(84 days)
Not Found
No
The document mentions the "Glasgow algorithm" for ECG interpretation, which is a known rule-based algorithm, not typically considered AI/ML in the modern sense. There is no mention of AI, ML, deep learning, neural networks, or training/inference processes characteristic of AI/ML.
No
The Tempus Pro is a vital signs monitor used by clinicians for monitoring various physiological parameters; it does not actively treat or provide therapy to a patient.
Yes
The device is described as a "portable vital signs monitor" that is "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." It provides numerous physiological measurements such as ECG, NIBP, CO2, SpO2, and temperature, which are used to assess a patient's health status. Furthermore, it explicitly mentions "12-lead ECG recording with interpretation" and "real-time arrhythmia detection/alarming," which are diagnostic functions.
No
The device description clearly states it is a "multi-parameter vital signs monitoring system" and lists numerous hardware components and capabilities (ECG monitoring, NIBP, SpO2, ETCO2, temperature, invasive pressure, integrated camera, GPS receiver, optional thermal printer, compatibility with ultrasound probes and video laryngoscopes). While it includes software for data transmission and interpretation, 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 Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- 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.). While it processes data derived from the patient, it does not analyze in vitro specimens.
- 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 an in vitro diagnostic function.
- Device Description: The description details the various physiological measurements it takes directly from the patient.
- Lack of Specimen Analysis: There is no mention of the device analyzing blood, urine, or other bodily fluids.
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 or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for: 3-, 4- and 5-lead ECG monitoring; 12-lead ECG recording with interpretation; real-time arrhythmia detection/alarming; QT measurement/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; carboxyhaemoglobin (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, CCK, DPS, DQA, DRG, DRT, DSB, DSK, DXN, FLL, ITX, IYO, MNR, MWI, NSX
Device Description
The Tempus Pro Patient Monitor 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-Lead and 5-Lead ECG monitoring, 12-Lead ECG recording, real-time arrhythmia detection and alarming, QT interval measurement and alarming, ST segment measurement and alarming, impedance respiration, pulse oximetry (including Masimo Rainbow® co-oximetry measurements i.e. SpOC, SpHb, SpMet, SpCO, PVI, and PD, noninvasive 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 (called i2i) expected to be based in a facility far from the user e.g. a response center facility. As an alternative to i2i response center software, Tempus Pro Monitor also uses IntelliSpace Corsium, which is a web-based software platform for near real-time patient data transfer and two- way communication between healthcare professional. In addition to sending all vital signs, the system can also send pictures or video via an integrated camera, geographic positions by an integrated GPS receiver, and voice via a wired or wireless headset.
Additionally, Tempus Pro has an optional thermal printer, which enables the user to print medical records on-demand and allows other compatible external devices to print medical records as well using the optional thermal printer when paired to the Tempus Pro via a secure 1-to-1 data link called Tempus Data Link (TDL).
The Tempus Pro is provided to the user non-sterile. No accessories manufactured by RDT for use with Tempus Pro are provided sterile. The Tempus Pro does not come into direct or indirect contact with the patient. The Tempus Pro is compatible with 3rd party manufacturer accessories, for which patient contact and sterility requirements are determined by the 3rd party manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Test set for Glasgow algorithm verification:
- Sample size: 612 known vectors.
- Data source: Test vector files provided by Glasgow University.
- Annotation protocol: Tempus Pro output interpretations were compared with known reference interpretations for the input vectors to show that there were no differences between the known reference interpretations and the output produced after the Glasgow Algorithm had been integrated into the Tempus Pro.
Test set for Glasgow interpretation software under different conditions:
- Test includes consistency of Glasgow interpretation between Tempus Pro user interface, Tempus Pro pdf report, thermal printer output, display on Intellispace Corsium ECG tab and Intellispace Corsium pdf report.
