910
Computer, Blood-pressure (DSK)	870.1110
Transmitters and Receivers, Physiological Signal, Radiofrequency (DRG)	870.2910

5.3 Device Description

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RDT Abbreviated 510(k) Submission - Tempus Pro (EF)

5.4 Indications for Use

The following indications for the Tempus Pro remain unchanged by addition of the extended features for ECG recording, pulse oximetry and invasive blood pressure monitoring to the Tempus Pro, with the exception of removal of "(SpO2)" as additional pulse oximetry measurements are being added.

"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 with interpretation, impedance pneumography, non-invasive blood pressure (NIBP), end-tidal CO2 (ETCO2), respiration rate, pulse oximetry (SpO2), contact temperature, invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (SpCO), metheglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) measurements.

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, pediatrics and neonates."

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 by the addition of optional extended features to the ECG recording, pulse oximetry, and invasive blood pressure functions, which are specifically:

I Extended Pulse Oximetry capability to include optional carboxy haemoglobin (SpCO). metheglobin (SpMet) total haemoglobin (SpHb) and total oxygen content (SpOC) measurements
. Optional 12-Lead ECG Recording Interpretation
. 2 optional additional Invasive Blood Pressure Channels

5.6 Substantial Equivalence

In adding some of the optional features, it has been necessary to cite other predicates for specific functionality provided:

. Pulse Oximetry - new Masimo SET Rainbow module and associated sensors/patient cable, incorporating original SET oxygen saturation technology as used in cleared Tempus Pro plus 4 new measurement capabilities, is substantially equivalent to the same module incorporated into the Masimo Radical-7 device (K110028)
I Invasive Blood Pressure - additional external IBP module which uses same Medlab IBP module as already incorporated internally into the cleared Tempus Pro device (K130773)
ECG Recording Interpretation enabling the interpretation output of the ■ mymisys32.dll, which is already an integral part of the cleared Tempus Pro, but the interpretation output is not currently displayed to the user. The dll is part of the CardioView software package from QRS Diagnostic (K083749).

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RDT Abbreviated 510(k) Submission - Tempus Pro (EF)

Hence, the new pulse oximetry module with sensors and cables, the additional invasive blood pressure, and the ECG recording 12 lead interpretation are the same as those used by the original equipment manufacturers in their cleared devices.

The 510(k) numbers for the predicate devices to which we are claiming substantial equivalence are K110028, K130773, and K083749.

5.7 Summary of Non-Clinical Testing

ﺮ ﺍ

All of the above modifications 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.

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

Area	Testing Performed
Safety	The device has been tested to IEC60601-1.
Defibrillation andelectrosurgicalprotection	The device has been tested for operation with a defibrillatorand operation with an electro-surgical unit according toIEC60601-1 (and relevant particular standards).
Environmental	The device has been tested to a range of environmental(temperature, altitude, humidity, vibration, shock) testsaccording to RTCA DO-160, MIL810, EN1789, EN13718-1,EN60068.
Ingress Protection	The device has been tested to IEC 60529 for solid and wateringress.
EMC	The device has been tested to IEC 60601-1-2 for emissionsand immunity and RTCA DO-160 for radiated emissions.(including immunity at 20 V/m)
Invasive pressure	The device has been tested to IEC 60601-2-34.
Pulse oximeter	The device has been tested to IEC 9919.
Comparative testing topredicates	Comparative testing has been performed to demonstrate thatthe performance of the device is equivalent to the predicates.
Software	The requirements of the FDA document Guidance for theContent of Premarket Submissions for Software in Pre-MarketSubmissions has been applied. In addition, the requirementsof IEC 62304 have been addressed.
Bench testing	All parameters of the device have been tested to confirm theyoperate to specification across their stated performance rangeand across their stated temperature range.
Bench testing	The product has been bench tested to confirm that all data istransmitted reliably and accurately.

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RDT Abbreviated 510(k) Submission - Tempus Pro (EF)

Area	Testing Performed
Wireless co-existence testing	The thermometer has been tested to confirm it operates reliably in the presence of other wireless fields as per the FDA Guidance for Radio-Frequency Wireless Technology in Medical Devices.

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 (EF) is almost 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.

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 this extended version of the Tempus Pro Patient Monitor is safe and effective, and substantially equivalent to the unmodified version of this device and other cleared devices used as predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Image /page/4/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol to the right and text arranged in a circle to the left. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol is a stylized representation of a human figure.

May 16, 2014

Remote Diagnostic Technologies Ltd. · Dr. Leigh Cornock Director of Systems Engineering and Test The Old Coach House, The Avenue Farleigh Wallop, Basingstoke, Hampshire, UK

K133988 Re:

Trade/Device Name: Tempus pro extended features Regulation Number: 21 CFR 870.2300 Regulation Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Regulatory Class: Class II Product Codes: MWI, DRT, DPS, DSB, DXN, CCK, MNR, DQA, FLL, DSK, DRG Dated: April 14, 2014 Received: April 23, 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.

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Page 2 - Leigh Cornock

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 devicerelated 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/ReportalProblem/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 vours

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

K133988 Page 1 of 1

510(k) Number (if known):

Device Name: Tempus Pro (EF)

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, pediatrics and neonates.

Prescription Use V_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (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:
2014.05.16
12:28:44 -04'00'

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).