The M3810A Philips TeleMonitoring System with M3812B TeleStation is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction, and other post cardiac events. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

Device Description

The M3810A Philips TeleMonitoring System with M3812B TeleStation is intended to be used upon prescription by a licensed physcian or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure, and non-diagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a healthcare professional at the authorized provider. Apart from the convenience features added for enhanced interaction, and blood glucose meter data transmission, that is the same intended use as previously cleared for the M3810A Interactive Health System

AI/ML Overview

The M3810A Philips TeleMonitoring System with M3812B TeleStation underwent verification and validation testing to establish its performance and reliability characteristics. The acceptance criteria for these tests were based on the specifications cleared for the predicate device (K993169, cleared September 22, 1999).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the testing conducted in general terms, stating that "Acceptance criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." However, it does not provide a specific table detailing the acceptance criteria for each measured parameter (e.g., accuracy for blood pressure, ECG, weight) nor the quantitative reported device performance against those criteria.

The modifications primarily involve adding functionality for glucose meter downloads and subjective questions (automated interactions). Therefore, it can be inferred that the performance of the core physiological measurements (weight, blood pressure, non-diagnostic ECG) was expected to be equivalent to the predicate device.

Measurement/Functionality	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (Inferred from Substantial Equivalence Claim)
Core Physiological Measurements:
Weight	Equivalent to predicate device K993169 specifications	Substantially equivalent to predicate device
Blood Pressure	Equivalent to predicate device K993169 specifications	Substantially equivalent to predicate device
Non-diagnostic ECG	Equivalent to predicate device K993169 specifications	Substantially equivalent to predicate device
New Functionality:
Glucose Meter Downloads	Successful and accurate data transmission	Demonstrated to function as intended
Subjective Questions (Automated Interactions)	Correct operation and recording of responses	Demonstrated to function as intended
General Device Performance:
Biocompatibility	Met established safety standards	Passed laboratory studies
Electrical Safety	Met established safety standards	Passed laboratory studies
EMC (Electromagnetic Compatibility)	Met established safety standards	Passed laboratory studies
Radio Telemetry	Reliable and effective wireless communication	Passed laboratory studies
Consumer Accuracy (User Evaluation)	Met intended accuracy for home use	Passed user evaluations

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

The document mentions "laboratory studies" and "user evaluations for consumer accuracy" without specifying the sample sizes for these tests. It also does not explicitly state the data provenance (e.g., country of origin or whether data was retrospective or prospective). Given the nature of a Special 510(k) for a device modification, it's likely that a mix of prospective performance testing for new features and re-validation of existing features was conducted. The lack of detail suggests these were internal validation studies rather than a large-scale clinical trial.

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

The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth. For a device like this, ground truth would typically involve:

For blood pressure: Comparison against a reference standard (e.g., mercury sphygmomanometer) as read by trained clinicians.
For weight: Comparison against a calibrated reference scale.
For ECG: Comparison against simultaneously acquired, higher-fidelity ECGs interpreted by cardiologists or electrophysiologists (though the ECG here is "non-diagnostic").

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method. Considering the description of "laboratory studies" and "user evaluations," it's more probable that direct comparisons to reference instrumentation or expert assessments were made, rather than a multi-reader adjudication process typically associated with diagnostic image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done or reported. The modifications are related to data transmission and interaction, not advanced diagnostic interpretation requiring human-in-the-loop performance evaluation for improved diagnostic accuracy. The device is for "collect[ing] and transmit[ting] medical information," and the ECG is explicitly "non-diagnostic."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance assessment was effectively done for the device itself. The "verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device." This would include evaluating the accuracy of the measurements (weight, blood pressure) and the functionality of data transmission and automated interactions, independent of a specific human interpreter's real-time interaction influencing the primary data acquisition.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth. However, for a physiological monitoring system measuring weight, blood pressure, and non-diagnostic ECG, the ground truth would typically be:

Reference standard measurements: Comparison of device readings against highly accurate and calibrated reference instruments (e.g., certified scales for weight, calibrated blood pressure devices for blood pressure, and potentially simultaneous recordings from clinical-grade ECG machines for basic rhythm assessment for the "non-diagnostic ECG").
Functional verification: For the new glucose meter downloads and subjective questions, ground truth would be established by verifying that the data is accurately transmitted and recorded as intended by checking the source data against the received data.

