(30 days)
Not Found
No
The summary describes a vital signs monitor with standard monitoring and data transmission capabilities. There is no mention of AI or ML in the intended use, device description, or sections specifically looking for these terms. The modifications described are related to a thermal printer.
No.
The device is a vital signs monitor and does not provide therapy; it only monitors patient data.
Yes
The device is described as a "portable vital signs monitor" and is "intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs." It provides numerous measurements (ECG, NIBP, SpO2, CO2, temperature, etc.) and can detect arrhythmias. Monitoring vital signs and detecting abnormalities like arrhythmias are diagnostic functions, as they aid in identifying or determining a medical condition.
No
The device description clearly states it is a "multi-parameter vital signs monitoring system" and lists numerous hardware components and capabilities (ECG, NIBP, SpO2, temperature, pressure, capnometry, integrated camera, GPS receiver, etc.). It also mentions the addition of an optional thermal printer. This is a hardware device with integrated software, not a software-only medical device.
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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Tempus Pro Function: The Tempus Pro is a vital signs monitor. It measures physiological parameters directly from the patient's body (ECG, blood pressure, SpO2, temperature, etc.) using sensors applied externally or invasively. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "attended or unattended monitoring of single or multiple vital signs." This is a monitoring function, not a diagnostic test performed on a specimen.
- Device Description: The description details the various physiological measurements it takes and its capabilities as a telemedicine system, all of which relate to direct patient monitoring.
Therefore, the Tempus Pro falls under the category of a patient monitoring device, 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 vital signs in clinical and pre-hospital care applications. The device is indicated for: 3 & 5 Lead ECG monitoring; 12 Lead ECG recording with interpretation; real-time arritythmia detection / alarming: OT measurement / alarming and ST measurements / alarming: impedance pneumography; noninvasive blood pressure (NIBP); end-tidal CO2 (ETCO2) and respiration rate: pulse oximetry (SpO2); contact temperature; and invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (SpCO), methaemoglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) measurements.
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
MHX, MWI, CCK, DPS, DSB, DXN, DRT, IYO, ITX, MNR, DQA, FFL, DSK, DRG, NSX
Device Description
The Tempus Pro is a multi-parameter vital signs monitoring system designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3 & 5 lead ECG recording, real-time arrhythmia detection & alarming, QT interval measurement & alarming, ST segment & alarming, impedance respiration, pulse oximetry (including Masimo Rainbow® co-oximetry measurements i.e. SpOC, SpHb, SpMet, SpCO, PVI and Pl), non-invasive blood pressure, sidestream capnometry, contact temperature, invasive pressure, and user configurable alarms. Third-party video laryngoscopes and ultrasound probes may also be connected to the device. In addition, it provides the ability to transmit all vital signs data via wired or wireless connections to a telemedicine software system expected to be based in a facility far from the user e.g. 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.
This submission is to notify the FDA of our intent to market the Tempus Pro modified by the addition of an optional thermal printer, which enables the user of a Tempus Pro to print medical records on-demand. Additionally, compatible external devices may also print medical records on the Tempus Pro's optional thermal printer when paired to the Tempus Pro via a secure 1-to-1 data link called Tempus Data Link (TDL).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, Video (laryngoscope)
Anatomical Site
Not Found
Indicated Patient Age Range
adults, paediatrics and neonates.
Intended User / Care Setting
clinicians and medically qualified personnel / 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)
Non-clinical testing has been performed to demonstrate that the safety and efficacy of the device remains substantially equivalent to its predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tempus Pro Patient Monitor, K170567
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Remote Diagnostic Technologies Ltd. James Hamlyn Senior Regulatory Affairs Specialist Pavilion C2, Ashwood Park, Ashwood Way Basingstoke, Hampshire RG23 8BG UNITED KINGDOM
Re: K173768
Trade/Device Name: Tempus Pro Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, MWI, CCK, DPS, DSB, DXN, DRT, IYO, ITX, MNR, DQA, FFL, DSK, DRG
Dear James Hamlyn:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 10, 2018. Specifically, FDA is updating this SE Letter to remove the secondary product code NSX as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter, please contact Aneesh Deoras, OHT2: Office of Cardiovascular Devices, 240-402-4363, Aneesh.Deoras@fda.hhs.gov.
