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-, 4- and 5-lead ECG monitoring; 12-lead ECG recording with interpretation; real-time arrhythmia detection/alarming; QT measurement/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; carboxyhaemoglobin (SpCO), methaemoglobin (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, 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 Patient Monitor 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-Lead and 5-Lead ECG monitoring, 12-Lead ECG recording, real-time arrhythmia detection and alarming, QT interval measurement and alarming, ST segment measurement and alarming, impedance respiration, pulse oximetry (including Masimo Rainbow® co-oximetry measurements i.e. SpOC, SpHb, SpMet, SpCO, PVI, and PD, noninvasive 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 (called i2i) expected to be based in a facility far from the user e.g. a response center facility. As an alternative to i2i response center software, Tempus Pro Monitor also uses IntelliSpace Corsium, which is a web-based software platform for near real-time patient data transfer and two- way communication between healthcare professional. In addition to sending all vital signs, the system can also send pictures or video via an integrated camera, geographic positions by an integrated GPS receiver, and voice via a wired or wireless headset.

Additionally, Tempus Pro has an optional thermal printer, which enables the user to print medical records on-demand and allows other compatible external devices to print medical records as well using the optional thermal printer when paired to the Tempus Pro via a secure 1-to-1 data link called Tempus Data Link (TDL).

The Tempus Pro is provided to the user non-sterile. No accessories manufactured by RDT for use with Tempus Pro are provided sterile. The Tempus Pro does not come into direct or indirect contact with the patient. The Tempus Pro is compatible with 3rd party manufacturer accessories, for which patient contact and sterility requirements are determined by the 3rd party manufacturer.

AI/ML Overview

The provided text describes the acceptance criteria and a study to prove the device meets these criteria for the Tempus Pro Patient Monitor with the addition of the Glasgow Algorithm for 12-lead ECG interpretation.

Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
All interpretations output from the Glasgow library run on Tempus Pro shall match the known reference interpretations (for Glasgow algorithm test vectors).	PASS: A total of 612 known vectors were used for comparison with interpretations from Tempus Pro. The results obtained were consistent with the results expected by Glasgow University.
The interpretation statement shall be printed in bulleted format without any heading and shall be identical between the Tempus display, the thermal printer output, PDF report, Intellispace Corsium review display, and Intellispace Corsium PDF.	PASS: Glasgow library was tested for reliability and consistency. Interpretation results were found to be identical on Tempus Pro, Corsium, thermal printer output, PDF reports, and Corsium PDF reports.
All software features tested shall output the expected result per the protocol and associated software specification (for Tempus Pro software changes testing).	PASS: All software features tested performed as specified in the protocol and associated SW specification document.
Outputs shall meet the acceptance criteria defined in the Integration Acceptance Test Protocol (IATP) protocol.	PASS: All outputs met the acceptance criteria defined in the IATP protocol.
Outputs of software and unit test shall meet the criteria defined in the relevant software specifications.	PASS: All system and unit testing met the criteria per the relevant software specifications.
Compliance with IEC 60601-2-25: 2011, Medical Electrical Equipment Part 2-25: Particular Requirements for The Basic Safety and Essential Performance of Electrocardiographs (Clause 201.12.1.101).	Test results confirmed that the acceptance criteria defined by IEC 60601-2-25:2011 was met.

Study Details

2. Sample size used for the test set and the data provenance:

Sample Size for testing the Glasgow Algorithm: 612 known test vectors.
Data Provenance: The test vectors were "provided by Glasgow University". The document does not specify the country of origin of the data within these test vectors or whether they were retrospectively or prospectively collected.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number or qualifications of experts used to establish the ground truth for the 612 test vectors provided by Glasgow University. It simply refers to "known reference interpretations."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method for the test set. The validation relies on comparing the device's output to "known reference interpretations."

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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical testing was performed."
This study focuses on the standalone performance and integration of the Glasgow Algorithm, which is an "optional off-the-shelf ECG interpretation algorithm" for the device, rather than its impact on human reader performance.

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

Yes, a standalone performance evaluation of the Glasgow Algorithm was conducted. The core of the software verification and validation section details how the Glasgow Algorithm's interpretations (when run on Tempus Pro) were compared against "known reference interpretations" using 612 test vectors.
Additionally, the consistency of the algorithm's output across various display and reporting formats (Tempus Pro display, thermal printer, PDF reports, Intellispace Corsium) was verified.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the Glasgow Algorithm validation consists of "known reference interpretations" provided by Glasgow University. While the underlying method for establishing these reference interpretations is not detailed, it implies a pre-established clinical gold standard for the specific ECG waveforms in the test vectors.

