Who is the manufacturer of REMOTE CARE MANAGEMENT SYSTEMS (RCMS)?

Bl Healthcare, Inc. filed the 510(k) submission for REMOTE CARE MANAGEMENT SYSTEMS (RCMS) (K051470).

What is the FDA product code for REMOTE CARE MANAGEMENT SYSTEMS (RCMS)?

DRG. It is classified under 21 CFR 870.2910 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for REMOTE CARE MANAGEMENT SYSTEMS (RCMS)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like REMOTE CARE MANAGEMENT SYSTEMS (RCMS)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

REMOTE CARE MANAGEMENT SYSTEMS (RCMS)

Q: What are the predicate devices for REMOTE CARE MANAGEMENT SYSTEMS (RCMS)?

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).

K051470 · Bl Healthcare, Inc. · DRG · Jun 8, 2005 · Cardiovascular

Device Facts

Record ID	K051470
Device Name	REMOTE CARE MANAGEMENT SYSTEMS (RCMS)
Applicant	Bl Healthcare, Inc.
Product Code	DRG · Cardiovascular
Decision Date	Jun 8, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2910
Device Class	Class 2
Attributes	3rd-Party Reviewed

Indications for 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.

Device Story

System acts as communication link between patient-side medical devices (blood pressure monitor, glucose meter, weight scale) and remote healthcare facility server; utilizes broadband internet for data transmission. Features TV interface for video conferencing, medication reminders, and instructional video clips. Operated by patients at home; healthcare providers access data via server software. System collects/transmits physiological measurements; enables provider-patient interaction. Does not provide real-time alarms; requires clinical judgment for interpretation. Benefits include remote management of chronic conditions without requiring additional computer hardware for the patient.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence demonstrated through functional testing of the communication interface and system integration with previously cleared medical devices.

Technological Characteristics

System consists of a hub connecting to external medical devices via serial or infrared ports. Connectivity: Broadband internet. Wireless frequency: 915MHz (FCC assigned). Power: AC wall plug for hub, batteries for peripheral devices. Interface: TV-based display for video conferencing and data/trend viewing. Software: Proprietary data collection and transmission software.

Indications for Use

Indicated for patients requiring remote monitoring of chronic conditions, including blood pressure, pulse rate, weight, and blood glucose, under the prescription of a licensed physician or healthcare provider. Not for use in time-sensitive clinical situations or as a substitute for emergency care.

Regulatory Classification

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.

Predicate Devices

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)

Reference Devices

A&D Medical (Lifesource) Model # UA 767PC (K982481)
Roche Accu-Chek Compact system (K022171, K004010)

Submission Summary (Full Text)

{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}------------------------------------------------ K051470 #### 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 Page 1 of ____________________________________________________________________________________________________________________________________________________________________

REMOTE CARE MANAGEMENT SYSTEMS (RCMS)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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