Predicate Devices

Reference Devices

K040371, K090671, K081285, K092620, K081703, K101242, K141792, K112858, K053122, K011291, K091054

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software program for retrospectively receiving, displaying, and storing vital sign data. There is no mention of AI, ML, or any algorithms that would suggest their use for analysis or interpretation beyond simple data display and user-defined alerts.

Therapeutic

No.
The device is a software program that retrospectively receives, displays, and stores monitored vital signs parameters and related data for review and interpretation by a healthcare professional. It is explicitly stated that "LifeStream is not intended for emergency use or real-time monitoring" and its purpose is not to treat or prevent a disease or condition.

Diagnostic

No

The device is designed to "retrospectively receive, display and store monitored vital signs parameters and related data" for review and interpretation by a healthcare professional. While it provides data for interpretation, it does not perform analysis or provide a diagnosis itself. It explicitly states it "is not intended for emergency use or real-time monitoring," which further suggests it's a data management and display tool rather than a diagnostic one.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "stand alone, prescription-based software program" and its components are listed as a hosted web server, hosted database server, and client interfaces (Windows and web). While it interfaces with external medical devices for data acquisition, the device itself is solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, LifeStream 5 is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
LifeStream 5's Function: LifeStream 5's intended use is to receive, display, and store monitored vital signs parameters and related data from medical devices. This data includes things like blood pressure, SpO2, weight, temperature, ECG, etc. While it does handle blood glucose and prothrombin time data, which are often obtained from blood samples, the software itself is not performing the in vitro test on the specimen. It's receiving the results of those tests (and other vital signs) from other devices.
No Specimen Handling: The description does not mention LifeStream 5 handling or analyzing biological specimens.

Therefore, LifeStream 5 functions as a data management and display system for vital signs and related information, not as a device that performs tests on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healtheare professionals. It consists of a hosted web server, a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface.

LifeStream software's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages.

LifeStream retrospectively displays the data, user-defined data alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.

Product codes

DRG, DXN, FRI, DQA, NBW, BZH, GJS, NXB, OUG, FLL, DPS

Device Description

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthcare professionals. It consists of a hosted web server and two types of client interfaces, one that is provided by Windows client and one that is provided by a web client interface. LifeStream 5, like the predicate LifeStream 4.0, is configured to accept patient data that is acquired periodically and displayed retrospectively from Honeywell HomMed Patient Monitors (e.g. Genesis Touch). LifeStream 5 can also interface with 3nd party compatible medical device data systems (e.g. Govsphere TV). LifeStream 5 has the same intended use as the predicate, LifeStream 4.0. LifeStream 5, like LifeStream 4.0 is not intended for emergency use or real-time monitoring. Both are designed to retrospectively receive, display and store scheduled vital sign parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, ECG, peak flow, prothrombin time and retrospective PERS messages.

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

Not Found

Intended User / Care Setting

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healtheare professionals.

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)

Both the subject device and predicate device are software programs that were developed in the same software engineers, using same or equivalent testing protocols. The applicable test methods include the following:

Functional testing of each functional requirement
Validation testing of complete systems
Automated regression testing
Black box testing
Localization testing
Deployment testing
External evaluation by Honeywell clinical team

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K072272

Reference Device(s)

K040371, K090671, K081285, K092620, K081703, K101242, K141792, K112858, K053122, K011291, K091054

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 3, 2016

Honeywell Hommed, LLC % John Ziobro Spectramedex, LLC 3215 Gold Road Delafield. Wisconsin 53018

Re: K153719

Trade/Device Name: LifeStream™ 5 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: April 28, 2016 Received: May 2, 2016

Dear John Ziobro:

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 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.

1

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, Shawn W. Forrest -S 2016.06.03 10:52:43 -04'00'

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

2

Indications for Use

510(k) Number (if known) K153719

Device Name LifeStream™ 5

Indications for Use (Describe)

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healtheare professionals. It consists of a hosted web server, a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface.

LifeStream software's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages.

