(85 days)
Motiva is used in non-clinical settings to support effective care management of in home patients, by collecting, documenting and transmitting historical healthrelated patient information.
The Motiva Monitor Device Connectivity is used in conjunction with Motiva's Guide Service as a communication tool enabling healthcare providers the ability to remotely educate, motivate, and communicate with their patients, in combination with the ability to automatically collect in home patient parameter, information derived from approved medical devices.
Motiva is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the direct supervision and oversight of an appropriate healthcare professional.
The Motiva Monitor Device Connectivity (Motiva System) uses broadband and wireless technologies to create a link between the user and the user's Care Team. Information, such as educational videos, health surveys, and messages are sent to the user's television by way of a broadband connection. If the user has been supplied a Home Measurement Device, such as a Blood Pressure Monitor, Glucose Meter and Weight scale, readings are delivered to Motiva and retrievable by both the user and members of the user's Care Team. Based on the user's answers to assessment and stratification questions, The Motiva System enables the staff member to assign a Care Plan to the patient that provides a schedule for the delivery of educational materials, creates tasks for Care Team members when limits are exceeded, automates duties such as the delivery of reminders and motivational messages, and alerts Care Team members to users who may be at risk for not meeting care plan requirements.
A user interacts with the Motiva System by periodically (typically once or twice per day) using one or more measurement devices such as Blood Pressure Monitor, Glucose Meter or Weight Scale located in their home. These devices employ a wireless (Bluetooth) or wired link to communicate measurement data to an Internet Protocol Set Top Box, also located in the user's home. In turn, the Set Top Box communicates with the Medical Server (which includes Motiva Application software) using the user's broadband Internet connection. The information is sent to the healthcare professional's clinical client (containing Motiva Clinical Client software), which allows the healthcare professional to communicate back to the user in his/her home via the Internet to his or her own television set.
Here's an analysis of the provided text regarding the Philips Motiva Monitor Device Connectivity.
This submission does not contain a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than providing detailed performance studies or specific acceptance criteria.
The document explicitly states: "Substantial equivalence is not based on non-clinical or clinical performance data." This means that the FDA's decision to clear this device was based on its similarity in intended use and technological characteristics to an existing device (BL Healthcare Remote Care Management System K051470), and not on a separate performance study with acceptance criteria.
Therefore, many of the requested points about acceptance criteria, study details, sample sizes, ground truth, and expert involvement are not applicable or findable within this specific 510(k) summary. I can, however, extract the comparative information that is present regarding technological characteristics and intended use.
Acceptance Criteria and Device Performance (Not applicable for this 510(k) summary)
As stated in the document, "Substantial equivalence is not based on non-clinical or clinical performance data." This means specific acceptance criteria and a performance study demonstrating the device meets them were not part of this 510(k) submission. The FDA cleared this device based on its substantial equivalence to a predicate device.
Details of the Substantial Equivalence Comparison (Not a performance study)
While not a performance study against acceptance criteria, the document does contain a comparison of technological characteristics and intended use between the subject device (Motiva Monitor Device Connectivity) and the predicate device (BL Healthcare Remote Care Management system K051470).