Summary of Performance Studies
Study Type: Software Verification and Validation
Sample Size: 612 test vectors (for Glasgow algorithm verification)
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
- Glasgow algorithm verification: A total of 612 known vectors were used for comparison with interpretations from Tempus Pro. The results obtained were consistent with the results expected by Glasgow University, indicating that all interpretations output from the Glasgow library run on Tempus Pro matched the known reference interpretations. (PASS)
- Functions of Glasgow interpretation software under different conditions: Glasgow library was tested for reliability and consistency. Interpretation results were found to be identical on Tempus Pro, Corsium, thermal printer output, PDF reports and Corsium PDF reports, meaning the interpretation statement was printed in bulleted format without any heading and was identical between the Tempus display, the thermal printer output, pdf report, Intellispace Corsium review display and Intellispace Corsium pdf. (PASS)
- Tempus Pro Software Changes Testing: All software features tested performed as specified in the protocol and associated SW specification document. (PASS)
- Integration Acceptance Test Protocol (IATP): All outputs met the acceptance criteria defined in the IATP protocol. (PASS)
- Software unit and system testing: All system and unit testing met the criteria per the relevant software specifications. (PASS)
Study Type: Electrical Testing
Sample Size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
- Compliance with IEC 60601-2-25: 2011, Medical Electrical Equipment Part 2-25: Particular Requirements for The Basic Safety and Essential Performance of Electrocardiographs (Clause 201.12.1.101). Test results confirmed that the acceptance criteria defined by IEC 60601-2-25:2011 was met.
Study Type: Clinical Testing
Sample Size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results: No clinical testing was performed. Clinical reference data, in the form of recorded ECG databases, were used for initial validation of the Glasgow Algorithm and integration testing specific to use with Tempus Pro.
Key Metrics
Not Found
Predicate Device(s)
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.
September 1, 2023
Remote Diagnostic Technologies Limited % Neha Hardiya Regulatory Affairs Specialist Philips North America LLC 22100 Bothell Everett Highway Bothell. Washington 98021
Re: K201746
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, CCK, DPS, DQA, DRG, DRT, DSB, DSK, DXN, FFL, ITX, IYO, MNR, MWI
Dear Neha Hardiya:
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 September 18, 2020. 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
1
Image /page/1/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
September 18, 2020
Remote Diagnostic Technologies Limited % Neha Hardiva Regulatory Affairs Specialist Philips North America LLC 22100 Bothell Everett Highway Bothell, Washington 98021
Re: K201746
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, CCK, DPS, DQA, DRG, DRT, DSB, DSK, DXN, FLL, ITX, IYO, MNR, MWI, NSX Dated: August 18, 2020 Received: August 19, 2020
Dear Neha Hardiya:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
2
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S5
for
Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201746
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 or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for: 3-, 4- and 5-lead ECG monitoring; 12-lead ECG recording with interpretation; real-time arrhythmia detection/alarming; QT measurement/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; carboxyhaemoglobin (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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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5. 510(k) Summary
510(k) Summary
This 510(k) summary was prepared in accordance with the requirements of 21 CFR §807.92.
I. Contact Information
| Submitter | |
|---|---|
| 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 |
| Correspondent | |
| Name | Neha Hardiya |
| Phone No. | 425-908-2569 |
| neha.hardiya@philips.com | |
| Date Prepared | August 18, 2020 |
II. Device Information
| Trade Name | Tempus Pro Patient Monitor |
|---|---|
| Common Name | Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms) |
| Classification | Class II (21 CFR 870.1025) |
| Product Code | MHX |
| Secondary Product Codes | CCK, DPS, DQA, DRG, DRT, DSB, DSK, DXN, FLL, ITX, IYO, MNR, MWI, NSX |
III. Predicate Device Information
| Primary Predicate Name | Tempus Pro Patient Monitor |
|---|---|
| 510(k) Submission No. | K173768 |
| Classification | Class II (21 CFR 870.1025) |
| Product Code | MHX |
| Secondary Product Codes | CCK, DPS, DQA, DRG, DRT, DSB, DSK, DXN, |
| FLL, ITX, IYO, MNR, MWI, NSX | |
| Secondary Predicate Name | Infinity CentralStation Wide |
| 510(k) Submission No. | K151860 |
| Classification | Class II (21 CFR 870.1025) |
| Product Code | MHX |
| Secondary Product Code | N/A |
Prior Submission
This is an original submission. There has been no prior submission for the subject device.
