Master Caution Device (MCD) is intended to condition an electrocardiographic signal, so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Master Caution Device (MCD) is designed to be used by a patient to transmit a 12 lead ECG, posture and motion , respiration and skin temperature (IR) signals, in near real-time to enable review at a physician's office, hospital or other remote medical receiving center. Master Caution Device (MCD) target population is adults above the age of 21.

Device Description

The HealthWatch Master Caution Device (MCD) is a personal, hand-held battery powered, ECG device that can be connected to any approved and market cleared, ten standard ECG electrodes, configuring a 12-lead ECG device.

The MCD is a miniature ECG device with an embedded processor containing data acquisition, data storage, data processing accelerometers, respiration, skin temperature (IR) and BT (Bluetooth) capabilities. The HealthWatch Master Caution Device (MCD) acquires ECG data via the connected electrodes. The HealthWatch Master Caution Device (MCD) transmits the data in near real time to a suitable Bluetooth communication device for forwarding to a remote location for professional review.

A communication device is defined as any device that is capable of receiving the ECG data via Bluetooth and forwarding it via WIFI or cellular network (3G/4G). Communication devices can be cellphones, computers or other dedicated communication modems.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Healthwatch Master Caution Device (MCD). It asserts substantial equivalence to predicate devices rather than providing a detailed study proving device performance against specific acceptance criteria. Therefore, several of the requested sections cannot be fully populated as the information is not present in the document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics in a readily extractable table. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to relevant performance standards.

The document mentions that "Bench testing demonstrated that the HealthWatch Master Caution Device (MCD™) is as safe and effective as the cleared predicate device." This is a general statement rather than specific performance data.

2. Sample size used for the test set and the data provenance

The document does not detail a specific test set or data provenance for performance evaluation of the MCD itself. It states that for the MCD, performance bench tests were conducted to demonstrate equivalence to the predicate device. However, no sample sizes or data provenance are provided for these bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the document does not describe a clinical study with a ground truth established by experts for the MCD directly.

4. Adjudication method for the test set

This information is not provided as the document does not describe a clinical study with an adjudication method for the MCD directly.

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

No such MRMC comparative effectiveness study is mentioned for the Master Caution Device (MCD). The MCD is described as a device that conditions and transmits ECG signals, not an AI-assisted diagnostic tool.

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

This is not applicable as the MCD is a hardware device for signal acquisition and transmission, not an algorithm, and its intended use is for review by a physician.

7. The type of ground truth used

For the MCD, the document does not indicate the use of specific ground truth types (e.g., pathology, outcomes data) in a clinical study. The device's performance is gauged against its ability to acquire and transmit physiological signals accurately, and its equivalence to predicate devices through bench testing and compliance with standards.

8. The sample size for the training set

This information is not applicable. The MCD is a hardware device for signal acquisition and transmission and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as above.

Summary based on the document:

The HealthWatch Master Caution Device (MCD) received 510(k) clearance based on demonstrating substantial equivalence to legally marketed predicate devices. The primary arguments for equivalence are:

Same Intended Use: The MCD's intended use is to condition and transmit electrocardiographic signals and other physiological data (posture, motion, respiration, skin temperature) for remote review.
Similar Technology: It utilizes the same transmission method (Bluetooth) as its predicate devices.
Performance Bench Tests: Bench testing was conducted to verify that the MCD is "as safe and effective" as the cleared predicate device, without raising new safety or effectiveness concerns. These tests presumably assessed the device's ability to acquire and transmit the specified signals correctly and reliably. However, specific performance metrics or detailed results from these bench tests are not provided in this summary.
Compliance with Standards: The device complies with several international and US standards related to medical electrical equipment safety, electromagnetic compatibility, software life cycle processes, risk management, and labeling (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, ISO 62304, ISO 14971, ISO 15223-1, ASTM D4169).
Reliance on Predicate Device Studies: The document explicitly states, "Due to the comprehensive clinical studies already performed by the predicate and other devices, published in scientific literature, and since the performance testing shows its substantial equivalence, HealthWatch believes that animal and clinical studies are not necessary to determine the substantial equivalence of the HealthWatch Master Caution Device (MCDTM)." This indicates that no new clinical studies or detailed performance studies with human subjects were conducted for the MCD itself to prove its effectiveness beyond substantial equivalence.