8. The Sample Size for the Training Set:

The document does not mention a training set or its sample size. This is expected as the device is a physiological transmitter and receiver, not an AI/Machine Learning algorithm that requires a distinct training phase.

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

This question is not applicable as there is no mention of a training set, indicating this is not an AI/ML device in the context of this submission.

Summary

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Confidential

Special 510(k) Modification

K023749

NOV 1 9 2002

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 C.F.R. §807.92.

The submitter of thispremarket notificationis:	J. P. OuelletteQuality Program ManagerCardiac and Monitoring SolutionsNew Clinical Ventures Division/eCare MS 0024Philips Medical Systems3000 Minuteman RoadAndover MA 01810-1099Tel: (978) 659-4308Fax: (978) 659-3456e-mail: joe.ouellette@philips.com
Date of summary	October 25, 2002
Device name	The M3810A Philips TeleMonitoring System with M3812B TeleStation
Common name	Physiological Transmitter and Receiver
Classification names	Regulation Number	ProCode	Classification Name
	870.2910	DRG	Physiological SignalTransmitters AndReceivers
	870.1130	DXN	Non-invasive BloodPressureMeasurement System
	870.2340	DPS	Electrograph
	870.2720	FRW	Patient Scale
Predicate Devices	The modified device is substantially equivalent to the previously clearedModification of Physiological Signal Transmitter & Receiver pursuant toK993169 (September 22, 1999).
Modifications	The primary modification is a change to add the functionality of glucosemeter downloads and subjective questions (automated interactions).
Intended Use	The modified device has the same intended use as the legally marketedpredicate devices. The M3810A Philips TeleMonitoring System withM312B TeleStation is intended to be used upon prescription by a licensedphyscian or authorized healthcare provider by patients as a means toautomatically collect and transmit medical information, such as weight,blood pressure, and non-diagnostic ECG, over normal residential telephonelines, between a patient, typically at home, and a healthcare professional at

Philips Medical Systems

Page 54 of 87

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Confidential	Special 510(k) Modification
	the authorized provider. Apart from the convenience features added forenhanced interaction, and blood glucose meter data transmission, that is thesame intended use as previously cleared for the M3810A Interactive HealthSystem
Technologicalcharacteristics	The modified device has the same technological characteristics as thelegally marketed predicate devices.
Testing	Verification and validation testing activities were conducted to establish theperformance and reliability characteristics of the modified device.Testing involved safety testing from the risk analysis, including laboratorystudies for biocompatibility electrical safety testing, EMC testing and radiotelemetry testing and user evaluations for consumer accuracy. Acceptancecriteria were based on the specifications cleared for the predicate device andtest results showed substantial equivalence.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems c/o Mr. J.P. Ouellette, M.S. Quality Program Manager 3000 Minuteman Road Andover, MA 01810

Re: K023749

Trade Name: The M3810A Philips TeleMonitoring System with M3812B TeleStation Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: November 6, 2002 Received: November 8, 2002

Dear Mr. Ouellette:

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. J.P. Ouellette, M.S.

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (301) 594-4646: Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely vours.

Ana Alumku fo
Brant D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k): Device Modification

3.1 ODE Indications Statement

Indications for Use Statement

510(k) Number (if known)

Device Name: The M3810A Philips TeleMonitoring System with M3812B TeleStation

Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Division of Cardiovascular & Respiratory Devices
510(k) Number K023749
DOF 11/18

Philips Medical Systems

Page 13 of 87

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).