(225 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard vital signs monitoring and data transmission.
No
The device is described as a vital signs monitor, intended for monitoring and recording physiological data, not for treating or providing therapy to a patient.
Yes
Explanation: The device is a vital signs monitor that measures several physiological parameters (ECG, NIBP, SpO2, ETCO2, temperature, respiration, invasive pressure) and can integrate with ultrasound and video laryngoscopy. This collection and display of patient physiological data are used to assess medical conditions, which falls under the definition of a diagnostic device.
No
The device is described as a "portable vital signs monitor" and a "multi-parameter vital signs monitor," explicitly mentioning hardware components like sensors for ECG, NIBP, SpO2, ETCO2, temperature, and invasive pressure, as well as an integrated camera and GPS receiver. While it includes software for data transmission and display, it is fundamentally a hardware device with integrated software.
Based on the provided information, the Tempus Pro is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Tempus Pro Function: The Tempus Pro is a vital signs monitor that measures physiological parameters directly from the patient's body (ECG, NIBP, SpO2, ETCO2, temperature, invasive pressure, respiration). It also displays images from ultrasound and video laryngoscopy, which are also direct measurements or visualizations of the body.
- No Specimen Analysis: The description does not mention the analysis of any biological specimens (blood, urine, tissue, etc.) in vitro.
Therefore, the Tempus Pro falls under the category of a patient monitoring device or vital signs monitor, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 & 5 Lead ECG monitoring and 12 Lead ECG recording, impedance pneumography, non-invasive blood pressure (NIBP), end-tidal CO2 (ETCO2) and respiration rate, pulse oximetry (SpO2), contact temperature and invasive pressure.
The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
The device is indicated for adults, paediatrics and neonates.
The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz Small Parts / Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. These optional accessories are to be used in accordance with their Indications For Use.
Product codes (comma separated list FDA assigned to the subject device)
MWI, IYO, ITX
Device Description
The Tempus Pro is a multi-parameter vital signs monitor designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3&5 lead ECG monitoring, 12 lead ECG recording, pulse oximetry, non-invasive blood pressure, sidestream capnometry, contact temperature, impedance respiration, invasive pressure and user configurable alarms.
In addition, it provides the ability to transmit all vital signs data via wired or wireless connections to a software system (called i2i) expected to be based in a facility far from the user e.q. a response centre facility. In addition to sending all vital signs, the system can also send pictures or video via an integrated camera, geographic position by an integrated GPS receiver and voice via a wired or wireless headset.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, Video laryngoscopy
Anatomical Site
Not Found
Indicated Patient Age Range
Adults, paediatrics and neonates.
Intended User / Care Setting
Clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications.
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)
Study Type: Non-Clinical Testing
Testing Performed:
- Comparative Testing to predicates: Comparative testing has been performed to demonstrate that the performance of the device is equivalent to the predicates.
- 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 IEC 62304 have been addressed.
- Bench testing: All parameters of the device have been tested to confirm they operate to specification across their stated performance range and across their stated temperature range with the new accessories attached.
- Bench testing: The product has been bench tested to confirm that all data is transmitted reliably and accurately.
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized representation of a human figure with three heads in profile, suggesting a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national scope.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2014
Remote Diagnostic Technologies Ltd. Leigh Cornock Director Of Systems Engineering & Test The Old Coach House, The Avenue Farleigh Wallop, Basingstoke Hampshire, RG25 2HT UK
Re: K134014
Trade/Device Name: Tempus Pro Accessories (ultrasound & video laryngoscope probe) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, IYO, ITX Dated: June 25, 2014 Received: July 3, 2014
Dear Dr Leigh Cornock,
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 (reporting of medical device
1
related 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.
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,
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known): K134014
Device Name: Tempus Pro
Indications for Use:
The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 & 5 Lead ECG monitoring and 12 Lead ECG recording, impedance pneumography, non-invasive blood pressure (NIBP), end-tidal CO2 (ETCO2) and respiration rate, pulse oximetry (SpO2), contact temperature and invasive pressure.
The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
The device is indicated for adults, paediatrics and neonates.