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IV. Device Description
The Tempus Pro Patient Monitor 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-Lead and 5-Lead ECG monitoring, 12-Lead ECG recording, real-time arrhythmia detection and alarming, QT interval measurement and alarming, ST segment measurement and alarming, impedance respiration, pulse oximetry (including Masimo Rainbow® co-oximetry measurements i.e. SpOC, SpHb, SpMet, SpCO, PVI, and PD, noninvasive 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 (called i2i) expected to be based in a facility far from the user e.g. a response center facility. As an alternative to i2i response center software, Tempus Pro Monitor also uses IntelliSpace Corsium, which is a web-based software platform for near real-time patient data transfer and two- way communication between healthcare professional. In addition to sending all vital signs, the system can also send pictures or video via an integrated camera, geographic positions by an integrated GPS receiver, and voice via a wired or wireless headset.
Additionally, Tempus Pro has an optional thermal printer, which enables the user to print medical records on-demand and allows other compatible external devices to print medical records as well using the optional thermal printer when paired to the Tempus Pro via a secure 1-to-1 data link called Tempus Data Link (TDL).
The Tempus Pro is provided to the user non-sterile. No accessories manufactured by RDT for use with Tempus Pro are provided sterile. The Tempus Pro does not come into direct or indirect contact with the patient. The Tempus Pro is compatible with 3rd party manufacturer accessories, for which patient contact and sterility requirements are determined by the 3rd party manufacturer.
Reason for Change
This submission is to notify the FDA of our intent to market the Tempus Pro modified by the addition of an optional off-the-shelf ECG interpretation algorithm, known as the Glasgow Algorithm. This off-the-shelf ECG algorithm will be available to the customer as an optional alternative to the ECG interpretation algorithm cleared under the previous 510(k) for Tempus Pro, known as the Louvain Algorithm.
The Glasgow ECG algorithm is being added to the Tempus Pro Monitor to accommodate customer preference. Users already familiar with use of the Glasgow ECG Algorithm on existing alternative devices have expressed interest in availability of Glasgow for the Tempus Pro.
If the user does not choose to purchase the new Glasgow Algorithm option via a software key, the Tempus Pro will continue to provide the 12-Lead ECG Interpretation using the
6
Louvain Algorithm originally cleared under 510(k) K133988. If the Glasgow Algorithm option is purchased, the Tempus Pro will output 12-lead ECG interpretations from Glasgow only (there is no option to use both 12-lead interpretation algorithms on the same device).
The Glasgow Algorithm is able to provide ECG interpretations for adult, pediatric, and neonate patients, when compared with the Louvain Algorithm that only provides the ECG interpretation for adults. However, the Tempus Pro already includes pediatrics and neonates in its labeled indications.
In addition to providing 12-lead ECG interpretations for adults, pediatric and neonate populations, Glasgow Algorithm is able to consider additional inputs for ECG analysis (e.g. age and sex), and is able provide interpretations under a greater breadth of conditions (e.g. waveforms that include pacemaker signals). However, this modification will not remove or change any other features available on the Tempus Pro device. Addition of the off-the-shelf Glasgow ECG interpretation algorithm will not change the indications for use or intended use for the Tempus Pro. As detailed in Section 13, algorithm validation data supports use of the Glasgow Algorithm in adults, pediatrics, and neonates.
Product Model Numbers
Table 5-1 below lists the Tempus Pro model numbers that are the subject of this 510(k).
| Model Number | Description |
|---|---|
| 00-1004-R | Standard configuration with invasive pressure (2 channels), ETCO2 |
| and contact temperature (1 or 2 channels). | |
| 00-1007-R | Standard configuration with invasive pressure (2 channels), ETCO2, |
| contact temperature (1 or 2 channels) and Bluetooth headset. | |
| 00-1024-R | Standard configuration with printer, ETCO2 and contact temperature |
| (1 or 2 channels). | |
| 00-1026-R | Standard configuration with printer, invasive pressure (2 channels), |
| ETCO2 and contact temperature (1 or 2 channels). |
Table 5-1. Tempus Pro Patient Monitor Model Numbers
V. Intended Use
No changes to the Tempus Pro Intended Use are proposed by this submission.
The Tempus Pro is a portable vital sign 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.
RDT assumes that users of the product are clinically trained in how to take and interpret a patient's vital signs. The Tempus Pro is intended to be used by such clinically-trained personnel. Before attempting to work with the Tempus Pro, the user must read, understand,
7
and strictly observer all warnings, cautions and safety markings in the User/Operator Manual, other associated labeling and on the equipment.
