(132 days)
No
The summary describes a system for collecting and transmitting patient data for retrospective review by a healthcare provider. There is no mention of AI, ML, or any form of automated analysis or interpretation of the data. The summary explicitly states that interpretation requires clinical judgment.
No.
The device collects and transmits medical information for retrospective review and monitoring, but it does not claim to treat, prevent, or mitigate any disease or condition. It explicitly states it is "not intended to provide time sensitive data or alarms" and "may not be used as a substitute for direct medical intervention or emergency care."
Yes
The device collects and transmits medical information (e.g., weight, blood pressure, pulse rate, blood glucose), which is then interpreted by a healthcare professional for clinical judgment, indicating its role in diagnosis or monitoring related to patient health status.
No
The device description explicitly states it serves as a "communication link between compatible devices and the server software". This implies the system includes hardware components (the "compatible devices") that collect the data, and the system facilitates the transmission of this data. While software is a key part of the system, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of this device clearly states its purpose is to collect and transmit medical information such as weight, blood pressure, pulse rate, blood glucose, SPO2, FEV1 and PEF from the patient. These are physiological measurements taken directly from the patient, not analyses of specimens.
- The device acts as a communication link and data transmission system. It collects data from compatible devices (which might be IVDs themselves, like a blood glucose meter) but the device itself is not performing the diagnostic test on a specimen.
- The interpretation of the data requires clinical judgment by an experienced medical professional. This further emphasizes that the device is a tool for data collection and transmission, not a diagnostic test that provides a result for interpretation.
The device falls under the category of remote patient monitoring systems or telehealth systems, which are distinct from IVD devices.
N/A
Intended Use / 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)
Product codes
DRG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider at another facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K051470, K040966, K001308, K031863
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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: (508) 543-4150 Fax: (508) 543-6150
Contact Person: Michael Mathur President and CEO Mmathur@BLHealthcare.com
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
:
1
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.
.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
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.
3
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 (240) 276-0210. 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 (800) 638-2041 or (301) 443-6597 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
4
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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