(26 days)
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 and other devices 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 judgement by an experienced medical professional.
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.
This 510(k) summary does not contain the kind of detailed information about acceptance criteria and specific study results that you are requesting. This document is a declaration of substantial equivalence, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria with detailed clinical studies.
Here's why the requested information cannot be extracted from the provided text:
- No acceptance criteria tables or performance data: The document discusses "Software verification and validation" and "Electrical safety and Electromagnetic compatibility tests" but provides no specific acceptance criteria (e.g., accuracy, sensitivity, specificity, data transmission rates, error rates) or the quantitative results of these tests.
- No clinical or comparative effectiveness study details: The submission explicitly states "Summary of nonclinical testing," indicating that the verification and validation were primarily non-clinical. There is no mention of studies involving human subjects for evaluating the device's performance, let alone multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Focus on data transmission, not diagnostic accuracy: The device, TCx-I Remote Care Management system, is described as a system to "collect and transmit measurement information such as weight, blood pressure and pulse rate, and Blood Glucose data." Its function is data transfer, not making diagnostic interpretations itself. Therefore, concepts like "ground truth," "expert consensus," "sample size for test/training sets," or "adjudication methods" for diagnostic accuracy are not relevant to the described function of this device and are not elaborated upon. The document clearly states, "Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional."
In summary, the provided text establishes substantial equivalence for a data transmission system through non-clinical testing, but it does not detail performance acceptance criteria or provide the results of clinical studies to prove those criteria are met for diagnostic or interpretative purposes.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answers to the other specific questions about studies, ground truth, and expert involvement, as this information is not present in the provided 510(k) summary.
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BL Healthcare Inc
KI13493
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 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: 22 Nov 2011
Device Information Trade Name: TCx-I Remote Care Management system Common Name: Telemedicine systems Classification Product Codes: DRG, DXN, NBW, LFR, BZH, DQA, DQD, FLL, GJS
Legally Marketed Predicate Device(s): TCx-I Remote Care Management System (K101078)
Submission 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.
Intended use and 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.
Summary of nonclinical testing
Software verification and validation was performed on the device to ensure that the product requirements were met. Electrical safety and Electromagnetic compatibility tests were performed on the device to ensure conformance to FDA recognized standards.
Substantial Equivalence Summary
The TCx-I Remote Care Management system has the same fundamental technology as the predicate device.
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Conclusion:
The TCx-I system is substantially equivalent to the predicate device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 1 2011
BL Healthcare Inc. Inc. c/o Mr. Michael Mathur President & CEO 33 Commercial Street, Suite #3 Foxboro, MA 02035
Re: K113493
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 Codes: DRG, DXN, NBW, LFR, BZH, DQA, FLL, GJS, DQD Dated: November 22, 2011 Received: November 25, 2011
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. 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
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Page 2 - Mr. Michael Mathur
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mathi Jelln for
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 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 and other devices 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 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)
Math
bi Brum Zuckerman
(Division Sign-Off) Director DCD
Division of Cardiovascular Devices
2113493.
510(k) Number K113975
§ 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).