TEMPUSIC PATIENT MONITOR

K082718 · Remote Diagnostic Technologies , Ltd. · DXH · Oct 10, 2008 · Cardiovascular

Device Facts

• Record ID: K082718
• Device Name: TEMPUSIC PATIENT MONITOR
• Applicant: Remote Diagnostic Technologies , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Oct 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• 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 is suitable for use on adults or children (over 10 years old and over 20kg in weight).

Device Story

TempusIC is a portable multi-parameter vital signs monitor for remote use by trained non-experts. Device captures vital signs, voice, and video; transmits data automatically via satellite or terrestrial links to TempusNET server system. TempusNET station (commercial PC) at a response center allows physicians to view, store, and manipulate data, and provide remote guidance to the operator. System facilitates stabilization advice or diversion decisions for patients in remote settings. Benefits include access to expert medical assessment in locations distant from hospitals.

Clinical Evidence

No clinical data. Bench testing and performance testing conducted for all functions. Conventional desat study performed to verify combined PCB and probe performance. OEM medical modules used have prior 510(k) clearance.

Technological Characteristics

Portable monitor utilizing OEM medical modules and sensors. Features integrated voice link and video camera. Connectivity via satellite/terrestrial communications. Software compliant with IEC 60601-1-4 and FDA guidance for software in medical devices. Designed for robustness and compact form factor.

Indications for Use

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

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• Tempus 2000 Patient Monitor (K033410)
• Tempus 2000 Patient Monitor (K040436)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness OCT 1 0 2008

## 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: | August 2008 |
| Device Name | |
| Common Name: | Portable Patient Monitor |
| Proprietary Name: | Tempus ICT Patient Monitor |
| 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.

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 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

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

TempusNET™ also supports a full patient records database.

# Intended Use

The Tempus/C™ 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 vachts while sailing at considerable distances from land, and during flight on commercial /private jets as well as in other situations.

The TempusIC™ 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 to be used as either a stand-alone monitor 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 TM 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.

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.

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

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

### Predicate Devices

The TempusIC has been shown to be substantially equivalent to the Tempus 2000 Patient Monitor, which was the subject of two previous submissions (K033410 & K404436).

#### K 010436

Operation of the new device is essentially the same in terms of medical and Operation of the notion, but the TempusIC™ employs the latest hardware and software technology and materials to provide a more compact and robust unit. The TempusIC™ has been tested to the same standards as the predicate monitor.

All of the OEM medical modules and sensors used in the TempusIC™ have 510(k) clearance, and are used as intended by their manufacturers.

#### Evidence of Conformity to Essential Principles

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

Specifically, this evidence includes performance testing, software validation, electrical safety, electromagnetic compatibility, and risk analysis, where third party testing has been conducted, if appropriate.

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.

#### Software

The requirements of the FDA document Guidance for the Content of Premarket Submissions for Software contained in Medical Devices have been applied. In addition, the requirements of IEC 60601-1-4 have been addressed.

#### User Evaluations

User evaluations have been carried out with representative groups of professional. non-professional but trained, and untrained users, to confirm the ease-of-use design objective has been met.

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

#### Clinical Tests

Clinical tests have not been performed as all of the medical devices are currently cleared to market in applications that are individually substantially equivalent to the intended use of each medical parameter within the TempusIC™. Consequently, the use of clinical investigations to prove the efficacy of the measurement techniques was otherwise not required.

The functions and features of the TempusIC™ that are additional to the measurement of medical parameters have been tested and proven by bench and performance testing. In addition to bench testing of the various parameters, a conventional desat study was carried out to verify that the performance of the combined PCB and probe were within specification.

#### 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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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the bird figure. The text is in all capital letters and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 0 2008

Remote Diagnostic Technologies Limited c/o Mr. Kachi C. Envinna Intertek Testing Services NA, Inc. 2307 E Aurora Rd. Unit B7 Twinsburg, OH 44087

Re: K082718

Trade/Device Name: TempusIC™M Patient Monitor Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitters and Receivers Regulatory Class: Class II Product Codes: DXH Dated: September 16, 2008 Received: September 17, 2008

Dear Mr. Enyinna:

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 such 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

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Page 2 -- Mr. Kachi C. Enyinna

CFR Part 807): labeling (21 CFR Part 801): 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zackerman, 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 Kc82718

Device Name:

TempusICTM Patient Monitor

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 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)

| | for B Zuckerman |
|------------------------------------|-----------------|
| (Division Sign-Off) | 10/6/08 |
| Division of Cardiovascular Devices | |

510(k) Number_ K082718