The Huma platform is a modular software as a medical device (SaMD) which may utilize compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management. It is intended to be used for the physiological and non-physiological intermittent or spot-check monitoring of all condition patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient's home setting. It is intended for the monitoring of patients by trained healthcare professionals.

Device Description

The Huma RPM is a digital remote patient monitoring platform that empowers patients to better manage their own health. The modular solution tracks symptoms and vital signs, flags deterioration, incorporates telemedicine functionality and can be connected to other medical devices.

Data from the App is surfaced and analyzed in the Portal which has flagging for easy triage and decision making. The Portal enables clinicians to safely monitor patients, spot deterioration and intervene early to improve outcomes and avoid unnecessary clinic, outpatient and hospital attendance.

The portal can display information about individual patients and visualize data trends. Clinicians can add notes and collaborate with colleagues to ensure the patient receives the optimal care they need. The platform also has messaging capability and telemedicine for patient video consultations. The platform can be integrated with EHR systems and existing patient portals. The clinician portal also allows for Role-Based-Access-control (RBAC) based on a person's role within the healthcare facility according to data view rights for different healthcare system personnel.

AI/ML Overview

The provided document is a 510(k) summary for the Huma RPM device. It largely focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics, and describes software development, testing, and compliance with standards. However, it does not contain details about specific acceptance criteria, a comparative effectiveness study (MRMC), standalone performance (algorithm only), or how ground truth was established for a test set or training set.

The document discusses "Acceptance Testing" as part of their robust software development process, but this refers to internal quality assurance for functional requirements rather than a clinical performance study with predefined metrics. The "Anomalies" section states "No anomalies were discovered during the verification/validation testing," which is a statement about internal software quality, not clinical performance.

Therefore, many of the requested details cannot be extracted directly from this 510(k) summary. I will answer based on the information available and explicitly state when information is not present in the provided text.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

Based on the provided 510(k) summary (K230214) for Huma RPM, the document primarily focuses on establishing substantial equivalence to predicate devices through a comparison of intended use and technological characteristics, along with verification and validation of the software development process. It does not present a detailed clinical study with specific quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy) relative to a ground truth.

The "Performance Testing" section describes a robust software development process including Unit and Integration Testing, Acceptance Testing (internal quality assurance), Demo Smoke Testing, and Demo Sanity Testing. It also lists compliance with various FDA guidances and international standards related to software, risk management, cybersecurity, usability, and alarm systems. However, these are descriptions of the software development lifecycle and compliance efforts, not a clinical study demonstrating performance against specific clinical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

As a clinical performance study with explicit quantitative acceptance criteria is not described in the provided document, a table of such criteria and performance metrics cannot be generated. The document primarily relies on demonstrating that the device is "substantially equivalent" to established predicate devices based on its intended use and technological features.

The internal Acceptance Testing mentioned (within "Performance Testing") is described as:

"completed by entering test cases, organizing test suites, executing test runs, and tracking their results, all through a robust web interface."
"followed a centralized test management concept that helped in easy communication and enabled cross-checking of tasks across the Quality Acceptance Testers."
"for all agreed requirements were executed on the Quality Acceptance environment."
The "Anomalies" section states: "No anomalies were discovered during the verification/validation testing."

This indicates system-level functional and non-functional requirements were tested, but no specific performance statistics are provided.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document describes software validation and verification but does not detail a clinical test set with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. Since a clinical test set requiring expert ground truth is not described, this information is not applicable from the provided text.

