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 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:

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).

AI/ML Overview

The provided text is a 510(k) summary for the Isansys Lifecare Ltd Patient Status Engine. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not contain a specific study that proves the device meets explicit acceptance criteria in the format requested.

The document states that no human clinical testing was required to support the medical device, as its indications for use are equivalent to the predicate device. It relies instead on non-clinical performance tests against applicable standards. Therefore, an analysis of acceptance criteria and proven device performance as typically found in clinical studies (e.g., sensitivity, specificity, AUC) is not present.

Below is an attempt to structure the available information regarding "acceptance criteria" based on the non-clinical performance data provided.

1. Table of Acceptance Criteria and Reported Device Performance

Given that no clinical study with specific performance metrics (like accuracy, sensitivity, specificity) against a ground truth is provided, the "acceptance criteria" here refer to compliance with various electrical, electromagnetic, biocompatibility, risk management, and software standards.

Acceptance Criteria (Reference Standard)	Reported Device Performance (Result)
Electrical safety (BS EN 60601-1:2006+A12:2014)	Passed
Electromagnetic compatibility (BS EN 60601-1-2: 2007)	Passed
Homecare environment (BS EN 60601-1-11:2010)	Passed
Electrocardiographic monitoring equipment (BS EN 60601-2-27:2014)	Passed
Biocompatibility (BS EN ISO 10993-1:2009)	Passed
Risk Management (BS EN ISO 14971:2012)	Passed
Software (BS EN 62304:2006+A1:2015)	Passed
Usability (BS EN 62366-1:2015)	Passed

2. Sample size used for the test set and the data provenance

Not applicable. The "tests" were non-clinical performance and engineering validation tests, not tests on a dataset of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for clinical performance studies (e.g., diagnoses by experts, pathology reports) was not established for patient data in this submission. The "ground truth" for the non-clinical tests was compliance with international standards, which is evaluated by test engineers and accredited laboratories.

4. Adjudication method for the test set

Not applicable, as no external test set requiring expert adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a remote monitoring system, not an AI-assisted diagnostic tool that would typically involve human readers. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The evaluation was for the entire system's compliance with safety and performance standards for a monitoring device, not a standalone AI algorithm.

7. The type of ground truth used

The "ground truth" for this submission was the compliance with established international and national standards for medical device safety, electromagnetic compatibility, biocompatibility, software development, usability, and risk management.

8. The sample size for the training set

Not applicable. No machine learning model or "training set" is mentioned in the context of this 510(k) submission.

9. How the ground truth for the training set was established

Not applicable, as there was no training set.

Summary

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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);

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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

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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.

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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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.

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6. Device Description

Device Name:	Patient Status Engine
Components and Subsystems:	Patient Gateway (Samsung Tablet) – Manufactured by SamsungPatient Gateway Software – Manufactured by Isansys Lifecare LtdLifetouch Blue Sensor – Manufactured by Isansys Lifecare LtdLifetemp Sensor– Manufactured by Isansys Lifecare LtdLifeguard Server Software – Manufactured by Isansys Lifecare Ltd
Additional third party Accessories:	Pulse Oximeter 3150– Manufactured by NoninBlood Pressure Monitor UA767– Manufactured by A&D MedicalSkintact ECG Electrodes – Manufactured by Leonhard LangAmbu White Sensors – Manufactured by Ambu Inc.

7. Indication for Use Statement

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.