LifeStream retrospectively displays the data, user-defined data alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.

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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Honeywell HomMed LifeStream™ 5 510(k) Summary Statement

Summary Date: 12/17/2015

| Applicant Name:
and Address: | Honeywell HomMed, LLC
3400 Intertech Drive, Suite 200
Brookfield, Wisconsin 53045
Ph: (262) 252-783-5440
Establishment Registration #3004183721 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Site: | Honeywell HomMed, LLC
3400 Intertech Drive, Suite 200
Brookfield, Wisconsin 53045
Ph: (262) 252-783-5440
Establishment Registration #3004183721 |
| Corporate Contact: | Greg Lillegard, Operations, Vice President
Honeywell HomMed, LLC
Ph: (262) 252-6062
Fax: (262) 252-6119 |

Contact Person: John Ziobro

Principal Consultant SpectraMedEx, LLC 3215 Golf Road, #149 Delafield, WI 53018 Ph: (262) 719-89228 Fax: (262) 968-2915

Model Number LifeStream™ 5

Common Name: Patient Vital Signs Monitor Viewing Station

LifeStream™ 5 Brand/Trade Names:

Reason for Traditional 510(k) : New Submission

Indications For Use:

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthicare professionals. It consists of a hosted web server a hosted database server and two types of client interfaces - one that is provided by Windows client and one that is provided by a web client interface.

LifeStream software's intended use is to retrospectively receive, display and store monitored vital signs parameters and Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, related data. temperature, dispensed medicine, ECG, peak flow, prothrombin time and retrospective PERS messages.

LifeStream retrospectively displays the data, user-defined data alerts for review and interpretation by a healthcare professional. LifeStream is not intended for emergency use or real-time monitoring.

4

| Regulation
Number | Review Panel | Product
Code | Classification Name | Device
Class |
|--------------------------------------------------------------------------------------------|-----------------------|-----------------|-----------------------------------------------------------------|-----------------|
| 870.2910 | Cardiovascular | DRG | Radiofrequency physiological signal
transmitter and receiver | II |
| Subsequent product codes also supported by LifeStream by means of separate medical devices | | | | |
| 870.1130 | Cardiovascular | DXN | Noninvasive blood pressure measurement
system | II |
| 880.2700 | General
Hospital | FRI | Patient Weight Scale | I |
| 870.2700 | Anesthesiology | DQA | Oximeter | II |
| 862.1345 | Clinical
Chemistry | NBW | Glucose Test System | II |
| 868.1860 | Anesthesiology | BZH | Meter, Peak Flow, Spirometry | II |
| 864.7750 | Hematology | GJS | Test, Time, Prothrombin | II |
| 890.5050 | Physical
Medicine | NXB | Dispenser, solid medication | I |
| 880.6310 | General
Hospital | OUG | Medical Device Data System | I |
| 880.2910 | General
Hospital | FLL | Clinical Electronic Thermometer | II |
| 870.2340 | Cardiovascular | DPS | Electrocardiograph | II |

Central Station, Version 4.0, K072272, branded as the LifeStream™ 4.0. Predicate Device(s):

Predicate Classification Information:

| Regulation
Number | Review Panel | Product
Code | Classification Name | Device
Class |
|----------------------|----------------|-----------------|--------------------------------------------------|-----------------|
| 870.1130 | Cardiovascular | DXN | Noninvasive blood pressure measurement
system | II |

Device Description:

LifeStream 5 is a stand alone, prescription-based software program designed to operate in a clinical setting by healthcare professionals. It consists of a hosted web server and two types of client interfaces, one that is provided by Windows client and one that is provided by a web client interface. LifeStream 5, like the predicate LifeStream 4.0, is configured to accept patient data that is acquired periodically and displayed retrospectively from Honeywell HomMed Patient Monitors (e.g. Genesis Touch). LifeStream 5 can also interface with 3nd party compatible medical device data systems (e.g. Govsphere TV). LifeStream 5 has the same intended use as the predicate, LifeStream 4.0. LifeStream 5, like LifeStream 4.0 is not intended for emergency use or real-time monitoring. Both are designed to retrospectively receive, display and store scheduled vital sign parameters and related data. Such data includes patient blood pressure (NIBP), oxygen saturation (SpO2), weight, blood glucose, temperature, ECG, peak flow, prothrombin time and retrospective PERS messages.

