(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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510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirement of 21 CFR 807.92
Submitter: Michael Mathur President and CEO BL Healthcare, Inc 33 Commercial Street, Suite #3 Foxboro, MA 02035 Phone: (508) 543-4150 Fax: (508) 543-6150
Contact Person: Michael Mathur President and CEO Mmathur@BLHealthcare.com
Date Prepared: 18 Apr 05
Device Information Trade Name: BL Healthcare Remote Care Management system Common Name: Telemedicine systems
The BL Healthcare Remote Care Management system
Classification Names:
| RegulationNumber | ProductCode | Classification Name | Devicessupported bythe system | Device 510(k)Number |
|---|---|---|---|---|
| 870.2910 | DRG | Physiological SignalTransmitters AndReceivers | ||
| 870.1130 | DXN | System,measurement, blood-pressure, non-invasive | A&D Medical(Lifesource)Model # UA767PC | K982481 |
| 870.2720 | FRW | Patient Scale | A&D Medical(Lifesource) | Exempt per880.2700 |
| 862.1345 | NBW | Glucose test system. | Roche Accu-Chek Compactsystem | K022171K004010 |
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051470
Predicate Device(s):
The BL Healthcare Remote Care Management system is substantially equivalent in functionality to the following predicate device(s):
M3810a Philips Telemonitoring system, K023749 Carematix Wellness system, K031840 Carematix Wellness system, K040966 AvidCare Series 100 Telemanagement System, K011779 AvidCare Corporation Home Health Monitoring System, K010029 Aviva Systems, K981533
Submission Device Description:
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.
Intended use and indications for use:
The purpose of the BL Healthcare Remote Care Management 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.
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Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.
Substantial Equivalence Comparison
| Feature | Avid CareK011779 andK023749 | PhilipsK030419 | AmericanTelecareAVIVASYSTEMSMODELNUMBERS1010, 2020K981533 | CarematixModifiedSystemK040966 | BL HealthcareRemote CareManagementsystem |
|---|---|---|---|---|---|
| Indications of use | EnablehealthcareProviders toManagechronicConditions ofpatientsremotely. | EnablehealthcareProviders toManage chronicConditions ofpatientsremotely. | EnablehealthcareProviders toManage chronicConditions ofpatientsremotely. | EnablehealthcareProviders toManage chronicConditions ofpatientsremotely. | EnablehealthcareProviders toManage chronicConditions ofpatientsremotely. |
| Intended use | TelemedicineSystem | TelemedicineSystem | TelemedicineSystem | TelemedicineSystem | TelemedicineSystem |
| Intended Users | Home users | Home users | Home users | Home users | Home users |
| Site of Use | Home; clinic | Home; clinic | Home; clinic | Home; clinic | Home; clinic |
| DataCollectionsoftware | ProprietarySoftware | ProprietarySoftware | ProprietarySoftware | ProprietarySoftware | ProprietarySoftware |
| Communicationmethod withRemote CareManagementSystem | Via modemover telephoneline | Via modem overtelephone line | Via modem overtelephone line | Via modem overtelephone line | BroadbandInternetconnection |
| Types ofsensors which canbeinterfaced(wired orwirelessly) toreceiver hub | Blood PressureWeightGlucose levelsOxygensaturationPT/INRFEV/PEF | Blood PressureWeightGlucose levelsOxygensaturationPT/INRFEV/PEF | Blood PressureWeightGlucose levelsOxygensaturationPT/INRTemperature | Blood PressureWeightGlucose levelsOxygensaturationPT/INRFEV/PEF | Blood PressureWeightGlucose levels |
| Implementation-method ofcollectingclearance bydata fromsensors | Modify off theshelf sensorswith previous510(k)approval byaddingcommunications interfacewithoutaltering thesensors | Modify off theshelf sensorswith previous510(k) approvalby addingcommunicationsinterface withoutaltering thesensors | Modify off theshelf sensorswith previous510(k) approvalby addingcommunicationsinterface withoutaltering thesensors | Modify off theshelf sensorswith previous510(k) approvalby addingcommunicationsinterface withoutaltering thesensors | Externalcommunicationdevice |
| Sensor Software | Unchanged | Unchanged | Unchanged | Unchanged | Unchanged |
| Connectivity | Wired to hub | Wired to hub | Wired to hub | Wireless to hub | Wireless to hub |
| Communicationmethod of hubwith devices | Wired overserial port | wireless to hubWireless RFprotocol | Wireless RFprotocol | Wireless RFprotocol | Wireless RFprotocol |
| Communicationsprotocol | Proprietary | Proprietary | Proprietary | Proprietary | Proprietary |
| Wirelessfrequency | Not applicable | 915MHz FCCassignedchannel | 915MHz FCCassignedchannel | 915MHz FCCassignedchannel | 915MHz FCCassignedchannel |