8. The sample size for the training set:
The document does not provide the sample size for the training set of the Glasgow Algorithm. It states that "Clinical reference data, in the form of recorded ECG databases, were used for initial validation of the Glasgow Algorithm," but no training set size is mentioned.

9. How the ground truth for the training set was established:
The document does not describe how the ground truth for the training set of the Glasgow Algorithm was established. It only broadly states "Clinical reference data, in the form of recorded ECG databases, were used for initial validation of the Glasgow Algorithm."

Summary

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September 1, 2023

Remote Diagnostic Technologies Limited % Neha Hardiya Regulatory Affairs Specialist Philips North America LLC 22100 Bothell Everett Highway Bothell. Washington 98021

Re: K201746

Trade/Device Name: Tempus Pro Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including St-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, CCK, DPS, DQA, DRG, DRT, DSB, DSK, DXN, FFL, ITX, IYO, MNR, MWI

Dear Neha Hardiya:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 18, 2020. Specifically, FDA is updating this SE Letter to remove the secondary product code NSX as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter, please contact Aneesh Deoras, OHT2: Office of Cardiovascular Devices, 240-402-4363, Aneesh.Deoras@fda.hhs.gov.

Sincerely,

Aneesh S. Deoras -S

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

September 18, 2020

Remote Diagnostic Technologies Limited % Neha Hardiva Regulatory Affairs Specialist Philips North America LLC 22100 Bothell Everett Highway Bothell, Washington 98021

Re: K201746

Trade/Device Name: Tempus Pro Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including St-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, CCK, DPS, DQA, DRG, DRT, DSB, DSK, DXN, FLL, ITX, IYO, MNR, MWI, NSX Dated: August 18, 2020 Received: August 19, 2020

Dear Neha Hardiya:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Stephen C. Browning -S5

for

Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K201746

Device Name Tempus Pro Patient Monitor

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

510(k) Summary

This 510(k) summary was prepared in accordance with the requirements of 21 CFR §807.92.

I. Contact Information

Submitter
Name	Remote Diagnostic Technologies Limited
Address	Pavilion C2, Ashwood Park, Ashwood Way,Basingstoke, RG23 8BG, United Kingdom
Phone No.	+44 (0) 1256 362 400
Fax No.	+44 (0) 1256 362 415
Correspondent
Name	Neha Hardiya
Phone No.	425-908-2569
Email	neha.hardiya@philips.com
Date Prepared	August 18, 2020

II. Device Information

Trade Name	Tempus Pro Patient Monitor
Common Name	Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Classification	Class II (21 CFR 870.1025)
Product Code	MHX
Secondary Product Codes	CCK, DPS, DQA, DRG, DRT, DSB, DSK, DXN, FLL, ITX, IYO, MNR, MWI, NSX

III. Predicate Device Information

Primary Predicate Name	Tempus Pro Patient Monitor
510(k) Submission No.	K173768
Classification	Class II (21 CFR 870.1025)
Product Code	MHX
Secondary Product Codes	CCK, DPS, DQA, DRG, DRT, DSB, DSK, DXN,FLL, ITX, IYO, MNR, MWI, NSX
Secondary Predicate Name	Infinity CentralStation Wide
510(k) Submission No.	K151860
Classification	Class II (21 CFR 870.1025)
Product Code	MHX
Secondary Product Code	N/A

Prior Submission

This is an original submission. There has been no prior submission for the subject device.

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IV. Device Description

Reason for Change

This submission is to notify the FDA of our intent to market the Tempus Pro modified by the addition of an optional off-the-shelf ECG interpretation algorithm, known as the Glasgow Algorithm. This off-the-shelf ECG algorithm will be available to the customer as an optional alternative to the ECG interpretation algorithm cleared under the previous 510(k) for Tempus Pro, known as the Louvain Algorithm.

The Glasgow ECG algorithm is being added to the Tempus Pro Monitor to accommodate customer preference. Users already familiar with use of the Glasgow ECG Algorithm on existing alternative devices have expressed interest in availability of Glasgow for the Tempus Pro.

