(127 days)
Unknown
The summary mentions "data analytics, risk scores and static algorithms" which could potentially involve AI/ML, but it doesn't explicitly state the use of AI, ML, or related terms like DNN. The "Mentions AI, DNN, or ML" section is marked as "Not Found".
No
The device is described as a "remote patient monitoring platform" intended for "monitoring disease or deterioration, improvement and to support clinical decision making and to encourage self-management of disease by the patients." Its function is to collect, display, and analyze patient data for healthcare professionals to aid in clinical management and decision-making, rather than directly treating or curing a disease.
Yes
The text explicitly 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." Diagnostic devices are those used to identify the nature or cause of a disease or condition, and the mention of "diagnosis" clearly indicates this functionality.
Yes
The device is explicitly described as "modular software as a medical device (SaMD)" and its components are listed as a mobile app, web app, and web portal. While it can utilize compatible devices to obtain data, the device itself is the software platform for data collation, delivery, viewing, and analysis.
Based on the provided text, the Huma platform is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Huma Platform's Function: The Huma platform is described as a "modular software as a medical device (SaMD)" that collects and displays physiological and non-physiological data obtained via a mobile app or web app, potentially utilizing compatible devices. It focuses on monitoring, data visualization, trend analysis, risk assessment, and communication.
- Lack of Sample Testing: There is no mention of the Huma platform performing any tests on biological samples taken from the patient. Its function is to collect, process, and display data that is either entered by the patient/caregiver or obtained from connected devices.
The Huma platform falls under the category of a Software as a Medical Device (SaMD) used for remote patient monitoring and clinical decision support, but it does not perform the in vitro testing that defines an IVD.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
MWI, MSX
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.
Mentions image processing
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).
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric populations
Intended User / Care Setting
Trained healthcare professionals in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient's home setting.
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)
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.
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
The results of the performance testing conclude the Huma RPM is substantially equivalent to the aforementioned predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
Indications for Use
Submission Number (if known)
K230214
Device Name
Huma RPM (RPM)
Indications for Use (Describe)
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.
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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3
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 Arrythmia
detection or alarms); System, Network and
Communication, 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
4
Reference Device:
- (1) AirStrip One Web Client with ACM, cleared under K211949, by AirStrip Technologies
DESCRIPTION OF THE DEVICE 4.
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.
5. INTENDED USE
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.
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 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
5
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 (Subject
| and Predicate) | Intended Use/Indications for Use |
|---|---|
| Subject Device | |
| Huma RPM | |
| Medopad Inc | 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. 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 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. 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. | |
| Predicate 1 | |
| AirStrip One Web | |
| Client | |
| (K160862) | Information is generated by other medical devices and patient information |
| system, and not by this device. This device captures this information from these | |
| Devices (Subject | |
| and Predicate) | Intended Use/Indications for Use |
| other systems and displays it for clinicians. This device is intended to be used | |
