(158 days)
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.
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.
The Honeywell HomMed LifeStream™ 5 is a software program designed to retrospectively receive, display, and store monitored vital signs parameters and related data for review and interpretation by healthcare professionals. It is not intended for emergency use or real-time monitoring.
Here's an analysis of its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific quantitative acceptance criteria for performance. The "acceptance criteria" here are implied by the claim of substantial equivalence in intended use, users, use environment, technological characteristics, and safety to the predicate device, LifeStream™ 4.0.
The performance reported is qualitative, stating that LifeStream 5 is substantially equivalent to LifeStream 4.0 and that differences "do not affect the relative safety and/or effectiveness."
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (LifeStream 5) |
|---|---|---|
| Intended Use | To retrospectively receive, display, and store monitored vital signs parameters and related data for review and interpretation by healthcare professionals. Not for emergency or real-time monitoring. | LifeStream 5's intended use is identical to the predicate: "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." |
| User Population | Health care professionals. | Identical: Health care professionals. |
| Environment of Use | Healthcare related environment. | Identical: Intended to be used in a healthcare related environment by healthcare providers. |
| Technological Characteristics | Software programs (C#), operating on PCs (AC Mains/battery), displaying various vital signs. | LifeStream 5 is a software program (C#) operating on Commercial PCs via AC Mains or battery. It collects and displays an equivalent range of vital signs (NIBP, SpO2, weight, blood glucose, temperature, ECG, peak flow, prothrombin time, PERS messages) and has similar UI, database, security, and administration features. Expanded access via web client, addition of Honeywell-defined disease management protocols, and interface with 3rd party MDDS systems are noted but deemed not to affect safety/effectiveness. |
| Safety and Effectiveness | Equivalent to predicate device. | The document explicitly concludes: "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." This statement implies that the device maintained the same level of safety and effectiveness as the predicate. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical performance evaluation using patient data. This 510(k) submission primarily relies on demonstrating substantial equivalence through non-clinical performance testing (bench testing) and comparison of technological characteristics with a predicate device.
Therefore, there is:
- No specific sample size for a test set of patient data mentioned.
- No data provenance (country of origin, retrospective/prospective) related to a clinical test set.
The "validation testing of complete systems" and "black box testing" likely used simulated data or internal test cases, but no details on their size or origin are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since there is no mention of a clinical test set requiring expert ground truth, this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
As there is no clinical test set with expert ground truth mentioned, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical and functional comparison to a predicate device and non-clinical testing, not on comparative effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a "standalone, prescription-based software program" for retrospective display and storage of vital signs, intended for use by healthcare professionals for review and interpretation. The "Performance / Bench Testing" section describes functional, validation, automated regression, black box, localization, and deployment testing, along with "External evaluation by Honeywell clinical team." This evaluation represents the standalone performance of the software in its intended function of receiving, displaying, and storing data correctly, as it is a device intended to assist human professionals, not to make diagnoses autonomously. However, these are engineering/software tests, not clinical performance studies measuring diagnostic accuracy of an algorithm.
7. The Type of Ground Truth Used
For the non-clinical performance/bench testing, the "ground truth" would be established by the expected behavior and output defined in the software's functional specifications and requirements. For example:
- Functional Testing: The "ground truth" is that the software correctly performs its intended function (e.g., displaying specific vital sign data accurately, registering alerts based on defined thresholds).
- Validation Testing: The "ground truth" is that the complete system meets all specified requirements.
- Automated Regression Testing: The "ground truth" is that previously corrected defects remain fixed and new changes haven't introduced new errors.
There is no mention of pathology, outcomes data, or expert consensus serving as ground truth for a clinical dataset in this submission.
8. The Sample Size for the Training Set
Not applicable. This submission describes a medical device, LifeStream™ 5, which is a software system for managing vital signs data. It is not an AI/Machine Learning algorithm that typically requires a "training set" of data to learn patterns or make predictions. The software's functionality is pre-programmed based on defined rules and specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/Machine Learning algorithm. The software's "ground truth" for its development would be its functional and system requirements.