4. Adjudication Method for the Test Set

This information is not provided in the document, as a clinical test set requiring adjudication is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not provided in the document. The filing focuses on demonstrating substantial equivalence of the device's function (data display, flagging, analytics) to predicate devices, rather than a comparative effectiveness study of human readers with vs. without AI assistance. The described "Performance Testing" is related to software verification and validation, not clinical efficacy or comparative effectiveness.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document states: "The platform may also provide data analytics, risk scores and static algorithms that may assist in the assessment of risk prediction, diagnosis, disease monitoring and prognostication." However, it does not contain details of a standalone performance study for these algorithms (e.g., how accurate the risk predictions are, or diagnostic performance metrics) against a defined ground truth. The overall device is described as "delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management" and "intended for the monitoring of patients by trained healthcare professionals," indicating a human-in-the-loop context.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not provided in the document, as a clinical study with an established ground truth is not detailed. For the internal "Acceptance Testing," the "ground truth" would be the predefined functional and non-functional requirements of the software.

8. The Sample Size for the Training Set

This information is not provided in the document. While the platform mentions "data analytics, risk scores and static algorithms," there is no mention of a machine learning model that would require a "training set" in the context of this 510(k) summary. The algorithms are referred to as "static algorithms," suggesting pre-defined rules rather than adaptive machine learning models.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document, as a training set for machine learning is not mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

June 2, 2023

Medopad Inc Mani Shanmugham Head of Quality and Regulatory 101 6th Avenue New York, New York 10013

Re: K230214

Trade/Device Name: Huma RPM (RPM) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI. MSX Dated: April 20, 2023 Received: May 2, 2023

Dear Mani Shanmugham:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K230214

Device Name

Huma RPM (RPM)

Indications for Use (Describe)

The Huma platform comprises a number of different modules and functionalities that can be selected by the customer for configuration of care plans which can be further personalized for the patients. Clinical information collected from these modules is displayed on a clinician web portal and patient app with the addition of flagging out of range datasets, trend visualization, goal setting and communication channels between clinicians and patients.

The data displayed on the mobile app, web portal or web app can be labeled, flagged for the purposes of monitoring disease or deterioration, improvement and to support clinical decision making and to encourage self-management of disease by the patients. The platform may also provide data analytics, risk scores and static algorithms that may assist in the assessment of risk prediction, diagnosis, disease monitoring and prognostication. The Huma platform can be used for adult and pediatric populations with functionality to accommodate data entry by caregivers and guardians. The Huma platform is not intended for use in high-acuity environments, such as ICU or operating rooms.

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

1. GENERAL INFORMATION

1.1 Submitter and 510(k) Owner

Medopad Inc 101, Avenue of the Americas Ofc 327 New York, NY 10023

Official Correspondent 1.2

Mani Shanmugham, Ph.D. 101, Avenue of the Americas Ofc 327 New York, NY 10023 Ph: 801-673-9973 Email: mani.shanmugham@huma.com

1.3 Date of Preparation

April 14, 2023

NAME OF THE DEVICE 2.

2.1 Trade/Proprietary Name

Huma RPM

2.2 Common/Usual Name

Monitor, Physiological, Patient (without Arrhythmia detection or alarms) System, Network and Communication, Physiological Monitoring

2.3 Classification Information

Classification Name:	Monitor, Physiological, Patient (without Arrythmiadetection or alarms); System, Network andCommunication, Physiological Monitors
Classification Regulation:	21 CFR 870.2300
Class:	2
Product Code:	MWI, MSX
Panel:	Cardiovascular

3. PREDICATE DEVICES

Predicates: AirStrip Remote Patient Monitoring (RPM) and Web Client

(1) AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing, cleared under K122133, by AirStrip Technologies
(2) AirStrip One Web Client, cleared under K160862, by AirStrip Technologies

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Reference Device:

(1) AirStrip One Web Client with ACM, cleared under K211949, by AirStrip Technologies

DESCRIPTION OF THE DEVICE 4.

5. INTENDED USE

The data displayed on the mobile app, web portal or web app can be labeled, flagged and triaged for the purposes of monitoring disease or deterioration, improvement and to support clinical decision making and to encourage self-management of disease by the patients. The

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platform may also provide data analytics, risk scores and static algorithms that may assist in the assessment of risk prediction, diagnosis, disease monitoring and prognostication. The Huma platform can be used for adult and pediatric populations with functionality to accommodate data entry by caregivers and guardians. The Huma platform is not intended for use in high-acuity environments, such as ICU or operating rooms.

