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510(k) Data Aggregation
(5 days)
The BL Healthcare Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, blood glucose monitor, and weight scale upon the prescription of a licensed physician or healthcare provider. The BL Healthcare Remote Care Management system serves as the communication link between the compatible devices and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center.
The purpose of the system is to collect and transmit medical information such as weight, blood pressure and pulse rate, and blood glucose from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
This system is installed by or with support from trained professionals.
This device is not intended to provide time sensitive data or alarms. This system may not be used as a substitute for direct medical intervention or emergency care.
Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.
BL Healthcare Remote Care Management system serves as the communication link between FDA approved compatible devices such as Blood Pressure monitor, Blood Glucose Instrument and Weight Scale, and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center. The system enables video conferencing over broadband and a TV Interface between the Healthcare provider and the patient. The Healthcare provider may also enable video clips, automatic medication reminders and other training materials for the user to view. The TV interface provides this information on a specific TV channel and the user is informed of new updates or videoconferencing request via audio-visual indicators on the TV Interface remote.
The purpose of the system is to collect and transmit measurement information such as weight, blood pressure and pulse rate, and blood glucose from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
The provided text is a 510(k) summary for the BL Healthcare Remote Care Management system, focusing on its substantial equivalence to predicate devices rather than a detailed performance study with specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, especially in the context of an AI/ML device, cannot be extracted directly from this document.
The device described is a telemedicine system that acts as a communication link to transmit data from FDA-approved medical devices (blood pressure monitor, blood glucose instrument, weight scale) to healthcare providers. It also offers video conferencing and medication reminders. It is not an AI/ML diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC a study design for AI.
Here's an attempt to answer the questions based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present explicit acceptance criteria or a performance table in the way one would for a diagnostic or AI/ML device. The "performance" being evaluated here is the functional equivalence of the communication system to predicate telemedicine devices.
| Acceptance Criteria (Implied for communication function) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Functional Equivalence: Ability to collect and transmit medical information (weight, blood pressure, glucose) from compatible devices to a healthcare facility. | The BL Healthcare Remote Care Management system is demonstrated to be substantially equivalent in functionality to predicate telemedicine systems (e.g., M3810a Philips Telemonitoring system, Carematix Wellness system, AvidCare Series 100 Telemanagement System, Aviva Systems). |
| Data Integrity: Transmission of data without alteration from connected devices. | "The external connectivity does not alter the intended use of the devices since the devices provide connectivity to a computer serial port in that configuration." "The BL Healthcare Remote Care Management system does not alter the measurement technology of the connected devices." |
| Safety: No new risks posed by the differences between the device and predicates (e.g., broadband connection, video conferencing via TV). | "The differences pose no new risks..." |
| Compatibility: Ability to connect with FDA-approved medical devices via serial or infrared connection. | "The BL Healthcare Remote Care Management system connects externally to the FDA approved medical devices using a serial or infrared connection." |
| Intended Use Fulfillment: System effectively serves its purpose as a communication link for remote care management. | "Purpose of the system is to collect and transmit measurement information...to their healthcare provider." This is stated as being fulfilled. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission describes substantial equivalence testing for a communication system, not a clinical trial with a "test set" of patient data or samples. The "testing" referred to is functional testing, not statistical evaluation with a patient cohort.
- Data Provenance: Not applicable for the reasons above. The document does not mention data from specific countries or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant to this type of device submission. The device's function is data transmission, not interpretation or diagnosis.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" in the context of clinical data requiring adjudication mentioned in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No, an MRMC study was not done.
- Effect Size: Not applicable. This device is a data transmission system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable. This device is not an algorithm performing a standalone diagnostic function. It is a communication device; human interpretation is explicitly part of its intended use ("Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.").
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. The concept of "ground truth" (e.g., pathology, outcomes data) is not relevant for demonstrating the substantial equivalence of a communication device for remote monitoring. The "truth" here relates to the reliable and accurate transmission of data from existing, FDA-cleared medical devices.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not employ machine learning that would require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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