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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.
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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
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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, LLC3400 Intertech Drive, Suite 200Brookfield, Wisconsin 53045Ph: (262) 252-783-5440Establishment Registration #3004183721 |
|---|---|
| Manufacturing Site: | Honeywell HomMed, LLC3400 Intertech Drive, Suite 200Brookfield, Wisconsin 53045Ph: (262) 252-783-5440Establishment Registration #3004183721 |
| Corporate Contact: | Greg Lillegard, Operations, Vice PresidentHoneywell HomMed, LLCPh: (262) 252-6062Fax: (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.
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| RegulationNumber | Review Panel | ProductCode | Classification Name | DeviceClass |
|---|---|---|---|---|
| 870.2910 | Cardiovascular | DRG | Radiofrequency physiological signaltransmitter and receiver | II |
| Subsequent product codes also supported by LifeStream by means of separate medical devices | ||||
| 870.1130 | Cardiovascular | DXN | Noninvasive blood pressure measurementsystem | II |
| 880.2700 | GeneralHospital | FRI | Patient Weight Scale | I |
| 870.2700 | Anesthesiology | DQA | Oximeter | II |
| 862.1345 | ClinicalChemistry | NBW | Glucose Test System | II |
| 868.1860 | Anesthesiology | BZH | Meter, Peak Flow, Spirometry | II |
| 864.7750 | Hematology | GJS | Test, Time, Prothrombin | II |
| 890.5050 | PhysicalMedicine | NXB | Dispenser, solid medication | I |
| 880.6310 | GeneralHospital | OUG | Medical Device Data System | I |
| 880.2910 | GeneralHospital | 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:
| RegulationNumber | Review Panel | ProductCode | Classification Name | DeviceClass |
|---|---|---|---|---|
| 870.1130 | Cardiovascular | DXN | Noninvasive blood pressure measurementsystem | 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.
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led, LLC
| LifeStream Manager 4.0 Predicate | ||||
|---|---|---|---|---|
| Manufacturer, Model | Description | 510(k) Number | CommunicationMethod | |
| Vital Signs Data Acquisition (communicates with Monitors) | ||||
| Blood PressureSystolic mmHg,Diastolic mmHg | A&D Digital UA-767 Plus BT-CiA&D Digital UA-767BT | noninvasive blood pressuremonitornoninvasive blood pressuremonitor | K040371K040371 | Bluetooth |
| Pulse OximetryPulse Rate and OxygenSaturation | Contec CMS50EWNonin Onyx II 9560ChoiceMed MD300C318 | Fingertip pulse oximeterFingertip pulse oximeterFingertip pulse oximeter | K090671K081285K092620 | Bluetooth |
| WeightPounds, lbs orKilograms, Kgs | Honeywell HomMed5002100A1A&D Medical UC-321PBTNCI Technology Inc. AccuroHRS305 | ScaleScaleHand rail scale | exemptexemptexempt | Bluetooth |
| Blood Sugarmg/dL | Entra Health SystemsMyGlucoHealth (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 MonitoringSystem | K101242 | Web Services |
| Genesis Touch | Honeywell HomMed | Single-patient MonitoringSystem | K141792K112858 | Web Services |
| Medicine Dispenser | MedPartner | Daily Activity Assist Device | K053122 | Web Services |
| Disease ManagementProtocol | Pre-defined by User | Users: Various | N/A | Honeywell SecureServers(central servers) |
| Graphical user interface | Honeywell HomMed,LifeStream Management Suite4.0 | Windows-based SoftwareApplication used by HealthcareProvider to manage datareceived from Genesis Monitor s | K072272 | Honeywell SecureServers(central servers) |
| LifeStream Manager 5.0 Subject Device | ||||
|---|---|---|---|---|
| Manufacturer, Model | Description | 510(k) Number | Communication to Monitor | |
| Blood PressureSystolic mmHg,Diastolic mmHg | A&D Digital UA-767 Plus BT-CiA&D Digital UA-767BT | noninvasive blood pressure monitornoninvasive blood pressure monitor | K040371 | BlueTooth |
| Pulse OximetryPulse Rate and OxygenSaturation | Contec CMS50EWNonin Onyx II 9560ChoiceMed MD300C318 | Fingertip pulse oximeterFingertip pulse oximeterFingertip pulse oximeter | K090671K081285K092620 | BlueTooth |
