Alcatel-Lucent TeleHealth Manager is a Remote Patient Monitoring solution intended to provide monitoring services of patient vital signs and other physiological data by remote data transmission from a patient to the practitioner.

The system can be used by patients during their daily lives and allows the collection, recording and transmission of physiological information such as blood glucose levels, using a glucometer, and non-invasive blood pressure measurements.

The transmission of data to a secure server hosting platform is carried out over existing telecommunications infrastructure via common telephone lines and mobile networks. The data is collected in a secure server hosting platform, which stores the information and allows its remote access by the patient and/or health care professional.

Alcatel-Lucent TeleHealth Manager is intended as an aid for the continuous monitoring of physiological processes and is not intended as a replacement of the medical oversight of a trained healthcare professional.

Device Description

Alcatel-Lucent TeleHealth Manager is a software system that collects patient physiological data such as blood pressure and blood sugar levels, via Bluetooth technology combined with cellular or plain old telephone system (POTS) home access point, for transmission to a secure central storage server which can be accessed by health care professionals for analysis and intervention. This data is also available to the patient for viewing purposes and as an aid in the self management of their specific health condition.

As Alcatel-Lucent TeleHealth Manager main function is to relay a reading to the appropriate users without alteration or post processing of the measurement, it is the responsibility of the patient-user to verify that the reading has been correctly executed.

With respect to patient data privacy, patient data is encrypted by the Alcatel-Lucent TeleHealth Manager system in such a way that it can be securely accessed only by the authorized users.

AI/ML Overview

The provided document describes the Alcatel-Lucent TeleHealth Manager, a software system that collects patient physiological data via Bluetooth and cellular/POTS for transmission to a secure central storage server. The document serves as a 510(k) summary for FDA clearance.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy percentages, latency thresholds). Instead, it broadly describes the expected performance and the types of testing conducted.

Acceptance Criterion (Implicit from text)	Reported Device Performance and Study Findings (from "Testing" and "Conclusion" sections)
Reliable Remote Patient Monitoring Functionality: The ability to provide continuous monitoring of physiological processes.	"Alcatel-Lucent has conducted extensive validation testing of the Alcatel-Lucent TeleHealth Manager system, as a telemonitoring system that is capable of providing reliable remote patient monitoring functionalities." "The system incorporates the necessary communication protocols to enable the patient to use home medical monitoring devices such as a blood pressure monitor or a glucometer." "Alcatel-Lucent TeleHealth Manager is a Remote Patient Monitoring solution intended to provide monitoring services of patient vital signs and other physiological data by remote data transmission..."
Proper Storage of Physiologic Data: Data received from patient measuring devices is stored correctly.	"Testing was carried out to [...] verify that the physiologic data received by the patient measuring devices is stored properly..."
Secure and Integral Transmission of Data: Data is transmitted to the healthcare practitioner in a manner that maintains security and integrity.	"Testing was carried out to [...] verify that the data is transmitted to the healthcare practitioner in a manner that maintains the security and integrity of the information." "With respect to patient data privacy, patient data is encrypted by the Alcatel-Lucent TeleHealth Manager system in such a way that it can be securely accessed only by the authorized users."
Safe and Effective Overall System Operation: The system as a whole provides all capabilities necessary to operate safely and effectively.	"All of the different components of Alcatel-Lucent TeleHealth Manager have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate safely and effectively." "The Alcatel-Lucent TeleHealth Manager device raises no new safety or effectiveness issues."
Substantial Equivalence: To predicate devices in terms of indications for use, performance, technological characteristics, and communication methods.	The device was found substantially equivalent to the Carematix Wellness System (K040966) for indications for use, performance, and technological characteristics, and to Confidant 2.5 (K072698) for communication method with the hosting server.
No Alteration or Post-processing of Measurement: The device acts as a relay without changing the data.	"Alcatel-Lucent TeleHealth Manager main function is to relay a reading to the appropriate users without alteration or post processing of the measurement..." This isn't a performance metric as much as a fundamental design principle that would be verified through functional testing.

Important Note: The document lacks specific quantitative metrics or thresholds for the acceptance criteria. It describes the types of performance considerations but not the levels of performance achieved (e.g., "99% data integrity" or "less than 1-second latency").

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Alcatel-Lucent has conducted extensive validation testing" and that "All of the different components of Alcatel-Lucent TeleHealth Manager have been stress tested." However, it does not specify the sample size used for the test set (e.g., number of patients, number of data transmissions, duration of tests) or the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be internal validation rather than a clinical trial with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a ground truth for a test set. The validation described focuses on the technical performance of the system (data storage, transmission, security) rather than clinical accuracy against a "ground truth" derived from expert consensus or clinical outcomes. The device's function is to relay data, not interpret it clinically.

4. Adjudication Method for the Test Set

Since there is no mention of experts or a ground truth established by them, there is no adjudication method described for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study is mentioned. The device is a data transmission system, not an interpretive AI tool designed to assist human readers in diagnosing cases. Its purpose is to facilitate the delivery of physiological data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The entire system is essentially "standalone" in its core function of collecting, transmitting, and storing data without human intervention in that specific process. The device description highlights that its main function is to "relay a reading to the appropriate users without alteration or post processing of the measurement." The "algorithm" here is the software system managing data flow. Users (patients) are responsible for taking readings, and healthcare professionals access the data for analysis. There is no mention of an algorithm making diagnostic decisions that would typically require validation as a "standalone" AI medical device.