INTENDED USE COMPARED TO THE PREDICATES 6.

The Huma RPM has an intended use statement that is comprised of a combination of the intended uses from the two (2) Predicates and the reference device. The statement is very similar with the exception of several word changes specific to the subject device as the subject device is device-, condition - and system- agnostics. The devices also share the same target patient population, the same users and conditions of use (Table 1).

Devices (Subjectand Predicate)	Intended Use/Indications for Use
Subject DeviceHuma RPMMedopad Inc	The Huma platform is a modular software as a medical device (SaMD) whichmay utilize compatible devices and software to obtain data collated via a mobileapp or web app and delivered to the clinician via a web portal or web app whereit may be viewed to drive clinical management. It is intended to be used for thephysiological and non-physiological intermittent or spot-check monitoring ofall condition patients in professional healthcare facilities, such as clinics,hospitals or skilled nursing facilities, or in the patient's home setting. It isintended for the monitoring of patients by trained healthcare professionals. TheHuma platform comprises a number of different modules and functionalities thatcan be selected by the customer for configuration of care plans which can befurther personalized for the patients.Clinical information collected from these modules is displayed on a clinicianweb portal and patient app with the addition of flagging out of range datasets,trend visualization, goal setting and communication channels between cliniciansand patients.The data displayed on the mobile app, web portal or web app can be labeled,flagged and triaged for the purposes of monitoring disease or deterioration,improvement and to support clinical decision making and to encourage self-management of disease by the patients. The platform may also provide dataanalytics, risk scores and static algorithms that may assist in the assessment ofrisk prediction, diagnosis, disease monitoring and prognostication. The Humaplatform can be used for adult and pediatric populations with functionality toaccommodate data entry by caregivers and guardians.The Huma platform is not intended for use in high-acuity environments, suchas ICU or operating rooms.
Predicate 1AirStrip One WebClient(K160862)	Information is generated by other medical devices and patient informationsystem, and not by this device. This device captures this information from these
Devices (Subjectand Predicate)	Intended Use/Indications for Use
	other systems and displays it for clinicians. This device is intended to be usedby clinicians for the following purposes:• To view the near real-time waveforms remotely• To remotely review other standard or critical near real-time patient data fromthe monitored system• To provide a request for remote consultation regarding a patient's waveformor other dataThis device software can display the following the physiologic data captured byother medical devices: ECG Waveform; Heart Rate Monitored; Manuallycounted chest wall movement; Oxygen Saturation; Intracranial Pressure;Central Venous Pressure; Pulmonary Capillary Wedge Pressure; CardiacIndex; Cardiac Output; Cerebral Perfusion Pressure; Systolic Blood PressureInvasive; Mean Arterial Pressure Invasive; Diastolic Blood Pressure Invasive;Systolic Blood Pressure Cuff ;Mean Arterial Pressure Cuff ; Diastolic BloodPressure Cuff
Predicate 2AirStrip RemotePatientMonitoring(RPM) RemoteData Viewing(K122133)	AirStrip RPM is software capable of displaying physiologic and other patientinformation. This information is generated by other medical devices and patientinformation system, and not by AirStrip RPM. Airstrip RPM captures thisinformation from these other systems and displays it for clinicians. AirStripRPM is intended to be used by clinicians for the following purposes:• By using a cellular telephone or other device on which AirStrip RPM isinstalled, to review physiologic data of a patient when the clinician is notat the hospital• To view the near real-time waveforms remotely and to remotely reviewother standard or critical near real-time patient data from themonitored system• To provide a request for remote consultation regarding a patient'swaveform or other dataThe AirStrip RPM software can display the following the physiologic datacaptured by other. medical devices: - ECG Waveform - Heart Rate Monitored;Manually counted chest wall movement; Oxygen Saturation; IntracranialPressure; Central Venous Pressure - Pulmonary Capillary Wedge Pressure;Cardiac Index; Cardiac Output; Cerebral Perfusion Pressure; Urine Output -Urine/Stool Mix Output; Systolic Blood Pressure Invasive; Mean ArterialPressure Invasive - Diastolic Blood Pressure Invasive; Systolic Blood PressureCuff; Mean Arterial Pressure Cuff; Diastolic Blood Pressure Cuff - VasoactiveInfusions; Antiarrhythmics - Sedation - Paralytics -Laboratory Data including -Blood Gas -Chemistry -Hematology -Coagulation; Allergies; MedicationsCounter-indication
ReferenceDeviceAirStrip ONEWeb Clientwith Alarm	AirStrip ONE Web Client with ACM gathers data from the medical devicesthat are connected to the patient. AirStrip ONE Web Client with ACM is notdirectly connected to the individual, but to a networked medical devicereceiving data, and connects that data to individuals by medical record number
Devices (Subjectand Predicate)	Intended Use/Indications for Use
CommunicationManagement(ACM)	or defined patient ID. AirStrip ONE Web Client with ACM is intended to beused by clinicians for the following purposes:To visualize physiological data using a web viewer to assess clinical status of apatient when the source system cannot be observed directly by the clinicianTo view the near real-time and historic waveformsTo view other near real-time patient data from a monitored system.To provide a request for remote consultation regarding a patient's waveform orother data and to send electronic images of the cardiac rhythm to the medicalrecordTo allow clinicians to manage secondary alarm transmission by suppressingnon-critical alarms