Sincerely,
Aneesh S. Deoras -S
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
September 1, 2023
1
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
January 10, 2018
Remote Diagnostic Technologies Ltd. James Hamlyn Senior Regulatory Affairs Specialist Pavilion C2. Ashwood Park. Ashwood Wav Basingstoke, RG23 8BG UK
Re: K173768
Trade/Device Name: Tempus Pro Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, MWI, CCK, DPS, DSB, DXN, DRT, IYO, ITX, MNR, DQA, FFL, DSK, DRG, NSX Dated: December 4, 2017 Received: December 11, 2017
Dear James Hamlyn:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
2
Page 2 - James Hamlyn
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Hillebrand
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name Tempus Pro Patient Monitor
Indications for Use (Describe)
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 vital signs in clinical and pre-hospital care applications. The device is indicated for: 3 & 5 Lead ECG monitoring; 12 Lead ECG recording with interpretation; real-time arritythmia detection / alarming: OT measurement / alarming and ST measurements / alarming: impedance pneumography; noninvasiveblood pressure (NIBP); end-tidal CO2 (ETCO2) and respiration rate: pulse oximetry (SpO2); contact temperature; and invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (SpCO), methaemoglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) measurements.
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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K173768
510(k) SUMMARY
Submitter's Information
| Name: | Remote Diagnostic Technologies Limited |
|---|---|
| Address: | Pavilion C2, Ashwood Park, Ashwood Way, Basingstoke, RG23 |
| 8BG, United Kingdom | |
| Phone No: | +44 (0) 1256 362 400 |
| Fax No: | +44 (0) 1256 362 415 |
| Contact Person: | James Hamlyn, Senior Regulatory Affairs Specialist |
| Date Summary Prepared: | December 04, 2017 |
Device Identification
| Device Name: | Tempus Pro Patient Monitor |
|---|---|
| Common Name: | Patient Monitoring System |
| Classification: | II |
| Product Code: | MHX |
| Secondary Product Codes: | MWI, CCK, DPS, DSB, DXN, DRT, IYO, ITX, MNR, DQA, FLL |
| DSK, DRG, NSX | |
| Regulation Number: | 21 CFR 870.1025 |
Predicate Device(s)
Tempus Pro Patient Monitor, K170567
Device Description
The Tempus Pro is a multi-parameter vital signs monitoring system designed for use in pre-hospital care and remote clinical locations by trained healthcare professionals. It provides 3 & 5 lead ECG recording, real-time arrhythmia detection & alarming, QT interval measurement & alarming, ST segment & alarming, impedance respiration, pulse oximetry (including Masimo Rainbow® co-oximetry measurements i.e. SpOC, SpHb, SpMet, SpCO, PVI and Pl), non-invasive blood pressure, sidestream capnometry, contact temperature, invasive pressure, and user configurable alarms. Third-party video laryngoscopes and ultrasound probes may also be connected to the device. In addition, it provides the ability to transmit all vital signs data via wired or wireless connections to a telemedicine software system expected to be based in a facility far from the user e.g. 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.
This submission is to notify the FDA of our intent to market the Tempus Pro modified by the addition of an optional thermal printer, which enables the user of a Tempus Pro to print medical records on-demand. Additionally, compatible external devices may also print medical records on the Tempus Pro's optional thermal printer when paired to the Tempus Pro via a secure 1-to-1 data link called Tempus Data Link (TDL).
Page 1 of 2 K173768
5
Indications for Use
No changes to the Indications for Use are proposed by this submission. The Indications for Use are as follows: 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: 12 Lead ECG recording with interpretation: real-time arrhythmia detection / alarming: QT measurement / alarming and ST measurements / alarming; impedance pneumography; non-invasive blood pressure (NIBP); end-tidal CO2 (ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (SpCO), methaemoglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) The monitor is intended to be used as a stand-alone monitor or as a telemedicine system measurements. (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.
Comparison of Technological Characteristics
The unmodified Tempus Pro currently enables a user to print medical records on an external printer connected via USB cable, and to also export patient records to ePCR, email, and USB flash drives. The modified Tempus Pro will continue to provide these features but with the addition of an optional printing function that will enable a user to print medical data directly from the device's thermal printer. Additionally, compatible external devices may also print records on the Tempus Pro's optional thermal printer when paired with the Tempus Pro via a secure 1-to-1 data link. All other functionality of the Tempus Pro monitor remains unchanged. No changes have been made to the device's indications for use, intended use, or fundamental scientific technology as a result of the modification that has prompted this submission.
Substantial Equivalence – Non-Clinical Evidence
The modifications to the device have been designed and assessed under design control processes compliant with FDA 21 CFR 820. Non-clinical testing has been performed to demonstrate that the safety and efficacy of the device remains substantially equivalent to its predicate.
Substantial Equivalence - Clinical Evidence
Clinical evidence was not necessary to demonstrate substantial equivalence.
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 Monitoring System with the changes described in this pre-market notification is as safe, as effective, and substantially equivalent to the predicate device.
Page 2 of 2 K173768