The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm, or generates an alert manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center provides the ECG data to the medical practitioner for evaluation.

The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor and Arrhythmia Detector is intended to be prescribed for patients who have demonstrated a need for cardiac monitoring and are at low risk of developing life-threatening arrhythmias. Conditions where the system should not be used include patients likely to experience primary Ventricular Fibrillation or Ventricular Tachycardia and patients who have other co-morbid cardiovascular conditions where an arrhythmia could be potentially life threatening.

The device has been validated for use on patients 6 years of age and older.

Device Description

The MCT 3L Continuous ECG Monitor and Arrhythmia Detector is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center.

The chest-worn sensor is used for the acquisition, recording, and transmission of the ECG signal. The device is equipped with 4 electrodes on a harness and it houses a 3.6V AA battery, a Bluetooth transceiver and a patient alert buzzer.
The ECG signals are transmitted via Bluetooth to a handheld device with a proprietary interactive application, configured to process and transmit the ECG recordings. The handheld device is a mobile computing device with a display and a touch input such as a cell phone. It has sufficient memory and processing capability to run the proprietary application.
When an arrhythmia event is detected, the handheld device transmits the recorded ECG information automatically via cellular link, to the Monitoring Center for professional analysis. When cellular service is unavailable the patient has an option to transmit via a landline telephone.

The MCT 3L does contain software. The device is not supplied sterile or intended to be sterilized by the operator prior to use, and is not intended for single use.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria. Instead, it is a 510(k) summary for the LifeWatch Mobile Cardiac Telemetry 3 Lead (MCT 3L), which focuses on demonstrating substantial equivalence to a predicate device (K143359 CG-6108 ACT 3L).

Here's what can be extracted and what is not available based on your request:

1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing specific performance metrics against pre-defined acceptance criteria for the new device's arrhythmia detection algorithm.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document explicitly states: "No clinical data was necessary to support substantial equivalence of the proposed device compared to the predicate." Therefore, no test set for clinical performance is detailed. The only "testing" mentioned is bench testing for engineering standards and human factors for pediatric use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As no clinical test set is mentioned, there is no discussion of ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No test set is detailed.

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
This information is not provided. The device is an "Arrhythmia Detector and Alarm" that automatically generates alerts and transmits data to a monitoring center for "professional analysis." While it uses an "arrhythmia detection algorithm," the document does not describe it as an "AI" in the context of improving human reader performance. It functions more as an automated detection system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions as a standalone algorithm for detection: "The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm..." However, the performance metrics of this standalone algorithm (e.g., sensitivity, specificity for various arrhythmias) are not detailed in the document. The alert then transmits data to a monitoring center, implying a subsequent human review.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. Without a detailed clinical performance study, the type of ground truth used for evaluating the arrhythmia detection algorithm is not specified.

8. The sample size for the training set
This information is not provided. The document makes no mention of training data for the device's algorithms.

9. How the ground truth for the training set was established
This information is not provided. As no training set is mentioned, how its ground truth was established is also not discussed.

Summary of Device Performance/Validation provided:

The submission focuses on demonstrating substantial equivalence to a predicate device (K143359 CG-6108 ACT 3L). The key statements related to performance and validation are:

"The Indications for Use for the proposed MCT 3L device are identical to those of the predicate device with the exception that use for pediatrics age 6 and older is not excluded in the MCT 3L labeling."
"Bench testing of the proposed MCT 3L was conducted to demonstrate substantial equivalence to the predicate device."
"Insignificant historical changes are listed within the device description. No changes have been made to the user interface, device algorithms, or applications software compared to the predicate device."
"The proposed device has the same intended use and employs the same fundamental scientific technology."
Non-Clinical Testing:
- IEC 62366-1:2015 (human factors validation testing for pediatric use age 6-21 with adult caregivers)
- ISO 14971:2012 (evaluation of use-related risks)
- ANSI/AAMI/IEC 60601-1-2 Edition 4:2014-02 (Electromagnetic Compatibility)
- Wireless Coexistence Testing (in accordance with FDA guidance)
Clinical Testing: "No clinical data was necessary to support substantial equivalence of the proposed device compared to the predicate."

Essentially, the FDA clearance for K170565 relies on the demonstrated substantial equivalence to a previously cleared device (K143359), with specific non-clinical tests conducted to address a labeling change for pediatric use and ensure compliance with relevant engineering standards. The performance of the arrhythmia detection algorithm itself is presumed to be equivalent to the predicate device, given "no changes have been made to the user interface, device algorithms, or applications software compared to the predicate device."

Summary

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November 15, 2023

LifeWatch Services, Inc Stefanie Martinez-Koenig Sr. Director Regulatory and Clinical Trials 10255 W Higgins Road Suite 100 Rosemont, Illinois 60018

Re: K170565

Trade/Device Name: LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: QYX, DSI

Dear Stefanie Martinez-Koenig:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 1, 2017. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Kozen, OHT2: Office of Cardiovascular Devices, 301-796-5813, jennifer.kozen@fda.hhs.gov.

Sincerely.

Jennifer W. Shih -S

Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

August 1. 2017

LifeWatch Services, Inc. Stefanie Martinez-Koenig Sr. Director Regulatory and Clinical Trials 10255 W Higgins Road Suite 100 Rosemont, Illinois 60018

Re: K170565

Trade/Device Name: LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L (CG-6108 ACT-3L) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: DSI Dated: June 30, 2017 Received: July 3, 2017

Dear Stefanie Martinez-Koenig:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

M.A. Wilhelmsson
for

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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Indications for Use

510(k) Number (if known) K170565

Device Name

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L (CG-6108 ACT-3L)

Indications for Use (Describe)

The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arthythmia. The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm, or generates an alert manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center provides the ECG data to the medical practitioner for evaluation.

