BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM

K101078 · Bl Healthcare, Inc. · DRG · May 10, 2010 · Cardiovascular

Device Facts

• Record ID: K101078
• Device Name: BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM
• Applicant: Bl Healthcare, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: May 10, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The purpose of the TCx-I 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. The system supports videoconferencing, multimedia education and messages. 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 judgment by an experienced medical professional.

Device Story

TCx-I Remote Care Management System collects physiological data (weight, blood pressure, pulse rate, blood glucose) from patients; transmits data to healthcare providers at remote facilities. System supports videoconferencing, multimedia education, and messaging. Installed by trained professionals; operated by patients for data collection. Healthcare providers review transmitted results to support clinical decision-making. Device does not provide real-time alarms or emergency monitoring; requires clinical judgment for interpretation. Benefits include remote patient monitoring and improved access to care.

Clinical Evidence

No clinical data. Bench testing only. Verification testing performed to ensure correct data collection and transmission to server, following FDA guidance on software validation.

Technological Characteristics

Remote physiological data transmission system. Conforms to IEC60601-1-1 and IEC60601-1-2. Software-based data collection and transmission. Connectivity via telephonic/networked infrastructure.

Indications for Use

Indicated for patients requiring remote collection and transmission of physiological data (weight, blood pressure, pulse rate, blood glucose) to healthcare providers. 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

• Telephone Based TCx-I Remote Care Management system (RCMS) (K052608)
• TCx-I Remote Care Management system (K051470)
• TCx-I Remote Care Management System (K093379)
• RNK Telephonic Stethoscope Model TR-1 (K034046)
• Carematix Wellness System (K073038)

Submission Summary (Full Text)

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MAY 1 0 2010

# 12.0 510(k) Summary

1 Submitter's name, address, telephone number, contact person and date This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirement of 21 CFR 807.92 Submitter's Name: Michael Mathur Address, telephone number, contact person and date: BL Healthcare, Inc 33 Commercial Street, Suite #3 Foxboro, MA 02035 Telephone number: [phone] Fax: [phone] Contact person: Michael Mathur President and CEO, BL Healthcare, Inc. [e-mail] Date: 15 Apr 2010

# 2. Name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name if known:

Trade Name: TCx-I Remote Care Management system Common Name: Telemedicine systems, Remote Healthcare System, eHealth device

## 3. Legally Marketed Predicate Device(s):

Telephone Based TCx-I Remote Care Management system (RCMS) (K052608) TCx-I Remote Care Management system (K051470) TCx-I Remote Care Management System (K093379) RNK Telephonic Stethoscope Model TR-1 (K034046) Carematix Wellness System (K073038)

## 4. Device Description:

TCx-I Remote Care Management system collects and transmits measurement information such as weight, blood pressure and pulse rate, and Blood Glucose data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.

## 5. A statement of indications for use:

The purpose of the system is to collect and transmit medical information such as weight, blood pressure and pulse rate, and Blood Glucose data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.

Page 1 of 2

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## 6. If the device has the same or different technological characteristics as compared to the predicate device.

The TCx-I Remote Care Management system has the same fundamental technology as the predicate devices.

### 6. (b) An assessment of performance data. 6. (b) (1) non-clinical tests

. Non clinical substantial equivalency testing and Risk based verification testing was performed based on FDA guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" to ensure that the data is collected and transmitted correctly to the server.

- . The device conforms to FDA recognized standards IEC60601-1-1 and IEC60601-1-2.
Labeling was written in accordance with FDA's guidance "Guidance on Medical . Device Patient labeling" April 19, 2001.

6. (b)(2) Assessment of the clinical tests submitted No clinical tests were performed as part of the testing.

6. (b)(3) Conclusions drawn from non-clinical and clinical tests that demonstrate that the device is as safe and effective as the predicate device.

In conclusion, the non-clinical testing performed on the TCx-I Remote Care Management System met the required objective, it demonstrated that the device is as safe and effective as the predicate device. In addition, the TCx-I Remote Care Management System has the same fundamental technology as the predicate devices and therefore it is substantially equivalent to the predicate devices.

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FDA 510(k) Page 26

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

BL Healthcare Inc. c/o Mr. Michael Mathur President and CEO 33 Commercial Street, Suite #3, Foxboro, MA 02035

MAY 1 0 2010

Re: K101078

Trade/Device Name: TCx-I Remote Care Management System Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: II (two) Product Code: 74 DRG Dated: April 13, 2010 Received: April 19, 2010

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 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. Michael Mathur

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely

Of 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 Inc

### 1401078 11.0 Indication for Use

The purpose of the TCx-I 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. The system supports videoconferencing, multimedia education and messages.

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 judgment by an experienced medical professional.

Prescription Use____________X (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)

J. Wood

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