(130 days)
Not Found
No
The summary describes a multi-parameter patient monitor that collects and transmits physiological data for remote assessment by medical professionals. There is no mention of AI, ML, or any automated analysis or interpretation of the data by the device itself. The decision-making is explicitly stated to be done by trained staff at the Response Centre.
No
The device is described as a "patient monitor" that collects and displays physiological data for assessment and advice, not for direct treatment.
No
Explanation: The document states, "The device is not intended to be applied to allow the operator to make any clinical decision for treatment or diagnosis. ... Nor can a trained person use the Tempus 2000 Patient Monitor as a standalone diagnostic device." It also clarifies that medical staff at a Response Centre make clinical assessments based on the transmitted information.
No
The device description clearly states it is a portable, multi-parameter patient monitor housed in a plastic enclosure with a screen, battery, keypad, and camera, and it measures physiological data using hardware components like ECG leads, blood pressure cuffs, and temperature sensors. While it includes software for data display and transmission, it is fundamentally a hardware device with integrated software.
Based on the provided text, the Tempus 2000 Patient Monitor System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Tempus 2000 Functionality: The Tempus 2000 Patient Monitor System measures physiological parameters directly from the patient's body (in vivo). These include ECG, blood pressure, temperature, respiration rate, end-tidal CO2, pulse rate, and SpO2. It collects and displays this data and transmits it to a remote location for assessment.
- Lack of Sample Analysis: The description does not mention the device analyzing any biological samples taken from the patient. Its function is to monitor vital signs directly from the patient.
Therefore, the Tempus 2000 Patient Monitor System falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tempus 2000 Patient Monitor System is intended to be used when a medical situation rises at a location remote from readily available medical expertise. Situations demanding use af the Tempus 2000 Patient Monitor System can occur at remote land locations on private yachts while sailing at considerable distances from land, and during flight on commercial /private iets as well as in other situations.
The Tempus 2000 Patient Monitor is intended to be used by trained non-experts upon people rne rompac Lowell. It is designed with the most ease of use for the operator so that it can be prooming as alliably, with minimum training and with little or no support from medical staff. This allows the Tempus 2000 Patient Monitor to be used as either a stand-alone monitor or also connected to the Tempus Monitoring Station. In the latter mode, the Tempus 2000 Patient Monitor connects to a sister device, called the Tempus Monitoring Station, allowing the recorded data to be viewed, stored and manipulated by trained medical staff.
The Tempus Monitoring Station is a normal, commercial grade PC which is dedicated to running the software that enables it to communicate with the Tempus 2000 Patient Monitor. The Tempus 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.
The Tempus 2000 Patient Monitor is a patient monitor intended to be used in remote locations where medical staff may not be present.
The device is intended to be applied to the patient by a trained operator who is not a medical rric device is intended to be applied to allow the operator to make any clinical decision for treatment or diagnosis. The device permits the operator to take measurements from a patient, troutinon. of aller transmission or transmit medical information to a Response Centre at the time of recording, where trained staff can make clinical assessments based on the information transmitted and advise the operator on the nature of the medical incident. A trained information transmitted annous 2000 Patient Monitor as a standalone diagnostic device.
The Tempus 2000 Patient Monitor is suitable for use on adults or children (over 10 years old and over 20kg in weight).
Product codes
DXH
Device Description
The Tempus 2000 Patient Monitor is a portable, multi-parameter patient monitor. The unit is housed in a plastic enclosure and comprises a large colour screen, a rechargeable battery and a wrist-mounted keypad which incorporates a digital camera.
The device can measure a patient's ECG (Electro Cardio Graph) using a 12-lead harness, noninvasive blood pressure, temperature (infra-red tympanic), respiration rate, end-tidal exhaled CO2, pulse rate and Sp02 (blood oxygen saturation).
The device collects the patient's physiological data and displays the data in numeric and graphical form to the operator and, remotely, to a Response Centre.
The operator interfaces with the device via 8 control buttons (with an additional button on the thermometer, a battery power level button and an on/off button on the front panel) and by graphical help-screens that are displayed in a logical sequence for ease of use.
The device is fitted with a colour, digital video-stills camera for transmitting images of the patient to the Response Centre.
The Tempus 2000 Patient Monitor is designed to connect only to a PC which is configured with the Tempus Monitoring Station software.
Mentions image processing
The device is fitted with a colour, digital video-stills camera for transmitting images of the patient to the Response Centre.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults or children (over 10 years old and over 20kg in weight)
Intended User / Care Setting
Used by trained non-experts in a remote location and connected to a Tempus Monitoring Station, which is a normal, commercial grade PC installed at a Response Centre (typically an emergency room within a hospital) and operated by experts from the hospital staff.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The revised Tempus 2000 design has been tested to determine that the device meets relevant international performance standards or guidelines e.g. IEC60601-1 and IEC60601-1-2.