| by 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 from | |
| the monitored system | |
| • To provide a request for remote consultation regarding a patient's waveform | |
| or other data | |
| This device software can display the following the physiologic data captured by | |
| other medical devices: ECG Waveform; Heart Rate Monitored; Manually | |
| counted chest wall movement; Oxygen Saturation; Intracranial Pressure; | |
| Central Venous Pressure; Pulmonary Capillary Wedge Pressure; Cardiac | |
| Index; Cardiac Output; Cerebral Perfusion Pressure; Systolic Blood Pressure | |
| Invasive; Mean Arterial Pressure Invasive; Diastolic Blood Pressure Invasive; | |
| Systolic Blood Pressure Cuff ;Mean Arterial Pressure Cuff ; Diastolic Blood | |
| Pressure Cuff | |
| Predicate 2 | |
| AirStrip Remote | |
| Patient | |
| Monitoring | |
| (RPM) Remote | |
| Data Viewing | |
| (K122133) | AirStrip RPM is software capable of displaying physiologic and other patient |
| information. This information is generated by other medical devices and patient | |
| information system, and not by AirStrip RPM. Airstrip RPM captures this | |
| information from these other systems and displays it for clinicians. AirStrip | |
| RPM is intended to be used by clinicians for the following purposes: | |
| • By using a cellular telephone or other device on which AirStrip RPM is | |
| installed, to review physiologic data of a patient when the clinician is not | |
| at the hospital | |
| • To view the near real-time waveforms remotely and to remotely review | |
| other standard or critical near real-time patient data from the | |
| monitored system | |
| • To provide a request for remote consultation regarding a patient's | |
| waveform or other data | |
| The AirStrip RPM software can display the following the physiologic data | |
| captured by other. medical devices: - ECG Waveform - Heart Rate Monitored; | |
| Manually counted chest wall movement; Oxygen Saturation; Intracranial | |
| Pressure; 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 Arterial | |
| Pressure Invasive - Diastolic Blood Pressure Invasive; Systolic Blood Pressure | |
| Cuff; Mean Arterial Pressure Cuff; Diastolic Blood Pressure Cuff - Vasoactive | |
| Infusions; Antiarrhythmics - Sedation - Paralytics -Laboratory Data including - | |
| Blood Gas -Chemistry -Hematology -Coagulation; Allergies; Medications | |
| Counter-indication | |
| Reference | |
| Device | |
| AirStrip ONE | |
| Web Client | |
| with Alarm | AirStrip ONE Web Client with ACM gathers data from the medical devices |
| that are connected to the patient. AirStrip ONE Web Client with ACM is not | |
| directly connected to the individual, but to a networked medical device | |
| receiving data, and connects that data to individuals by medical record number | |
| Devices (Subject | |
| and Predicate) | Intended Use/Indications for Use |
| Communication | |
| Management | |
| (ACM) | or defined patient ID. AirStrip ONE Web Client with ACM is intended to be |
| used by clinicians for the following purposes: | |
| To visualize physiological data using a web viewer to assess clinical status of a | |
| patient when the source system cannot be observed directly by the clinician | |
| To view the near real-time and historic waveforms | |
| To view other near real-time patient data from a monitored system. | |
| To provide a request for remote consultation regarding a patient's waveform or | |
| other data and to send electronic images of the cardiac rhythm to the medical | |
| record | |
| To allow clinicians to manage secondary alarm transmission by suppressing | |
| non-critical alarms |
Table 1. Intended Use / Indications for Use Comparison
6
7
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 - Huma
RPM | Predicates 1 & 2
AirStrip One Web Client
(K160862) &
AirStrip (RPM) Remote
Data Viewing
(K122133) | Reference Device
AirStrip One Web Client
with ACM (K211949) | Same or Different |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Intended user | Clinicians and patients | Clinicians | Clinicians | Similar. Patient
interface allows
patients to view their
own information. |
| Targeted
users | Patients | Patients | Patients | Same |
| Targeted
population | Adults and Pediatric | Adults | Adults and Pediatric | Same |
| Directly
connected to
patient | No | No | No | Same |
| Health Data
collection | Patient physiological data
including blood pressure,
cardiac monitor, breathing
pressure, breathing rate
cardiac monitor, | ECG Waveform; Heart
Rate Monitored;
Respiratory Rate; Oxygen
