TEMPUSIC PATIENT MONITOR

K113105 · Remote Diagnostic Technologies , Ltd. · MWI · Dec 15, 2011 · Cardiovascular

Device Facts

• Record ID: K113105
• Device Name: TEMPUSIC PATIENT MONITOR
• Applicant: Remote Diagnostic Technologies , Ltd.
• Product Code: MWI · Cardiovascular
• Decision Date: Dec 15, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Tempus IC 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. Tempus IC 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. Tempus IC 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 IC measures non-invasive blood pressure, SpO2, pulse rate, respiration rate and ETCO2, 12 Lead ECG, tympanic temperature (via a wireless external module) and blood glucose (via a wireless external module). Tempus IC is suitable for use on adults or children (over 10 years old and over 20kg in weight).

Device Story

Tempus IC is a portable multi-parameter patient monitor for remote use by trained non-experts; inputs include non-invasive blood pressure, SpO2, pulse, respiration, ETCO2, 12-lead ECG, tympanic temperature (via wireless module), and blood glucose (via wireless glucometer). Device transmits voice, video, and vital signs data via satellite or terrestrial links to TempusNET software at a response center; remote physicians view data on a PC-based monitoring station to provide clinical guidance. System enables real-time assessment and stabilization advice for patients in remote environments. Benefits include rapid access to medical expertise for patients in isolated locations.

Clinical Evidence

Bench testing only. Comparative testing demonstrated performance equivalence to predicates. Testing verified reliable and accurate data transmission from the tympanic thermometer and glucometer, including wireless range and co-existence testing per FDA guidance.

Technological Characteristics

Portable multi-parameter monitor; utilizes OEM sensing technology for ECG, SpO2, NIBP, ETCO2, pulse, and respiration. Connectivity via Bluetooth for external modules and satellite/terrestrial links for data transmission to TempusNET server. Software-based user interface and data management. Complies with IEC62366 (usability) and IEC60601-1-4.

Indications for Use

Indicated for adults and children (>10 years, >20kg) presenting as unwell in remote locations (land, sea, air) lacking immediate medical assistance. Used by trained non-experts to collect vital signs and transmit data to remote physicians for diagnostic aid and clinical guidance.

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 Patient Monitor (K082718)
• Tympanic thermometer (K101264)
• MyGlucoHealth glucometer (K081703)

Submission Summary (Full Text)

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K 113105° 1/4

RDT Tempus IC Patient Monitor 510k Summary of Safety and Effectiveness

DEC 1 5 2011

# 510(k) Summary of Safety and Effectiveness

#### Submitter Information

| Name: | Remote Diagnostic Technologies Ltd |
|----------------------|------------------------------------------------------------------------------------------------|
| Address: | The Old Coach House<br>The Avenue<br>Farleigh Wallop<br>Basingstoke RG25 2HT<br>United Kingdom |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Name: | Chris Hannan |
| Date Prepared: | 17 June 2011 |
| Device Name | |
| Common Name: | Portable Patient Monitor |
| Proprietary Name: | Tempus ICTM Patient Monitor, type 00-1001 |
| Classification Name: | Transmitters and Receivers, Electrocardiograph<br>Telephone |

# Device Description

The TempusIC™ is an advanced multi-parameter vital signs monitor designed for use in remote locations by trained non-expert users. It provides a wide range of features in a highly robust package, including integrated voice link and video camera.

The device remains unchanged from its previous/existing clearance with the exception that the device is now capable of receiving (wirelessly over a Bluetooth™ link) both tympanic temperature readings from a tympanic thermometer (cleared under K101264) and blood glucose data from the Entra Health Systems MyGlucoHealth glucometer (cleared under K081703),

Voice and data connections are made automatically via existing satellite or terrestrial communications systems.

The TempusIC™ is used in conjunction with TempusNET™ software, which provides a system for receiving real-time voice and vital signs data. The system

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ર્ત્વે વિવ

# RDT Tempus IC Patient Monitor 510k Summary of Safety and Effectiveness

enables users to receive voice, vital signs data, and still video pictures from TempusICTM devices located anywhere in the world.

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

It also provides a synchronised user interface, and remote control of the TempusIC™.

TempusNET™ also supports a full patient records database.

# Intended Use

The TempusIC™ Patient Monitor is intended to be used when a medical situation arises at a location remote from readily available medical expertise. Situations demanding use of the TempusIC™ Patient Monitor can occur at remote land locations on private yachts while sailing at considerable distances from land, and during flight on commercial /private jets as well as in other situations.

The Tempus!C™ Patient Monitor is intended to be used by trained non-experts upon people presenting as unwell. It is designed with the most ease of use for the operator so that it can be used quickly, reliably, with minimum training and with little or no support from medical staff. This allows the TempusIC™ Patient Monitor ikle of he capper. Tomment or also connected to the TempusNET™ server system.

