The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended 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, noninvasive 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.

Device Description

The Tempus Pro is a multi-parameter vital signs monitor designed for use in prehospital care and remote clinical locations by trained healthcare professionals. It provides 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 oximely (SpO2), contact temperature and invasive pressure ..

In addition, it provides the ability to transmit all vital signs data via wired Ethernet or wireless WiFi 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 capture and transmit other data including still or moving pictures via an integrated camera, geographic position by an integrated GPS receiver and voice via a wired or wireless headset.

AI/ML Overview

The provided text describes the Tempus Pro™ Patient Monitor, a multi-parameter vital signs monitor. However, the document primarily focuses on demonstrating its substantial equivalence to predicate devices through various safety and performance tests against established standards. It does not contain specific acceptance criteria, study designs, or reported device performance metrics in the format requested.

The document states: "The design of this device utilises currently available (OEM) technology found in many legally marketed devices. In terms of measurement performance, the Tempus Pro 14 is effectively identical to the devices that incorporate the same OEM technology." This suggests that the performance is expected to align with the OEM components, but explicit criteria and comparative performance data are not detailed.

Therefore, I cannot populate the table or answer all the questions as the specific information is not available in the provided text.

Here's a summary of what can be extracted and identified as missing or not explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (e.g., Specificity, Sensitivity, Accuracy)	Reported Device Performance
Not explicitly stated for individual parameters. The document implies performance is equivalent to predicate devices and meets relevant IEC/AAMI standards for specific functions.	Not explicitly stated for individual parameters. The document generally states that "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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not explicitly stated in the provided text. The document lists various types of testing performed (e.g., IEC60601-1, AAMI EC11 & EC13, comparative testing to predicates, bench testing for data transmission). These are generally engineering/bench tests rather than clinical studies with patient data.
Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The testing described is primarily technical and regulatory compliance testing against recognized standards, not expert-adjudicated ground truth for a diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. See point 3.

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. This device is a patient monitor, not an AI-powered diagnostic system requiring MRMC studies for human reader improvement. The document mentions "telemedicine capabilities" for "obtaining support in the diagnosis and treatment decisions," but this refers to transmitting data to human experts, not AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hardware patient monitor. Its primary function is to acquire and display vital signs. While it transmits data, it's not a standalone algorithm in the AI sense. The "bench testing" to confirm data transmission reliability and accuracy could be considered a form of standalone performance evaluation for that specific function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For regulatory and performance testing (e.g., ECG monitoring, NIBP, SpO2), the "ground truth" would be established by reference instruments or simulated physiological signals that meet the accuracy requirements of the relevant industry standards (e.g., AAMI, IEC). This is typically referred to as "reference standard" data.

8. The sample size for the training set:

Not applicable. The device is not an AI/machine learning model that typically requires a "training set."

9. How the ground truth for the training set was established:

Not applicable. See point 8.

In summary, the provided document details the testing performed to demonstrate the safety and effectiveness of a medical device (Tempus Pro™ Patient Monitor) for 510(k) clearance, primarily by showing conformity to international standards and substantial equivalence to predicate devices. It does not include the type of detailed performance study results, acceptance criteria, or ground truth establishment methods typically associated with AI/diagnostic device submissions.

Summary

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Remote Diagnostic Technologies Ltd - Tempus Pro™ Patient Monitor 510k Summary of Safety and Effectiveness

JUN 0 5 2013

510(k) Summary of Safety and Effectiveness

Submitter Information

Name:

Address:

Remote Diagnostic Technologies Ltd

The Old Coach House The Avenue Farleigh Wallop Basingsloke RG25 2HT United Kingdom

Phone Number:

+44 1256 362 415

Chris Hannan

January 2013

+44 1256 362 400

Contact Name:

Fax Number:

Date Prepared

Device Name

Portable Patient Monitor Common Name:

Tempus Pro7M Patient Monitor Proprietary Name:

Classification Name:

Monitor, physiological, patient (without arrhythmia detection or alarms)

Device Description

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Remote Diagnostic Technologies Ltd - Tempus Pro™ Patient Monitor 510k Summary of Safety and Effectiveness

It is expected that the ability to transmit data in real-time will be performed in remote locations typically using satellite or terrestrial communications systems.

The Tempus Pro Is used in conjunction with 121 software, which provides a system for receiving real-time voice and medical data. The system enables users to receive voice, vital signs data and other medical data, still and moving video pictures from the Tempus Pro devices.

The i2i system can be used by commercial response centre service providers or by individuals or organisations wishing to provide their own internal service

I2i also supports a full patient records database.

Intended Use

The Tempus Pro Patient Monitor is intended to be used in remote or pre-hospital care situations by frained healthcare professionals e.g. nurse, EMT, paramedic, physician, military medic etc.

