The Tempus IC2 is intended to aid with the diagnosis of a person presenting as unwell or sick when they are in a location remote from immediate medical assistance. The device allows the User to take vital signs data from a patient and to transmit that data to medical professionals located at the response centre elsewhere. Typical examples are remote land, sea or air locations. The Tempus IC2 is intended primarily to be used by medically unqualified people who have received basic training in the use of the device. Medical expertise is provided through communication with the Response Centre which would be staffed by physicians who would advise the operator on the nature of the medical incident.

The Tempus IC2 is intended to be used where a physician or other medically trained staff may or may not be present but where remote physician support is required.

Tempus IC2 measures non-invasive blood pressure, SpO2, pulse rate, respiration rate and ETC02, 12 Lead ECG, tympanic temperature (via a wireless external module) and blood glucose (via a wireless external module).

The Tempus IC2 is suitable for use on adults or children (over 10 years old and over 20kg in weight).

Device Description

The Tempus IC2 device is a portable vital signs monitor that can measure 12 Lead ECG, non-invasive blood pressure. SpO2 and pulse rate. ETCO2 and respiration rate, temperature (via an unmodified thirdparty Bluetooth enabled tympanic thermometer) and blood glucose (via an unmodified third-party Bluetooth enabled glucometer). It also provides an integral camera, built-in third-party Bluetooth headset, touchscreen and membrane button controls, user removable lithium-ion battery and Ethernet, Wi-Fi and cellular phone communications. These are all the same features as provided by the Tempus IC.

The Tempus IC2 is intended primarily to be used as a telemedicine device for trained, non-healthcare practitioners in remote locations e.q. cabin crew on aircraft. It is designed to be and to transmit all data displayed to a healthcare practitioner in a different location. The healthcare professional receives the data on a PC installed with a programme called i2i. The device also transmits still or lowrate moving images (from the device to the i2i software) and also transmits voice communications through the use of an off-the-shelf Bluetooth headset which is connected to the Tempus IC2. These descriptions are all the same as the Tempus IC.

The Tempus IC2 is provided in a bag which stores the device and the accessories and consumables needed to operate the device. This is the same as the Tempus IC which is also provided with a bag.

AI/ML Overview

The document does not contain specific acceptance criteria, reported device performance metrics (such as sensitivity, specificity, accuracy, or AUC), or detailed study results for a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.

However, it does provide general information about non-clinical testing performed to establish substantial equivalence to predicate devices. Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for the device's diagnostic capabilities. Instead, it states that "the results of this testing confirmed that acceptance criteria defined by the relevant standard, or other appropriate reference document had been met." The comparisons table on page 4 details specifications for several vital sign measurements (SpO2, Pulse Rate, Respiration Rate, ETCO2, Temperature) and indicates that the technology used in Tempus IC2 is "equivalent to that used in the Tempus IC" or has "generally similar specification."

SpO2:
- Tempus IC2 Range: 1-100%
- Tempus IC2 Accuracy (adults/child): no motion or low perfusion +/- 3 digits 70-100%
- Tempus IC Range: 50% - 100 %
- Tempus IC Accuracy: ±2 % at 70 % - 100 %
- Comparison: Both use previously cleared OEM technology; Tempus IC2 technology is equivalent.
Pulse Rate:
- Tempus IC2 Range: 25 - 239 BPM
- Tempus IC2 Accuracy (all ages): no motion ≤3 digits, motion ≤5 digits
- Tempus IC Range: 25 - 300 BPM
- Tempus IC Accuracy: ±1bpm
- Comparison: Technology used in Tempus IC2 remains substantially equivalent.
Respiration Rate (Capnometer):
- Tempus IC2 Range: 0 - 149 BPM
- Tempus IC2 Accuracy: 0-70 BPM ±1 BPM, 71-121 BPM ±2 BPM, 122-149 BPM ±3 BPM
- Tempus IC Range: 2-150 BPM
- Tempus IC Accuracy: ± 1BPM
- Comparison: Both enable monitoring via capnometry with similar specifications.
Sidestream ETCO2:
- Tempus IC2 Range: 0 - 150 mmHg
- Tempus IC2 Accuracy: 0-38 mmHg ±2 mmHg, 39-150 mmHg (accuracy not fully specified in snippet)
- Tempus IC Range: 0 - 150 mmHg
- Tempus IC Accuracy: ±2 % - ±10 %
- Comparison: Both utilize sidestream technology with similar specifications.
Tympanic Temperature:
- Tempus IC2 Range: 32°C - 43°C
- Tempus IC2 Accuracy: ±0.2°C (36-39°C) ±0.4°C (<36°C & >39°C)
- Tempus IC Range: 34°C - 42.2°C
- Tempus IC Accuracy: ±0.2°C (36-39°C) ±0.3°C (<36°C & >39°C)
- Comparison: Both use third-party Bluetooth tympanic thermometers; technology in Tempus IC2 remains substantially equivalent.