Indications for Use
No changes to the Tempus Pro Indications for Use are proposed by this submission.
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-, 4and 5-lead ECG monitoring: 12-lead ECG recording with interpretation: real-time arrhythmia detection/alarming: OT 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; carboxyhaemoglobin (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.
VI. Comparison of Technological Characteristics with the Predicate Device
The intended use, indications for use, and technology used in the Tempus Pro device remains essentially unchanged by the addition of the Glasgow Algorithm as an optional alternative 12-Lead ECG interpretation algorithm. Table 5-2 below provides a summary of similarities and differences between the modified Tempus Pro that is the subject of this 510(k) and the primary predicate device Tempus Pro cleared per K173768. Table 5-2 (a) provides a summary of similarities between the subject device and the secondary predicate devices specific to 12-Lead ECG interpretation feature.
| Similarities | |
|---|---|
| Indications for | |
| Use | There is no change in the indications for use for the subject device in |
| comparison to the primary predicate device. The subject device with alternative | |
| option for 12-Lead ECG interpretation algorithm is substantially equivalent to | |
| the primary predicate device. | |
| Physical | |
| Dimensions | No modifications have been made to the physical dimensions of the subject |
| device. It is substantially equivalent to the primary predicate device. |
| Table 5-2. Comparison of Technological Features with the Primary Predicate Device | ||
|---|---|---|
8
K201746
| Similarities | |
|---|---|
| Physiological | |
| Parameters | |
| Measured | There is no change in the physiological parameters measured for the subject |
| device. It is substantially equivalent to the primary predicate device. | |
| Alarms | There are no changes to alarms. The subject device is substantially equivalent |
| to the primary predicate device. | |
| Display | There are no changes to the display. The subject device is substantially |
| equivalent to the primary predicate device. | |
| On-Screen | |
| Trends and | |
| Events | There are no changes to the on-screen trends and events. The subject device is |
| substantially equivalent to the primary predicate device. | |
| 3-Lead and 5- | |
| Lead ECG | |
| Monitor | There are no changes to the 3-Lead and 5-Lead ECG monitoring. The subject |
| device is substantially equivalent to the primary predicate device. | |
| ECG | |
| Arrhythmia | |
| Monitoring | There are no changes to the ECG arrhythmia monitoring. The subject device is |
| substantially equivalent to the primary predicate device. | |
| Impedance | |
| Respiration | There are no changes to the impedance respiration specifications. The subject |
| device is substantially equivalent to the primary predicate device. | |
| Pulse Oximeter | There are no changes to the pulse oximeter specifications. The subject device is |
| substantially equivalent to the primary predicate device. | |
| Non-Invasive | |
| Blood Pressure | There are no changes to the non-invasive blood pressure specifications. The |
| subject device is substantially equivalent to the primary predicate device. | |
| Capnometer | There are no changes to the capnometer specifications. The subject device is |
| substantially equivalent to the primary predicate device. | |
| Contact | |
| Temperature | There are no changes to contact temperature specifications. The subject device |
| is substantially equivalent to the primary predicate device. | |
| Invasive | |
| Pressure | There are no changes to invasive pressure specifications. The subject device is |
| substantially equivalent to the primary predicate device. | |
| Ultrasound | There are no changes to the ultrasound specifications. The subject device is |
| substantially equivalent to the primary predicate device. | |
| Video | |
| Laryngoscope | There are no changes to the video laryngoscope. The subject device is |
| substantially equivalent to the primary predicate device. | |
| Communications | |
| and Wireless | There are no changes to communications or wireless specifications. The subject |
| device is substantially equivalent to the primary predicate device. |
9
| Similarities | |
|---|---|
| Printing | There are no changes to the printer and the subject device is substantially equivalent to the primary predicate device. |
| EMC | Addition of the alternative 12-Lead ECG interpretation algorithm for the subject device does not impact EMC. The subject device is substantially equivalent to the primary predicate device. |
| Environmental Performance | There are no changes to the environmental performance specifications. The subject device is substantially equivalent to the primary predicate device |
| Differences | |
| 12-Lead ECG | |
| Recorder | The Glasgow Algorithm is available as an alternative option for 12-Lead ECG interpretation in the subject device. |
While the Glasgow algorithm features additional input criteria for ECG interpretation, a more extensive ECG library, and is able to provide interpretations for adults, pediatrics, and neonates, it functions similar to the 12-Lead ECG algorithm (Louvain Algorithm) present in the primary predicate device and has the same intended use. Test data supports that this modification does not affect the substantial equivalence of the Tempus Pro device. |
| User Interface | With the addition of the Glasgow Algorithm to the subject device, the user interface has been updated to include:
Age/Sex warning message if no age/sex has been entered, which displays before entering the 12 lead view when Glasgow interpretation is installed. Maintenance menu updated to include option for either US or UK English. Service User Changes Glasgow 12-lead ECG waveform interpretation enabling option key under Maintenance and Settings option (Option key issued by RDT, for maintenance user personnel only) Test data supports that these modifications do not affect the safety or effectiveness of the Tempus Pro device. |
Table 5-2 (b) below provides a summary of similarities between the modified Tempus Pro (subject device) and the Infinity CentralStation Wide (secondary predicate device). This summary is specific to the 12-Lead ECG interpretation feature available in both the devices.