Where the modification has not affected parts of the device covered by other performance standards e.g. IEC60601-2-27, AAMI SP10, EN60601-2-30, EN865 and EN864, retesting has not been required as compliance remains unaffected by the change.
Bench Tests:
- The device still meets existing design specification criteria.
- The existing performance specification in terms of measurement accuracy remains unchanged.
- The implementation of DSVD has had no impact on the transmission of voice or data.
- The operation of the integrated cell phone has had no impact on the measurement accuracy or performance of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) Summary of Safety and Effectiveness 4
| 510(k) Summary | MAR - 5 2004 |
|---|---|
| ---------------- | -------------- |
| 510(k) number | K033410 |
|---|---|
| Submitter's name and address: | Remote Diagnostic Technologies Ltd (RDT), |
| The Old Coach House, | |
| The Avenue, | |
| Farleigh Wallop, | |
| Basingstoke, | |
| Hampshire, | |
| RG25 2HT, | |
| UK | |
| Tel: | 44 (0) 1256 362 400 |
| Fax: | 44 (0) 1256 362 415 |
| Contact person: | Mr Chris Hannan |
| Email: | channan@rdtltd.com |
| Device: | Tempus 2000 Patient Monitor |
| Tempus Monitoring Station | |
| Classification: | 74 DXH 21 CFR; 870.2920 |
Electrocardiograph DPS 21 CFR; 870.2340
Non-invasive blood pressure measurement system DXN; 21 CFR 870.1130
Oximeter DQA; 21CFR 870.2700
Clinical electronic thermometer FLL; 21 CFR 880.2910
Analyzer, carbon-dioxide, gaseous-phase CCK; 21 CFR; 868.4100
1
Introduction 4.1
This pre-market submission covers the modification of an existing device, the Tempus 2000 This pro maintor (part number 00-0001). The modification essentially provides increased r auchity of communications (the Tempus 2000 is a telemedicine product) by multiplexing the ifcating of communibutions (into a single channel. This enables communications over many more communications platforms e.g. medium-high bandwidth satellite terminals, whilst still maintaining all the ease of use features that the original device provided.
The modified product, the Tempus 2000 DSVD-GSM (part number 00-0002) will be marketed along side the original design.
As this submission is to support a modification, information from the original submission has As this submission is to ouplet a mound be noted that where some whole passages have been repeated e.g. Intended Use is repeated as the statements remains unchanged by the modification, a statement is given to inform the reader that this is the case.
4.2 Intended Use
The Tempus 2000 Patient Monitor System is intended to be used when a medical situation rises at a location remote from readily available medical expertise. Situations demanding use af the Tempus 2000 Patient Monitor System can occur at remote land locations on private yachts while sailing at considerable distances from land, and during flight on commercial /private iets as well as in other situations.
The Tempus 2000 Patient Monitor is intended to be used by trained non-experts upon people rne rompac Lowell. It is designed with the most ease of use for the operator so that it can be prooming as alliably, with minimum training and with little or no support from medical staff. This allows the Tempus 2000 Patient Monitor to be used as either a stand-alone monitor or also connected to the Tempus Monitoring Station. In the latter mode, the Tempus 2000 Patient Monitor connects to a sister device, called the Tempus Monitoring Station, allowing the recorded data to be viewed, stored and manipulated by trained medical staff.
The Tempus Monitoring Station is a normal, commercial grade PC which is dedicated to running the software that enables it to communicate with the Tempus 2000 Patient Monitor. The Tempus 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.
Note that the intended use of the product has not changed as a result of the modification detailed in this submission.
2
Indications/Contraindications 4.2.1
Indications 4.2.1.1
The Tempus 2000 Patient Monitor is a patient monitor intended to be used in remote locations where medical staff may not be present.
The device is intended to be applied to the patient by a trained operator who is not a medical rric device is intended to be applied to allow the operator to make any clinical decision for treatment or diagnosis. The device permits the operator to take measurements from a patient, troutinon. of aller transmission or transmit medical information to a Response Centre at the time of recording, where trained staff can make clinical assessments based on the information transmitted and advise the operator on the nature of the medical incident. A trained information transmitted annous 2000 Patient Monitor as a standalone diagnostic device.
The Tempus 2000 Patient Monitor is suitable for use on adults or children (over 10 years old and over 20kg in weight).
These indications have not changed as a result of the modification detailed in this submission.
Contraindications 4.2.1.2
The Tempus 2000 Patient Monitor is not intended to be used on extremely small or extremely large patients; this limit is set by the physical limits of the ECG harness.
