(443 days)
Not Found
No
The document explicitly states that the Adult IDO2 Index is derived by "mathematical manipulations" of physiological data and laboratory measurements, and there is no mention of AI, ML, or related concepts in the text.
No
The device aggregates and displays physiological and laboratory data, and calculates a risk index (Adult IDO2 Index) to aid clinical decisions, but it explicitly states that "no therapy or drugs can be administered based solely on the interpretation statements." It does not provide treatment or directly affect the body.
Yes
Explanation: The "T3 Adult Risk Analytics Engine software module" calculates the "Adult IDO2 Index for inadequate delivery of oxygen," which is used to assess the risk of inadequate oxygen delivery in post-surgical patients. This calculation and assessment falls under the definition of a diagnostic device as it processes patient data to provide insights into a patient's medical condition.
Yes
The device description explicitly states "Software-only solution no new bedside hardware required".
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health.
- This device primarily aggregates and visualizes physiological parameters measured by other bedside medical devices. These parameters are typically measured in vivo (within the body) or are derived from in vivo measurements.
- While the device can display laboratory measurements (like blood gases, CBC, lactic acid), it is displaying data captured by other devices, not performing the laboratory analysis itself. The laboratory analysis is the IVD component in that scenario.
- The T3 Adult Risk Analytics Engine module uses mathematical manipulations of the physiological data and laboratory measurements received to calculate an index. It is not performing a test on a biological sample.
The device's function is focused on data management, visualization, and risk assessment based on data from other sources, rather than performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Adult Risk Analytics Engine software module version 1.0.
The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes:
- To remotely consult regarding a patient's status, and
- To remotely review other standard or critical near real-time patient data in order to aid in . clinical decisions and deliver patient care in a timely manner.
The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices:
- Airway flow, volume, and pressure
- Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean)
- Bispectral index (BIS, signal quality index, suppression ratio)
- Cardiac Index
- Cardiac output
- Central venous pressure .
- Cerebral perfusion pressure
- End-tidal CO2
- Heart rate
- Heart rate variability
- Intracranial pressure .
- Left atrium pressure
- Oxygen saturation (intravascular, regional, SpO2) .
- Premature ventricular counted beats
- Pulmonary artery pressure (systolic, diastolic, and mean)
- Pulse pressure variation
- Pulse Rate
- Respiratory rate
- Right atrium pressure
- Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin)
- Umbilical arterial pressure (systolic, diastolic, and mean)
The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.
The T3 Data Aggregation & Visualization software module can display information captured by the T3 Adult Risk Analytics Engine software module.
The T3 Adult Risk Analytics Engine software module calculates the Adult IDO2 Index for inadequate delivery of oxygen. The Adult IDO2 Index is indicated for use by health care professionals with post-surgical patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The Adult IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the Adult IDO2 Index is increasing, it means that there is an increasing risk of madequate oxygen delivery and attention should be brought to the patient. The Adult IDO2 Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.
Product codes (comma separated list FDA assigned to the subject device)
PPW
Device Description
The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. System features include:
- Customizable display of physiologic parameters over entire patient stay
- Configurable annotation
- Web-based visualization that may be used on any standard browser
- Minimal IT footprint
- Software-only solution no new bedside hardware required
- Highly reliable and robust operation
- Auditable data storage
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
The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices.
The Adult IDO2 Index is indicated for use by health care professionals with post-surgical patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support.
Intended User / Care Setting
healthcare professionals, ICU
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
The adult IDO2 Index was validated utilizing a validation set that included data from different clinical sites in the US. The clinical study data were obtained by the T3 Platform software. No adverse effects or complications were noted. The indices were retrospectively computed on all de-identified patients. The index was evaluated against the same acceptance criteria as the supportive predicate device, being discriminatory power, range utilization, resolution/limitation, and robustness. A patient cohort was used to validate the Index. The distribution of the points included in the study among the participating centers totaling 4251 mixed venous oxygen saturation measurements from 634 patients were included in that validation data set. The demographics were 69% male, 31% females.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software documentation was provided in accordance with the 2017 FDA guidance document Software as a Medical Device (SAMD): Clinical Evaluation section 5.3 Analytical Validation of a SaMD to support device software with a moderate level of concern and to confirm and provide objective evidence that the software was correctly constructed.