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

The document mentions "Comparative testing has been performed using calibrated patient simulation equipment." This suggests that the testing was likely performed on simulated data/equipment rather than human patients. Details regarding the specific sample size of these simulations or data provenance (e.g., country of origin, retrospective/prospective) are not provided.

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

Not applicable. The testing described uses "calibrated patient simulation equipment," implying a ground truth established by the simulator's settings, not by human experts.

4. Adjudication method for the test set

Not applicable, as ground truth was established by calibrated patient simulation equipment, not expert consensus.

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 is mentioned in the provided text. The device is a patient monitor, not an AI diagnostic tool involving human readers interpreting AI outputs.

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

The "comparative testing" with "calibrated patient simulation equipment" could be considered a form of standalone performance assessment against a known simulated ground truth for the vital sign parameters. However, it's not described as an "algorithm only" study in the context of advanced AI diagnostics. The device itself is a measurement tool.

7. The type of ground truth used

The ground truth for the vital sign measurements was established by "calibrated patient simulation equipment."

8. The sample size for the training set

Not applicable. The document discusses device verification and validation against predicate devices and standards, not the training of an AI algorithm from a dataset.

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

Not applicable, as there is no mention of an AI training set.

Summary

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

October 28, 2015

Remote Diagnostics Technologies Ltd Chris Hannan Director of Operations & Compliance The Old Coach House, The Avenue, Farleigh Wallop Basingstoke, Hampshire RG25 2HT UK

Re: K152124

Trade/Device Name: Tempus IC2 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: August 17, 2015 Received: August 18, 2015

Dear Chris Hannan:

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 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.

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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,

Bram D. Zuckerman -S

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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K152124 Pg. 1 of 1

Indications for Use Statement

510(k) Number (if known):

Device Name: Tempus IC2

Indications for Use:

"The Tempus IC2 is intended to aid with the diagnosis of a person presenting as unwell or sick when they are in a location remote from immediate medical assistance. The device allows the User to take vital signs data from a patient and to transmit that data to medical professionals located at the response centre elsewhere. Typical examples are remote land, sea or air locations. The Tempus IC2 is intended primarily to be used by medically unqualified people who have received basic training in the use of the device. Medical expertise is provided through communication with the Response Centre which would be staffed by physicians who would advise the operator on the nature of the medical incident.

The Tempus IC2 is intended to be used where a physician or other medically trained staff may or may not be present but where remote physician support is required.

The Tempus IC2 is suitable for use on adults or children (over 10 years old and over 20kg in weight)."

Description Use X (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)

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510(k) Summary K152124

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:	Mr. Chris Hannan (Director of Operations & Compliance)
Date summary prepared:	17/07/2015

Device Identification

Device Trade Name:	Tempus IC2
Common Name:	Patient Monitor
Class:	II
Device Classification Name:	Cardiac Monitor (Including Cardiotachometer and Rate Alarm
Product Code:	MWI
Regulation Number:	21 CFR 870.2300

Device Description

The Tempus IC2 is provided in a bag which stores the device and the accessories and consumables needed to operate the device. This is the same as the Tempus IC which is also provided with a bag.