The device is not intended to, and does not, sound alarms for physiological parameters. The device does not replace physician's care. The device is not intended for neonatal use. The device is not an apnoea monitor. The device is not intended to be a long-term monitor, it is only intended to be used in short, discrete incidents where the immediate health of the patient is in question.
The device is not intended to be used in strong magnetic or electro-magnetic fields which are generated for medical purposes e.g. MRI.
The ECG is not suitable to be used on patients with prosthetic limbs.
Note that these contra-indications have not changed as a result of the modification outlined in this submission.
4.3 Device Description
The Tempus 2000 Patient Monitor is a portable, multi-parameter patient monitor. The unit is housed in a plastic enclosure and comprises a large colour screen, a rechargeable battery and a wrist-mounted keypad which incorporates a digital camera.
The device can measure a patient's ECG (Electro Cardio Graph) using a 12-lead harness, noninvasive blood pressure, temperature (infra-red tympanic), respiration rate, end-tidal exhaled CO2, pulse rate and Sp02 (blood oxygen saturation).
The device collects the patient's physiological data and displays the data in numeric and graphical form to the operator and, remotely, to a Response Centre.
3
The operator interfaces with the device via 8 control buttons (with an additional button on the thermometer, a battery power level button and an on/off button on the front panel) and by graphical help-screens that are displayed in a logical sequence for ease of use. The graphical holp or splayed for all operations including operating the main medical functions, no port one are acking the unit and clearing basic errors that can be expected when using the system e.g. blood pressure hose occlusions or telecoms connection errors.
The device is fitted with a colour, digital video-stills camera for transmitting images of the patient to the Response Centre.
The Tempus 2000 Patient Monitor is designed to connect only to a PC which is configured with the Tempus Monitoring Station software.
Only very minor changes have been made to the design of the hardware and software (including the User interface) of the Tempus 2000. The Tempus Monitoring Station remains almost completely unchanged as a result of this modification.
Modification to the Existing Design 4.4
In the original design, the Tempus 2000 was connected to the Response Centre by means of two internal modems (connected to two separate satellite channels). This was because most existing applications required communication over such low bandwidth systems (2.4kbaud) that the voice and data signals had to be kept separate.
Subsequent advances in commercial satellite systems have resulted in an increase in available bandwidth; this has enabled RDT to provide a voice and data connection between the Tempus 2000 and the Response Centre using only a single channel. RDT has called this technology Digital Simultaneous Voice and Data (DSVD).
DSVD provides the User with a slightly easier connection process (one cable instead of two) and enables the device to be used in locations where there is only one available channel e.g. hotel rooms. All data is still transmitted in real time with the same exception of large files i.e. ECGs and videos, whose transmission time is at least as fast as before.
In addition, the ability to transmit the voice and data signals over a single channel has enabled RDT to incorporate an OEM cellular (GSM) phone into the Tempus 2000. This enables the Tempus 2000 to provide a combined voice and data connection over a wireless link as well as being able to use a conventional landline or a satellite terminal.
This modification requires only additional hardware within the Tempus 2000 and does not affect any of the existing hardware. Software remains largely the same except with regards to the connection of voice and data communication.
4
Predicate Devices 4.5
We consider the RDT Tempus 2000 to be substantially equivalent to the following predicate svstems:
| Manufacturer | Device Name | 510(k) reference |
|---|---|---|
| RDT Ltd. | Tempus 2000 Patient Monitor (unmodified) | K010436 |
| Ortivus AB | MobiMed Patient Monitor | K973318 |
| Instromedix Inc. | Poseidon Cardiac Monitoring System | K964408 |
The modified Tempus 2000 is substantially equivalent to the original design as cleared to The modifica Tempao 2000 to Gaboxaniany out manket by the FDA. The product providing voice and data over one channel instead of two and with the but with the alteration of providing volos ation over an integrated cell phone instead of only via a wired connection.
The use of a multiplexed voice and data signal is predicated on the Poseidon Cardiac r he use of a maniplexou tornedix Inc (K964408). It should be noted that this device was Montoning Oyatorn by manomoun mo (10(k) as being a predicate device based on its similar licition in the original recorded are intended to record BP, ECG, SpO2 etc in the home application (boing a telomotion). This Poseidon device also provided a combined voice and data feature that gave the User a "press to speak" style voice link over the data link.
The use of a mobile (cell) phone for transmitting vital signs data is predicated on the MobiMed The use of a mobile (601) phone is than AB. This is a telemedicine device which provides realr anoht world manufacturers (12 lead ECG, blood pressure, SpO2 etc.) and transmission of the data to a physician via an integrated OEM cell phone.