Table 1. Intended Use / Indications for Use Comparison

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7. TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATES

A comparison of the technological features between the Huma RPM and the Predicates and Reference device is shown in Table 2 below for the Remote Patient Monitoring System.

Characteristics	Subject Device - HumaRPM	Predicates 1 & 2AirStrip One Web Client(K160862) &AirStrip (RPM) RemoteData Viewing(K122133)	Reference DeviceAirStrip One Web Clientwith ACM (K211949)	Same or Different
Intended user	Clinicians and patients	Clinicians	Clinicians	Similar. Patientinterface allowspatients to view theirown information.
Targetedusers	Patients	Patients	Patients	Same
Targetedpopulation	Adults and Pediatric	Adults	Adults and Pediatric	Same
Directlyconnected topatient	No	No	No	Same
Health Datacollection	Patient physiological dataincluding blood pressure,cardiac monitor, breathingpressure, breathing ratecardiac monitor,	ECG Waveform; HeartRate Monitored;Respiratory Rate; OxygenSaturation; IntracranialPressure; Central Venous	- ECG Waveform - HeartRate Monitored, Manuallycounted chest wallmovement, OxygenSaturation - Intracranial	Similar. The subjectdevice allowsmonitoring ofphysiological as well asother life-style related

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Characteristics	Subject Device - Huma	Predicates 1 & 2	Reference Device	Same or Different
	RPM	AirStrip One Web Client(K160862) &AirStrip (RPM) RemoteData Viewing(K122133)	AirStrip One Web Clientwith ACM (K211949)
	temperature, breathingfrequency, and oxygensaturation. In addition, thesubject also allows otherlife-style related factorssuch as exercising,smoking-vaping, stress,nutrition, diets, mentawell-being, orthopedicrelated information andCOVID-19 symptoms.	Pressure; PulmonaryCapillary Wedge Pressure;Cardiac Index; CardiacOutput; Cerebral PerfusionPressure; Systolic BloodPressure Invasive; MeanArterial Pressure Invasive;Diastolic Blood PressureInvasive; Systolic BloodPressure Cuff; MeanArterial Pressure Cuff;Diastolic Blood PressureCuff	Pressure, Central VenousPressure - PulmonaryCapillary Wedge Pressure,Cardiac Index, CardiacOutput, Cerebral PerfusionPressure - Urine Output -Urine/Stool Mix Output,Systolic Blood PressureInvasive, Mean ArterialPressure Invasive -Diastolic Blood PressureInvasive, Systolic BloodPressure Cuff, MeanArterial Pressure Cuff,Diastolic Blood PressureCuff - VasoactiveInfusions, Antiarrhythmics- Sedation - Paralytics -Laboratory Data including-Blood Gas -Chemistry -Hematology -Coagulation,Allergies- Medications	parameters suchexercising, smoking-vaping, stress relateddata capturing whereasthe predicates have fewonly physiologicalsigns capturing andmonitoring. The subjectdevice also allowsCOVID-19 andorthopedic relatedinformation to becaptured.
DeviceType/MaterialComposition	Software as a medicalDevice (SaMD)	Software as a medicalDevice (SaMD)	Software as a medicalDevice (SaMD)	Same
Connectivity	Secured Internet	Internet	Internet	Same
Datatransmission	Modem, Wi-Fi	Modem, Wi-Fi	Modem, Wi-Fi	Same