Technological Characteristics

Both the subject device and predicate device are software programs" with substantially equivalent intended uses, users, and use environments that were written in C# that operate on PCs powered by AC Mains / battery power.

Predicate Device Comparison:

As shown in the tables below, LifeStream 5 is substantially equivalent in operation and performance to predicate the LifeStream Central Station 4.0 cleared under K072272. See also the Substantial Equivalence (SE) table, attached.

5

led, LLC

LifeStream Manager 4.0 Predicate
	Manufacturer, Model	Description	510(k) Number	Communication
Method
Vital Signs Data Acquisition (communicates with Monitors)
Blood Pressure
Systolic mmHg,
Diastolic mmHg	A&D Digital UA-767 Plus BT-
Ci
A&D Digital UA-767BT	noninvasive blood pressure
monitor
noninvasive blood pressure
monitor	K040371
K040371	Bluetooth
Pulse Oximetry
Pulse Rate and Oxygen
Saturation	Contec CMS50EW
Nonin Onyx II 9560
ChoiceMed MD300C318	Fingertip pulse oximeter
Fingertip pulse oximeter
Fingertip pulse oximeter	K090671
K081285
K092620	Bluetooth
Weight
Pounds, lbs or
Kilograms, Kgs	Honeywell HomMed
5002100A1
A&D Medical UC-321PBT
NCI Technology Inc. Accuro
HRS305	Scale
Scale
Hand rail scale	exempt
exempt
exempt	Bluetooth
Blood Sugar
mg/dL	Entra Health Systems
MyGlucoHealth (US) MGH-
BT1	Glucometer	K081703	Bluetooth
ECG	No longer manufactured	Electrocardiograph	N/A	N/A
Vital Signs Monitors/Medicine Dispenser (Communicates with Honeywell Secure Servers
Genesis DM	Honeywell HomMed	Single/Multi-patient Monitoring
System	K101242	Web Services
Genesis Touch	Honeywell HomMed	Single-patient Monitoring
System	K141792
K112858	Web Services
Medicine Dispenser	MedPartner	Daily Activity Assist Device	K053122	Web Services
Disease Management
Protocol	Pre-defined by User	Users: Various	N/A	Honeywell Secure
Servers
(central servers)
Graphical user interface	Honeywell HomMed,
LifeStream Management Suite
4.0	Windows-based Software
Application used by Healthcare
Provider to manage data
received from Genesis Monitor s	K072272	Honeywell Secure
Servers
(central servers)

LifeStream Manager 5.0 Subject Device
	Manufacturer, Model	Description	510(k) Number	Communication to Monitor
Blood Pressure
Systolic mmHg,
Diastolic mmHg	A&D Digital UA-767 Plus BT-Ci
A&D Digital UA-767BT	noninvasive blood pressure monitor
noninvasive blood pressure monitor	K040371	BlueTooth
Pulse Oximetry
Pulse Rate and Oxygen
Saturation	Contec CMS50EW
Nonin Onyx II 9560
ChoiceMed MD300C318	Fingertip pulse oximeter
Fingertip pulse oximeter
Fingertip pulse oximeter	K090671
K081285
K092620	BlueTooth
Weight
Pounds, lbs or
Kilograms, Kgs	Honeywell HomMed
5002100A1
A&D Medical UC-321PBT
NCI Technology Inc. Accuro HRS305	Scale
Scale
Hand rail scale	exempt	BlueTooth
Blood Sugar
mg/dL	Entra Health Systems
MyGlucoHealth (US) MGH-BT1	Glucometer	K081703	BlueTooth
MDDS
Communications
Device	Govsphere VITAL Tablet;
Govsphere VITAL TV	Medical device data system	exempt	BlueTooth
Temperature	Exergen Temporal
Thermometer	Temporal scanner thermometer	K011291	Wire
ECG	et medical devices SpA
ECG@home	Electrocardiograph	K091054	N/A
Vital Signs Monitors/Medicine Dispenser (Communicates with Honeywell Secure Servers
Genesis DM	Honeywell HomMed	Single/Multi-patient Monitoring
System	K101242	Web Services
Genesis Touch	Honeywell HomMed	Single-patient Monitoring
System	K141792
K112858	Web Services
Medicine Dispenser	MedPartner	Daily Activity Assist Device	K053122	Web Services