Table 5-2 (a). Comparison of Technological Characteristics with Secondary Predicate Device (12-Lead ECG Interpretation)
| Similarities | |
|---|---|
| Product Code and | |
| Device Classification | Tempus Pro and Infinity CentralStation Wide have the same primary |
| product code MHX and are classified as Class II medical device (21CFR | |
| 870.1025). |
10
RDT Limited
| Similarities | |
|---|---|
| Indications for Use | Both Tempus Pro and Infinity CentralStation Wide are used as patient |
| monitoring systems and provide 12-Lead ECG interpretation. Per the | |
| assigned product code and device classification, both devices have the | |
| same common name: Monitor, Physiological, Patient (With Arrhythmia | |
| Detection Or Alarms). | |
| 12-Lead ECG | |
| Interpretation | Both Infinity CentralStation Wide and Tempus Pro uses Glasgow |
| Algorithm for 12-Lead ECG interpretation and also considers similar | |
| input criteria for providing interpretation e.g. Patient Age and Gender, | |
| indicated to be used for adult and pediatric population. |
Table 5-3 below provides the comparison for technological characteristics between the Louvain Algorithm cleared with the predicate Tempus Pro Monitor and the Glasgow Algorithm included with the proposed modified Tempus Pro.
Table 5-3. Comparison of Technological Characteristics between Louvain Algorithm and Glasgow Algorithm
| Characteristic | Louvain ECG
Algorithm (Included
with Predicate Device) | Glasgow ECG Algorithm
(Included with Subject
Device) | Comparison Summary |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 12-Lead ECG
Interpretation | 12-Lead ECG
Interpretation | Intended use is identical. |
| Target
Population
(Specific to
12-Lead ECG
Interpretation) | Used with Tempus Pro
Monitor for ECG
interpretation available
for patients aged 18
years and over. | Used with Tempus Pro
Monitor for ECG
interpretation available for
patients including adults,
neonate, and pediatric. | Glasgow Algorithm
provides interpretation for
adults, neonates, and
pediatric population as
compared to the Louvain
Algorithm that only
provides interpretation for
adult patients.
Note that Tempus Pro
Monitor is currently cleared
for adults, pediatrics, and
neonates in its labeled
indications. |
11
| Special 510(k)
Tempus Pro Patient Monitor
| RDT Limited | |||
|---|---|---|---|
| Characteristic | Louvain ECG Algorithm (Included with Predicate Device) | Glasgow ECG Algorithm (Included with Subject Device) | Comparison Summary |
| Method of Operation | The Louvain library software runs on the Tempus Pro at the end of recoding a 12-Lead ECG. |
Measurement and interpretation data indicated as statements on the monitor are then incorporated into the recorded ECG. See Figure 10-5.
These measurements and interpretation data can be displayed on the Tempus Pro, printed, exported or transferred over the telemedicine communication links. | The Glasgow library software runs on the Tempus Pro at the end of recording a 12-lead ECG.
Measurements and interpretation data indicated as statements on the monitor are then incorporated into the recorded ECG. See Figure 10-6.
