(126 days)
Not Found
No
The document describes a software for aggregating, storing, and displaying physiological data. There is no mention of AI, ML, or any analytical capabilities beyond basic derived measures configured by the user.
No.
Explanation: The device is intended for recording and displaying physiological parameters to aid in clinical decisions and patient care, but it is explicitly stated that "T3 is not an active patient monitoring system" and is "intended to supplement and not replace any part of the hospital's device monitoring." It does not directly treat or diagnose.
Yes
The T3 Software is intended to "aid in clinical decisions and deliver patient care in a timely manner" by displaying physiological parameters and laboratory measurements. This function of aiding in clinical decisions, even without providing a definitive diagnosis, falls under the broad scope of a diagnostic device.
Yes
The device description explicitly states "Software-only solution no new bedside hardware required" and the architecture description details a web-based software system.
Based on the provided information, the T3 Software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- T3 Software's Function: The T3 Software's primary function is to record and display physiological parameters from supported bedside medical devices. It also displays laboratory measurements, but it does not perform the laboratory testing itself. It aggregates and visualizes data that has already been generated by other devices or laboratory processes.
- Intended Use: The intended use is for healthcare professionals to remotely consult, review near real-time patient data, and aid in clinical decisions. This is focused on monitoring and managing patients based on data from existing medical devices and lab results, not on performing diagnostic tests on specimens.
- Lack of Specimen Handling/Analysis: The description does not mention any capability for the T3 Software to handle, process, or analyze biological specimens.
While the T3 Software displays some laboratory measurements, it is acting as a display and aggregation tool for data generated by actual laboratory testing devices, which would be the IVDs in that scenario. The T3 Software itself is a medical device, but it falls under a different classification than an IVD.
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.
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
MWI
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 T3 Software is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. T3 is not intended for alarm notification, nor is it intended to control any of the independent bedside devices to which it is connected
The T3 software can display user-defined, derived measures. These measures include the percentage of time within a time period that a particular variable is above or below a threshold. The user can configure the time period, threshold, and label of the resulting derived measure for ease of use considerations, only.
The 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.
T3 has a web architecture consisting of a user interface that runs in a browser, and a central web server. The T3 server, a set of cooperating web services written in Java, processes data as it is received, caches it in memory, and writes out copies of the data to a relational database and to the file system. In this manner, the data is available to the user interface to be visualized by the end user - a clinician.
Clinicians access the T3 user interface in a web browser. T3 runs in current browsers that support HTML5, Javascript and web sockets, such as Chrome, Firefox, Safari and Internet Explorer. The clinicians may be in the hospital, or may be outside the hospital accessing T3 over a Virtual Private Network (VPN). Clinicians use T3 in addition to the physiometric devices themselves and other information sources such as the electronic medical record to monitor the patient's condition.
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
Intended User / Care Setting
healthcare professionals; hospital
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 has been conducted for T3 Software and documentation has been provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005. T3 Software is considered a moderate level of concern since a malfunction of, or a latent design flaw in, the Software Device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor injury.
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).
0
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES • USA
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
Etiometry, Inc. % Richard Galgon Independent Consulting Associate Quintiles 1708 Suwannee Circle Waunakee, Wisconsin 53597
Re: K151715
Trade/Device Name: T3 Software Version 1.9 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardio-tachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: September 16, 2015 Received: September 25, 2015
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
1
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 devicerelated 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 vours.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151715 To be assigned
Device Name
T3 Software Version 1.9
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.
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PSC Publishing Services (301) 443-6740
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Etiometry
510(k) Summary
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: June 24, 2015
II. Device
Device Trade Name: T3 Software (Version 1.9.1)
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: MWI; monitor, physiological, patient (without arrhythmia detection or alarms)
III. Predicate Device
T3 Software (Version 1.8), cleared under K142732.
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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 T3 Software is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. T3 is not intended for alarm notification, nor is it intended to control any of the independent bedside devices to which it is connected
The T3 software can display user-defined, derived measures. These measures include the percentage of time within a time period that a particular variable is above or below a threshold. The user can configure the time period, threshold, and label of the resulting derived measure for ease of use considerations, only.
The 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.
T3 has a web architecture consisting of a user interface that runs in a browser, and a central web server. The T3 server, a set of cooperating web services written in Java, processes data as it is received, caches it in memory, and writes out copies of the data to a relational database and to the file system. In this manner, the data is available to the user interface to be visualized by the end user - a clinician.
Clinicians access the T3 user interface in a web browser. T3 runs in current browsers that support HTML5, Javascript and web sockets, such as Chrome, Firefox, Safari and Internet Explorer. The clinicians may be in the hospital, or may be outside the hospital accessing T3 over a Virtual Private Network (VPN). Clinicians use T3 in addition to the physiometric devices themselves and other information sources such as the electronic medical record to monitor the patient's condition.
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V. 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
- 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.
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..
The T3 and predicate T3 Software Indications for Use are the same with respect to recording and remote display of medical device data from supported devices. The Indications for Use are also the same with respect to the user and use environment, hospital. The T3 and predicate T3 Indications for Use differ insofar as T3 can additionally display laboratory measurements including arterial and venous blood gases, complete blood count and lactic acid.
Neither T3 nor the predicate T3 Software is intended to replace any part of the hospital's device monitoring systems; and are also not intended to be used as the sole source of information in the care of the patient.
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VI. Comparison of Technological Characteristics with the Predicate Device
T3 has similar features and functionality as the predicate T3 Software system with the exception of the differences noted above. The 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 technological characteristics implemented in T3 software to achieve this interaction are similar to the predicate device as well.
VII. Performance Data
Software verification and validation testing has been conducted for T3 Software and documentation has been provided in accordance with FDA 's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005. T3 Software is considered a moderate level of concern since a malfunction of, or a latent design flaw in, the Software Device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor injury.
Since T3 Software is a software medical device, biocompatibility testing, electrical safety and electromagnetic compatibility (EMC) testing, sterilization and shelf-life information were not required.
Animal testing was not required.
Clinical testing was not required.
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VIII. 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 can be considered substantially equivalent.