The device is intended to be used primarily as a standalone monitor for traditional monitoring applications. It is expected that its real-time telemedicine capabilities will be used in a minority of applications. When its telemedicine features are used it is intended that this will be for the purpose of obtaining support in the diagnosis and treatment decisions for the patient e.g. where the patient is in a remote country and the user's organisation needs to make an extraction or repatriation decision.

Indications for Use

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.

Contraindications

The Tempus Pro does not replace a physician's care. The device is not an apnoea monitor.

The Tempus Pro is not intended to be used in strong magnetic or electro-magnetic fields which are generated for medical purposes e.g. MRI.

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Remote Diagnostic Technologies Ltd - Tempus Pro™ Patient Monitor 510k Summary of Safety and Effectiveness

Predicate Devices

The Tempus Pro M Patient Monitor is predicated on our existing model, the Tempus IC Professional Patient Monitor, which was the subject of a previous submission (K101264). Additional predicates include: the Welch Allyn Propag 206 Encore Patient Monitor (K012451) to demonstrate substantial equivalence (SE) for the overall application and medical parameter modules.

The Tempus Pro Patient Monitor has the same intended use as the Tempus IC Professional Patient Monitor, with the following additions; the Tempus Pro Patient Monitor is also intended for monitoring neonates, and provides medical monitoring parameter functions for invasive pressure and impedance respiration.

Tesling

The Tempus IC Professional uses currently available (OEM) technology found in many legally marketed devices.

Area	Testing Performed
Safety	The device has been tested to IEC60601-1.
Defibrillation andelectrosurgicalprotection	The device has been tested for operation with adefibrillator and operation with an electro-surgical unitaccording to IEC60601-1 (and relevant particularstandards).
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 IEC60529 for solid andwater ingress.
ECG monitoring	Testing to AAMI EC11 & EC13 and IEC60601-2-25 &IEC60601-1-27 has been performed.
EMC	The device has been tested to IEC60601-1-2 foremissions and immunity and RTCA DO-160 for radiatedemissions.
Alarms	The alarm functions of the product have been tested toIEC60601-1-8.
Invasive pressure	The device has been tested to IEC60601-2-34.
Contact temperature	The device has been tested to EN12470-4 andIEC80601-2-56

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K130773

Remote Diagnostic Technologies Ltd - Tempus Pro™ Patient Monitor 510k Summary of Safety and Effectiveness

Area	Testing Performed
Comparative testing topredicates	Comparative testing has been performed to demonstratethat the performance of the device is equivalent to thepredicates.
Software	The requirements of the FDA document Guidance for theContent of Premarket Submissions for Software in Pre-Market Submissions has been applied. In addition, therequirements of IEC62304 and IEC60601-1-4 have beenaddressed.
Bench testing	All parameters of the device have been tested to confirmthey operate to specification across their statedperformance range and across their stated temperaturerange.
Bench testing	The product has been bench tested to confirm that alldata is transmitted reliably and accurately.
Wireless range	The device has been tested to confirm it operatesreliably at its maximum stated range.
Wirelessco-existencetesting	The thermometer has been tested to confirm it operatesreliably in the presence of other wireless fields as per theFDA Guidance for Radio-Frequency Wireless Technology inMedical Devices.

Evidence of Conformity to Essential Principles

The device has been shown to conform to the essential principles for safety and performance defined in guidance prepared by the Global Harmonization Task Force Study Group1 (GHTF/SG1/N14R9:2005), with supporting evidence prepared in the summary technical documentation (STED) format recommended in final version of GHTF guidance (SG1/N011: 2008).

Specifically, this evidence includes performance testing, software validation, electrical safety, electromagnetic compatibility etc..

The design of this device utilises currently available (OEM) technology found in many legally marketed devices. In terms of measurement performance, the Tempus Pro 14 is effectively identical to the devices that incorporate the same OEM technology.

Conclusion

On the basis of these results and the above referenced testing, if is our determination that the device is safe, effective and performs as well as, or better than, the legally marketed predicate device(s).

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Remote Diagnostic Technologies Ltd - Tempus Pro™ Patient Monitor 510k ic Technologies Lid - Tempus Fro - Patient Monitor STOX
Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

·.

Respectfully

: :

signature

Chris Hannan Programme & Regulatory Affairs Director

the submit and the submit of the subject of the subject of

. . . . .

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..............................................................................................................................................................................

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1999 - 1999 - 1999

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The logo is black and white.

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

June 5, 2013

Remote Diagnostic Technology Limited c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K130773

Trade/Device Name: Tempus Pro Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: II (two) Product Code: 74 MWI Dated: May 20, 2013 Received: May 21, 2013

Dear Mr. Job:

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 - Mr. Mark Job

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

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

Enclosure

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K130773

Statement of Indications for Use

510(k) Number (if known): Not known

Tempus Pro™ Patient Monitor

Indications for Use

Device Name:

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: YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use: NO (21 CFR 801 Subpart C)

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

-- Concurrence of EDRH, Office of Device Evaluation (ODE)-

Date: 2013.06.05 16:49:33-04'00' for Bram Zuckerman

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).