1. Table of Key Comparisons:
| Feature | Predicate Device (BL Healthcare K051470) | Subject Device (Motiva Monitor Device Connectivity) | Comparison Outcome / Impact |
|---|---|---|---|
| Intended Use | Collect & transmit medical info (weight, BP, glucose) to healthcare provider. | Collect, document & transmit historical health-related patient info; communication tool for remote education, motivation, and communication; automatic collection of in-home patient parameters from approved medical devices. | Similar in core function. Motiva adds explicit communication/education aspects. No impact on safety/effectiveness. |
| Treatment Decisions | Not intended to provide time-sensitive data or alarms. | Not intended to provide automated treatment decisions, nor be a substitute for professional healthcare judgment. | Similar in intent to avoid automated decisions. No impact. |
| Professional Judgment | Interpretation requires clinical judgment by experienced medical professional. | All patient medical diagnosis and treatment by appropriate healthcare professional. | Same. No impact. |
| Data Collection Software | Proprietary Software | Proprietary Software | Same. |
| Communication Method (System) | Broadband Internet connection | Broadband Internet connection | Same. |
| Types of Sensors | Blood Pressure, Weight, Glucose levels | Blood Pressure, Weight, Glucose levels | Same. |
| Sensor Data Collection Implementation | External communication device | Un-modified off-the-shelf 510(k) approved sensors | Difference 1: Subject device is more direct, using approved measurement devices "as-is" with data transmitted via Bluetooth Adapter or wired interface cable. This is considered "similar but communication is more direct." |
| Hub-Device Communication | Wireless RF protocol | Bluetooth Serial Port Profile | Difference 2: Subject device uses Bluetooth, an industry-standard method, vs. predicate's proprietary RF. Considered "very similar but non-proprietary, industry standard communication method is employed." |
| Communications Protocol | Proprietary | Bluetooth v1.2 | Difference 3: Subject device uses Bluetooth v1.2, an industry-standard protocol, vs. predicate's proprietary protocol. Considered "very similar but non-proprietary, industry standard communication method is employed." |
| Wireless Frequency | 915MHz FCC assigned channel | 2.402 to 2.480 GHz (FHSS) ISM Band | Difference 4: Subject device uses the 2.4 GHz ISM band, an industry-standard frequency, vs. predicate's 915MHz. Considered "very similar but non-proprietary, industry standard communication method is employed." |
| Video Conferencing | 2-way video conference | Not applicable | Difference 5: Subject device does not have video conferencing. This is compensated by message capability and care plan responses, serving similar communication functions. Considered "similar, user to healthcare provider communications are accomplished with message capability and care plan responses." |
| Care Plan Surveys | Not applicable | May be completed if enabled by Healthcare Provider | Difference 6: Subject device has care plan surveys. Considered "responses to care plans serve as a form of communication similar to that which occurs with video conferencing." |
| Messages | Not applicable | Text messages between Healthcare Provider and patient | Difference 7: Subject device has text messaging. Considered "messages serve as a form of communication similar to that which occurs with video conferencing." |
2. Sample Size Used for the Test Set and Data Provenance:
* Not applicable. The document explicitly states that substantial equivalence is not based on non-clinical or clinical performance data. Therefore, there was no "test set" in the context of device performance outlined in this 510(k).
3. Number of Experts and Qualifications:
* Not applicable. See point 2.
4. Adjudication Method:
* Not applicable. See point 2.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No. An MRMC study was not conducted or reported in this 510(k) summary. The claim of substantial equivalence was not based on human performance improvements with or without AI assistance.
6. Standalone Performance Study:
* No. A standalone algorithm performance study was not conducted or reported. The submission states, "Substantial equivalence is not based on non-clinical or clinical performance data."
7. Type of Ground Truth Used:
* Not applicable. Since no performance study was conducted, there was no ground truth established to evaluate the device's performance against.
8. Sample Size for the Training Set:
* Not applicable. This device is described as a "collection of off-the-shelf and custom designed Internet communication, audio / video interconnection devices and approved measuring devices." The "design of the device focuses largely on the software of the home and clinical user interfaces." There is no indication of a deep learning or AI model with a distinct "training set" in the modern sense that would require a ground truth for training within this document. The software itself is proprietary but isn't described as using a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
* Not applicable. See point 8.
Summary of 510(k) Approach:
This 510(k) submission for the Philips Motiva Monitor Device Connectivity relies entirely on demonstrating substantial equivalence to a previously cleared predicate device (BL Healthcare Remote Care Management System K051470) based on:
- Equivalent Intended Use: The overall purpose and clinical context are similar.
- Similar Technological Characteristics: While there are some differences (e.g., Bluetooth vs. proprietary RF, direct sensor connection vs. external communication device), Philips argues that these differences do not raise new questions of safety or effectiveness. The new features like surveys and text messages are presented as alternative communication methods that achieve similar goals to the predicate's video conferencing.
The absence of detailed performance data, acceptance criteria, or clinical study results is consistent with a 510(k) pathway that primarily focuses on comparing the new device to a predicate, rather than proving a specific performance claim through novel studies.
§ 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).