Cybersecurity information was provided in accordance with the 2014 FDA guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Additional summative evaluations were completed to demonstrate the consistency of the output, representative of the range of data sources and data quality, likely to be encountered.
Human factors testing was used to support that device users could safely use the device.
The adult IDO2 Index was validated using clinical datasets. The results from Performance Testing - Clinical Evaluation met acceptance criteria for discriminatory power, range utilization, and robustness.
The adult IDO2 Index was validated utilizing a validation set that included data from different clinical sites in the US. The clinical study data were obtained by the T3 Platform software. No adverse effects or complications were noted. The indices were retrospectively computed on all de-identified patients. The index was evaluated against the same acceptance criteria as the supportive predicate device, being discriminatory power, range utilization, resolution/limitation, and robustness.
A patient cohort was used to validate the Index. The distribution of the points included in the study among the participating centers totaling 4251 mixed venous oxygen saturation measurements from 634 patients were included in that validation data set. The demographics were 69% male, 31% females.
Software documentation was provided in accordance with the 2017 FDA guidance document Software as a Medical Device (SAMD): Clinical Evaluation section 5.3 Analytical Validation of a SaMD to support device software with a moderate level of concern and to yield a clinically meaningful output associated to the target use of the output in the target health care situation or condition identified in the definition statement.
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
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January 6, 2023
Etiometry. Inc. Tim Hanson VP of RA/QA 280 Summer St. 4th Floor Boston, Massachusetts 02210
Re: K213423
Trade/Device Name: T3 Platform software Regulation Number: 21 CFR 870.2200 Regulation Name: Adjunctive Cardiovascular Status Indicator Regulatory Class: Class II Product Code: PPW Dated: October 15, 2021 Received: October 20, 2021
Dear Tim Hanson:
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.
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
1
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 (OS) 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,
Robert T. Kazmierski -S
for
LCDR Stephen Browning 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
Enclosure
2
Indications for Use
510(k) Number (if known) K213423
Device Name The T3 Platform™ software
Indications for Use (Describe)
The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Adult Risk Analytics Engine software module version 1.0.
The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes:
- . To remotely consult regarding a patient's status, and
- To remotely review other standard or critical near real-time patient data in order to aid in . clinical decisions and deliver patient care in a timely manner.
The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices:
- · Airway flow, volume, and pressure
- · Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean)
- · Bispectral index (BIS, signal quality index, suppression ratio)
- · Cardiac Index
- . Cardiac output
- Central venous pressure .
- . Cerebral perfusion pressure
- · End-tidal CO2
- · Heart rate
- · Heart rate variability
- Intracranial pressure .
- . Left atrium pressure
- Oxygen saturation (intravascular, regional, SpO2) .
- · Premature ventricular counted beats
- · Pulmonary artery pressure (systolic, diastolic, and mean)
- · Pulse pressure variation
- · Pulse Rate
- · Respiratory rate
- · Right atrium pressure
- · Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin)
- · Umbilical arterial pressure (systolic, diastolic, and mean)
3
The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.
The T3 Data Aggregation & Visualization software module can display information captured by the T3 Adult Risk Analytics Engine software module.
The T3 Adult Risk Analytics Engine software module calculates the Adult IDO2 Index for inadequate delivery of oxygen. The Adult IDO2 Index is indicated for use by health care professionals with post-surgical patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The Adult IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the Adult IDO2 Index is increasing, it means that there is an increasing risk of madequate oxygen delivery and attention should be brought to the patient. The Adult IDO2 Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.
WARNINGS:
- · Do not use the T3 Platform™ software as an active patient monitoring system.
- Do not use the T3 Platform™ software to replace any part of the hospital's device monitoring. .
- · Do not rely on the T3 Platform™ software as the sole source of patient status information.
