Who is the manufacturer of Patient Status Engine?

Isansys Lifecare, Ltd. filed the 510(k) submission for Patient Status Engine (K172329).

What is the FDA product code for Patient Status Engine?

DRG. It is classified under 21 CFR 870.2910 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Patient Status Engine?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Patient Status Engine?

Vital Connect Platform/VitalPatch/HealthPatch MD (K152139).

Who can help prepare an FDA 510(k) submission like Patient Status Engine?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Patient Status Engine

K172329 · Isansys Lifecare, Ltd. · DRG · Apr 23, 2018 · Cardiovascular

Device Facts

Record ID	K172329
Device Name	Patient Status Engine
Applicant	Isansys Lifecare, Ltd.
Product Code	DRG · Cardiovascular
Decision Date	Apr 23, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2910
Device Class	Class 2

Indications for Use

The Patient Status Engine is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, heart rate variability (R-R interval), ECG derived respiration rate data (EDR), skin temperature, activity, posture and optional SpO2 and non-invasive Blood Pressure (BP). Data is transmitted wirelessly from the sensors to the Patient Gateways and from the Patient Gateways to a central Server where it is stored for analysis. The Patient Status Engine can include the ability to notify healthcare professionals when physiological data fall outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the Patient Status Engine is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or routine care.

Device Story

Wireless remote monitoring system; collects physiological data (HR, HRV, EDR, skin temp, activity, posture, optional SpO2/BP) via wearable sensors (Lifetouch Blue, Lifetemp). Data transmits to Patient Gateway (Samsung tablet) then to central Lifeguard Server for storage/analysis. Used in home/healthcare settings by healthcare professionals. Provides physiological information as aid to diagnosis/treatment; notifies clinicians of out-of-parameter data. Benefits patients through continuous monitoring outside critical care environments.

Clinical Evidence

No clinical data; bench testing only. Compliance with BS EN 60601-1, 60601-1-2, 60601-1-11, 60601-2-27, ISO 10993-1, ISO 14971, IEC 62304, and IEC 62366-1.

Technological Characteristics

Wireless physiological monitoring system. Components: Lifetouch Blue sensor, Lifetemp sensor, Samsung tablet Patient Gateway, Lifeguard Server. Connectivity: Wireless sensor-to-gateway, gateway-to-server. Standards: BS EN 60601-1, 60601-1-2, 60601-1-11, 60601-2-27, ISO 10993-1, ISO 14971, IEC 62304, IEC 62366-1. Battery-operated sensors; single-use.

Indications for Use

Indicated for general care patients 18+ years old in home and healthcare settings for continuous physiological monitoring (HR, HRV, EDR, skin temp, activity, posture, optional SpO2/BP). Not for critical care patients.

Regulatory Classification

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.

