(103 days)
Not Found
No
The description mentions "mathematical manipulations" to derive indices, but does not explicitly mention or describe the use of AI or ML algorithms. The validation is described as using clinical data sets to validate algorithm changes, which is common for non-AI/ML algorithms as well.
No.
The device aggregates and displays physiological parameters and calculates risk indices to aid in clinical decisions, but it explicitly states it 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" and "no therapy or drugs can be administered based solely on the interpretation statements." This indicates it does not directly deliver or control therapy.
Yes
The device (specifically "T3 Risk Analytics Engine software module") calculates two indices (IDO2 Index™ and IVCO2 Index™) that are derived from physiological data and laboratory measurements. These indices present "partial quantitative information about the patient's cardiovascular condition" and "respiratory condition", respectively, and are intended to "aid in clinical decisions and deliver patient care in a timely manner" by indicating "increasing risk of inadequate oxygen delivery" or "inadequate carbon dioxide ventilation". This function, which provides information to aid in diagnosis or clinical decision-making regarding a patient's condition, clearly classifies it as a diagnostic device.
Yes
The device description explicitly states "Software-only solution - no new bedside hardware required".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The T3 Data Aggregation & Visualization software module and the T3 Risk Analytics Engine software module primarily work with data already collected by other medical devices and laboratory measurements. It aggregates, visualizes, and performs calculations on this data.
- No Specimen Testing: The device itself does not perform any tests on biological specimens. It receives and processes data that has been generated by other devices or laboratory procedures.
- Focus on Data Processing and Visualization: The core functions described are data aggregation, visualization, and calculation of indices based on existing data.
While the device utilizes laboratory measurements (which are generated by IVDs), the device itself is not performing the in vitro diagnostic test. It is a software tool that processes and presents the results of those tests along with other physiological data.
N/A
Intended Use / Indications for Use
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.
T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module.
The T3 Risk Analytics Engine software module calculates two indices: the IDO2 Index™ for inadequate delivery of oxygen and the IVCO2 Index™ for inadequate ventilation of carbon dioxide.
IDO2 Index™ is indicated for use by health care professionals with post-surgical patients aged zero days to twelve years weighing 2 kg or more under intensive care. IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module, version 5.0 or higher. When the IDO2 Index™ is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the 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.
IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients aged 29 days to 12 years weighing 2 kg or more under intensive care. IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module, version 5.0 or higher. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.
Product codes
MWI, PLB
Device Description
The Tracking, Trajectory, Trigger (T3) 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
IDO2 Index™: zero days to twelve years
IVCO2 Index™: 29 days to 12 years
T3 Data Aggregation & Visualization software module: adult, pediatric, and neonatal patients
Intended User / Care Setting
Healthcare professionals in intensive care.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The changes to the algorithm were validated using clinical data sets. The software verification and validation testing were conducted for the subject device, and documentation was provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005. The results of this testing demonstrate that the safety and effectiveness of the subject T3 Platform™ software (subject device) are comparable to that of the predicate T3 Platform™ software (target device).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 25, 2020
Etiometry, Inc. Tim Hanson Director of RA/QA 280 Summer St. 4th Floor Boston, Massachusetts 02210
Re: K202306
Trade/Device Name: T3 Platform software Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, PLB Dated: August 5, 2020 Received: August 14, 2020
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
for LT Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: 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) K202306
Device Name
The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Risk Analytics Engine software module version 6.0.
Indications for Use (Describe)
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.
T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module.
The T3 Risk Analytics Engine software module calculates two indices: the IDO2 Index™ for inadequate delivery of oxygen and the IVCO2 Index™ for inadequate ventilation of carbon dioxide.
IDO2 Index™ is indicated for use by health care professionals with post-surgical patients aged zero days to twelve vears
3
weighing 2 kg or more under intensive care. IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module, version 5.0 or higher. When the IDO2 Index™ is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the 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.
IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients aged 29 days to 12 years weighing 2 kg or more under intensive care. IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module, version 5.0 or higher. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the IVCO2 Index™ presents partial quantitative information about the patient's respiratory 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 the IVCO2 Index as a substitute for arterial blood gases.
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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Image /page/4/Picture/0 description: The image shows the word "etiometry" in a sans-serif font. The letters are a gradient of blue, with the left side of the word being a darker blue and the right side being a lighter blue. Above the word is a curved line that forms an arc, with a blue triangle at the top of the arc.
October 28, 2020
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, Director 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 Platform™ software (T3 Data Aggregation & Visualization software |
| module version 5.0 and T3 Risk Analytics Engine software module | |
| version 6.0) | |
| Device Common/Usual Name | Data Management Software (without alarms) |
| Classification Name | Cardiac monitor (including cardiotachometer and rate alarm) |
| Classification Number | 870.2300 |
5
| Item | Description |
|---|---|
| Regulatory Class | Class II |
| The primary code is MWI: monitor, physiological, patient (without | |
| arrhythmia detection or alarms). | |
| The secondary code is PLB: automated calculation of a summary index | |
| (or indices) based on several individual measured vital sign inputs. |
4.3 Predicate Device
The T3 Platform™ software featuring the T3 Data Aggregation & Visualization software module version 3.3 and the T3 Risk Analytics Engine software module version 5.0, cleared under K190273.
4.4 Device Description
The Tracking, Trajectory, Trigger (T3) 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 Risk Analytics Engine software module version 6.0.
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 timelymanner.
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
6
- 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 Risk Analytics Engine software module.
The T3 Risk Analytics Engine software module calculates two indices: the IDO2 Index™ for inadequate delivery of oxygen and the IVCO2 Index™ for inadequate ventilation of carbon dioxide.
IDO2 Index™ is indicated for use by health care professionals with post-surgical patients aged zero days to twelve years weighing 2 kg or more under intensive care. IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module, version 5.0 or higher. When the IDO2 Index™ is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the 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.
IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients aged 29 days to 12 years weighing 2 kg or more under intensive care. IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module, version 5.0 or higher. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the patient. The IVCO2 Index™ presents partial quantitative information about the patient's respiratory 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 the IVCO2 Index™ as a substitute for arterial blood gases.
7
4.6 Comparison of Technological Characteristics with the Predicate Device
The subject and predicate T3 Platform™ software have the same Intended Use/Indication for Use. The subject and predicate devices differ with respect to several technological features. (see Table 2).
| Feature/Improvement | Description |
|---|---|
| Addition of data from regional oxygen saturation | |
| monitors as an input for the calculation of the | |
| IDO2 Index™ | Data from regional oxygen saturation monitors, when available, have |
| been added as an input to the Risk Analytics Engine module to | |
| facilitate the detection of inadequate oxygen delivery and | |
| respectively improve the performance of the IDO2 Index™. | |
| Specifically, data from regional oximetry are used as a noise proxy of | |
| mixed venous oxygen saturation which the hemodynamic model | |
| interprets in the context of other physiologic measurements to infer | |
| IDO2 value. The performance of the IDO2 Index™ was evaluated with | |
| and without regional oximetry to confirm the utility of the | |
| measurement as an input. | |
| Measure Contributions signifying measurement | |
| inputs which have the highest contribution to an | |
| increase in the IDO2 Index™ or the IVCO2 Index™ | To increase the transparency and understanding of the risk indices |
| computed by the platform, the computations have been | |
| supplemented with an external routine which computes how either | |
| removing an existing measurement as an input (if the measurement | |
| is not in the minimum data set required for the computation of the | |
| index) or setting a measurement to what the algorithms perceive as | |
| nominal (if the measurement is part of the minimum data set) affects | |