5.1 Indications for Use

The Tempus IC2 Indications for Use are the same as the predicate. The Indications for use are:

"The Tempus IC2 is intended to aid with the diagnosis of a person presenting as unwell or sick when they are in a location remote from immediate medical assistance. The device allows the

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Tempus IC2 Patient Monitor - 510(k) Summary K152124

User to take vital signs data from a patient and to transmit that data to medical professionals located at the response centre elsewhere. Typical examples are remote land, sea or air locations.

The Tempus IC2 is intended primarily to be used by medically unqualified people who have received basic training in the use of the device. Medical expertise is provided through communication with the Response Centre which would be staffed by physicians who would advise the operator on the nature of the medical incident.

The Tempus IC2 is intended to be used where a physician or other medically trained staff may or may not be present but where remote physician support is required.

Tempus IC2 measures non-invasive blood pressure, SpOz, pulse rate, respiration rate and ETCO2, 12 Lead ECG, tympanic temperature (via a wireless external module) and blood glucose (via a wireless external module).

The Tempus IC2 is suitable for use on adults or children (over 10 years old and over 20kg in weight)."

Comparison with Cleared Device

RDT are moving their existing Tempus IC user interface and feature set on to their Tempus Pro hardware platform. The result of which will be a new/enhanced iteration of the existing Tempus IC product. This is a multi-parameter vital signs patient monitor (VSM) that provides a telemedicine platform for remote diagnosis. It will be based on the experience gained in the development of the current products (the Tempus IC and Tempus Pro), and includes the proprietary communications technology developed for the Tempus Pro but with a reduced feature set compared to what is offered with the Tempus Pro.

The intended use and indications for use, as well as the fundamental technology used in the Tempus IC2 device, remain essentially unchanged from the cleared Tempus IC.

Predicate Devices

The predicate devices are as follows:

