(91 days)
The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, a mobile over-the-counter wireless communication hub, or MedApps HealthAIR, a portable over-the-counter wireless communication hub, which connects to commercially available glucose meters, scales, blood pressure monitors and pulse oximeters and HealthCOM, MedApps' secure host server system.
MedApps Remote Patient Monitoring devices receive and store measurements collected from the described monitors, either wirelessly (HealthPAL) or tethered (HealthPAL or HealthAIR). MedApps devices do not alter the indicated use of the peripheral monitors that they integrate with. MedApps devices indicate successful or failed reception and transmission of data with visual and audio cues (HealthPAL via OLED display screen, verbal message and audio tones; HealthAIR via LED lights and audio tones). MedApps devices store collected data and transmit to HealthCOM using commercially available, FCC compliant, wireless telecommunication protocols (including but not limited to cellular GSM, CDMA and WiMax),
Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven"t received a reading from you today, please send us your readings").
The MedApps 2.0 - Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
The MedApps 2.0 - Remote Patient Monitoring System consists of:
(1) MedApps HealthPAL hardware:
The physical component of the MedApps HealthPAL is an electronic device contained in a plastic enclosure with an OLED screen, built-in M2M cellular chip, speaker, smart cable connection, smart cables, wireless module, LED lights to indicate activity, timer button to assist patients with their reading schedule (i.e. remind them to take their reading in X minutes), last reading button, volume up and down buttons.
(2) MedApps HealthPAL firmware / software:
The firmware captures data from commercially available health monitors, and stores and transmits the information to the MedApps HealthCOM server, via the embedded communication chip / platform.
The firmware allows HealthPAL to receive information via wire or via embedded wireless module from accessory medical devices that are compatibly wireless enabled, which have been paired to the MedApps HealthPAL.
The firmware has many additional functions including:
Download of user profiles from the server to configure HealthPAL remotely.
HealthPAL has audio capability to deliver verbal announcement of readings and acknowledgment of data transmission from all connected accessory medical devices, time settings, volume control, educational content and reminders, in any language that is loaded to the device.
Timer capability, activated by the user to provide assistance with adhering to a reading schedule (reminders to take readings within a set timeframe).
OLED screen displays information regarding the HealthPAL's status including battery level, volume level, data transmission status, transmission pending indicator, activity icons / messages and other information to provide ease of use and promote patient adherence; as well as information received from accessory medical devices, such as the type of device, measurement, date and time of the last reading collected.
Battery charging, isolation circuits, and interfaces to individual accessory medical devices / protocols via the smart cable.
(3) MedApps HealthAIR hardware / software:
MA020 HealthAIR is a modified MA105 HealthPAL device. The physical component of the MedApps HealthAIR is an electronic device contained in a plastic enclosure with built-in M2M cellular chip, speaker, standard USB cable and USB Smart Cable connection, and LED lights to indicate activity regarding the receiving and transmitting of collected data.
Like the HealthPAL, HealthAIR's firmware / software captures, data from commercially available retail health monitors, and stores and transmits information to the MedApps HealthCOM server, via the embedded communication chip / platform.
The firmware allows HealthAIR to receive information via wire, either standard USB or with a MedApps USB Smart Cable, from accessory medical devices.
The firmware has many additional functions including:
Download of user profiles from the server to configure HealthAIR remotely.
HealthAIR's Audio feature uses audio tones to indicate acknowledgment of collected readings from all connected accessory medical devices as well as reading transmission via the cellular network.
HealthAIR's visual user interface utilizes LED lights of collected readings from all attached medical devices as well as reading transmission acknowledgements (via).
(5) MedApps HealthCOM software application:
The HealthCOM software application allows caregivers access to review patient data collected from accessory medical devices using MedApps hardware on the secure HealthCOM website. HealthCOM software allows professional caregivers to set patient readings.
HealthCOM software also allows the patient to establish an account and to direct / authorize their data to be directed to an outside, validated Personal Health Record (PHR), Electronic Health Record or Medical Record (EHR or EMR).
(6) MedApps IVR software application:
The IVR (Interactive Voice Response) software application provides the ability to contact the patient remotely, by phone (designated in the user profile), and executes an pre-approved ("canned") scripts to deliver preapproved ("canned") reminder messages ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings"), educational content and gather survey information.