These measurements and interpretation data can be displayed on the Tempus Pro, printed, exported or transferred over the telemedicine communication links. | Method of operation is identical. |
| Interpretation and Review | ECG data recorded in the SCP files is interpreted by AnalyzeSCP.exe and statement codes are displayed as sub-headings Rhythm Statement and Morphology Statement. See Figure 10-5. | ECG data recorded in the SCP files is interpreted by Glasgow and the statement codes for rhythm statement and morphology statement are displayed without any sub-headings. See Figure 10-6. | Interpretation data provided by Glasgow and Louvain Algorithm is similar. Louvain displays data with sub-headings and Glasgow displays date without sub-heading on the monitor. |
| Data Input Criteria | SCP files will be passed to AnalyzeSCP.exe only when the heart rate is greater than or equal to | Glasgow library is not limited by any heart rate restrictions and can | Glasgow Algorithm considers a wider range of input criteria for 12-Lead ECG interpretation as |
| Special 510(k)
Tempus Pro Patient Monitor
RDT Limited | | | |
| Characteristic | Louvain ECG
Algorithm (Included
with Predicate Device) | Glasgow ECG Algorithm
(Included with Subject
Device) | Comparison Summary |
| | 30 Bpm and less than or
equal to 160 Bpm.
Louvain library cannot
analyze recorded ECG
that contains pacemaker
signals. | analyze any recorded ECG
heart rate.
Glasgow library can
analyze recorded ECG that
contains pacemaker
signals. | compared to Louvain
Algorithm. |
| | Louvain library cannot
detect recorded ECGs
that contain periods of
lead-off or invalid data.
Patient age and gender is
not a required input
criteria. | The Glasgow library can
detect recorded ECGs that
contain periods of lead-off
or invalid data, provided
there is at least one V-lead
present throughout the
recording.
Patient age and gender is
required input criteria. | |
| Data Output
Criteria | Louvain can output ST20
and ST60 measurements
(ST elevation at the J-
point +20ms and
+60ms). | Glasgow provides ST
Elevation Myocardial
infarction (STEMI)
detection and
classification. ST20 and
ST60 measurements (ST
elevation at the J-point
+20ms and +60ms) would
primarily be used by the
clinical user to assist in the
diagnosis of ST Elevation
Myocardial infarction
(STEMI) and other related
conditions.
The Glasgow algorithm
provides STEMI detection
and classification, therefore the omission of
reported individual ST20
and ST60 lead
measurements is not
considered a loss of
functionality or
performance. | Both algorithms provide
analysis features relative to
diagnosis of ST Elevation
Myocardial infarction
(STEMI). The Glasgow
algorithm provides direct
STEMI detection and
classification, while
Louvain outputs ST20 and
ST60 elevation
measurements. |
12
13
RDT Limited
VII. Performance Data
Software Verification and Validation
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff-Guidance for the Content of Premarket Submission for Software Contained in Medical Devices (2005). The Software Level of Concern for Tempus Pro Monitor was determined to be Major, since failure or latent flaw in the software could cause harm to the patient indirectly due to a failure or fault in the presentation of data, resulting in delay in treatment or diagnosis.