The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz Small Parts / Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. These optional accessories are to be used in accordance with their Indications For Use.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Date:
2014.08.12
13:23:06 -04'00'
3
510(k) Summary of Safety and Effectiveness
5.1 Submitter's Information
The submitter of this special pre-market notification is:
| Name: | Remote Diagnostic Technologies Limited |
|---|---|
| Address: | The Old Coach House, Farleigh Wallop, Basingstoke, |
| RG25 2HT, United Kingdom | |
| Company Phone No: | +44 (0) 1256 362 400 |
| Company Fax No: | +44 (0) 1256 362 415 |
| Contact Person: | Dr Leigh Cornock (Director of Systems Eng. & Test) |
| Date summary prepared: | 23rd December, 2013 |
5.2 Device Identification
| Device Trade Name: | Tempus Pro |
|---|---|
| Common Name: | Patient Monitor (without arrhythmia detection or alarms) |
| Class: | II |
| Classification Panel: | 74 |
| Product Code: | MWI |
| Secondary Product Codes: | IYO & ITX |
| Regulation Number: | 870.2300 |
5.3 Device Description
The Tempus Pro is a multi-parameter vital signs monitor designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3&5 lead ECG monitoring, 12 lead ECG recording, pulse oximetry, non-invasive blood pressure, sidestream capnometry, contact temperature, impedance respiration, invasive pressure and user configurable alarms.
In addition, it provides the ability to transmit all vital signs data via wired or wireless connections to a software system (called i2i) expected to be based in a facility far from the user e.q. a response centre facility. In addition to sending all vital signs, the system can also send pictures or video via an integrated camera, geographic position by an integrated GPS receiver and voice via a wired or wireless headset.
5.4 Indications for Use
The following indications for use of the existing features of Tempus Pro Patient Monitor remain unchanged by addition of the option to used plug-in probes for displaying ultrasound and video laryngoscopy images on the monitor.
"The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 & 5 Lead ECG monitoring and 12 Lead ECG recording, impedance pneumography, non-invasive blood pressure (NIBP), endtidal CO2 (ETCO2) and respiration rate, pulse oximetry (SpO2), contact temperature and invasive pressure.
The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
The device is indicated for adults, paediatrics and neonates.
The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz Small Parts / Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. These optional accessories are to be used in accordance with their Indications For Use."
4
5.5 Comparison with Cleared Device
The intended use and indications for use, plus the fundamental technology used in the Tempus Pro device, remain essentially unchanged as a result of plugging in the optional accessories, the monitor may be used to display ultrasound and video laryngoscopy images.
5.6 Substantial Equivalence
The predicate for the Tempus Pro Patient Monitor with the specified accessories attached is the cleared Tempus Pro Patient Monitor (K130773).
The Predicate for the optional Ultrasound features are:
As the accessories are unmodified, claims for substantial equivalence relate to the display of images, using drivers supplied by the OEM (where appropriate) and additional RDT software to enable their display on the existing Tempus Pro screen.
5.8 Summary of Non-Clinical Testing
Addition of optional probes connected externally to Tempus Pro and changes to the associated software have been made under well-established design control procedures, which ensure that appropriate risk management processes have been carried out to determine their impact and ensure that appropriate verification/ validation testing is performed.
| Area | Testing Performed |
|---|---|
| Comparative Testing to | |
| predicates | Comparative testing has been performed to demonstrate that the |
| performance of the device is equivalent to the predicates. | |
| 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 IEC 62304 have been | |
| addressed. | |
| Bench testing | All parameters of the device have been tested to confirm they operate |
| to specification across their stated performance range and across their | |
| stated temperature range with the new accessories attached. | |
| Bench testing | The product has been bench tested to confirm that all data is |
| transmitted reliably and accurately. |
The non-clinical testing carried out in relation to addition of the optional imaging probes described above is summarized in the following table:
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 Pro used with these accessories is 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. The way the accessories are used is un-changed as a result of using them with the Tempus Pro. .
5.8 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 Pro Patient Monitor when used with optional probes for ultrasound and video laryngoscopy is safe and effective, and substantially equivalent to the unmodified version of this device.