If the user does not choose to purchase the new Glasgow Algorithm option via a software key, the Tempus Pro will continue to provide the 12-Lead ECG Interpretation using the

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Louvain Algorithm originally cleared under 510(k) K133988. If the Glasgow Algorithm option is purchased, the Tempus Pro will output 12-lead ECG interpretations from Glasgow only (there is no option to use both 12-lead interpretation algorithms on the same device).

The Glasgow Algorithm is able to provide ECG interpretations for adult, pediatric, and neonate patients, when compared with the Louvain Algorithm that only provides the ECG interpretation for adults. However, the Tempus Pro already includes pediatrics and neonates in its labeled indications.

In addition to providing 12-lead ECG interpretations for adults, pediatric and neonate populations, Glasgow Algorithm is able to consider additional inputs for ECG analysis (e.g. age and sex), and is able provide interpretations under a greater breadth of conditions (e.g. waveforms that include pacemaker signals). However, this modification will not remove or change any other features available on the Tempus Pro device. Addition of the off-the-shelf Glasgow ECG interpretation algorithm will not change the indications for use or intended use for the Tempus Pro. As detailed in Section 13, algorithm validation data supports use of the Glasgow Algorithm in adults, pediatrics, and neonates.

Product Model Numbers

Table 5-1 below lists the Tempus Pro model numbers that are the subject of this 510(k).

Model Number	Description
00-1004-R	Standard configuration with invasive pressure (2 channels), ETCO2and contact temperature (1 or 2 channels).
00-1007-R	Standard configuration with invasive pressure (2 channels), ETCO2,contact temperature (1 or 2 channels) and Bluetooth headset.
00-1024-R	Standard configuration with printer, ETCO2 and contact temperature(1 or 2 channels).
00-1026-R	Standard configuration with printer, invasive pressure (2 channels),ETCO2 and contact temperature (1 or 2 channels).

Table 5-1. Tempus Pro Patient Monitor Model Numbers

V. Intended Use

No changes to the Tempus Pro Intended Use are proposed by this submission.

The Tempus Pro is a portable vital sign 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.

RDT assumes that users of the product are clinically trained in how to take and interpret a patient's vital signs. The Tempus Pro is intended to be used by such clinically-trained personnel. Before attempting to work with the Tempus Pro, the user must read, understand,

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and strictly observer all warnings, cautions and safety markings in the User/Operator Manual, other associated labeling and on the equipment.

Indications for Use

No changes to the Tempus Pro Indications for Use are proposed by this submission.

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-, 4and 5-lead ECG monitoring: 12-lead ECG recording with interpretation: real-time arrhythmia detection/alarming: OT 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; carboxyhaemoglobin (SpCO), methaemoglobin (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, 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.

VI. Comparison of Technological Characteristics with the Predicate Device

The intended use, indications for use, and technology used in the Tempus Pro device remains essentially unchanged by the addition of the Glasgow Algorithm as an optional alternative 12-Lead ECG interpretation algorithm. Table 5-2 below provides a summary of similarities and differences between the modified Tempus Pro that is the subject of this 510(k) and the primary predicate device Tempus Pro cleared per K173768. Table 5-2 (a) provides a summary of similarities between the subject device and the secondary predicate devices specific to 12-Lead ECG interpretation feature.

Similarities
Indications forUse	There is no change in the indications for use for the subject device incomparison to the primary predicate device. The subject device with alternativeoption for 12-Lead ECG interpretation algorithm is substantially equivalent tothe primary predicate device.
PhysicalDimensions	No modifications have been made to the physical dimensions of the subjectdevice. It is substantially equivalent to the primary predicate device.

	Table 5-2. Comparison of Technological Features with the Primary Predicate Device

