T3 Software

K151715 · Etiometry, Inc. · MWI · Oct 29, 2015 · Cardiovascular

Device Facts

• Record ID: K151715
• Device Name: T3 Software
• Applicant: Etiometry, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Oct 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

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.

Device Story

T3 Software aggregates, stores, and displays physiological data from bedside medical devices for ICU clinicians. Inputs include numeric physiologic data (e.g., BP, HR, SpO2, CO2, pressures, temperature) and laboratory measurements (blood gases, blood count, lactic acid). System uses web-based architecture with Java-based web services to process, cache, and store data in a relational database. Clinicians access data via standard web browsers (Chrome, Firefox, Safari, IE) within the hospital or remotely via VPN. Device provides customizable displays and user-defined derived measures (e.g., percentage of time a variable exceeds a threshold). Output aids clinicians in remote consultation and clinical decision-making. Does not provide alarms or control bedside devices; intended as a supplementary information source.

Clinical Evidence

No clinical data. Bench testing only. Software verification and validation performed per FDA guidance for moderate level of concern software.

Technological Characteristics

Web-based software architecture; Java-based web services; relational database storage. Compatible with HTML5, Javascript, and web sockets. Operates on standard web browsers. No bedside hardware required. Software-only solution.

Indications for Use

Indicated for adult, pediatric, and neonatal patients. Used by healthcare professionals to remotely consult on patient status and review near real-time physiological data and laboratory measurements to aid clinical decision-making. Not for alarm notification, waveform display, or device control. Not an active monitoring system; must not be the sole source of patient status information.

Regulatory Classification

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.

Predicate Devices

• T3 Software (Version 1.8) (K142732)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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 [phone]

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement 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: [phone] ext. 2005 E-mail: [e-mail]

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.