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Image /page/6/Picture/0 description: The image contains the logo for Honeywell Life Care Solutions Honeywell HomMed, LLC. The word "Honeywell" is in red, and the words "Life Care Solutions" are in gray. The words "Honeywell HomMed, LLC" are in black.

| Disease Management Protocol | Pre-defined by Honeywell HomMed or/and User | Users: Various
Honeywell: COPD, Diabetes, CHF | N/A | |
|-----------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------------------------------------------------|
| Graphical user interface | Honeywell HomMed,
LifeStream Management Suite
5.0
(central viewing station) | Windows-based Software
Application or Web-based used
by Healthcare Provider to
manage data received from
Genesis Monitor s and
compatible 3rd party monitors | Subject Device | Honeywell Secure
Servers
(central servers) |

Substantial Equivalence (SE) table

Predicate Device(s)		510(k) Application
Feature/
Function	Central Station v4.0 branded LifeStream Manager 4.0;
K072272	LifeStream Manager 5.0
		Subject Device
	GENERAL DESCRIPTIONS
Intended Use /
Indications for
Use	Central Station's intended use is to retrospectively receive,
display and store monitored vital signs parameters and
related data. Central Station displays the data and system
alerts for review and interpretation by a healthcare
professional. Central Station is not intended for emergency
use or real-time monitoring.	LifeStream 5 is a stand alone, prescription-based software
program designed to operate in a clinical setting by healthcare
professionals. It consists of a hosted web server, a hosted
database server and two types of client interfaces - one that is
provided by Windows client and one that is provided by a web
client interface.
LifeStream software's intended use is to retrospectively receive,
display and store monitored vital signs parameters and related
data. Such data includes patient blood pressure (NIBP), oxygen
saturation (SpO2), weight, blood glucose, temperature, dispensed
medicine, ECG, peak flow, prothrombin time and retrospective
PERS messages.
		LifeStream retrospectively displays the data, user-defined data
alerts and system alerts for review and interpretation by a
healthcare professional. LifeStream is not intended for emergency
use or real-time monitoring.
User Population	Health care professionals	Health care professionals
Environment of
Use	Intended to be used in a healthcare related environment by
healthcare providers.	Intended to be used in a healthcare related environment by
healthcare providers.
Content	For informational purposes only and does not provide
professional medical advice, diagnosis, or treatment.	For informational purposes only and does not provide
professional medical advice, diagnosis, or treatment.
Contraindications
and Use
Limitations	LifeStream Manager 4.0 is not intended for emergency use
or real-time monitoring.
LifeStream Manager 4.0 is not intended to be accessed or
used directly by patients	LifeStream is NOT an emergency medical response system.
LifeStream does NOT provide real-time, critical-care monitoring
of patient vital signs. Reports generated by LifeStream are NOT
intended to be used as a patient medical record or patient vital
sign reporting documentation. LifeStream does not analyze or
perform calculations on the data collected by the peripheral
devices.
Regulation
Number &
Product Code	870.1130, DXN, Class II	870.2910, DRG, Class II
Subsequent/additional regulation numbers & codes
870.1130
DXN
880.2700
FRI
870.2700
DQA
862.1345
NBW
868.1860
BZH
864.7750
GJS
890.5050
NXB
880.6310
OUG
880.2910
FLL
870.2340 DPS
	Hardware-Related Technological Characteristics
Hardware
Platform	Commercial PC
Computer/Processor: 1 GHz or faster x86- or x64-bit
processor
Memory: 1 gigabyte (GB) RAM (32-bit); 2 gigabytes (GB)
RAM (64-bit)
Hard Disk: 1 gigabyte (GB) of disk space available
Display: 1024x768 or higher resolution monitor	Commercial PC
Computer/Processor: 1 GHz or faster x86- or x64-bit processor
Memory: 1 gigabyte (GB) RAM (32-bit); 2 gigabytes (GB) RAM
(64-bit) or greater
Hard Disk: 1 gigabyte (GB) of disk space available
Display: 1024x768 or higher resolution monitor
Predicate Device(s)	510(k) Application
Feature/
Function	Central Station v4.0 branded LifeStream Manager 4.0;
K072272	LifeStream Manager 5.0
		Subject Device
Hardware
Compliance/
Conformity
Standards	The medical device is software installed or accessed using
off-the-shelf PCs and not subject to EN60601-1-2.	The medical device is software accessed using off-the-shelf PCs
and not subject to IEC 60601-1 & 60601-1-2.
Hardware Power
Supply	AC Mains or battery	AC Mains or battery
	Software-Related Operating Environment / Principles / Technological Characteristics
Operating System	Operating System
Windows XP with all available Microsoft service packs
Windows Vista
Windows 7
NET Framework version 2.0
Web browser: Internet Explorer 9	Operating System
Windows Vista
Windows 7
NET Framework version 2.0
Web browser: Internet Explorer 9 or higher
Peripherals	Internet connection; mouse or compatible pointing device	Internet connection; mouse or compatible pointing device
Programming
Language	C#	C#
	Communications into LifeStream Database Server from the Patient Monitoring System
Transmission	POTS, Internet, SkyTel, PageNet	POTS, Internet