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K201746

Similarities
PhysiologicalParametersMeasured	There is no change in the physiological parameters measured for the subjectdevice. It is substantially equivalent to the primary predicate device.
Alarms	There are no changes to alarms. The subject device is substantially equivalentto the primary predicate device.
Display	There are no changes to the display. The subject device is substantiallyequivalent to the primary predicate device.
On-ScreenTrends andEvents	There are no changes to the on-screen trends and events. The subject device issubstantially equivalent to the primary predicate device.
3-Lead and 5-Lead ECGMonitor	There are no changes to the 3-Lead and 5-Lead ECG monitoring. The subjectdevice is substantially equivalent to the primary predicate device.
ECGArrhythmiaMonitoring	There are no changes to the ECG arrhythmia monitoring. The subject device issubstantially equivalent to the primary predicate device.
ImpedanceRespiration	There are no changes to the impedance respiration specifications. The subjectdevice is substantially equivalent to the primary predicate device.
Pulse Oximeter	There are no changes to the pulse oximeter specifications. The subject device issubstantially equivalent to the primary predicate device.
Non-InvasiveBlood Pressure	There are no changes to the non-invasive blood pressure specifications. Thesubject device is substantially equivalent to the primary predicate device.
Capnometer	There are no changes to the capnometer specifications. The subject device issubstantially equivalent to the primary predicate device.
ContactTemperature	There are no changes to contact temperature specifications. The subject deviceis substantially equivalent to the primary predicate device.
InvasivePressure	There are no changes to invasive pressure specifications. The subject device issubstantially equivalent to the primary predicate device.
Ultrasound	There are no changes to the ultrasound specifications. The subject device issubstantially equivalent to the primary predicate device.
VideoLaryngoscope	There are no changes to the video laryngoscope. The subject device issubstantially equivalent to the primary predicate device.
Communicationsand Wireless	There are no changes to communications or wireless specifications. The subjectdevice is substantially equivalent to the primary predicate device.

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Similarities
Printing	There are no changes to the printer and the subject device is substantially equivalent to the primary predicate device.
EMC	Addition of the alternative 12-Lead ECG interpretation algorithm for the subject device does not impact EMC. The subject device is substantially equivalent to the primary predicate device.
Environmental Performance	There are no changes to the environmental performance specifications. The subject device is substantially equivalent to the primary predicate device
Differences
12-Lead ECGRecorder	The Glasgow Algorithm is available as an alternative option for 12-Lead ECG interpretation in the subject device.While the Glasgow algorithm features additional input criteria for ECG interpretation, a more extensive ECG library, and is able to provide interpretations for adults, pediatrics, and neonates, it functions similar to the 12-Lead ECG algorithm (Louvain Algorithm) present in the primary predicate device and has the same intended use. Test data supports that this modification does not affect the substantial equivalence of the Tempus Pro device.
User Interface	With the addition of the Glasgow Algorithm to the subject device, the user interface has been updated to include:Age/Sex warning message if no age/sex has been entered, which displays before entering the 12 lead view when Glasgow interpretation is installed. Maintenance menu updated to include option for either US or UK English. Service User Changes Glasgow 12-lead ECG waveform interpretation enabling option key under Maintenance and Settings option (Option key issued by RDT, for maintenance user personnel only) Test data supports that these modifications do not affect the safety or effectiveness of the Tempus Pro device.

Table 5-2 (b) below provides a summary of similarities between the modified Tempus Pro (subject device) and the Infinity CentralStation Wide (secondary predicate device). This summary is specific to the 12-Lead ECG interpretation feature available in both the devices.

Table 5-2 (a). Comparison of Technological Characteristics with Secondary Predicate Device (12-Lead ECG Interpretation)

Similarities
Product Code andDevice Classification	Tempus Pro and Infinity CentralStation Wide have the same primaryproduct code MHX and are classified as Class II medical device (21CFR870.1025).

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RDT Limited

Similarities
Indications for Use	Both Tempus Pro and Infinity CentralStation Wide are used as patientmonitoring systems and provide 12-Lead ECG interpretation. Per theassigned product code and device classification, both devices have thesame common name: Monitor, Physiological, Patient (With ArrhythmiaDetection Or Alarms).
12-Lead ECGInterpretation	Both Infinity CentralStation Wide and Tempus Pro uses GlasgowAlgorithm for 12-Lead ECG interpretation and also considers similarinput criteria for providing interpretation e.g. Patient Age and Gender,indicated to be used for adult and pediatric population.

Table 5-3 below provides the comparison for technological characteristics between the Louvain Algorithm cleared with the predicate Tempus Pro Monitor and the Glasgow Algorithm included with the proposed modified Tempus Pro.

Table 5-3. Comparison of Technological Characteristics between Louvain Algorithm and Glasgow Algorithm

Characteristic	Louvain ECGAlgorithm (Includedwith Predicate Device)	Glasgow ECG Algorithm(Included with SubjectDevice)	Comparison Summary
Intended Use	12-Lead ECGInterpretation	12-Lead ECGInterpretation	Intended use is identical.
TargetPopulation(Specific to12-Lead ECGInterpretation)	Used with Tempus ProMonitor for ECGinterpretation availablefor patients aged 18years and over.	Used with Tempus ProMonitor for ECGinterpretation available forpatients including adults,neonate, and pediatric.	Glasgow Algorithmprovides interpretation foradults, neonates, andpediatric population ascompared to the LouvainAlgorithm that onlyprovides interpretation foradult patients.Note that Tempus ProMonitor is currently clearedfor adults, pediatrics, andneonates in its labeledindications.