| Device Change | Summary of Verification/Validation Methods | Acceptance Criteria | Summary of Results |
|---|---|---|---|
| Addition of | |||
| New 12-Lead | |||
| ECG Algorithm | |||
| (Glasgow | |||
| Algorithm) | Glasgow algorithm was tested using | ||
| test vector files provided by Glasgow | |||
| University to exercise the ECG | |||
| interpretation library on the Tempus | |||
| Pro. The Tempus Pro output | |||
| interpretations were compared with | |||
| known interpretations for the input | |||
| vectors to show that there were no | |||
| differences between the known | |||
| reference interpretations and the | |||
| output produced after the Glasgow | |||
| Algorithm had been integrated into | |||
| the Tempus Pro. | All interpretations | ||
| output from the | |||
| Glasgow library | |||
| run on Tempus | |||
| Pro shall match | |||
| the known | |||
| reference | |||
| interpretations. | PASS | ||
| A total of 612 | |||
| known vectors were | |||
| used for | |||
| comparison with | |||
| interpretations from | |||
| Tempus Pro. The | |||
| results obtained | |||
| were consistent | |||
| with the results | |||
| expected by | |||
| Glasgow | |||
| University. | |||
| Tested function of the Glasgow | |||
| interpretation software under | |||
| different conditions. This included | |||
| testing consistency of the Glasgow | |||
| interpretation between the Tempus | |||
| Pro user interface, Tempus Pro pdf | |||
| report, thermal printer output, | |||
| display on Intellispace Corsium ECG | |||
| tab and Intellispace Corsium pdf | |||
| report. | The interpretation | ||
| statement shall be | |||
| printed in bulleted | |||
| format without | |||
| any heading and | |||
| shall be identical | |||
| between the | |||
| Tempus display, | |||
| the thermal printer | |||
| output, pdf report, | |||
| Intellispace | |||
| Corsium review | |||
| display and | |||
| Intellispace | |||
| Corsium pdf. | |||
| Additional criteria | PASS | ||
| Glasgow library | |||
| was tested for | |||
| reliability and | |||
| consistency. | |||
| Interpretation | |||
| results were found | |||
| to be identical on | |||
| Tempus Pro, | |||
| Corsium, thermal | |||
| printer output, PDF | |||
| reports and | |||
| Corsium PDF | |||
| reports. |
| Table 5-4. Summary of Software Testing | |
|---|---|
| ---------------------------------------- | -- |
14
RDT Limited
| Device Change | Summary of
Verification/Validation Methods | Acceptance
Criteria | Summary of
Results |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| | Tempus Pro Software Changes
Testing. The new features added to
the Tempus Pro software were
validated, including features related
to the addition of the Glasgow
Algorithm. | All software
features tested
shall output the
expected result per
the protocol and
associated
software
specification. | PASS
All software
features tested
performed as
specified in the
protocol and
associated SW
specification
document. |
| | Integration Acceptance Test Protocol
(IATP). This protocol describes a set
of testing (validation) for the
integrated Tempus Pro software; it
was constructed to exercise all the
main features of the software. This
protocol was used as final validation
and does not replace the detailed
Acceptance Test Protocols (ATPs)
exercised by the software
development test team. The protocol
included tests of the stand-alone
Tempus Pro and the system
including the Data Centre and i2i
(Response Centre). | Outputs shall meet
the acceptance
criteria defined in
IATP protocol. | PASS
All outputs met the
acceptance criteria
defined in the IATP
protocol. |
| | Software unit and system testing
performed by third party software
developer. | Outputs of
software and unit
test shall meet the
criteria defined in
the relevant
software
specifications. | PASS
All system and unit
testing met the
criteria per the
relevant software
specifications. |
Electrical Testing
The modification to the device was designed and assessed under design control processes compliant with FDA 21 CFR §820. Non-clinical testing was performed to demonstrate that the device is substantially equivalent to its predicate. The non-clinical testing performed to assess the addition of the Glasgow Algorithm included compliance with the following:
- IEC 60601-2-25: 2011, Medical Electrical Equipment Part 2-25: Particular Requirements for The Basic Safety and Essential Performance of Electrocardiographs (Clause 201.12.1.101)
Test results confirmed that the acceptance criteria defined by IEC 60601-2-25:2011 was met.
15
Clinical Testing
No clinical testing was performed. Clinical reference data, in the form of recorded ECG databases, were used for initial validation of the Glasgow Algorithm and integration testing specific to use with Tempus Pro.
Performance Testing not Impacted by Device Modification
As the addition of the Glasgow Algorithm is a software change only, it does not affect any Tempus Pro accessories, including any associated sterilization, biocompatibility, or shelf life testing. Because the user interface remains largely identical, with only an added age/sex warning message and option for either UK or US English interpretation output, it was determined that repeating usability and human factors testing was not necessary.
VIII. Conclusions
The results of the substantial equivalence assessment, taken together with software and electrical testing, demonstrate that the Tempus Pro Patient Monitor with the modifications described in this premarket notification does not raise different questions of substantial equivalence when compared to the predicate devices. The device performs as intended and has performance characteristics that are substantially equivalent to the Tempus Pro Patient Monitor predicate device cleared per K173768 and Infinity CentralStation Wide specific to 12-Lead ECG interpretation cleared per K151860.