| WeightPounds, lbs orKilograms, Kgs | Honeywell HomMed5002100A1A&D Medical UC-321PBTNCI Technology Inc. Accuro HRS305 | ScaleScaleHand rail scale | exempt | BlueTooth |
| Blood Sugarmg/dL | Entra Health SystemsMyGlucoHealth (US) MGH-BT1 | Glucometer | K081703 | BlueTooth |
| MDDSCommunicationsDevice | Govsphere VITAL Tablet;Govsphere VITAL TV | Medical device data system | exempt | BlueTooth |
| Temperature | Exergen TemporalThermometer | Temporal scanner thermometer | K011291 | Wire |
| ECG | et medical devices SpAECG@home | Electrocardiograph | K091054 | N/A |
| Vital Signs Monitors/Medicine Dispenser (Communicates with Honeywell Secure Servers | ||||
| Genesis DM | Honeywell HomMed | Single/Multi-patient MonitoringSystem | K101242 | Web Services |
| Genesis Touch | Honeywell HomMed | Single-patient MonitoringSystem | K141792K112858 | 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: VariousHoneywell: COPD, Diabetes, CHF | N/A | |
|---|---|---|---|---|
| Graphical user interface | Honeywell HomMed,LifeStream Management Suite5.0(central viewing station) | Windows-based SoftwareApplication or Web-based usedby Healthcare Provider tomanage data received fromGenesis Monitor s andcompatible 3rd party monitors | Subject Device | Honeywell SecureServers(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 forUse | Central Station's intended use is to retrospectively receive,display and store monitored vital signs parameters andrelated data. Central Station displays the data and systemalerts for review and interpretation by a healthcareprofessional. Central Station is not intended for emergencyuse or real-time monitoring. | LifeStream 5 is a stand alone, prescription-based softwareprogram designed to operate in a clinical setting by healthcareprofessionals. It consists of a hosted web server, a hosteddatabase server and two types of client interfaces - one that isprovided by Windows client and one that is provided by a webclient interface.LifeStream software's intended use is to retrospectively receive,display and store monitored vital signs parameters and relateddata. Such data includes patient blood pressure (NIBP), oxygensaturation (SpO2), weight, blood glucose, temperature, dispensedmedicine, ECG, peak flow, prothrombin time and retrospectivePERS messages. | |
| LifeStream retrospectively displays the data, user-defined dataalerts and system alerts for review and interpretation by ahealthcare professional. LifeStream is not intended for emergencyuse or real-time monitoring. | |||
| User Population | Health care professionals | Health care professionals | |
| Environment ofUse | Intended to be used in a healthcare related environment byhealthcare providers. | Intended to be used in a healthcare related environment byhealthcare providers. | |
| Content | For informational purposes only and does not provideprofessional medical advice, diagnosis, or treatment. | For informational purposes only and does not provideprofessional medical advice, diagnosis, or treatment. | |
| Contraindicationsand UseLimitations | LifeStream Manager 4.0 is not intended for emergency useor real-time monitoring.LifeStream Manager 4.0 is not intended to be accessed orused directly by patients | LifeStream is NOT an emergency medical response system.LifeStream does NOT provide real-time, critical-care monitoringof patient vital signs. Reports generated by LifeStream are NOTintended to be used as a patient medical record or patient vitalsign reporting documentation. LifeStream does not analyze orperform calculations on the data collected by the peripheraldevices. | |
| RegulationNumber &Product Code | 870.1130, DXN, Class II | 870.2910, DRG, Class IISubsequent/additional regulation numbers & codes870.1130DXN880.2700FRI870.2700DQA862.1345NBW868.1860BZH864.7750GJS890.5050NXB880.6310OUG880.2910FLL870.2340 DPS | |
| Hardware-Related Technological Characteristics | |||