In the latter mode, the TempusIC™ Patient Monitor connects through TempusNET™ server system to a sister device, called the TempusNET™ monitoring station allowing the recorded data to be viewed, stored and manipulated by trained medical staff.

The TempusNETTM monitoring station comprises a normal, commercial grade PC which is dedicated to running the software that enables it to communicate with the TempusIC™ Patient Monitor. The TempusNET™ monitoring station is installed at a Response Centre (typically an emergency room within a hospital) and is operated by experts from the hospital staff.

The operator at the Response Centre is able to receive voice calls and data on the patient's condition for assessment and consequently advise on an appropriate course of action. Such action may include advice on treatments to stabilize the condition, or instructions to return to land or divert from the planned journey, if the patient is at sea or in the air.

# Indications for Use

Tempus IC 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.

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# RDT Tempus IC Patient Monitor 510k Summary of Safety and Effectiveness

Tempus IC 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.

Tempus IC 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 IC measures non-invasive blood pressure, SpO2, pulse rate, respiration rate and ETCO2, 12 Lead ECG, tympanic temperature (via a wireless external module) and blood glucose (via a wireless external module).

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

#### Predicate Devices

The Tempus IC Patient Monitor is predicated on itself (as cleared to market without the ability to receive data from the thermometer or the MyGlucoHealth device). The clearance for the Tempus IC was granted under K082718.

The use of the tympanic thermometer is predicated on the clearance of the same thermometer with the Tempus IC Professional (granted under K101264).

The use of the MyGlucoHealth glucometer is predicated on the clearance of the same glucometer when it was cleared in its own right under K081703.

Operation of the device remains the same except with the addition of the two wireless peripherals, both of which have been cleared to market in the same form in previous applications which are substantially equivalent to their use with the Tempus IC.

# 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).

The design of this device utilises currently available (OEM) technology found in many legally marketed devices. In terms of measurement performance, the Tempus 2000 is effectively identical to the devices that incorporate the same OEM technology.

# Testing

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

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# RDT Tempus IC Patient Monitor 510k Summary of Safety and Effectiveness

| Area | Testing Performed |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparative testing to<br>predicates | Comparative testing has been performed to demonstrate that the<br>performance of the device is equivalent to the predicates. This<br>comprised benchmarking to confirm the MyGlucoHealth data was<br>received reliably and accurately. |
| Software | The requirements of the FDA document Guidance for the Content of<br>Premarket Submissions for Software in Pre-Market Submissions has<br>been applied. In addition, the requirements of IEC62366 and<br>IEC60601-1-4 have been addressed. |
| Bench testing | The glucometer has been bench tested to confirm that transmitted<br>data is transmitted reliably and accurately. |
| Wireless range | The glucometer has been tested to confirm it operates reliably and<br>accurately at its maximum stated range. |
| Wireless co-existence<br>testing | The glucometer has been tested to confirm it operates reliably in the<br>presence of other wireless fields as per the FDA Guidance for Radio-<br>Frequency Wireless Technology in Medical Devices. |
| Usability | Usability has been address by the application of IEC62366. |

### Conclusion

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

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

Chris Hannan Regulatory Affairs and Operations Manager

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing strokes, representing life, health, and the pursuit of happiness. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the eagle.

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

DEC 1 5 2011

Remote Diagnostic Technologies, Ltd c/o Mr. William Sammons Third Party reviewer, Intertek Testing Services 2307 East Aurora Road, Unit B7

Twinsburg, Ohio 44087

Re: K113105

Trade/Device Name: Tempus IC Patient Monitor Model 00-1001 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor

Regulatory Class: Class II (two) Product Code: MWI Dated: November 30, 2011 Received: December 1, 2011

Dear Mr. Sammons:

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.

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

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# Page 2 - Mr. Sammons

or any Federal statutes and regulations administered by other Federal agencies. You must of any I cut all the Act's requirements aincluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CITY an 607); laboring (21 OFF 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by stories (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 ir you desire specific advice to: your conters offices/CDRH/CDRHOffices/ucm115809.htm for go to mip.//www.lua.gov.il Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radiosonding by reference to premarket notification" (21CFR Part note the regulations 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 rou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

(000) 030 = 64a.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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# Statement of Indications for Use

510(k) Number (if known):

Not known

Device Name:

TempusICTM Patient Monitor

00-1001 Model number:

Indications for Use:

Tempus IC 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.

Tempus IC 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.

Tempus IC 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 IC measures non-invasive blood pressure, SpO2, pulse rate, respiration rate and ETCO2, 12 Lead ECG, tympanic temperature (via a wireless external module) and blood glucose (via a wireless external module).

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

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 CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

**510(k) Number** K113105