| the individual indices. This computing routine enables assessment of | |
| the "contribution" of each available input in both the IDO2 Index™ or | |
| the IVCO2 Index™. The three measurements with the highest | |
| contribution, i.e. the measurements whose removal or setting to | |
| nominal leads to the highest drop in a particular index are then | |
| displayed as the major contributing measurements at the particular | |
| time instance. | |
| User selectable thresholds for defining | |
| Inadequate Oxygen Delivery and Inadequate | |
| Ventilation of Carbon Dioxide | The previously cleared version of the software computed the IDO2 |
| Index™ and the IVCO2 Index™ as the likelihood of SvO2 50 mmHg respectively. Using the same computation | |
| framework, the current version enables several more thresholds that | |
| a clinical user can configure. This facilitates individualizing the indices | |
| based on patient condition or other clinical considerations. | |
| Modification of minimum data required to | |
| compute IVCO2 Index™ | The minimum set for the IVCO2 Index™ to exclude the arterial blood |
| gases requirement. | |
| Support for encrypted data feeds into the | |
| platform | To improve the cybersecurity of the platform, the software |
| introduces the ability to accept encrypted data feeds from hospital | |
| data sources. | |
| Display of complete lab panel information | The software introduces a detailed view of a plotted lab result to |
| provide additional clinical context to the results. This allows clinicians | |
| to both contextualize lab results with physiologic data, but also with | |
| other lab results within the panel. | |
| Embedded Standalone Platform Manual | To further ensure labeling availability and distribution, the software |
| has embedded the complete platform manual as part of the release. | |
| Users can easy access, consult, and/or download the manual within | |
| the system. | |
| Feature/Improvement | Description |
| Addition of Tele-medicine Census view in the | |
| existing User Interface | The User Interface introduces a new feature to facilitate the viewing |
| of the status of all patients in an ICU in a single display, which can | |
| serve as a starting point for a more detailed review of individual | |
| patient information. The tool supports interpreting trends for | |
| selected variables, understanding the trajectory of patients, and | |
| supporting bedside clinicians in their decision making. For each bed | |
| in the ICU, the bed number is displayed along with the last name and | |
| age if there is currently a patient in that bed. This tool differs from | |
| the Census Overview by displaying for each patient the most recent | |
| vital signs and algorithm values in tiles containing graphs instead of a | |
| table of rows | |
| Integration of Single Sign-on | To facilitate access to the platform, the software has an added |
| capability to integrate with an Electronic Medical Record system | |
| (EMR). A user can navigate to display T3 patient information from the | |
| EMR with a single click, which automatically authenticates them in T3 | |
| and navigates them to the patient of interest. | |
| Miscellaneous Updates of the Hemodynamic | |
| Model Employed to Infer the IDO2 Index™ | The hemodynamic model powering the IDO2 Index™ has been |
| updated by improving specific modeled physiologic effects such as | |
| the adaptable relationship between pulse pressure and stroke | |
| volume which now utilizes a logarithmic relationship to facilitate | |
| linear estimation. The updated IDO2 Index™ algorithm was subject to | |
| full performance clinical testing. | |
| Addition of a Retrospective Teaching Census | To facilitate software education and training, the platform introduces |
| the ability to collate, de-identify, and save a specific patient case in a | |
| hospital specific teaching census for use as a training resource. | |
| Repair incorporation of incorrectly labeled SvO2 | |
| measurements into the algorithm | The software has been modified to reject measurements which may |
| not correctly be associated with mixed or central venous oxygen | |
| saturation. The software classifies venous oxygen saturation | |
| measurements as either validated or non-validated and incorporates | |
| the measures under different conditions based on that classification. |
8
Table 2: Summary of Changes
4.7 Performance Data
The changes to the algorithm were validated using clinical data sets. The software verification and validation testing were conducted for the subject device, and documentation was provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005. The results of this testing demonstrate that the safety and effectiveness of the subject T3 Platform™ software (subject device) are comparable to that of the predicate T3 Platform™ software (target device).
4.8 Conclusions
Substantial equivalence of the T3 Platform™ software is demonstrated through performance testing. 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 are 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.