Predicate Devices

Vital Connect Platform/VitalPatch/HealthPatch MD (K152139)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 23, 2018 Isansys Lifecare Ltd % André Kindsvater Senior Consultant RA & OA Emergo Global Consulting, LLC 2500 Bee Cave Road Austin, Texas 78746 Re: K172329 Trade/Device Name: Patient Status Engine Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: March 26, 2018 Received: March 27, 2018 Dear André Kindsvater: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ ## Page 2 - André Kindsvater and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, M.A. Wilhelm for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172329 Device Name Patient Status Engine #### Indications for Use (Describe) The Patient Status Engine is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate variability (R-R interval), ECG derived respiration rate data (EDR), skin temperature, activity, posture and optional SpO2 and noninvasive Blood Pressure (BP). Data is transmitted wirelessly from the Patient Gateways and from the Patient Gateways to a central Server where it is stored for analysis. The Patient Status Engine can include the ability to notify healthcare professionals when physiological data fall outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the Patient Status Engine is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or routine care. 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary Patient Status Engine K 172329 #### 1. Submission Sponsor Isansys Lifecare Ltd 8C Park Square Milton Park Abingdon Oxfordshire OX14 4RR United Kingdom Phone number: +44 (0) 1235 436225 Contact: Julian Jones Title: Chief Compliance Officer ## 2. Submission Correspondent Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 Cell Phone: +41 78 843 7077 Office Phone: (512) 327 9997 Fax: (512) 327 9998 Contact: Andre Kindsvater, Senior Consultant, Regulatory Email: project.management@emergogroup.com #### 3. Date Prepared July 28, 2017 #### 4. Device Identification | Trade/Proprietary Name: | Patient Status Engine | |-------------------------|------------------------------------------------------------------| | Common/Usual Name: | Wireless Remote Monitoring System | | Classification Name: | Transmitters and Receivers, Physiological Signal, Radiofrequency | | Regulation Number: | 870.2910 | | Product Code: | DRG | | Device Class: | Class II | | Classification Panel: | Cardiovascular | #### 5. Legally Marketed Predicate Device K152139 - Vital Connect Platform/VitalPatch/HealthPatch MD by Vital Connect Inc. {4}------------------------------------------------ ### 6. Device Description The Patient Status Engine (PSE2) is a wireless data collection system that monitors physiological data and consists of the following components / subsystems and optional third party devices as listed below: | Device Name: | Patient Status Engine | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Components and Subsystems: | Patient Gateway (Samsung Tablet) – Manufactured by Samsung Patient Gateway Software – Manufactured by Isansys Lifecare Ltd Lifetouch Blue Sensor – Manufactured by Isansys Lifecare Ltd Lifetemp Sensor– Manufactured by Isansys Lifecare Ltd Lifeguard Server Software – Manufactured by Isansys Lifecare Ltd | | Additional third party Accessories: | Pulse Oximeter 3150– Manufactured by Nonin Blood Pressure Monitor UA767– Manufactured by A&D Medical Skintact ECG Electrodes – Manufactured by Leonhard Lang Ambu White Sensors – Manufactured by Ambu Inc. | At the subsystem level the Patient Gateway, Lifetouch Blue Sensor and Lifetemp Sensor are collectively identified as the Patient Digitisation Engine (PDE2). The inclusion of the Lifeguard Server completes the Patient Status Engine (PSE2). #### 7. Indication for Use Statement The Patient Status Engine is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, heart rate variability (R-R interval), ECG derived respiration rate data (EDR), skin temperature, activity, posture and optional SpO2 and non-invasive Blood Pressure (BP). Data is transmitted wirelessly from the sensors to the Patient Gateways and from the Patient Gateways to a central Server where it is stored for analysis. The Patient Status Engine can include the ability to notify healthcare professionals when physiological data fall outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the Patient Status Engine is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or routine care. #### 8. Substantial Equivalence Discussion The following table compares the Patient Status Engine to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device. | Manufacturer | Isansys Lifecare Ltd | Vital Connect Inc. | Variances / Equivalence | |-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Patient Status Engine | Vital Connect Platform, Healthpatch MD, VitalPatch | | | 510(k) Number | | K152139 | N/A | | Product Code | DRG | DRG | Same | | Manufacturer | Isansys Lifecare Ltd | Vital Connect Inc. | Variances / Equivalence | | Trade Name | Patient Status Engine | Vital Connect Platform, Healthpatch MD, VitalPatch | | | Regulation Number and Regulation Name | 870.2910 Transmitters and Receivers, Physiological Signal, Radiofrequency | 870.2910 Transmitters and Receivers, Physiological Signal, Radiofrequency | Same | | Indications for Use | The Patient Status Engine is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, heart rate variability (R-R interval), ECG derived respiration rate data (EDR), skin temperature, activity, posture and optional SpO2 and non- invasive Blood Pressure (BP). | The Vital Connect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). | Equivalent - the differences not affecting safety or effectiveness The Patient Status Engine does not have electrocardiography ECG. The Patient Status Engine does include optional SpO2 and non- invasive Blood Pressure, supplied as optional cleared third party accessories. | | | Data is transmitted wirelessly from the sensors to the Patient Gateways and from the Patient Gateways to a central Server where it is stored for analysis | Data are transmitted wirelessly from the Vital Connect Sensor for storage and analysis. | Equivalent | | | The Patient Status Engine can include the ability to notify healthcare professionals when physiological data fall outside selected parameters | The Vital Connect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters | Equivalent | | | The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, | The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. | Equivalent | | Manufacturer | Isansys Lifecare Ltd | Vital Connect Inc. | Variances / Equivalence | | Trade Name | Patient Status Engine | Vital Connect Platform, Healthpatch MD, VitalPatch | | | | The data from the Patient Status Engine is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or routine care. | The data from the Vital Connect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. | Equivalent | | Mechanism of Action | Physiological data acquisition (wireless) and display | Physiological data acquisition (wireless) and display | Equivalent | | Technology Overview | PEMS and Software, wireless communication | PEMS and Software, wireless communication | Equivalent | | Touchscreen with Graphical User Interface | Touchscreen to operate Graphical User Interface (GUI) on the Patient Gateway. | The Software Library is run in third party devices. No other information publicly available. | Equivalent - the differences does not affect safety or effectiveness, as determined by verification and validation testing | | Ambulatory monitoring sensors | Yes | Yes | Equivalent | | Heart Rate, | Yes | Yes | Equivalent | | R-R interval | Yes | Yes | Equivalent - the differences do not affect safety or effectiveness, as demonstrated by V&V testing. | | Manufacturer | Isansys Lifecare Ltd | Vital Connect Inc. | Variances / Equivalence | | Trade Name | Patient Status Engine | Vital Connect Platform, Healthpatch MD, VitalPatch | | | Electrocardiography (ECG) | No | Yes | Different - The Patient Status Engine does not include ECG in the indications for use and make no claims of such. This does not raise new questions of safety and effectiveness for its intended use. | | Respiration Rate, | Yes | Yes | Equivalent - the differences do not affect safety or effectiveness, as demonstrated by V&V testing. | | Thermistor Probe to detect skin Temperature | Yes | Yes | Equivalent - the differences do not affect safety or effectiveness, as demonstrated by V&V testing. | | Skin Temperature | Yes | Yes | Equivalent - the differences not affecting safety and effectiveness. | | Activity | Yes | Yes | Equivalent | | Posture | Yes | Yes | Equivalent | | SpO2 | Yes | No | Different - the Patient Status Engine may be used with an FDA cleared SpO2 oximeter. This is an addition to the indications for use as compared to the predicate, but this has been demonstrated as safe and effective through V&V testing. | | Manufacturer | Isansys Lifecare Ltd | Vital Connect Inc. | Variances / Equivalence | | Trade Name | Patient Status Engine | Vital Connect Platform, Healthpatch MD, VitalPatch | | | Non-invasive Blood Pressure (BP) | Yes | No | Different - the Patient Status Engine may be used with an FDA cleared BP monitor. This is an addition to the indications for use as compared to the predicate, but this has been demonstrated as safe and effectives through V&V testing. | | Sterile | No | No | Equivalent | | Single-Use | Yes | Yes | Equivalent | | Battery Operated | Yes | Yes | Equivalent - the differences not affecting safety and effectiveness. | | AC Powered | No | No | Equivalent | | Central Server | Yes | Yes | Equivalent - the difference does not affect safety or effectiveness.. Both servers offer a secure means of managing the upload, processing, storage and display of sensor derived data. | | Complies with BS EN ISO 10993-1 | Yes | Yes | Equivalent. | | Electrical Safety Testing | Yes | Yes | Equivalent. | #### Table 5A - Comparison of Characteristics {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### 9. Non-Clinical Performance Data As part of demonstrating safety and effectiveness of the Patient Status Engine and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Isansys Lifecare Ltd completed a number of non-clinical performance tests against applicable standards. | Table 3B - Performance Standards Testing Summary | | | | |--------------------------------------------------|----------------------------------|-------------------------------------------|---------| | | Test | Pass / fail criteria | Results | | 1 | Electrical safety | Compliance to BS EN 60601-1:2006+A12:2014 | Passed | | 2 | Electromagnetic compatibility | Compliance to BS EN 60601-1-2: 2007 | Passed | Table 5B – Performance Standards Testing Summary {9}------------------------------------------------ | Test | | Pass / fail criteria | Results | |------|----------------------------------------------|----------------------------------------|---------| | | | | | | 3 | Homecare environment | Compliance to BS EN 60601-1-11:2010 | Passed | | 4 | Electrocardiographic monitoring equipment | Compliance to BS EN 60601-2-27:2014 | Passed | | 5 | Biocompatibility | Compliance to BS EN ISO 10993-1:2009 | Passed | | 6 | Risk Management | Compliance to BS EN ISO 14971:2012 | Passed | | 7 | Software | Compliance to BS EN 62304:2006+A1:2015 | Passed | | 8 | Usability | Compliance to BS EN 62366-1:2015 | Passed | The Patient Status Engine passed all the testing in accordance with internal requirements, national standards, and international standards to support substantial equivalence of the subject device: #### 10. Clinical Performance Data There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device. #### 11. Statement of Substantial Equivalence By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics, but can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device. lt has been shown through the documents provided in this 510(k) submission that the minor differences between the Patient Status Engine and the predicate devices Vital Connect Platform/Healthpatch MD/VitalPatch do not raise any new questions regarding its safety and performance. The Patient Status Engine has the same intended use and the same or similar indications for use and technological characteristics as the previously cleared predicate device, Vital Connect Platform/Healthpatch MD/VitalPatch. The Patient Status Engine as designed and manufactured, is determined to be substantially equivalent to the predicate device.

Patient Status Engine

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Patient Status Engine

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps

Welcome

Check your email

Welcome!