- Do not use any of the T3 Platform™ indices as a substitute for taking blood samples. .
- Do not use the Adult IDO2 Index for patients on Mechanical Circulatory Support ●
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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4
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Dec 7, 2022
This 510(k) summary has been prepared in accordance with Title 21 CFR §807.92 and FDA's guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k)" July 28, 2014
4.1 510(k) Submitter
Timothy Hanson, VP of Regulatory Affairs and Quality Assurance 280 Summer St., 4th Floor Boston, MA 02210 Tel: 857.366.9333 ext. 2020 Email: THanson@etiometry.com
4.2 Device
| Item | Description |
|---|---|
| Device Trade Name | T3 PlatformTM software (T3 Data Aggregation & Visualization software |
| module version 5.0 and T3 Adult Risk Analytics Engine software module | |
| version 1.0) | |
| Device Common/Usual Name | Clinical Decision Support Software (without alarms) |
| Classification Name | Adjunctive cardiovascular status indicator |
| Classification Number | 870.2200 |
| Regulatory Class | Class II with special controls - the primary code is PPW: The adjunctive |
| cardiovascular status indicator is a prescription device based on sensor | |
| technology for the measurement of a physical parameter(s). This device is | |
| intended for adjunctive use with other physical vital sign parameters and | |
| patient information and is not intended to independently direct therapy. |
Table 7: Device Information
5
4.3 Predicate Devices
The predicate device is the T3 Platform™ software featuring the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Risk Analytics Engine software module version 8.0, cleared under K213230.
4.4 Device Description
The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. System features include:
- · Customizable display of physiologic parameters over entire patient stay
- Configurable annotation
- Web-based visualization that may be used on any standard browser
- Minimal IT footprint
- Software-only solution no new bedside hardware required
- Highly reliable and robust operation
- Auditable data storage
- 4.5 Indications for Use
The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Adult Risk Analytics Engine software module version 1.0.
The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes:
- · To remotely consult regarding a patient's status, and
- To remotely review other standard or critical near real-time patient data in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices:
- · Airway flow, volume, and pressure
- Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean)
- · Bispectral index (BIS, signal quality index, suppression ratio)
- Cardiac Index
- Cardiac output
- Central venous pressure
- Cerebral perfusion pressure
- End-tidal CO2
- Heart rate
- Heart rate variability
- Intracranial pressure
6
- · Left atrium pressure
- Oxygen saturation (intravascular, regional, SpO2)
- Premature ventricular counted beats
- Pulmonary artery pressure (systolic, diastolic, and mean)
- Pulse pressure variation
- Pulse Rate
- Respiratory rate
- Right atrium pressure
- Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin)
- · Umbilical arterial pressure (systolic, diastolic, and mean)
The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.
The T3 Data Aggregation & Visualization software module can display information captured by the T3 Adult Risk Analytics Engine software module.
The T3 Adult Risk Analytics Engine software module calculates the Adult IDO2 Index for inadequate delivery of oxygen. The Adult IDO2 Index is indicated for use by health care professionals with post-surgical patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The Adult IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the Adult IDO2 Index is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the patient. The Adult IDO2 Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.
WARNINGS:
- Do not use the T3 Platform™ software as an active patient monitoring system. .
- . Do not use the T3 Platform™ software to replace any part of the hospital's device monitoring.
- Do not rely on the T3 Platform™ software as the sole source of patient status information.
- Do not use any of the T3 Platform™ indices as a substitute for taking blood samples. .
- . Do not use the Adult IDO2 Index for patients on Mechanical Circulatory Support
4.6 Comparison of Technological Characteristics with the Predicate Device
The subject and predicate T3 Platform™ software have the same Intended Use, brining attention to patients and providing an IDO2 Index, but for different patient populations. The predicate device, having the product code PPW, is intended for use as a multiparameter monitor that uses sensor technology to measure a specific parameter. The devices that fall under this regulation product code (Adjunctive cardiovascular status indicator 21 CFR 870.2200) do not have alarms and do not have a set decision point, matching the functionalities of the subject device. The regulation product code of the primary predicate device includes special controls that were applied to the subject T3 Platform™ software. The regulation product codes between the subject T3 Platform™ software and supportive predicate T3 Platform™ software were unchanged.
