TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)

K052608 · Bl Healthcare, Inc. · DRG · Feb 1, 2006 · Cardiovascular

Device Facts

• Record ID: K052608
• Device Name: TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)
• Applicant: Bl Healthcare, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Feb 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The purpose of the Telephone based BL Healthcare Remote Care Management System is to collect and transmit medical information such as weight, blood pressure and pulse rate, blood glucose, SPO2, FEV1 and PEF 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 compatible medical devices and healthcare facility server software. Collects physiological data (weight, BP, pulse, glucose, SPO2, FEV1, PEF) from peripheral devices; transmits data to remote healthcare provider. Used in home or clinical settings; installed by trained professionals. Healthcare providers access data via server for retrospective review and monitoring. Does not provide real-time alarms or emergency intervention; requires clinical judgment for interpretation. Benefits patients by facilitating remote monitoring of chronic conditions or physiological status.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System functions as a radiofrequency physiological signal transmitter and receiver (Product Code: DRG). Acts as a communication gateway/hub for peripheral medical devices. Connectivity involves data transmission to a remote server. No specific materials, energy sources, or software architecture details provided beyond its role as a communication link.

Indications for Use

Indicated for patients requiring remote monitoring of vital signs and physiological data, including weight, blood pressure, pulse rate, blood glucose, SPO2, FEV1, and PEF. Not for time-sensitive data, alarms, or 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

• BL Healthcare Remote Care Management Systems (K051470)
• Carematix Modified System (K040966)
• Zymed EasyView telemetry system (K001308)
• Motion Media Care Station 126S Videophone (K031863)

Submission Summary (Full Text)

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K052608

F li...

# BL Healthcare

2006 FEB 1

#### 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: [phone] Fax: [phone]

Contact Person: Michael Mathur President and CEO [e-mail]

Date Prepared: 18 Apr 05

### Trade Name: Telephone based BL Healthcare Remote Care Management System Common Name: Telemedicine systems

Regulation Number: 870.2910, DRG Regulatory Status: Class II

### Predicate Devices:

:

BL Healthcare Remote Care Management Systems, K051470 Carematix Modified System, K040966 Zymed EasyView telemetry system (K001308) Motion Media Care Station 126S Videophone (K031863)

### Submission Device Description and Intended use:

Telephone based BL Healthcare Remote Care Management system serves as the communication link between compatible devices and the server software at a compatible healthcare facility. The purpose of the system is to collect and transmit patient vital signs and other physiological data and transmit these results to their healthcare provider at another facility. The healthcare provider is able to access the data for retrospective review and monitoring.

### Substantial Equivalence Discussion

The submission device substantially equivalent to the BL Healthcare Remote Care Management System (K) With respect to Pulse Oximetry, substantial equivalence is clair red to Zymed EasyView telemetry system (K001308) and Care Station 126S Videophone

:

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## BL Healthcare

(K031863). The Carematix Modified System supports monitoring of Peak Flow and Oxygen (18031607). The Oaremannelonod glucose and spirometer similar to the submission device.

### Non-clinical testing

Substantial equivalence testing demonstrated with objective evidence that the functionality of the Telephone based BL Healthcare Remote Care Management system is substantially equivalent to those of the predicate devices.

### Conclusion:

Conceasion. Care Management system is substantially equivalent to the predicate devices. The BL Healthcare Remote Care Management system does not alter the measurement technology or the intended use of these devices.

.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 FEB 1

BL Healthcare, Inc. c/o Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Rd. Newtown, CT 06470

Re: K052608

Trade Name: Telephone based BL Healthcare Remote Care Management System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: January 12, 2006 Received: January 17, 2006

Dear Mr. Borsai:

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 Please be advised that I Dri 3 issuation of a succession complies with other requirements of the Act that IDA has made a decornmances and regulations administered by other Federal agencies. You must of any Federal statutes and regulations adminities. but not limited to: registration and listing (21 comply with an the Act 3 requirements, n.e.s.a.g., and manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 001), good mark 820); and if applicable, the electronic form in the quality systems (QS) rogusions (Sections 531-542 of the Act); 21 CFR 1000-1050. product taulation control pro ristein (seeting your device as described in your Section 510(k) This letter witi anow you to oegin manies of substantial equivalence of your device to a legally premaired notification: "The PDF Intainssification 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 If you ucsire specific arrest 10. Jour [phone]. Also, please note the regulation entitled, Colliati the Office of Compilance w (21 CFR Part 807.97) you may obtain. Misoranums by reference to promazibilities under the Act may be obtained from the Other general information on your responsible and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B.V.mmnmafor

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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### BL Healthcare

### Indications for Use

510(k) Number (if known): K052608

Device Name: Telephone based BL Healthcare Remote Care Management System (RCMS)

#### Indications for Use

The purpose of the Telephone based BL Healthcare Remote Care Management System is to collect and transmit medical information such as weight, blood pressure and pulse rate, blood glucose, SPO2, FEV1 and PEF 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 (Part 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)

Blossom

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