(21 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 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.
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.
The BL Healthcare Inc. TCx-I Remote Care Management System (RCMS) is a telemedicine system designed to collect and transmit medical information (weight, blood pressure, pulse rate, blood glucose) from patients to healthcare providers. The provided document is a 510(k) summary and submission acceptance letter, which details its regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than a full clinical study with specific acceptance criteria and performance metrics for an AI algorithm.
Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication methods, MRMC studies, and standalone performance for an AI-powered device is not applicable or not provided in this document. The device described here is a data collection and transmission system, not an AI diagnostic or assistive tool in the way current AI medical devices are typically evaluated.
Here's what can be extracted from the document based on your questions:
1. Table of acceptance criteria and the reported device performance
Based on the document, there are no specific numeric acceptance criteria or reported device performance metrics in terms of accuracy, sensitivity, specificity, etc., as typically associated with AI performance. The "acceptance criteria" here relate to regulatory compliance and the system's ability to correctly transmit data.
| Acceptance Criteria Category | Specific Criteria (as inferred) | Reported Device Performance (as inferred) |
|---|---|---|
| Data Collection & Transmission | Ensure data is collected and transmitted correctly to the server. | Non-clinical substantial equivalency testing and Risk-based verification testing performed per FDA guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" demonstrated correct data collection and transmission. |
| Safety and Effectiveness | Device is as safe and effective as predicate devices. | Non-clinical testing met required objectives, demonstrating safety and effectiveness comparable to predicate devices. |
| Regulatory Compliance | Conforms to relevant FDA recognized standards. | Conforms to IEC60601-1-1 and IEC60601-1-2. Labeling conforms to FDA guidance "Guidance on Medical Device Patient labeling" April 19, 2001. |
| Technological Characteristics | Same fundamental technology as predicate devices. | The TCx-I Remote Care Management system has the same fundamental technology as the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/Not provided. The evaluation was based on non-clinical software validation and risk-based verification testing, not a clinical "test set" of patient data in the context of an AI algorithm.
- Data provenance: Not applicable/Not provided in the context of an AI algorithm's test data. The testing focused on the system's functional integrity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the sense of expert-labeled data for algorithm evaluation, was not established for this type of system validation. The "ground truth" implicitly was whether the system correctly collected and transmitted the input data.
4. Adjudication method for the test set
Not applicable. No adjudication method for a test set was mentioned, as it was not a study evaluating human interpretation or AI performance on medical images/signals.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. This device is a data transmission system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone performance evaluation (in the context of an AI algorithm's diagnostic or predictive capabilities) was done. The focus was on the reliability of data transmission.
7. The type of ground truth used
The "ground truth" for this system's validation would be the accurate transmission and display of the measured physiological parameters (weight, BP, pulse, blood glucose). This is established through engineering and software testing protocols, verifying that what is measured at the patient end is accurately reflected at the healthcare provider end. It does not involve expert consensus, pathology, or outcomes data in the typical sense of AI evaluation.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that undergoes "training" on a dataset. Its primary function is data acquisition and transmission.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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: (508) 543-4150 Fax: (508) 543-6150 Contact person: Michael Mathur President and CEO, BL Healthcare, Inc. mmathur@BLHealthcare.com 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.
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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.
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(b)(2) Assessment of the clinical tests submitted No clinical tests were performed as part of the testing.
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(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 (800) 638-2041 or (301) 796-7100 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
loti
§ 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).