| Power Source | Wall plug forhub (a/c) andbatteries indevices | Wall plug forhub (a/c) andbatteries indevices | Same | Wall plug forhub (a/c) andbatteries indevices | Wall plug forhub (a/c) andbatteries indevices |
| Display | On devices,hub, andmonitorsconnected toRemote CareManagementSystem | On devices, hub,and monitorsconnected toRemote CareManagementSystem | On devices, hub,and monitorsconnected toRemote CareManagementSystem | On devices, hub,and monitorsconnected toRemote CareManagementSystem | On devices, hub,and monitorsconnected toRemote CareManagementSystem |
| Videoconferencing | Not applicable | Not applicable | VideoConferencingover phone line | Not applicable | 2 way Videoconference via abroadbandinternetconnection |
| MedicineReminders | Not applicable | Not applicable | Not Available | Not applicable | The systemreminds the userto takemedication if theinformation isprogrammed bythe HealthcareProvider |
| Video UserTraining | Not applicable | Not applicable | Not applicable | Not applicable | InstructionalVideo clips maybe viewed by theuser by selectingthem from themenu if enabledby theHealthcareProvider |
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Substantial Equivalence Discussion
The differences between the predicate devices and the BL Healthcare Remote Care Management system are:
The BL Healthcare Remote Care Management system enables videoconferencing and access to the WTVI menu on a specific TV channel.
The BL Healthcare Remote Care Management system provides the ability to videoconference using a broadband connection and for the patient to use the TV screen as a videoconference screen.
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51470
BL Healthcare
The BL Healthcare Remote Care Management system allows the care provider to enable selection of instructional video clips for the patient to view on the TV. Scientif of Inburbished on the Management system allows the patient to view uploaded data from the devices and trends.
These differences provide enhanced interaction between the Care provider and the Patient. The patient is able to videoconference without additional computer systems using the simple TV Interface and a camera.
The BL Healthcare Remote Care Management system uses a secure Broadband Internet The DE Trean.transfer data for data transfer similar to the Carematix Wellness System, which uses a phone line or a serial port connection to a computer to send data to an Internet Server.
The BL Healthcare Remote Care Management system connects externally to the FDA approved medical devices using a serial or infrared connection. The devices currently enable uppro rea their devices in this configuration. The differences pose no new risks and the functionality has been demonstrated to be substantially equivalent to the predicate devices.
Non-clinical testing
Similar to the predicate devices, the BL Healthcare Remote Care Management system utilizes devices that have already received 510(k) clearance. The BL Healthcare Remote Care do roos that have may ides and external interface to these FDA approved 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.
Substantial equivalence testing demonstrated with objective evidence that the basic functionality of the BL Healthcare Remote Care Management system is substantially equivalent to those of the predicate devices.
Conclusion:
Analysis of the substantial equivalence testing concluded that the BL Healthcare Remote Care Management system is substantially equivalent to the predicate devices. The BL Healthcare Remote Care Management system does not alter the measurement technology of the connected devices. The BL Healthcare Remote Care Management system provides and external interface to these FDA approved 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, suggesting a person in profile.
JUN 8 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BL Healthcare, Inc. c/o Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Road Newtown, CT 06470
Re: K051470
Trade Name: Remote Care Management System Regulation Number: 21 CFR 870.2910 Regulation Name: Physiological Signal Transmitters and Receivers Regulatory Class: Class II (two) Product Code: DRG Dated: June 1, 2005 Received: June 5, 2005
Dear Mr. Mathur:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Tamas Borsai
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 statutes and regulations administered by other Federal agencies. You must or uny 1 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) remarket notification. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blizummumafer
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indication of Use
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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummenauer
Initials Sign-Off
ular Devices
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§ 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).