| HardwarePlatform | Commercial PCComputer/Processor: 1 GHz or faster x86- or x64-bitprocessorMemory: 1 gigabyte (GB) RAM (32-bit); 2 gigabytes (GB)RAM (64-bit)Hard Disk: 1 gigabyte (GB) of disk space availableDisplay: 1024x768 or higher resolution monitor | Commercial PCComputer/Processor: 1 GHz or faster x86- or x64-bit processorMemory: 1 gigabyte (GB) RAM (32-bit); 2 gigabytes (GB) RAM(64-bit) or greaterHard Disk: 1 gigabyte (GB) of disk space availableDisplay: 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 | |||
| HardwareCompliance/ConformityStandards | The medical device is software installed or accessed usingoff-the-shelf PCs and not subject to EN60601-1-2. | The medical device is software accessed using off-the-shelf PCsand not subject to IEC 60601-1 & 60601-1-2. | |
| Hardware PowerSupply | AC Mains or battery | AC Mains or battery | |
| Software-Related Operating Environment / Principles / Technological Characteristics | |||
| Operating System | Operating SystemWindows XP with all available Microsoft service packsWindows VistaWindows 7NET Framework version 2.0Web browser: Internet Explorer 9 | Operating SystemWindows VistaWindows 7NET Framework version 2.0Web browser: Internet Explorer 9 or higher | |
| Peripherals | Internet connection; mouse or compatible pointing device | Internet connection; mouse or compatible pointing device | |
| ProgrammingLanguage | 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 SoftwareLevel of Concern | Moderate | Moderate | |
| Clinical Features of the Software | |||
| Patient TaskScreen | Alert Limits, Vitals Current Status, Demographics,Equipment & Question Setup/Configuration, PatientInformation, Patient List, Vitals Tabular Trends, PatientMessages | Alert Limits, Vitals Current Status, Demographics, Equipment &Question Setup/Configuration, Patient Information, Patient List,Vitals Tabular Trends, Questions graph, Patient Messages | |
| OrganizationScreen | 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 PatientData Displayed | Weight, Systolic, Diastolic, SpO2, Heart rate, Temperature,Questions & Question responses | Weight, Systolic, Diastolic, SpO2, Heart rate, Temperature,Questions & Question responses, Pain Answers | |
| Optional PatientData Displayed | Blood glucose, Spirometry, PT/INR and ECG, ID CardReader, 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 violationBrown - LifeStream MobileHelp Mobile PersonalEmergency Response System (PERS) notificationsBlue - No limits set (monitor only)Orange - Transmit error, Null (empty) data packetYellow - Missing data (one or more, but not all vitals aremissing)Green - Data complete & Vital sign readings are within setlimitsPurple - Vital signs for this patient are on holdMedPartner:Red - MissedBlue - UnauthorizedOrange - Null (empty) data packet or No Data Received(NDR)Yellow – Out of Sync (LifeStream/MedPartnersynchronization error)Green - Conformance | Vital Signs:Dark Red (H) - Limit violation (highest level of user definedalert)Medium Red (M) - Medium Alert (medium level of user definedalert)Light Red (L) - Low Alert (lowest level of user defined alert)Brown - LifeStream MobileHelp Mobile Personal EmergencyResponse System (PERS) notificationsBlue - No limits set (monitor only)Orange - Transmit error, Null (empty) data packetYellow - Missing data (one or more, but not all vitals are missing)Green - Data complete & Vital sign readings are within set limitsPurple - Vital signs for this patient are on hold | |
| Window Layout(regardless ifaccessed viaWindows or WebServer) | Title Bar - Application name, selected patient and windowcontrol buttonsMenu Bar - Menu titlesTool bar – Navigation & toolbar buttonsSites/Categories Drop down boxTrend Days Selector (optional)Minimize, Maximize & Close - Minimizes, maximizes andcloses the application windowMain Window - The overall display of dataStatus Bar - Displays the current quantity of eachunacknowledged readingsNavigation Pane - Provides the most common optionsavailable for each user's role and privileges. | Title Bar - Application name, selected patient and window controlbuttonsMenu Bar - Menu titlesTool bar – Navigation & toolbar buttonsSites/Categories Drop down boxTrend Days Selector (optional)Minimize, Maximize & Close - Minimizes, maximizes and closesthe application windowMain Window - The overall display of dataStatus Bar - Displays the current quantity of eachunacknowledged readingsNavigation Pane - Provides the most common options availablefor each user's role and privileges. | |