7. The Type of Ground Truth Used

The document describes testing to verify the technical functionality and integrity of the system (e.g., proper storage, secure transmission, operational effectiveness). The concept of a "ground truth" in the clinical sense (e.g., pathology, outcomes data, expert consensus) is not applicable or mentioned given the device's function as a data relay system. The "truth" being validated is whether the system accurately and securely moves data from point A to point B without corruption.

8. The Sample Size for the Training Set

The document describes "extensive validation testing" and "stress testing" for the system, but it does not mention a training set or a sample size for one. This indicates that the device is likely a rules-based software system or a system integrating existing communication protocols, rather than a machine learning/AI model that requires a distinct training phase.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set or a machine learning component, this information is not provided.

Summary

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Alcatel·Lucent

510(k) Summary (in accordance with 21 CFR 807.92)

510(k) Number KO92635

I. Applicant Information

Applicant:

Alcatel-Lucent Canada Inc 1380 Rodick Road Markham, Ontario Canada L3R 4G5

Contact Person:

Alex Giosa President Tel: (905) 943-5768 Fax: (905) 943-5768 e-mail: agiosa@alcatel-lucent.com

Application Correspondent:

SALVEO 101-2550 Sandra Schmirler Way Regina, SK S4P 3Y2 Canada

Contact Person:

Ms. Pat Tulloch, Chief Operating Officer Tel: (306) 337-0506 Fax: (306) 337-0512 e-mail: pat.tulloch@salveo.ca

Date Prepared:

July 3, 2009

II. Device Name and Classification

Proprietary Name: Classification Name:

Common/Usual Name: Regulation Number: Product Codes: Classification: Classification Panel:

Alcatel-Lucent TeleHealth Manager Radiofrequency Physiological Signal Transmitter and Receiver Telemedicine System 870.2910 DRG Class II Cardiovascular Devices

Alcatel-Lucent TeleHealth Manager

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Predicate Devices III.

The Alcatel-Lucent TeleHealth Manager device is substantially equivalent to the following two FDA cleared predicate devices:

510(k) Number:	K040966
Trade Name:	Carematix Wellness System
Manufacturer:	Carematix, Inc.
Classification Name:	Radiofrequency Physiological Signal Transmitterand Receiver
Common/Usual Name:	Telemedicine System
Regulation Number:	870.2910
Product Codes:	DRG
Classification:	Class II
SE with respect to:	Indications for use, performance and technologicalcharacteristics
510(k) Number:	K072698
Trade Name:	Confidant 2.5
Manufacturer:	Confidant International, LLC
Classification Name:	Radiofrequency Physiological Signal Transmitterand Receiver
Common/Usual Name:	Telemedicine System
Regulation Number:	870.2910
Product Codes:	DRG
Classification:	Class II
SE with respect to:	Communication method with the hosting server

IV. Device Description

Alcatel-Lucent TeleHealth Manager

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Alcatel·Lucent

With respect to patient data privacy, patient data is encrypted by the Alcatel-Lucent TeleHealth Manager system in such a way that it can be securely accessed only by the authorized users.

V. Intended Use

The transmission of data to a secure server hosting platform is carried out over existing telecommunications infrastructure via common telephone lines and mobile networks. The data is collected in a secure server hosting platform. which stores the information and allows its remote access by the patient and/or health care professional.

VI. Summary of the Technical Characteristics

The Alcatel-Lucent TeleHealth Manager system is comprised of a software component (downloaded and installed by the user in their mobile phone), a central server component (for secure data storage), a web communication protocol component (for making data available on line), and a SMTP getaway and Interactive Voice Response system components (used for user and/or health care provider notification).

Collection, transmission, and storage of physiological and lifestyle data originating from patients is part of this automated telemonitoring system. The system incorporates the necessary communication protocols to enable the patient to use home medical monitoring devices such as a blood pressure monitor or a glucometer. Readings are taken in the same fashion as any patient currently using these devices would do. Data readings remain in the original medical monitoring devices as per manufacturer's specifications.

Alcatel-Lucent TeleHealth Manager

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VII. Testing

Alcatel-Lucent has conducted extensive validation testing of the Alcatel-Lucent TeleHealth Manager system, as a telemonitoring system that is capable of providing reliable remote patient monitoring functionalities. Testing was carried out to verify the product requirements and functional specifications, to verify that the physiologic data received by the patient measuring devices is stored properly and to verify that the data is transmitted to the healthcare practitioner in a manner that maintains the security and integrity of the information. All of the different components of Alcatel-Lucent TeleHealth Manager have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate safely and effectively.

VIII. Safety & Effectiveness Conclusions

Based on the comparison of intended use and technological characteristics, the Alcatel-Lucent TeleHealth Manager system is substantially equivalent to the Carematix Wellness System manufactured by Carematix, Inc. (K040966), with respect to indications for use, performance and technological characteristics, and to the Confidant 2.5 (K072698) manufactured by Confidant International, LLC, with respect to the communication method with the hosting server.

The Alcatel-Lucent TeleHealth Manager device raises no new safety or effectiveness issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Alcatel-Lucent Canada, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K092635

Trade/Device Name: Alcatel-Lucent TeleHealth Manager Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Code: DRG, DXG, DXN, NBW Dated: August 26, 2009 Received: August 27, 2009

Dear Mr. Job:

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.

SFP 1 0 2009

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Page 2 - Mr. Mark Job

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 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,

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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4. Indication for Use Statement

510(k) Number (if known): K092635

Device Name:

Alcatel-Lucent TeleHealth Manager

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)
(Division Sign-Off) Division of Cardiovascular Devices	Page 1 of
510(k) Number

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).