Tempus IC2

K152124 · Remote Diagnostics Technologies, Ltd. · MWI · Oct 28, 2015 · Cardiovascular

Device Facts

• Record ID: K152124
• Device Name: Tempus IC2
• Applicant: Remote Diagnostics Technologies, Ltd.
• Product Code: MWI · Cardiovascular
• Decision Date: Oct 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

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. 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 Story

Portable vital signs monitor for remote telemedicine; inputs include 12-lead ECG, NIBP, SpO2, pulse rate, respiration rate, ETCO2, tympanic temperature (Bluetooth), and blood glucose (Bluetooth). Device features touchscreen, membrane buttons, integral camera, and Bluetooth headset for voice communication. Operated by trained non-healthcare personnel in remote locations; transmits data/images/voice via cellular/Wi-Fi/Ethernet to a remote Response Centre. Healthcare professionals receive data via 'i2i' software on a PC to advise on medical incidents. Facilitates remote diagnosis and clinical decision-making by providing real-time patient data to off-site physicians.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via comparative testing against predicates using calibrated patient simulation equipment to ensure equivalent accuracy for all vital sign parameters. Safety testing performed per IEC 60601-1 3rd ed.

Technological Characteristics

Portable multi-parameter monitor; lithium-ion battery; touchscreen/membrane controls. Connectivity: Ethernet, Wi-Fi, cellular (quad-band). Sensors: 12-lead ECG, NIBP, SpO2, capnometry (sidestream), Bluetooth-enabled tympanic thermometer, Bluetooth-enabled glucometer. Software developed per IEC 62304 and FDA guidance.

Indications for Use

Indicated for adults and children (>10 years, >20kg) presenting as unwell or sick in remote locations (land, sea, air) requiring diagnostic aid and remote physician support. Intended for use by medically untrained personnel with basic training.

Regulatory Classification

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.

Predicate Devices

• Tempus IC (K113105)

Reference Devices

• Tempus Pro (K133988)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles a human figure or a bird in flight, composed of three overlapping profiles facing to the right.

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 [phone] or [phone] 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 [phone] or [phone] 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.

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)."

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, RG25<br>2HT, United Kingdom |
| Company Phone No: | [phone] |
| Company Fax No: | [phone] |
| 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 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.

