(233 days)
Not Found
No
The description mentions a "Patient Risk Analytics Engine" that calculates an index based on "mathematical manipulations" of physiological data. While this involves data processing and analysis, the language used ("mathematical manipulations") does not explicitly indicate the use of AI or ML algorithms. The summary also explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The T3 Software is intended for displaying physiological parameters and an index to aid in clinical decisions and patient care, not for administering therapy or treatment.
Yes
The device aids in clinical decisions by remotely reviewing patient data and calculating an Inadequate Oxygen Delivery Index (IDO2) to identify increased risk of inadequate oxygen delivery, which are diagnostic functions.
Yes
The device description explicitly states "Software-only solution no new bedside hardware required". The intended use and device description focus solely on the software's function of aggregating, storing, and displaying data, and performing calculations. While it receives data from other medical devices, the T3 software itself is presented as a standalone software product.
Based on the provided text, the T3 Software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- T3 Software's Function: The T3 Software aggregates, stores, and displays physiological parameters and laboratory measurements received from other medical devices. It does not perform any tests or analyses on specimens taken directly from the patient.
- Data Source: The data it uses comes from bedside monitoring devices and existing laboratory measurements, not from its own in vitro testing process.
- Intended Use: Its intended use is for remote consultation, review of near real-time patient data, and aiding in clinical decisions based on this aggregated information. While it uses laboratory measurements, it doesn't perform the laboratory tests themselves.
Therefore, the T3 Software falls under the category of a medical device that processes and displays data from other sources, rather than an IVD device that performs in vitro tests on patient specimens.
N/A
Intended Use / Indications for Use
The T3 Software is intended for the recording and display of multiple physiological parameters of adult, pediatric and neonatal patients from supported bedside devices. T3 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. T3 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.
T3 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)
It can also display laboratory measurements including arterial and venous blood count, and lactic acid.
T3 includes a Patient Risk Analytics Engine that calculates an index (the Inadequate Oxygen Delivery Index) that is indicated for use by health care professionals with post-surgical neonatal patients weighing 2 kg or more under intensive care. The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery and attention should be brought to the 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.
WARNING: T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring. Do not rely on the T3 Software Solution as the sole source of patient status information.
Product codes
PLB, MWI
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 in real-time. 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.
The subject device is a modification of the T3 Software that includes Risk Analytics Engine that computes an Inadequate Oxygen Delivery Index (IDO2). The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. This index provides an interpretation of how different the patient's physiologic measures are from normality.
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
adult, pediatric and neonatal patients.
post-surgical neonatal patients weighing 2 kg or more.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing was 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 the safety and effectiveness of the subject T3 software product (Ver. 2.0.1) is comparable to that of the predicate T3 software products (Ver. 1.9) and the Visensia device.
Additionally, validation study results using clinical data gathered in the intended patient population demonstrate the IDO2 Index included in the subject device correlates with changes in the patient's physical status, as does the Visensia Index.
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.
K142732, K151715, K081140, K110953
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing right. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
Etiometry, Inc. % Richard Galgon Independent Consulting Associate Quintiles 5846 Cobblestone Lane Waunakee, Wisconsin 53597
Re: K152258
Trade/Device Name: T3 Software Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: PLB, MWI Dated: February 19, 2016 Received: February 24, 2016
Dear Richard Galgon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152258
Device Name T3 Software Version 2.0.1
Indications for Use (Describe)
The T3 Software is intended for the recording and display of multiple physiological parameters of adult, pediatric and neonatal patients from supported bedside devices. T3 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. T3 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.
T3 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)
It can also display laboratory measurements including arterial and venous blood count, and lactic acid.
T3 includes a Patient Risk Analytics Engine that calculates an index (the Inadequate Oxygen Delivery Index) that is indicated for use by health care professionals with post-surgical neonatal patients weighing 2 kg or more under intensive care. The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery and attention should be brought to the 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.
3
WARNING: T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring. Do not rely on the T3 Software Solution as the sole source of patient status information.
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
510(k) Summary
510(k) Number K152258
I. 510(k) Submitter
Company Name and Address:
Etiometry, Inc. 119 Braintree Street Boston, MA 02134
Company Contact: Dimitar Baronov, PhD Chief Technology Officer Phone: 857.366.9333 ext. 2005 E-mail: baronov@etiometry.com
Date Prepared: March 30, 2016
II. Device
Device Trade Name: T3 Software (Version 2.0.1)
Device Common/Usual Name: Data Management Software (without alarms)
Classification Name: Cardiac monitor (including cardiotachometer and rate alarm)
Classification Number: 870.2300
Regulatory Class: II
Product Code: PLB: Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs. Secondary code is MWI; monitor, physiological, patient (without arrhythmia detection or alarms)
III. Predicate Device
- T3 Software (Version 1.9) cleared under K142732 and K151715. 1.
- Visensia cleared under K081140 and K110953. 2.
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IV. 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 in real-time. 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 .
The subject device is a modification of the T3 Software that includes Risk Analytics Engine that computes an Inadequate Oxygen Delivery Index (IDO2). The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. This index provides an interpretation of how different the patient's physiologic measures are from normality.
Indications for Use
The T3 Software is intended for the recording and display of multiple physiological parameters of adult, pediatric and neonatal patients from supported bedside devices. T3 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. T3 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.
T3 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)
It can also display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.
T3 includes a Patient Risk Analytics Engine that calculates an index (the Inadequate Oxygen Delivery Index) that is indicated for use by health care professionals with postsurgical neonatal patients weighing 2 kg or more under intensive care. The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery and attention should be brought to the patient. The 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.
WARNING: T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring. Do not rely on the T3 Software Solution as the sole source of patient status information.
V. Comparison of Technological Characteristics with the Predicate Device
The subject and predicate T3 Software systems are web based and designed to acquire data from the network source and display the information remotely for clinicians to use in the care of their patients. The subject T3 software is designed for future scalability and requires a second server where the Risk Analytics Engine runs.
The subject T3 and predicate Visensia software are designed to acquire data from the network source and display the information remotely for clinicians to use in the care of their patients, alongside a derived index. The subject T3 software differs from the predicate Visensia device in requiring a more powerful CPU, more RAM, and a bigger hard drive. Also the subject T3 software runs on Red Hat Enterprise Linux while the predicate Visensia device runs on Microsoft Windows
VI. Performance Data
Software verification and validation testing was 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
7
results of this testing demonstrate the safety and effectiveness of the subject T3 software product (Ver. 2.0.1) is comparable to that of the predicate T3 software products (Ver. 1.9) and the Visensia device.
Additionally, validation study results using clinical data gathered in the intended patient population demonstrate the IDO2 Index included in the subject device correlates with changes in the patient's physical status, as does the Visensia Index.
VII. Conclusions
Substantial equivalence of the T3 Software is demonstrated through performance testing. The T3 Software has equivalent design, features and functionality as the predicate T3 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 devices.