Data sourcelocation	Hospital	Hospital	Hospital	Same
Data Storage	Securely stores andmanagesencrypted patientmeasurements.Medical device data setsare providedthrough the user interfaceof choicefor the patient, physicians,or other partners tosecurely access thepatient's information.	Securely stores andmanages encryptedpatient measurements,medical device data setsareprovided through theuser interface of choicefor the patient,physicians, or otherpartners to securelyaccess the patient'sinformation.	Securely stores andmanages encryptedpatient measurements,medical device data setsareprovided through theuser interface of choicefor the patient,physicians, or otherpartners to securelyaccess the patient'sinformation.	Same
Use Environment	Hospital, Patient's home ifthe patient is at home	Hospital	Hospital	Similar. The subjectdevice allows patientsto be at their homeenvironment and input

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Characteristics	Subject Device – HumaRPM	Predicates 1 & 2AirStrip One Web Client(K160862) &AirStrip (RPM) RemoteData Viewing(K122133)	Reference DeviceAirStrip One Web Clientwith ACM (K211949)	Same or Different
OperatingSystem	IOS (IPhone), Android	IOS (IPhone); Android;other devices where theAirStrip App is installed	IOS (IPhone); Android;other devices where theAirStrip App is installed	physician-specifieddataSimilar. The subjectdevice program can beinstalled on 2 primarymobile device operatingsystems iOS andAndroid.
Ability to viewreal-timedata/visualization	Yes	Yes	Yes	Yes
Data generatedby Software	Information is collectedfrom other devices and notby this subject device.	Information is generatedby other medical devicesand patient informationsystem, and not by thisdevice.	Information is generatedby other medical devicesand patient informationsystem, and not by thisdevice.	Same
Possibility offlagging, triagingbased onalgorithm	Yes; possible	No	Yes. Allows clinicians toset rules and enabletriaging for alarms/alerts	Same
Data ExportingCapability	Yes	Unknown	Unknown	Different

7.1 Similarities and Differences in Technology Comparison

The Huma RPM is equivalent to the combination of the AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing (K122133), AirStrip One Web Client (K160862) and the reference device AirStrip One Web Client with ACM Module (K211949).

The technology of the Subject Huma RPM combines the convenience of web portal interface and mobile device data input. This consolidation allows greater flexibility to clinicians and patients to choose their own data collection/viewing mode. In other words, Huma RPM integrates with compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management.

Similar to the predicate devices, Huma platform can be accessed from any internet connected device with compatibility across multiple web browsers. The Huma remote patient monitoring (RPM) platform comprises a smartphone Patient App (available on Android and iOS) and a web-browser Clinician Portal. The patient app can also be deployed on webbrowser for patients who do not have or do not wish to use a smartphone or smartphone App.