4.6 Testing
The revised Tempus 2000 design has been tested to determine that the device meets relevant international performance standards or guidelines e.g. IEC60601-1 and IEC60601-1-2.
Where the modification has not affected parts of the device covered by other performance wholo the modified.com nos fever 1-2-27, AAMI SP10, EN60601-2-30, EN865 and EN864, retesting has not been required as compliance remains unaffected by the change.
4.7 Software
The requirements of the FDA document Guidance for the Content of Premarket Submissions for Software in Pre-Market Submissions has been applied. In addition, the requirements of IEC60601-1-4 have been addressed.
4.8 User Trials
The modification to the User interface was not significant therefore formal trials on the device were not required. However, feedback on the design was obtained from Users during the design process.
4.9 Clinical Tests
The nature of the modification did not require clinical re-validation of the Tempus 2000. All medical aspects of the Tempus 2000 remain unchanged.
5
4.10 Bench Tests
The revised Tempus 2000 design has been tested to determine that:
- The device still meets existing design specification criteria. .
- The existing performance specification in terms of measurement accuracy remains . unchanged.
- The implementation of DSVD has had no impact on the transmission of voice or data. .
- The operation of the integrated cell phone has had no impact on the measurement . accuracy or performance of the device.
Conclusion 4.11
On the basis of these results and the above referenced testing, it is our determination that the On the basis of those round 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
CB
S. Setenta 2003
Chris Hannan Product Validation Manager
6
Image /page/6/Picture/1 description: The image is a seal for the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2004
Remote Diagnostic Technologies Ltd c/o Ms. Patricia L. Murphy KEMA Medical 4377 County Line Road Chalfont, PA 18914
K033410 Re:
Trade Name: Tempus 2000 Patient Monitor, Model 00-0002 Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: 74 DXH Dated: February 19, 2004 Received: February 20, 2004
Dear Ms. Murphy:
We have reviewed your Section 510(k) premarket notification of intent to market the devices we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure to regally manation in the Medical Device American by to commerce prior 10 May 20, 1770, the enacement with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvile the general controls provisions of the Act. The You may, therefore, market the de requirements for annual registration, Irsting of gencial controls provisions of wactice, 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 If your device is classifica (sec above) me claist on a control and control on the can and may be subject to such additional controller Life. 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please oe advised that I Dril Shounce or our device complies with other requirements of the Act that I DA has made a dolorimiation administered by other Federal agencies. You must of ally reactal statutes and regaranents ancluding, but not limited to: registration and listing (21
7
Page 2 -- Ms. Patricia L. Murphy
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set a CFK Part 807), labeling (21 CFR Part 807), good maxart 820); and if applicable, the electronic form in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1 product radiation control provisions (Decizens over device as described in your Section 510(k) I his letter will anow you to begin manketing your antial equivalence of your device to a legally premarket nother 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 Pair 801), please If you desire specific advice for your do not an also, please note the regulation entitled, contact the Office of Comphalled at (50 r/65 - 15 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - Division - 5 Small " Misoranding by Iciclence to premaixer routineas in the Act from the Division of Small other general information on your responsionals as its toll-free number (800) 638-2041 or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dana P. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number: K033410
Device Name: Tempus 2000, Model 00-0002
Indications For Use:
Indications For Use.
The Tempus 2000 Patient Monitor is a patient monitor intended to be used in remote locations where medical staff may not be present.
The device is intended to be applied to the patient by a trained operator who is not a medical expert. The The device is intended to be applied to the patiently of clinical decision for treatment or diagnosis. The device is not intended to anow thee measurements from a patient, store this information for later device permis the operator to take medical information to a Response Centre at the time the anarates on the trails mission of transmit modioun the information transmitted and advise the operator on the ടികീ Can make cillincal assessments baoed on the mismally as a low Patient Monitor as a standalone diagnostic device.
The Tempus 2000 Patient Monitor is suitable for use on adults or children (over 10 years old and over 20kg in weight).
Contra-Indications:
Contra-matons.
The Tempus 2000 Patient Monitor is not intended to be used on extremely small or extremely large patients; this limit is set by the physical limits of the ECG harness.
The device is not intended to, and does not, sound alarms for physiological parameters. The device does The device is not intended to, and does not intended for neonatal use. The device is not an apnea not replace physician's care. The donoo is not intended to be used intended to be used in short, monitor. "The downediate health of the patient is in question
The device is not intended to be used in strong magnetic fields which are generated for medical purposes e.g. MR1.
The ECG is not suitable to be used on patients with prosthetic limbs.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Vachnel
Division Sian-C Division of Cardiovascular Devices
510(k) Number
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