The device has been validated for use on patients 6 years of age and older.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the LifeWatch logo, which features a series of curved lines in shades of green and blue, resembling a waveform. To the right of the waveform is the word "LifeWatch" in a stylized font, with a trademark symbol next to it. The text "K170565" is located in the upper right corner of the image.

510(k) Summary

This document contains the 510(k) summary for the LifeWatch Mobile Cardiac Telemetry 3 Lead Continuous ECG Monitor and Arrhythmia Detector. The content of this summary is based on the requirements of 21 CFR Section 807.92(c)

Submission Date: February 24, 2017

Submitter Information:

Submitted By:	Stefanie Martinez-Koenig, Senior Director, Regulatory and ClinicalTrials10255 W Higgins Rd Suite 100Rosemont, IL 60018Email: SMartinezKoenig@LifeWatch.com
Contact Person:	Robin Martin, Regulatory Consultant10255 W Higgins Rd Suite 100Rosemont, IL 60018Email: CT-RMartin@LifeWatch.com
Device Information:
Trade Name:	LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT3L(CG-6108 ACT-3L)
Common Name:	MCT 3L
Classification Name:	Detector and Alarm, ArrhythmiaTransmitters and Receivers, Electrocardiograph, Telephone
Device Classification:	870.1025870.2920
Predicate Device(s):	K143359 CG-6108 ACT 3L Continuous ECG Monitor andArrhythmia DetectorLifeWatch Technologies, Ltd. (DSI and DXH)
Device Description:	The MCT 3L Continuous ECG Monitor and Arrhythmia Detector isdesigned for self-testing by patients at home and for analysis bymedical professionals at a remote Monitoring Center.
510(k) Premarket Notification
	The chest-worn sensor is used for the acquisition, recording, andtransmission of the ECG signal. The device is equipped with 4electrodes on a harness and it houses a 3.6V AA battery, aBluetooth transceiver and a patient alert buzzer.The ECG signals are transmitted via Bluetooth to a handhelddevice with a proprietary interactive application, configured toprocess and transmit the ECG recordings. The handheld device is amobile computing device with a display and a touch input such asa cell phone. It has sufficient memory and processing capability torun the proprietary application.When an arrhythmia event is detected, the handheld devicetransmits the recorded ECG information automatically via cellularlink, to the Monitoring Center for professional analysis. Whencellular service is unavailable the patient has an option to transmitvia a landline telephone.
	The MCT 3L does contain software. The device is not suppliedsterile or intended to be sterilized by the operator prior to use,and is not intended for single use.
Indications for Use:	The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor andArrhythmia Detector is intended for use by patients whoexperience transient symptoms that may suggest cardiacarrhythmia. The device continuously monitors patient ECG,automatically generates an alert triggered by an arrhythmiadetection algorithm, or generates an alert manually triggered bythe patient, and transmits the recorded data transtelephonicallyto a monitoring center. The monitoring center provides the ECGdata to the medical practitioner for evaluation.
	The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor andArrhythmia Detector is intended to be prescribed for patients whohave demonstrated a need for cardiac monitoring and are at lowrisk of developing life-threatening arrhythmias. Conditions wherethe system should not be used include patients likely toexperience primary Ventricular Fibrillation or VentricularTachycardia and patients who have other co-morbidcardiovascular conditions where an arrhythmia could bepotentially life threatening.The device has been validated for use on patients 6 years of ageand older.

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Image /page/5/Picture/0 description: The image contains the logo for LifeWatch, which includes a series of curved lines in shades of green and blue, followed by the company name in a stylized font. To the right of the logo, the text "K170565" is visible.

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Image /page/6/Picture/0 description: The image shows the LifeWatch logo. The logo features a series of curved lines in shades of blue and green, resembling a wave pattern. To the right of the wave pattern is the word "LifeWatch" in a stylized font, with a trademark symbol next to it.

K170565

510(k) Premarket Notification

Comparison to Predicate:	The Indications for Use for the proposed MCT 3L device are identical to those of the predicate device with the exception that use for pediatrics age 6 and older is not excluded in the MCT 3L labeling. Bench testing of the proposed MCT 3L was conducted to demonstrate substantial equivalence to the predicate device. Insignificant historical changes are listed within the device description. No changes have been made to the user interface, device algorithms, or applications software compared to the predicate device.
	The proposed device has the same intended use and employs the same fundamental scientific technology.
Performance Testing:
Non-Clinical:	The design and development of the MCT 3L device conforms to LifeWatch Service's Quality System. Because the subject of this premarket notification is a labeling change, and certain predicate standards test reports remain applicable to the device, testing to only the following voluntary standards are submitted to support substantial equivalence to the predicate device: IEC 62366-1:2015, including human factors validation testing related to the use of the device in the pediatric patient population (age 6 to 21) with adult caregivers, where appropriate.ISO 14971:2012, including evaluation of use-related risksANSI/AAMI/IEC 60601-1-2 Edition 4:2014-02, Electromagnetic CompatibilityWireless Coexistence Testing in accordance with FDA's guidance entitled, "Radio Frequency Wireless Technology in Medical Devices", dated August 14, 2013
Clinical:	No clinical data was necessary to support substantial equivalence of the proposed device compared to the predicate.
Conclusion:	The above testing supports that the proposed device is as safe, effective and performs as well as the legally marketed predicate in its intended use. Therefore, the proposed device is substantially equivalent to the predicate.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.