The subject and predicate devices differ with respect to several technological features. (see Table 8).
7
| Feature/Improvement | Description |
|---|---|
| Replacing the Risk Analytics Engine with the | |
| Adult Risk Analytics Engine with Adult IDO2 | |
| Index | The subject device, the T3 Platform software for adults is a |
| standalone application that was abstracted as an instance from the T3 | |
| Data Aggregation & Visualization software module version 5.0 and the | |
| T3 Risk Analytics Engine software module version 8.0 cleared under | |
| K213230. The Risk Analytics Engine module was modified to become | |
| the Adult Risk Analytics Engine software module, version 1.0, with the | |
| Adult IDO2 Index and compatible with the T3 Data Aggregation & | |
| Visualization software module version 5.0. |
Adult Risk Analytics Engine is responsible for the continuous
computation in near-real-time of the likelihood that a patient, 18
years of age or older, is experiencing Inadequate Delivery of Oxygen
defined as the Adult IDO2 index. Adult Risk Analytics Engine version
1.0 employs the same model of human physiology as the one utilized
in Risk Analytics Engine version 8.0 cleared under K213230 for the
computation of the IDO2 index in pediatric patients (0 to 12 years of
age), however, the physiology model has been modified to extend the
age-based parameterization. Adult Risk Analytics Engine version 1.0 is
also different from Risk Analytics Engine version 8.0 with respect to
the IDO2 index being computed as the likelihood of mixed venous
oxygen saturation that is below a single non-configurable threshold of
50%. |
Table 8: Summary of Changes
4.7 Summary of Non-Clinical Performance Testing
Software documentation was provided in accordance with the 2017 FDA guidance document Software as a Medical Device (SAMD): Clinical Evaluation section 5.3 Analytical Validation of a SaMD to support device software with a moderate level of concern and to confirm and provide objective evidence that the software was correctly constructed.
Cybersecurity information was provided in accordance with the 2014 FDA guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Additional summative evaluations were completed to demonstrate the consistency of the output, representative of the range of data sources and data quality, likely to be encountered.
Human factors testing was used to support that device users could safely use the device.
- 4.8 Summary of Clinical Performance Testing
The adult IDO2 Index was validated using clinical datasets. The results from Performance Testing - Clinical Evaluation met acceptance criteria for discriminatory power, range utilization, and robustness.
The adult IDO2 Index was validated utilizing a validation set that included data from different clinical sites in the US. The clinical study data were obtained by the T3 Platform software. No adverse effects or complications were noted. The indices were retrospectively computed on all de-identified patients. The index was evaluated
8
against the same acceptance criteria as the supportive predicate device, being discriminatory power, range utilization, resolution/limitation, and robustness.
A patient cohort was used to validate the Index. The distribution of the points included in the study among the participating centers totaling 4251 mixed venous oxygen saturation measurements from 634 patients were included in that validation data set. The demographics were 69% male, 31% females.
Software documentation was provided in accordance with the 2017 FDA guidance document Software as a Medical Device (SAMD): Clinical Evaluation section 5.3 Analytical Validation of a SaMD to support device software with a moderate level of concern and to yield a clinically meaningful output associated to the target use of the output in the target health care situation or condition identified in the definition statement.
4.9 Summary
The T3 Platform™ software was found to have a safety and effectiveness profile that is substantial equivalent to the predicate device.
4.10 Conclusions
Substantial equivalence of the T3 Platform™ software has been demonstrated. The T3 Platform™ software has the equivalent design, features and functionality as the predicate T3 Platform™ software with few exceptions and these exceptions do not affect the safety or effectiveness of the system. No new questions of safety or effectiveness were raised as a result of the differences when compared to the predicate device, and the data provided in the submission show that the subject device is substantially equivalent to the legally-marketed predicate device.