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Special 510(k)Tempus Pro Patient MonitorRDT Limited
Characteristic	Louvain ECG Algorithm (Included with Predicate Device)	Glasgow ECG Algorithm (Included with Subject Device)	Comparison Summary
Method of Operation	The Louvain library software runs on the Tempus Pro at the end of recoding a 12-Lead ECG.Measurement and interpretation data indicated as statements on the monitor are then incorporated into the recorded ECG. See Figure 10-5.These measurements and interpretation data can be displayed on the Tempus Pro, printed, exported or transferred over the telemedicine communication links.	The Glasgow library software runs on the Tempus Pro at the end of recording a 12-lead ECG.Measurements and interpretation data indicated as statements on the monitor are then incorporated into the recorded ECG. See Figure 10-6.These measurements and interpretation data can be displayed on the Tempus Pro, printed, exported or transferred over the telemedicine communication links.	Method of operation is identical.
Interpretation and Review	ECG data recorded in the SCP files is interpreted by AnalyzeSCP.exe and statement codes are displayed as sub-headings Rhythm Statement and Morphology Statement. See Figure 10-5.	ECG data recorded in the SCP files is interpreted by Glasgow and the statement codes for rhythm statement and morphology statement are displayed without any sub-headings. See Figure 10-6.	Interpretation data provided by Glasgow and Louvain Algorithm is similar. Louvain displays data with sub-headings and Glasgow displays date without sub-heading on the monitor.
Data Input Criteria	SCP files will be passed to AnalyzeSCP.exe only when the heart rate is greater than or equal to	Glasgow library is not limited by any heart rate restrictions and can	Glasgow Algorithm considers a wider range of input criteria for 12-Lead ECG interpretation as
Special 510(k)Tempus Pro Patient MonitorRDT Limited
Characteristic	Louvain ECGAlgorithm (Includedwith Predicate Device)	Glasgow ECG Algorithm(Included with SubjectDevice)	Comparison Summary
	30 Bpm and less than orequal to 160 Bpm.Louvain library cannotanalyze recorded ECGthat contains pacemakersignals.	analyze any recorded ECGheart rate.Glasgow library cananalyze recorded ECG thatcontains pacemakersignals.	compared to LouvainAlgorithm.
	Louvain library cannotdetect recorded ECGsthat contain periods oflead-off or invalid data.Patient age and gender isnot a required inputcriteria.	The Glasgow library candetect recorded ECGs thatcontain periods of lead-offor invalid data, providedthere is at least one V-leadpresent throughout therecording.Patient age and gender isrequired input criteria.
Data OutputCriteria	Louvain can output ST20and ST60 measurements(ST elevation at the J-point +20ms and+60ms).	Glasgow provides STElevation Myocardialinfarction (STEMI)detection andclassification. ST20 andST60 measurements (STelevation at the J-point+20ms and +60ms) wouldprimarily be used by theclinical user to assist in thediagnosis of ST ElevationMyocardial infarction(STEMI) and other relatedconditions.The Glasgow algorithmprovides STEMI detectionand classification, therefore the omission ofreported individual ST20and ST60 leadmeasurements is notconsidered a loss offunctionality orperformance.	Both algorithms provideanalysis features relative todiagnosis of ST ElevationMyocardial infarction(STEMI). The Glasgowalgorithm provides directSTEMI detection andclassification, whileLouvain outputs ST20 andST60 elevationmeasurements.

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RDT Limited

VII. Performance Data

Software Verification and Validation

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff-Guidance for the Content of Premarket Submission for Software Contained in Medical Devices (2005). The Software Level of Concern for Tempus Pro Monitor was determined to be Major, since failure or latent flaw in the software could cause harm to the patient indirectly due to a failure or fault in the presentation of data, resulting in delay in treatment or diagnosis.