Saturation; Intracranial
Pressure; Central Venous | - ECG Waveform - Heart
Rate Monitored, Manually
counted chest wall
movement, Oxygen
Saturation - Intracranial | Similar. The subject
device allows
monitoring of
physiological as well as
other life-style related |
8
| Characteristics | Subject Device - Huma | Predicates 1 & 2 | Reference Device | Same or Different |
|---|---|---|---|---|
| RPM | AirStrip One Web Client | |||
| (K160862) & | ||||
| AirStrip (RPM) Remote | ||||
| Data Viewing | ||||
| (K122133) | AirStrip One Web Client | |||
| with ACM (K211949) | ||||
| temperature, breathing | ||||
| frequency, and oxygen | ||||
| saturation. In addition, the | ||||
| subject also allows other | ||||
| life-style related factors | ||||
| such as exercising, | ||||
| smoking-vaping, stress, | ||||
| nutrition, diets, menta | ||||
| well-being, orthopedic | ||||
| related information and | ||||
| COVID-19 symptoms. | Pressure; Pulmonary | |||
| Capillary Wedge Pressure; | ||||
| Cardiac Index; Cardiac | ||||
| Output; Cerebral Perfusion | ||||
| Pressure; Systolic Blood | ||||
| Pressure Invasive; Mean | ||||
| Arterial Pressure Invasive; | ||||
| Diastolic Blood Pressure | ||||
| Invasive; Systolic Blood | ||||
| Pressure Cuff; Mean | ||||
| Arterial Pressure Cuff; | ||||
| Diastolic Blood Pressure | ||||
| Cuff | Pressure, 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 Arterial | ||||
| Pressure Invasive - | ||||
| Diastolic Blood Pressure | ||||
| Invasive, Systolic Blood | ||||
| Pressure Cuff, Mean | ||||
| Arterial Pressure Cuff, | ||||
| Diastolic Blood Pressure | ||||
| Cuff - Vasoactive | ||||
| Infusions, Antiarrhythmics |
- Sedation - Paralytics -
Laboratory Data including
-Blood Gas -Chemistry -
Hematology -Coagulation,
Allergies- Medications | parameters such
exercising, smoking-
vaping, stress related
data capturing whereas
the predicates have few
only physiological
signs capturing and
monitoring. The subject
device also allows
COVID-19 and
orthopedic related
information to be
captured. |
| Device
Type/Material
Composition | Software as a medical
Device (SaMD) | Software as a medical
Device (SaMD) | Software as a medical
Device (SaMD) | Same |
| Connectivity | Secured Internet | Internet | Internet | Same |
| Data
transmission | Modem, Wi-Fi | Modem, Wi-Fi | Modem, Wi-Fi | Same |
| Data source
location | Hospital | Hospital | Hospital | Same |
| Data Storage | Securely stores and
manages
encrypted patient
measurements.
Medical device data sets
are provided
through the user interface
of choice
for the patient, physicians,
or other partners to
securely access the
patient's information. | Securely stores and
manages encrypted
patient measurements,
medical device data sets
are
provided through the
user interface of choice
for the patient,
physicians, or other
partners to securely
access the patient's
information. | Securely stores and
manages encrypted
patient measurements,
medical device data sets
are
provided through the
user interface of choice
for the patient,
physicians, or other
partners to securely
access the patient's
information. | Same |
| Use Environment | Hospital, Patient's home if
the patient is at home | Hospital | Hospital | Similar. The subject
device allows patients
to be at their home
environment and input |
9
| Characteristics | Subject Device – Huma
RPM | Predicates 1 & 2
AirStrip One Web Client
(K160862) &
AirStrip (RPM) Remote
Data Viewing
(K122133) | Reference Device
AirStrip One Web Client
with ACM (K211949) | Same or Different |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
System | IOS (IPhone), Android | IOS (IPhone); Android;
other devices where the
AirStrip App is installed | IOS (IPhone); Android;
other devices where the
AirStrip App is installed | physician-specified
data
Similar. The subject
device program can be
installed on 2 primary
mobile device operating
systems iOS and
Android. |
| Ability to view
real-time
data/visualization | Yes | Yes | Yes | Yes |
| Data generated
by Software | Information is collected
from other devices and not
by this subject device. | Information is generated
by other medical devices
and patient information
system, and not by this
device. | Information is generated
by other medical devices
and patient information
system, and not by this
device. | Same |
| Possibility of
flagging, triaging
based on
algorithm | Yes; possible | No | Yes. Allows clinicians to
set rules and enable
triaging for alarms/alerts | Same |
| Data Exporting
Capability | 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.