#### 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 Interface<br>User interface is provided by a<br>touch screen, and simple<br>graphically labelled buttons.<br>The user speaks with the physician<br>via a wireless headset for hands-free operation.<br>All activities supported by full color<br>helpscreens and graphics-based<br>GUI. Requires as little as three<br>hours training. Users are able to<br>switch between multiple<br>pre-configured communications<br>options with only two button<br>presses | Control Interface<br>User interface is provided by a<br>touch screen, jog wheel and simple<br>graphically labelled buttons.<br>The user speaks with the physician<br>via a wireless headset for hands-free operation All activities<br>supported by full color helpscreens<br>and graphics-based GUI Requires<br>as little as three hours training<br>Users are able to switch between<br>multiple pre-configured<br>communications options with only<br>two button presses | The Tempus IC2 is same as<br>Tempus IC but the jog wheel has<br>not been included on the Tempus<br>IC2 |
| Tempus IC2 | Tempus IC (K113105) | Comparisons |
| Pulse Oximeter | | |
| SpO2<br>Range: 1-100%<br>Accuracy (adults/child): no motion<br>or low perfusion +/- 3 digits 70-<br>100%,<br>Perfusion Index range: 0.02% -<br>20% Signal strength indicator<br>Uses comfortable, waterproof soft-<br>tip sensor<br>Pulse Rate<br>Range: 25 - 239 BPM<br>Accuracy (all ages): no motion ≤3<br>digits, motion ≤5 digits | SpO2<br>Range: 50% - 100 %<br>Accuracy: ±2 % at 70 % - 100 %<br>Perfusion Index range: 1% - 20 %<br>Signal strength indicator<br>Employs patented SAC technology,<br>Nellcor compatible<br>Uses comfortable, waterproof soft-<br>tip sensor<br>Pulse Rate<br>Range: 25 - 300 BPM Graphic<br>display range<br>25-200 bpm Accuracy ±1bpm<br>Resolution: 1bpm | Both devices use pulse oximetry<br>to monitor blood oxygen<br>saturation levels. Both devices<br>use previously cleared OEM<br>technology, the technology in the<br>Tempus IC2 is equivalent to that<br>used in the Tempus IC.<br>The technology used in the<br>Tempus IC2 remains substantially<br>equivalent to that used in the<br>Tempus IC based on its generally<br>similar specification. |
| Capnometer | | |
| Respiration Rate<br>Range: 0 - 149 BPM<br>Accuracy: 0-70 BPM ±1 BPM, 71-<br>121 BPM ±2<br>BPM, 122-149 BPM ±3 BPM<br>Sidestream ETCO2<br>Range: 0 - 150 mmHg<br>Flow rate: 50 ml/min -7.5 + 15<br>ml/min Uses Oridion®<br>Microstream® technology<br>Accuracy: 0-38 mmHg ±2 mmHg,<br>39-150 mmHg | Respiration Rate Range 2-150<br>BPM Accuracy: ± 1BPM<br>Sidestream ETCO2<br>Range: 0 - 150 mmHg<br>Accuracy: ±2 % - ±10 %<br>Delay time: <3 seconds | Tempus IC & Tempus IC2 both<br>enable monitoring of respiration<br>rate and ETCO2 via capnometry.<br>And both utilise sidestream<br>technology with similar<br>specifications and features. |
| Thermometer | | |
| Hand-held, Bluetooth® enabled<br>infra-red tympanic thermometer<br>Measurement range: 32°C - 43°C<br>(target) (89.6°F – 109.4°F)<br>Resolution: 0.1°C (0.1°F)<br>Accuracy: ±0.2°C (36-39°C) ±0.4°C<br>(<36°C & >39°C) [±0.4°F (96.8-<br>102.2°F) ±0.5°F (<96.8°F &<br>>102.2°F)]<br>Bluetooth® communications range<br>0 - 10 m (0 - 32' 9") | Hand-held, Bluetooth® enabled<br>infra-red tympanic thermometer<br>Measurement range: 34°C - 42.2°C<br>(target) (93.2°F - 108°F)<br>Resolution: 0.1°C (0.2°F)<br>Accuracy: ±0.2°C (36-39°C) ±0.3°C<br>(<36°C & >39°C) [±0.36°F (96.8-<br>102.2°F) ±0.54°F (<96.8°F &<br>>102.2°F)]<br>Display convertible to °F<br>Bluetooth® communications range<br>0 - 10m (0 - 32' 9") | Both devices use a third party<br>Bluetooth tympanic thermometer<br>to measure temperature. Both<br>devices use previously cleared<br>OEM technology.<br>The technology used in the<br>Tempus IC2 remains substantially<br>equivalent to that used in the<br>Tempus IC based on its generally<br>similar specification. |
| Integral 3G/GSM Cell Phone | | |
| Tempus IC2 | Tempus IC (K113105) | Comparisons |
| Able to connect over 2G GPRS<br>networks (GSM 850, EGSM 900,<br>DCS 1800 & PCS 1900)<br>Able to connect over 3G GPRS<br>networks (UMTS 850/Band V,<br>UMTS 900/ Band VIII, UMTS 1900/<br>Band II & UMTS 2100/ Band I) | Able to connect over tri-band GPRS<br>networks Operates over 900MHz,<br>1800MHz and 1900MHz bands | Device is the same as the<br>predicate except it uses a quad<br>band radio instead of a tri band<br>radio. |

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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 a<br>qualified testing laboratory. |
| Ingress Protection | Ingress protection testing has been repeated in a qualified testing<br>laboratory. |
| Comparative testing to<br>predicates | Comparative testing has been performed using calibrated patient<br>simulation equipment to demonstrate that the performance of the<br>device is equivalent to the predicates. |
| Software | The requirements of the FDA document Guidance for the Content<br>of Premarket Submissions for Software in Pre-Market Submissions<br>has been applied. In addition, the requirements of IEC 62304 have<br>been addressed. |
| Bench testing | The product has been bench tested to confirm that all data is<br>transmitted 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.