Device Change	Summary of Verification/Validation Methods	Acceptance Criteria	Summary of Results
Addition ofNew 12-LeadECG Algorithm(GlasgowAlgorithm)	Glasgow algorithm was tested usingtest vector files provided by GlasgowUniversity to exercise the ECGinterpretation library on the TempusPro. The Tempus Pro outputinterpretations were compared withknown interpretations for the inputvectors to show that there were nodifferences between the knownreference interpretations and theoutput produced after the GlasgowAlgorithm had been integrated intothe Tempus Pro.	All interpretationsoutput from theGlasgow libraryrun on TempusPro shall matchthe knownreferenceinterpretations.	PASSA total of 612known vectors wereused forcomparison withinterpretations fromTempus Pro. Theresults obtainedwere consistentwith the resultsexpected byGlasgowUniversity.
	Tested function of the Glasgowinterpretation software underdifferent conditions. This includedtesting consistency of the Glasgowinterpretation between the TempusPro user interface, Tempus Pro pdfreport, thermal printer output,display on Intellispace Corsium ECGtab and Intellispace Corsium pdfreport.	The interpretationstatement shall beprinted in bulletedformat withoutany heading andshall be identicalbetween theTempus display,the thermal printeroutput, pdf report,IntellispaceCorsium reviewdisplay andIntellispaceCorsium pdf.Additional criteria	PASSGlasgow librarywas tested forreliability andconsistency.Interpretationresults were foundto be identical onTempus Pro,Corsium, thermalprinter output, PDFreports andCorsium PDFreports.

Table 5-4. Summary of Software Testing
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RDT Limited

Summary ofVerification/Validation Methods	AcceptanceCriteria	Summary ofResults
Tempus Pro Software ChangesTesting. The new features added tothe Tempus Pro software werevalidated, including features relatedto the addition of the GlasgowAlgorithm.	All softwarefeatures testedshall output theexpected result perthe protocol andassociatedsoftwarespecification.	PASSAll softwarefeatures testedperformed asspecified in theprotocol andassociated SWspecificationdocument.
Integration Acceptance Test Protocol(IATP). This protocol describes a setof testing (validation) for theintegrated Tempus Pro software; itwas constructed to exercise all themain features of the software. Thisprotocol was used as final validationand does not replace the detailedAcceptance Test Protocols (ATPs)exercised by the softwaredevelopment test team. The protocolincluded tests of the stand-aloneTempus Pro and the systemincluding the Data Centre and i2i(Response Centre).	Outputs shall meetthe acceptancecriteria defined inIATP protocol.	PASSAll outputs met theacceptance criteriadefined in the IATPprotocol.
Software unit and system testingperformed by third party softwaredeveloper.	Outputs ofsoftware and unittest shall meet thecriteria defined inthe relevantsoftwarespecifications.	PASSAll system and unittesting met thecriteria per therelevant softwarespecifications.

Electrical Testing

The modification to the device was designed and assessed under design control processes compliant with FDA 21 CFR §820. Non-clinical testing was performed to demonstrate that the device is substantially equivalent to its predicate. The non-clinical testing performed to assess the addition of the Glasgow Algorithm included compliance with the following:

IEC 60601-2-25: 2011, Medical Electrical Equipment Part 2-25: Particular Requirements for The Basic Safety and Essential Performance of Electrocardiographs (Clause 201.12.1.101)
Test results confirmed that the acceptance criteria defined by IEC 60601-2-25:2011 was met.

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Clinical Testing

No clinical testing was performed. Clinical reference data, in the form of recorded ECG databases, were used for initial validation of the Glasgow Algorithm and integration testing specific to use with Tempus Pro.

Performance Testing not Impacted by Device Modification

As the addition of the Glasgow Algorithm is a software change only, it does not affect any Tempus Pro accessories, including any associated sterilization, biocompatibility, or shelf life testing. Because the user interface remains largely identical, with only an added age/sex warning message and option for either UK or US English interpretation output, it was determined that repeating usability and human factors testing was not necessary.

VIII. Conclusions

The results of the substantial equivalence assessment, taken together with software and electrical testing, demonstrate that the Tempus Pro Patient Monitor with the modifications described in this premarket notification does not raise different questions of substantial equivalence when compared to the predicate devices. The device performs as intended and has performance characteristics that are substantially equivalent to the Tempus Pro Patient Monitor predicate device cleared per K173768 and Infinity CentralStation Wide specific to 12-Lead ECG interpretation cleared per K151860.

Regulation Number and Section

§ 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.