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Further, Huma RPM platform allows for the simple export and download of patient data and records from the Clinician Portal via a couple of standard file formats - CSV and JSON. The export / download is configurable and can be generated based on client requirements. The export / download can be customised to include data in a required format (e.g. grouped by patient or grouped by data module - such as individual vital sign, patient notes or patient symptoms only or attached pictures / images, or call out specific data modules and dates / time periods). This offers flexibility to clinicians to further process patient data, if needed.

The data displayed on the mobile app, web portal or web app can be labelled, flagged and triaged for the purposes of monitoring disease or deterioration. improvement and to support clinical decision making and to encourage self-management of disease by the patients. The platform may also provide data analytics, risk scores and static algorithms that may assist in the assessment of risk prediction, diagnosis, disease monitoring and prognostication.

PERFORMANCE TESTING 8.

Huma RPM was designed and developed according to a robust software development process and was rigorously verified and validated. As Huma RPM utilizes a modular approach in order to allow a number of different configurations on a single platform, each configuration is tailored to a specific disease area and patient cohort. The test approach consisted of the following:

Unit and Integration Testing

Unit and Integration Testing were completed against the separate components of the product, split into the following:

. Backend
. Android App
iOS App •
Clinician Portal .

Acceptance Testing

The acceptance test was completed by entering test cases, organizing test suites, executing test runs, and tracking their results, all through a robust web interface. It followed a centralized test management concept that helped in easy communication and enabled crosschecking of tasks across the Quality Acceptance Testers. Acceptance tests for all agreed requirements were executed on the Quality Acceptance environment.

Demo Smoke Testing

Smoke Testing is a type of testing that comprises a non-exhaustive set of tests that aim at ensuring that the most important functions work. Smoke tests were executed on Demo environment to see that the features are working as expected.

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Demo Sanity Testing

Sanity test of the release specific features (based on the features supported on Demo deployment builds) was performed on Demo environments to ensure the readiness of the release build.

Anomalies

No anomalies were discovered during the verification/validation testing. Furthermore, Huma RPM was tested for performance in accordance with following internal product requirements:

Risk Control Measure Verification ●
Interoperability Verification ●
ISO 27001: 2013 Certification ●
Network Testing ●
Vulnerability Scan
o Code Analysis

Huma RPM complies with the following standards/guidance, as appropriate, through testing and/or analysis:

FDA guidance: Off-the-shelf software use in medical devices, 27 Sep 19.
FDA guidance: General principles of software validation; Final guidance for . industry and FDA staff, 11 Jan 02.
. Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 06 Sep 17.
IEC 62304 A1: 2015, Medical device software Software life cycle processes. ●
ISO 14971: 2019, Medical devices Application of risk management to medical ● devices.
ISO /IEC 27001: 2013, Information technology Security techniques -. Information security management systems - Requirements.
FDA Guidance: Cybersecurity in Medical Devices: Quality System Considerations . and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff, 8 Apr 22.

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. FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05.
IEC 82304-1:2016, Health software Part 1: General requirements for product ● safety.
IEC 62366-1: 2015, Medical Devices – Part 1, Application of usability engineering to medical devices.
. ISO 60601-1-8: 2006: Part 1-8 General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems.

Biological Safety and Materials Testing

The subject product, Huma RPM, is a SaMD. Therefore, no biocompatibility and Materials Testing are required.

Packaging, Sterilization and Shelf-life

There is no primary or secondary packaging or other special packaging associated with the device. Huma platform does not contain any form of composition, dimension or sterilization requirements. The platform is a software as a medical device (SaMD). Furthermore, there is no defined shelf-life for this SaMD.

The results of the performance testing conclude the Huma RPM is substantially equivalent to the aforementioned predicate and reference devices.

CONCLUSIONS 9.

The information presented in this 510(k) submission demonstrates that the Medopad Inc's Huma RPM is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).