Tempus IC2	Tempus IC (K113105)	Comparisons
Ease of Use
Control InterfaceUser interface is provided by atouch screen, and simplegraphically labelled buttons.The user speaks with the physicianvia a wireless headset for hands-free operation.All activities supported by full colorhelpscreens and graphics-basedGUI. Requires as little as threehours training. Users are able toswitch between multiplepre-configured communicationsoptions with only two buttonpresses	Control InterfaceUser interface is provided by atouch screen, jog wheel and simplegraphically labelled buttons.The user speaks with the physicianvia a wireless headset for hands-free operation All activitiessupported by full color helpscreensand graphics-based GUI Requiresas little as three hours trainingUsers are able to switch betweenmultiple pre-configuredcommunications options with onlytwo button presses	The Tempus IC2 is same asTempus IC but the jog wheel hasnot been included on the TempusIC2
Tempus IC2	Tempus IC (K113105)	Comparisons
Pulse Oximeter
SpO2Range: 1-100%Accuracy (adults/child): no motionor low perfusion +/- 3 digits 70-100%,Perfusion Index range: 0.02% -20% Signal strength indicatorUses comfortable, waterproof soft-tip sensorPulse RateRange: 25 - 239 BPMAccuracy (all ages): no motion ≤3digits, motion ≤5 digits	SpO2Range: 50% - 100 %Accuracy: ±2 % at 70 % - 100 %Perfusion Index range: 1% - 20 %Signal strength indicatorEmploys patented SAC technology,Nellcor compatibleUses comfortable, waterproof soft-tip sensorPulse RateRange: 25 - 300 BPM Graphicdisplay range25-200 bpm Accuracy ±1bpmResolution: 1bpm	Both devices use pulse oximetryto monitor blood oxygensaturation levels. Both devicesuse previously cleared OEMtechnology, the technology in theTempus IC2 is equivalent to thatused in the Tempus IC.The technology used in theTempus IC2 remains substantiallyequivalent to that used in theTempus IC based on its generallysimilar specification.
Capnometer
Respiration RateRange: 0 - 149 BPMAccuracy: 0-70 BPM ±1 BPM, 71-121 BPM ±2BPM, 122-149 BPM ±3 BPMSidestream ETCO2Range: 0 - 150 mmHgFlow rate: 50 ml/min -7.5 + 15ml/min Uses Oridion®Microstream® technologyAccuracy: 0-38 mmHg ±2 mmHg,39-150 mmHg	Respiration Rate Range 2-150BPM Accuracy: ± 1BPMSidestream ETCO2Range: 0 - 150 mmHgAccuracy: ±2 % - ±10 %Delay time: <3 seconds	Tempus IC & Tempus IC2 bothenable monitoring of respirationrate and ETCO2 via capnometry.And both utilise sidestreamtechnology with similarspecifications and features.
Thermometer
Hand-held, Bluetooth® enabledinfra-red tympanic thermometerMeasurement range: 32°C - 43°C(target) (89.6°F – 109.4°F)Resolution: 0.1°C (0.1°F)Accuracy: ±0.2°C (36-39°C) ±0.4°C(<36°C & >39°C) [±0.4°F (96.8-102.2°F) ±0.5°F (<96.8°F &>102.2°F)]Bluetooth® communications range0 - 10 m (0 - 32' 9")	Hand-held, Bluetooth® enabledinfra-red tympanic thermometerMeasurement range: 34°C - 42.2°C(target) (93.2°F - 108°F)Resolution: 0.1°C (0.2°F)Accuracy: ±0.2°C (36-39°C) ±0.3°C(<36°C & >39°C) [±0.36°F (96.8-102.2°F) ±0.54°F (<96.8°F &>102.2°F)]Display convertible to °FBluetooth® communications range0 - 10m (0 - 32' 9")	Both devices use a third partyBluetooth tympanic thermometerto measure temperature. Bothdevices use previously clearedOEM technology.The technology used in theTempus IC2 remains substantiallyequivalent to that used in theTempus IC based on its generallysimilar specification.
Integral 3G/GSM Cell Phone
Tempus IC2	Tempus IC (K113105)	Comparisons
Able to connect over 2G GPRSnetworks (GSM 850, EGSM 900,DCS 1800 & PCS 1900)Able to connect over 3G GPRSnetworks (UMTS 850/Band V,UMTS 900/ Band VIII, UMTS 1900/Band II & UMTS 2100/ Band I)	Able to connect over tri-band GPRSnetworks Operates over 900MHz,1800MHz and 1900MHz bands	Device is the same as thepredicate except it uses a quadband radio instead of a tri bandradio.

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In addition, reference is made to the cleared Tempus Pro patient monitor (K133988) which provides the hardware design (and consequently the burden of product verification testing) which the Tempus IC2 utilizes. The Tempus IC2 uses the majority of the Tempus Pro's hardware but does not make all the same performance claims and does not have the same Indications for Use or Intended Use and consequently a claim of substantial equivalence is not being made to the Tempus Pro.

Summary of Non-Clinical Testing

The non-clinical testing carried out is summarized in the following table:

Area	Testing Performed
Safety	Updated certification has been obtained to IEC 60601-1 3rd ed by aqualified testing laboratory.
Ingress Protection	Ingress protection testing has been repeated in a qualified testinglaboratory.
Comparative testing topredicates	Comparative testing has been performed using calibrated patientsimulation equipment to demonstrate that the performance of thedevice is equivalent to the predicates.
Software	The requirements of the FDA document Guidance for the Contentof Premarket Submissions for Software in Pre-Market Submissionshas been applied. In addition, the requirements of IEC 62304 havebeen addressed.
Bench testing	The product has been bench tested to confirm that all data istransmitted reliably and accurately.

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 IC2 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.

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 IC2 Patient Monitor is substantially equivalent to the unmodified version of this device and other cleared devices used as predicates.

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).