| Check NewReadings | Automatic or Manual | Automatic or Manual | |
| Vital SignsTransmissionTimes | Scheduled - one to four per dayMonitor configuration can be updated from monitor and/orLifeStream | Scheduled – one to four per dayMonitor configuration can be updated from monitor and/orLifeStream | |
| Alert Limits | Manual- User configured | Manual- User configured, with three levels: low, medium andhigh alerts. Two additional levels have been added to allow thehealthcare provider to further divide the red alerts. | |
| Vital Signs StatusTriage | Listed in order of oldest and most critical (# of vitals outsideset parameters) | Listed in order of oldest and most critical (# of vitals outside setparameters) | |
| Vital SignsReports(Read/writecapability) | Patient Lists, patient information, tabular trends, multi-patient trends, patient compliance (vital signs), equipmenthistory (all enabled equipment, single item history, patient'sequipment history), alert limit history, graphical trends andnotes | When accessed via the LifeStream Windows Client: Patient Lists,patient information, tabular trends, multi-patient trends, patientcompliance (vital signs), equipment history (all enabledequipment, single item history, patient's equipment history), alertlimit history, graphical trends and notes (read + write underlyingdata)When accessed via the LifeStream Web Client: Read underlyingdata only) | |
| EquipmentTracking | If enabled, the system allows users to track monitors, IDcards, scales, pagers and MedPartner-K053122 | If enabled, the system allows users to track monitors, ID cards,scales | |
| DiseaseManagement | 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 | |
| AdditionalSoftware 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, K061088Genesis Monitors: K040799, K061087,Genesis DM Monitors: K101242Genesis Touch Monitors: K112858, K141792 | Genesis DM Monitors: K101242Genesis Touch Monitors: K112858, K141792Govsphere VITAL Tablet: MDDS (exempt)Govsphere VITAL TV: MDDS (exempt) | |
| Administration | |||
| SystemAdministrationReports | Audit logs - Monitors/ID cards Report, Site Report, UsersReport 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 SystemStatus Report (read underlying data)When accessed via the LifeStream Web Client: No access forthese System Administration Reports. | |
| System Log | Presents a list of database and communication server errors | Presents a list of database and communication server errors | |
| SystemConfiguration | 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 Exportand Equipment tracking options; Enable/disable OutcomesQuestionnaire functionality | |
| System Security | |||
| System Security& Access Control | PIN & Username & password -Single Login for Dual role Administrator/ClinicianSmart Passwords | PIN (with check digit functionality) & Username & password -Single Login for Dual role Administrator/ClinicianSmart 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 PermissionsIdle session limit | Roles and PermissionsIdle 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 isa function of the Patient Monitoring system. The dataintegrity 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 afunction of the Patient Monitoring system. The data integrity isincluded as part of the encryption algorithm. Data hostingdatabase is firewall and antivirus protected. | |
| HIPAACompliant | Yes | Yes |
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Honeywell HomMed, LLC
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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
§ 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).