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 Numberand RegulationName	870.2910Transmitters andReceivers, PhysiologicalSignal, Radiofrequency	870.2910Transmitters andReceivers, PhysiologicalSignal, Radiofrequency	Same
Indications for Use	The Patient Status Engineis a wireless remotemonitoring systemintended for use byhealthcare professionalsfor continuous collectionof physiological data inhome and healthcaresettings.This includes heart rate,heart rate variability (R-Rinterval), ECG derivedrespiration rate data(EDR), skin temperature,activity, posture andoptional SpO2 and non-invasive Blood Pressure(BP).	The Vital Connect Platformis a wireless remotemonitoring systemintended for use byhealthcare professionalsfor continuous collection ofphysiological data in homeand healthcare settings.This can include heart rate,electrocardiography (ECG),heart rate variability, R-Rinterval, respiratory rate,skin temperature, activity(including step count), andposture (body positionrelative to gravity includingfall).	Equivalent - thedifferences not affectingsafety or effectivenessThe Patient StatusEngine does not haveelectrocardiographyECG.The Patient StatusEngine does includeoptional SpO2 and non-invasive Blood Pressure,supplied as optionalcleared third partyaccessories.
	Data is transmittedwirelessly from thesensors to the PatientGateways and from thePatient Gateways to acentral Server where it isstored for analysis	Data are transmittedwirelessly from the VitalConnect Sensor for storageand analysis.	Equivalent
	The Patient Status Enginecan include the ability tonotify healthcareprofessionals whenphysiological data falloutside selectedparameters	The Vital Connect Platformcan include the ability tonotify healthcareprofessionals whenphysiological data falloutside selectedparameters	Equivalent
	The device is intended foruse on general carepatients who are 18 yearsof age or older as ageneral patient monitor,	The device is intended foruse on general carepatients who are 18 yearsof age or older as a generalpatient monitor, to providephysiological 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 PatientStatus Engine is intendedfor use by healthcareprofessionals as an aid todiagnosis and treatment.It is not intended for useon critical care patientsnor replace standardmonitoring and/orroutine care.	The data from the VitalConnect Platform areintended for use byhealthcare professionals asan aid to diagnosis andtreatment. The device isnot intended for use oncritical care patients.	Equivalent
Mechanism of Action	Physiological dataacquisition (wireless) anddisplay	Physiological dataacquisition (wireless) anddisplay	Equivalent
TechnologyOverview	PEMS and Software,wireless communication	PEMS and Software,wireless communication	Equivalent
TouchscreenwithGraphicalUserInterface	Touchscreen to operateGraphical User Interface(GUI) on the PatientGateway.	The Software Library is runin third party devices.No other informationpublicly available.	Equivalent - thedifferences does notaffect safety oreffectiveness, asdetermined byverification andvalidation testing
Ambulatorymonitoring sensors	Yes	Yes	Equivalent
Heart Rate,	Yes	Yes	Equivalent
R-R interval	Yes	Yes	Equivalent - thedifferences do notaffect safety oreffectiveness, asdemonstrated by V&Vtesting.
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 PatientStatus Engine does notinclude ECG in theindications for use andmake no claims of such.This does not raise newquestions of safety andeffectiveness for itsintended use.
Respiration Rate,	Yes	Yes	Equivalent - thedifferences do notaffect safety oreffectiveness, asdemonstrated by V&Vtesting.
Thermistor Probe todetect skinTemperature	Yes	Yes	Equivalent - thedifferences do notaffect safety oreffectiveness, asdemonstrated by V&Vtesting.
Skin Temperature	Yes	Yes	Equivalent - thedifferences not affectingsafety andeffectiveness.
Activity	Yes	Yes	Equivalent
Posture	Yes	Yes	Equivalent
SpO2	Yes	No	Different - the PatientStatus Engine may beused with an FDAcleared SpO2 oximeter.This is an addition tothe indications for useas compared to thepredicate, but this hasbeen demonstrated assafe and effectivethrough 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 BloodPressure (BP)	Yes	No	Different - the PatientStatus Engine may beused with an FDAcleared BP monitor.This is an addition tothe indications for useas compared to thepredicate, but this hasbeen demonstrated assafe and effectivesthrough V&V testing.
Sterile	No	No	Equivalent
Single-Use	Yes	Yes	Equivalent
Battery Operated	Yes	Yes	Equivalent - thedifferences not affectingsafety andeffectiveness.
AC Powered	No	No	Equivalent
Central Server	Yes	Yes	Equivalent - thedifference does notaffect safety oreffectiveness.. Bothservers offer a securemeans of managing theupload, processing,storage and display ofsensor derived data.
Complies with BS ENISO 10993-1	Yes	Yes	Equivalent.
Electrical SafetyTesting	Yes	Yes	Equivalent.

Table 5A - Comparison of Characteristics

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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	Electromagneticcompatibility	Compliance to BS EN 60601-1-2: 2007	Passed

Table 5B – Performance Standards Testing Summary

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Test		Pass / fail criteria	Results

3	Homecare environment	Compliance to BS EN 60601-1-11:2010	Passed
4	Electrocardiographicmonitoring 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.

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).