Output Devices	Fax, Printer, email	Fax, Printer, email
	Communications out of LifeStream Database Server to the Patient Monitoring System
Transmission	Web services (	Web services
Output Devices	Fax, Printer, email	Fax, Printer, email
User Interface	LifeStream Windows Client	LifeStream Windows Client and LifeStream Web Client
Database	Honeywell hosted Database service	Honeywell hosted Database service
FDA Software
Level of Concern	Moderate	Moderate
	Clinical Features of the Software
Patient Task
Screen	Alert Limits, Vitals Current Status, Demographics,
Equipment & Question Setup/Configuration, Patient
Information, Patient List, Vitals Tabular Trends, Patient
Messages	Alert Limits, Vitals Current Status, Demographics, Equipment &
Question Setup/Configuration, Patient Information, Patient List,
Vitals Tabular Trends, Questions graph, Patient Messages
Organization
Screen	Care Providers, Diagnoses, Equipment List, Insurers,
Medications, Sites/Categories, System Configuration, Users	Care Providers, Diagnoses, Equipment List, Insurers,
Medications, Sites/Categories, System Configuration, Users
Tools Screen	Change Password, System Log, User Settings	Change Password, System Log, User Settings
System Screen	Logoff, Exit	Logoff, Exit
Standard Patient
Data Displayed	Weight, Systolic, Diastolic, SpO2, Heart rate, Temperature,
Questions & Question responses	Weight, Systolic, Diastolic, SpO2, Heart rate, Temperature,
Questions & Question responses, Pain Answers
Optional Patient
Data Displayed	Blood glucose, Spirometry, PT/INR and ECG, ID Card
Reader, MedPartner	Blood glucose, Spirometry, PT/INR and ECG, ID Card Reader
Predicate Device(s)		510(k) Application
Feature/	Central Station v4.0 branded LifeStream Manager 4.0;	LifeStream Manager 5.0
Function	K072272	Subject Device
Data Alert Status	Vital Signs:
Red - Limit violation
Brown - LifeStream MobileHelp Mobile Personal
Emergency Response System (PERS) notifications
Blue - No limits set (monitor only)
Orange - Transmit error, Null (empty) data packet
Yellow - Missing data (one or more, but not all vitals are
missing)
Green - Data complete & Vital sign readings are within set
limits
Purple - Vital signs for this patient are on hold
MedPartner:
Red - Missed
Blue - Unauthorized
Orange - Null (empty) data packet or No Data Received
(NDR)
Yellow – Out of Sync (LifeStream/MedPartner
synchronization error)
Green - Conformance	Vital Signs:
Dark Red (H) - Limit violation (highest level of user defined
alert)
Medium Red (M) - Medium Alert (medium level of user defined
alert)
Light Red (L) - Low Alert (lowest level of user defined alert)
Brown - LifeStream MobileHelp Mobile Personal Emergency
Response System (PERS) notifications
Blue - No limits set (monitor only)
Orange - Transmit error, Null (empty) data packet
Yellow - Missing data (one or more, but not all vitals are missing)
Green - Data complete & Vital sign readings are within set limits
Purple - Vital signs for this patient are on hold
Window Layout
(regardless if
accessed via
Windows or Web
Server)	Title Bar - Application name, selected patient and window
control buttons
Menu Bar - Menu titles
Tool bar – Navigation & toolbar buttons
Sites/Categories Drop down box
Trend Days Selector (optional)
Minimize, Maximize & Close - Minimizes, maximizes and
closes the application window
Main Window - The overall display of data
Status Bar - Displays the current quantity of each
unacknowledged readings
Navigation Pane - Provides the most common options
available for each user's role and privileges.	Title Bar - Application name, selected patient and window control
buttons
Menu Bar - Menu titles
Tool bar – Navigation & toolbar buttons
Sites/Categories Drop down box
Trend Days Selector (optional)
Minimize, Maximize & Close - Minimizes, maximizes and closes
the application window
Main Window - The overall display of data
Status Bar - Displays the current quantity of each
unacknowledged readings
Navigation Pane - Provides the most common options available
for each user's role and privileges.
Check New
Readings	Automatic or Manual	Automatic or Manual
Vital Signs
Transmission
Times	Scheduled - one to four per day
Monitor configuration can be updated from monitor and/or
LifeStream	Scheduled – one to four per day
Monitor configuration can be updated from monitor and/or
LifeStream
Alert Limits	Manual- User configured	Manual- User configured, with three levels: low, medium and
high alerts. Two additional levels have been added to allow the
healthcare provider to further divide the red alerts.
Vital Signs Status
Triage	Listed in order of oldest and most critical (# of vitals outside
set parameters)	Listed in order of oldest and most critical (# of vitals outside set
parameters)
Vital Signs
Reports
(Read/write
capability)	Patient Lists, patient information, tabular trends, multi-
patient trends, patient compliance (vital signs), equipment
history (all enabled equipment, single item history, patient's
equipment history), alert limit history, graphical trends and
notes	When accessed via the LifeStream Windows Client: Patient Lists,
patient information, tabular trends, multi-patient trends, patient
compliance (vital signs), equipment history (all enabled
equipment, single item history, patient's equipment history), alert
limit history, graphical trends and notes (read + write underlying
data)

