Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related technologies in the intended use, device description, or performance studies. The system focuses on data collection, transmission, storage, and basic parameter-based notifications.

Therapeutic

No.
The device is a monitoring system intended to aid in diagnosis and treatment by collecting physiological data, not to provide therapy itself.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The data from the Patient Status Engine is intended for use by healthcare professionals as an aid to diagnosis and treatment."

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as the Lifetouch Blue Sensor, Lifetemp Sensor, and optional third-party accessories like a Pulse Oximeter and Blood Pressure Monitor, in addition to software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
Device Function: The Patient Status Engine is described as a system for the continuous collection of physiological data directly from the patient's body (heart rate, respiration, temperature, activity, posture, SpO2, BP). This is done in vivo (within the living body), not in vitro.
Intended Use: The intended use is for monitoring physiological data and providing information to healthcare professionals as an aid to diagnosis and treatment. This is consistent with a patient monitoring system, not an IVD.
Components: The components listed are sensors applied to the body, a gateway for data transmission, and server software for data storage and analysis. None of these are typical components of an IVD test kit or analyzer that processes biological samples.

Therefore, the Patient Status Engine falls under the category of a patient monitoring device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes

DRG

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 UA77– 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).

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

18 years of age or older

Intended User / Care Setting

Healthcare professionals for continuous collection of physiological data in home and healthcare settings.

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)

Non-clinical performance tests against applicable standards, including electrical safety, electromagnetic compatibility, homecare environment, electrocardiographic monitoring equipment, biocompatibility, risk management, software, and usability. The device passed all tests. No human clinical testing was required.

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

Not Found

Predicate Device(s)

K152139

Reference Device(s)

Not Found

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

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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.

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)

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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

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

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	Electromagnetic
compatibility	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	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.