(5 days)
No
The description focuses on data collection, transmission, and communication features, with no mention of AI/ML for analysis or interpretation. The summary explicitly states that interpretation requires clinical judgment.
No.
The device acts as a communication link to collect and transmit medical information; it does not directly provide therapy or treatment.
No.
The device serves as a communication link to collect and transmit medical information from other monitoring devices; it does not perform diagnostic functions itself. The interpretation of the collected information requires clinical judgment by an experienced medical professional.
No
The device description explicitly states it serves as a communication link between FDA approved compatible devices (hardware) and server software, and also mentions a TV Interface and remote, indicating hardware components are part of the system.
Based on the provided text, the BL Healthcare Remote Care Management system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- BL Healthcare System Function: The BL Healthcare system's primary function is to collect and transmit data from other medical devices (blood pressure monitor, blood glucose monitor, weight scale) to a healthcare provider. It acts as a communication link and data relay system.
- No Specimen Analysis: The system itself does not perform any analysis on biological specimens. The analysis is done by the separate monitoring devices (which may or may not be IVDs themselves, like a blood glucose monitor).
- Focus on Data Transmission and Communication: The description emphasizes the system's role in transmitting data, enabling video conferencing, and providing information/reminders. These are not the core functions of an IVD.
Therefore, the BL Healthcare Remote Care Management system falls under the category of a remote patient monitoring or telehealth system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home users; Home; clinic
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K023749, K031840, K040966, K011779, K010029, K981533
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K982481, Exempt per 880.2700, K022171, K004010, K030419
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
| Regulation
Number | Product
Code | Classification Name | Devices
supported by
the system | Device 510(k)
Number |
|----------------------|-----------------|--------------------------------------------------------------|----------------------------------------------------|-------------------------|
| 870.2910 | DRG | Physiological Signal
Transmitters And
Receivers | | |
| 870.1130 | DXN | System,
measurement, blood-
pressure, non-
invasive | A&D Medical
(Lifesource)
Model # UA
767PC | K982481 |
| 870.2720 | FRW | Patient Scale | A&D Medical
(Lifesource) | Exempt per
880.2700 |
| 862.1345 | NBW | Glucose test system. | Roche Accu-
Chek Compact
system | K022171
K004010 |
1
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.
2
Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.
Substantial Equivalence Comparison
| Feature | Avid Care
K011779 and
K023749 | Philips
K030419 | American
Telecare
AVIVA
SYSTEMS
MODEL
NUMBERS
1010, 2020
K981533 | Carematix
Modified
System
K040966 | BL Healthcare
Remote Care
Management
system |
|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications of use | Enable
healthcare
Providers to
Manage
chronic
Conditions of
patients
remotely. | Enable
healthcare
Providers to
Manage chronic
Conditions of
patients
remotely. | Enable
healthcare
Providers to
Manage chronic
Conditions of
patients
remotely. | Enable
healthcare
Providers to
Manage chronic
Conditions of
patients
remotely. | Enable
healthcare
Providers to
Manage chronic
Conditions of
patients
remotely. |
| Intended use | Telemedicine
System | Telemedicine
System | Telemedicine
System | Telemedicine
System | Telemedicine
System |
| 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 |
| Data
Collection
software | Proprietary
Software | Proprietary
Software | Proprietary
Software | Proprietary
Software | Proprietary
Software |
| Communication
method with
Remote Care
Management
System | Via modem
over telephone
line | Via modem over
telephone line | Via modem over
telephone line | Via modem over
telephone line | Broadband
Internet
connection |
| Types of
sensors which can
be
interfaced
(wired or
wirelessly) to
receiver hub | Blood Pressure
Weight
Glucose levels
Oxygen
saturation
PT/INR
FEV/PEF | Blood Pressure
Weight
Glucose levels
Oxygen
saturation
PT/INR
FEV/PEF | Blood Pressure
Weight
Glucose levels
Oxygen
saturation
PT/INR
Temperature | Blood Pressure
Weight
Glucose levels
Oxygen
saturation
PT/INR
FEV/PEF | Blood Pressure
Weight
Glucose levels |
| Implementation-
method of
collecting
clearance by
data from
sensors | Modify off the
shelf sensors
with previous
510(k)
approval by
adding
communications interface
without
altering the
sensors | Modify off the
shelf sensors
with previous
510(k) approval
by adding
communications
interface without
altering the
sensors | Modify off the
shelf sensors
with previous
510(k) approval
by adding
communications
interface without
altering the
sensors | Modify off the
shelf sensors
with previous
510(k) approval
by adding
communications
interface without
altering the
sensors | External
communication
device |
| Sensor Software | Unchanged | Unchanged | Unchanged | Unchanged | Unchanged |
| Connectivity | Wired to hub | Wired to hub | Wired to hub | Wireless to hub | Wireless to hub |
| Communication
method of hub
with devices | Wired over
serial port | wireless to hub
Wireless RF
protocol | Wireless RF
protocol | Wireless RF
protocol | Wireless RF
protocol |
| Communications
protocol | Proprietary | Proprietary | Proprietary | Proprietary | Proprietary |
| Wireless
frequency | Not applicable | 915MHz FCC
assigned
channel | 915MHz FCC
assigned
channel | 915MHz FCC
assigned
channel | 915MHz FCC
assigned
channel |
| Power Source | Wall plug for
hub (a/c) and
batteries in
devices | Wall plug for
hub (a/c) and
batteries in
devices | Same | Wall plug for
hub (a/c) and
batteries in
devices | Wall plug for
hub (a/c) and
batteries in
devices |
| Display | On devices,
hub, and
monitors
connected to
Remote Care
Management
System | On devices, hub,
and monitors
connected to
Remote Care
Management
System | On devices, hub,
and monitors
connected to
Remote Care
Management
System | On devices, hub,
and monitors
connected to
Remote Care
Management
System | On devices, hub,
and monitors
connected to
Remote Care
Management
System |
| Video
conferencing | Not applicable | Not applicable | Video
Conferencing
over phone line | Not applicable | 2 way Video
conference via a
broadband
internet
connection |
| Medicine
Reminders | Not applicable | Not applicable | Not Available | Not applicable | The system
reminds the user
to take
medication if the
information is
programmed by
the Healthcare
Provider |
| Video User
Training | Not applicable | Not applicable | Not applicable | Not applicable | Instructional
Video clips may
be viewed by the
user by selecting
them from the
menu if enabled
by the
Healthcare
Provider |
3
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.
4
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.
5
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.
6
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
7
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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