When accessed via the LifeStream Web Client: Read underlying
data only) | |
| Equipment
Tracking | If enabled, the system allows users to track monitors, ID
cards, scales, pagers and MedPartner-K053122 | If enabled, the system allows users to track monitors, ID cards,
scales | |
| Disease
Management | End-User Configurable | End-User Configurable, Honeywell Pre-defined | |
| Predicate Device(s) | | 510(k) Application | |
| Feature/Function | Central Station v4.0 branded LifeStream Manager 4.0;
K072272 | LifeStream Manager 5.0 | |
| Additional
Software Features | LifeStream Connect: Streamline workflows by integrating with EHR and POC applications through HL7 standard interfaces. | LifeStream Analytics: Customizes and assesses telehealth program data to determine return on investment (ROI) and resource/care management. LifeStream Connect: Streamline workflows by integrating with EHR and POC applications through HL7 standard interfaces. LifeStream View: Browser-based interface allows care providers and family members to securely access patient data at any time. LifeStream MobileHelp MH3 Care Provider Portal: Access patient information for those using a Mobile Personal Emergency Response (mPERS) device. | |
| Compatibility | Sentry Monitors: K993938, K004044, K014025, K040651, K061088
Genesis Monitors: K040799, K061087,
Genesis DM Monitors: K101242
Genesis Touch Monitors: K112858, K141792 | Genesis DM Monitors: K101242
Genesis Touch Monitors: K112858, K141792
Govsphere VITAL Tablet: MDDS (exempt)
Govsphere VITAL TV: MDDS (exempt) | |
| | Administration | | |
| System
Administration
Reports | Audit logs - Monitors/ID cards Report, Site Report, Users
Report and System Status Report (read underlying data) | When accessed via the LifeStream Windows Client: Audit logs -
Monitors/ID cards Report, Site Report, Users Report and System
Status Report (read underlying data)