In addition, the MedApps IVR application will send out Email, SMS / Text Messages, Paging, IM and other forms of communications in order to contact patients or caregivers. This will include reminders and alerts, based on clinically defined parameters / thresholds established in HealthCOM by the professional care provider.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Predicate Devices - e.g., Intel Health Guide PHS6000, Confidant 2.5, MedApps K083862) | Reported Device Performance (MedApps 2.0 - HealthPAL & HealthAIR) |
|---|---|---|
| Indications of Use | Enables healthcare providers to monitor and manage chronic conditions of patients remotely. | Same: Enables healthcare providers to monitor and manage biometric patient data collected remotely. |
| Intended Use | Telemedicine System. | Same: Telemedicine System. |
| Intended Users | Home users and Healthcare providers. | Same: Home users and patients outside of the clinical setting, as well as Healthcare providers. |
| Site of Use | Home, Clinic. | Same: Remote setting (e.g., Home / Work), Clinic. |
| Data Collection Software functionality | Transmit data from Sensor devices to Central Database. | Same: Transmit data from Sensor devices to Central Database. |
| Communication method of hub with Central Server | Via DSL or Phone Line Connection (Intel), Via Cellular Phone (Confidant), Via Embedded Cellular Technology (MedApps K083862). | Via Embedded Cellular Technology (GSM or CDMA). |
| Types of sensors which can be interfaced | Glucose, Scale, Blood Pressure, Pulse Ox, Peak Flow (Intel); Glucose, Scale, Blood Pressure (Confidant); Glucose, Scale, Blood Pressure, Pulse Ox (MedApps K083862). | Medical Devices designed for Home use: Glucose, Scale, Blood Pressure, Pulse Ox. |
| Implementation method of collecting data from sensors | Short range radio system using Wireless (Bluetooth) and Wired (tethered) cables (Intel, MedApps K083862); Short range radio system using Bluetooth (Confidant). | HealthPAL: Short range radio system using Wireless (Bluetooth) and Wired / tethered (Smart Cables). HealthAIR: Wired / tethered connection (USB, Smart Cables). |
| Sensor Software | Unchanged. | Same: Unchanged. |
| Connectivity | Short range radio system using Bluetooth and Wired (tethered) cables (Intel, MedApps K083862); Short range radio system using Bluetooth (Confidant). | HealthPAL: Short range radio system using Wireless (Bluetooth) and Wired / tethered (Smart Cables). HealthAIR: Wired / tethered cables (Future capability to use Bluetooth dongles). |
| Communication method of hub with devices | Short range radio system using Wireless (Bluetooth) and Wired (tethered) cables (Intel, MedApps K083862); Short range radio system using Wireless (Bluetooth) (Confidant). | HealthPAL: Short range radio system using Wireless (Bluetooth) and Wired / tethered (Smart Cables). HealthAIR: Wired (tethered) cables. |
| Communications Protocol | Wireless (Bluetooth) V2.0 & Wired (Tethered). | HealthPAL: Wireless (Bluetooth) V2.0 and Wired (Tethered). HealthAIR: Wired (Tethered). |
| Communication Frequency | Bluetooth: 2.402 to 2.480 GHz; GSM: 850/900/1800/1950 Mhz (Confidant, MedApps K083862). | HealthPAL: Bluetooth: 2.402 to 2.480 GHz; GSM: 850/900/1800/1950 Mhz. HealthAIR: GSM: 850/900/1800/1950 Mhz. |
| Power Source | Wall power plug (120 VAC/50-60) and Rechargeable Batteries in Device (Confidant, MedApps K083862). | HealthPAL: Wall power plug (120 VAC/50-60) or Rechargeable Batteries in HealthPAL. HealthAIR: Wall power plug (120 VAC/50-60) (no rechargeable battery in HealthAIR). |
| Visual Feedback / Display | On devices and hub, and monitors connected to central server (Intel, Confidant); OLED for HealthPAL (MedApps K083862). | HealthPAL: OLED for HealthPAL. HealthAIR: LED light indicators. |
| Communication with Patients | On screen display (Intel, Confidant); Audio/visual reading feedback on screen and by speaker; and Interactive Voice Response (IVR) System for patient (MedApps K083862). | HealthPAL: Audio/visual reading feedback on screen and by speaker; and Interactive Voice Response (IVR) System for patient. HealthAIR: LED lights for visual feedback and audio tones (beeps); Interactive Voice Response (IVR) system for patient. |
| Certification Testing | Safety 60601-1, EMC/EMI/FCC (60601-1-2), ESD & Radiated Immunity, FCC Bluetooth, (PTCRB), CTIA (battery), ETSI. | Safety 60601-1, EMC/EMI/FCC (60601-1-2), ESD & Radiated Immunity, (PTCRB), ETSI. |
Study Proving Device Meets Acceptance Criteria:
The document describes a "Non-Clinical Performance Data Testing and Review" study.
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state a specific sample size for a "test set" in terms of number of patients or readings. Instead, it refers to:
- "testing of all executable code and functionality"
- "testing of all Design Specifications (Design Control Inputs)"
- "Product Verification and Release Plan execution on both HealthPAL and HealthAIR" with "each type of user accessory medical device (glucose, blood pressure monitor, scale, and pulse oximeter)"
This suggests that the testing was comprehensive across the device's functional aspects and integrated accessories rather than focused on a specific patient data set.
The data provenance is not specified as country of origin or retrospective/prospective, as the testing described appears to be internal device verification and validation rather than a clinical trial with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided. The study focuses on design control verification and validation of electrical, software, and communication functionalities, not on the interpretation of medical data by experts.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the non-clinical testing described, an adjudication method in the context of expert review of medical data would not be applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document states, "The MedApps 2.0 Remote Patient Monitoring System does not rely on an assessment of clinical performance data."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
While the device has software and firmware that perform functions autonomously (collecting, storing, and transmitting data, setting thresholds), the overall system is designed for "Remote Patient Monitoring" with "Healthcare professionals" reviewing the transmitted information in HealthCOM. There isn't a standalone algorithm-only performance evaluation in a diagnostic context described. The focus is on the reliable functionality of the device as a data collection and transmission hub.
7. The Type of Ground Truth Used:
The "ground truth" used for this non-clinical testing would be the design specifications and requirements for the device's functionality, safety, and electromagnetic compatibility. The testing aimed to confirm that the device met these predefined technical and regulatory standards. It was not based on expert consensus, pathology, or outcomes data, as it was not a clinical performance study.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. The device described is a remote patient monitoring system that collects and transmits data from other medical devices. It is not an AI/ML algorithm that requires a "training set" in the context of learning patterns from data to make predictions or diagnoses.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided since there is no mention of a "training set" for an AI/ML algorithm.
§ 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).