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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the BL Healthcare Remote Care Management System (K052608), focusing on acceptance criteria and the study proving it:

Important Note: The provided document is a 510(k) Summary and the corresponding FDA clearance letter. It is a regulatory submission, not a detailed scientific study report. As such, it focuses on demonstrating "substantial equivalence" to predicate devices rather than providing in-depth performance studies with acceptance criteria, sample sizes, and ground truth establishment in the way a clinical trial would.

Therefore, many of the requested details (especially quantitative performance metrics, sample sizes, ground truth specifics, and MRMC studies) are not present in this type of document. The 510(k) process for this device type primarily relies on demonstrating that the new device's technology, intended use, and performance are similar enough to legally marketed devices that it doesn't raise new questions of safety or effectiveness.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a remote monitoring system, the "acceptance criteria" are more conceptual regarding functionality and safety rather than specific diagnostic performance metrics found in imaging or AI device clearances. The "reported device performance" is framed in terms of achieving substantial equivalence.

Criteria Category	Specific Criteria (Inferred from 510(k))	Reported Device Performance (Inferred from 510(k))
Functionality	Ability to collect and transmit vital signs (weight, BP, pulse, blood glucose, SpO2, FEV1, PEF).	"Functionality of the Telephone based BL Healthcare Remote Care Management system is substantially equivalent to those of the predicate devices."
Intended Use	For retrospective review and monitoring by healthcare providers; not for time-sensitive data or emergencies; requires clinical judgment.	The system fulfills this intended use ("collect and transmit patient vital signs and other physiological data... for retrospective review and monitoring").
Safety	No alteration of measurement technology or intended use compared to predicates, implying no new safety risks.	"The BL Healthcare Remote Care Management system does not alter the measurement technology or the intended use of these devices."
Compatibility	Acts as a communication link between compatible devices and server software.	Implied by the system's description as a "communication link."
User Interface	System installed by/with support from trained professionals.	Stated in "Indications for Use."

Study Details

The document refers to "Non-clinical testing" as the study that demonstrates substantial equivalence.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. This typically involves technical testing of the device's components and system functionality, rather than patient data in the sense of a clinical trial.
- Data Provenance: Not specified. It would be internal testing by BL Healthcare.
- Retrospective or Prospective: Not applicable in the context of this type of non-clinical testing. It would be a prospective test of newly manufactured devices/software.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/specified. For a device like this, ground truth would relate to the accuracy of data transmission and device connectivity, confirmed by engineering and quality assurance personnel, not medical experts establishing a diagnosis.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1) are for human interpretation of data, often in diagnostic imaging, not for testing the fundamental data transmission and connectivity of a remote monitoring system.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is designed to compare the performance of human readers, typically in diagnostic tasks, with and without the assistance of AI. This device is a data transmission system, not an AI for diagnostic interpretation.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, in spirit. The "Non-clinical testing" assessed the device's technical functionality (its ability to collect and transmit data) in a standalone manner, without requiring a human medical professional to be in the loop of the testing itself to achieve the functional goal. The output of the device (the transmitted data) is intended for human review, but the device's core function of transmission is tested independently.
Type of Ground Truth Used:
- Technical Specifications/Predicate Device Equivalence. The ground truth for this device's performance would be successful data collection and transmission as verified against internal engineering specifications and, importantly, by demonstrating that its performance is equivalent to that of the predicate devices in terms of its ability to perform its stated functions.
Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data in the conventional sense. It's a communication system.
How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" referenced in the 510(k) is "Non-clinical testing." This testing was conducted to demonstrate that the functionality of the Telephone based BL Healthcare Remote Care Management system is "substantially equivalent" to its predicate devices (BL Healthcare Remote Care Management Systems, Zymed EasyView telemetry system, Motion Media Care Station 126S Videophone, and Carematix Modified System). This equivalence means it performs the same intended functions (collecting and transmitting vital signs like weight, blood pressure, pulse rate, blood glucose, SpO2, FEV1, and PEF) without introducing new questions of safety or effectiveness.

The explicit details typically found in an AI/ML or diagnostic device study (like specific performance metrics, clinical sample sizes, physician ground truth, etc.) are absent because the device's classification and the 510(k) pathway rely on demonstrating equivalence for a data communication and remote monitoring system, not on proving de novo diagnostic accuracy for an algorithm. The acceptance criteria are broadly met by showing that the device works as intended for its specified functions and is comparable to existing cleared devices.

Summary

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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: (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:

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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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.

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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 (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

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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

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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FDA 510(k) Page 8

Regulation Number and Section

§ 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).