When accessed via the LifeStream Web Client: No access for
these System Administration Reports. | |
| System Log | Presents a list of database and communication server errors | Presents a list of database and communication server errors | |
| System
Configuration | Ability to enter configuration information related to Skytel,
Data Export, Paging and Equipment tracking options;
Enable/disable Outcomes Questionnaire functionality | Ability to enter configuration information related to Data Export
and Equipment tracking options; Enable/disable Outcomes
Questionnaire functionality | |
| | System Security | | |
| System Security
& Access Control | PIN & Username & password -
Single Login for Dual role Administrator/Clinician
Smart Passwords | PIN (with check digit functionality) & Username & password -
Single Login for Dual role Administrator/Clinician
Smart Passwords | |
| Audit Logging | Date, Time, User I.D. Medications Diagnoses Monitor/ID card assignments All responses to vital signs Configuration MedPartner data | Date, Time, User I.D. Medications Diagnoses Monitor/ID card assignments All responses to vital signs Configuration | |
| Privacy | Roles and Permissions
Idle session limit | Roles and Permissions
Idle session limit | |
| Software Updates | Update software via update server | Update software via update server | |
| Data Integrity &
Protection | Encrypted in transit and storage. The encryption protocol is
a function of the Patient Monitoring system. The data
integrity is included as part of the encryption algorithm.
Data hosting database is firewall and antivirus protected. | Encrypted in transit and storage. The encryption protocol is a
function of the Patient Monitoring system. The data integrity is
included as part of the encryption algorithm. Data hosting
database is firewall and antivirus protected. | |
| HIPAA
Compliant | Yes | Yes | |

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Honeywell HomMed, LLC

8

Honeywell HomMed, LLC

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Honeywell
Life Care Solutions
Honeywell HomMed, LLC

Performance / Bench Testing

Both the subject device and predicate device are software programs that were developed in the same software engineers, using same or equivalent testing protocols. The applicable test methods include the following:

Functional testing of each functional requirement ●
Validation testing of complete systems .
Automated regression testing
Black box testing ●
Localization testing ●
Deployment testing
External evaluation by Honeywell clinical team ●

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Image /page/10/Picture/0 description: The image contains the logo for Honeywell Life Care Solutions Honeywell HomMed, LLC. The word "Honeywell" is in red, and the words "Life Care Solutions" and "Honeywell HomMed, LLC" are in gray. The logo is simple and clean, and it is likely used to represent the company's brand.

Conclusions:

Honeywell HomMed, LLC, believes the proposed LifeStream 5 device under review and the predicate device (LifeStream 4) are substantially equivalent in their intended users, intended use environment and indications for use. Furthermore, both systems have the same/equivalent technological characteristics, physical characteristics, labeling and safety standards. The differences that exist between the devices, relating to access the software program via the web (rather than just via Windows, the addition of Honeywell defined disease management protocols and the ability to interface with 510(k) exempt third-party MDDS systems do not affect the relative safety and/or effectiveness