Therefore, the document emphasizes regulatory compliance and comparison to existing devices rather than a detailed performance study with specific acceptance criteria and outcome measurements for the MCD as a standalone product.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

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

February 17, 2015

Healthwatch Ltd. % Yoram Levy Osite General Manager 31 Haavoda Street Binyamina, 30500 IL

Re: K142476 Trade/Device Name: Master Caution Device (MCD) Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH Dated: December 31, 2014 Received: January 7, 2015

Dear Yoram Levy,

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 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

{1}------------------------------------------------

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 yours,

Melissa A. Torres -S

For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K142476

Device Name Master Caution Device (MCD™)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Healthwatch Technologies LTD. The word "HEALTHWATCH" is written in a combination of green and red letters, with the "HEALTH" portion in green and the "WATCH" portion in red. To the right of the word "HEALTHWATCH" is a green circle. Below the word "HEALTHWATCH" is the phrase "TECHNOLOGIES LTD" in a smaller, gray font.

510(K) SUMMARY

HealthWatch Master Caution Device (MCDTM)

510(k) Number K142476

Applicant's Name:	HealthWatch Ltd.6 Hasadna StreetKfar Saba, Israel 4442405Tel: (972) 77 543 4541Fax: (972) 9 955 0615
Contact Person:	Yoram Levy, Qsite31 Haavoda StreetBinyamina, Israel 30500Tel (972)4-638-8837; Fax (972)4-638-0510Yoram@qsitemed.com
Trade Name:	Master Caution Device MCDTM
SummaryPreparation Date:	February 09, 2015
Classification:	Name: Telephone electrocardiograph transmitter and receiverProduct Code: DXHRegulation No: 21 CFR 870.2920Class: IIClassification Panel: Cardiovascular

Device Description:

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Healthwatch Technologies LTD. The word "HEALTHWATCH" is written in a combination of green and red letters. The word "HEALTH" is in green, and the word "WATCH" is in red. There is a green circle and a red circle overlapping each other to the right of the word "WATCH". Below the word "HEALTHWATCH" is the phrase "TECHNOLOGIES LTD" in a smaller font.

near real time to a suitable Bluetooth communication device for forwarding to a remote location for professional review.

Intended Use Statement:

Predicate Device:

Device Name	510k No	Date of Clearance
SHL Smartheart	K113514	February 22, 2012
MotionWatch and Pro-Diary	K132764	January 21, 2014
Avivo Mobile PatientManagement System	K083287	February 3, 2009
Hospira vital Signs wirelessmonitoring system	K090610	December 22, 2009

Substantial equivalence to the following predicate devices is claimed:

Substantial Equivalence to Predicate Device

The Health Watch Master Caution Device (MCD) utilizes the same transmission method using Bluetooth module and communication device, as its predicate devices.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image is a logo for Healthwatch Technologies LTD. The word "HEALTHWATCH" is written in a combination of green and red letters. The word "HEALTH" is in green, and the word "WATCH" is in red, with a green circle to the right of the word. Below the word "HEALTHWATCH" is the phrase "TECHNOLOGIES LTD" in a smaller, gray font.

Any minor differences in the human interface and features do not raise any new questions of safety and effectiveness issues, as verified by performance testing.

Results of tests and validations, performed with the proposed Health Watch Master Caution Device (MCD) demonstrates that substantial equivalence has been determined, without raising any new safety and/or effectiveness concerns.

Therefore, the HealthWatch Master Caution Device (MCD) is substantially equivalent to its predicate device.

Follows is a comparison of the technology features:

Feature	HealthWatchMaster CautionDevice	SHLSmartheart(K113514)	AVIVO Mobilepatientmanagementsystem(K083287)	Hospira vitalSigns wirelessmonitoringsystem(K090610)	MotionWatch(K132764)
Physiologicalparameterstransfer	Bluetooth	Bluetooth	Bluetooth	Bluetooth	Bluetooth
Bluetoothclass	Class II	Class II	Class II	Class II	Class II
ECGmeasures	Yes	Yes	Yes	Yes	N/A
Accelerationsensor	Yes	N/A	Yes	N/A	Yes
Respirationsensor	Yes	N/A	Yes	N/A	N/A
Skintemperaturesensor	Yes	N/A	Yes	N/A	N/A

Performance Standards:

The Healthwatch Master Caution Device (MCD™) device complies with the following standards:

IEC 60601-1 Medical Electrical Equipment-Part 1: General . Requirements for Safety. Collateral Standard: Safety Requirements for Medical Electrical Systems.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image is a logo for Healthwatch Technologies LTD. The word "HEALTHWATCH" is written in green and red, with the "HEALTH" portion in green and the "WATCH" portion in red. There is a green and red circle to the right of the word. Underneath the word is the phrase "TECHNOLOGIES LTD" in a smaller, gray font.

IEC 60601-1-2 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic Compatibility – Requirements and Tests.

IEC 60601-2-25 Medical electrical equipment - Part 2-22: . Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

· ISO 62304 Medical device software- Software life cycle processes
· ISO 14971 Medical Devices- Application of risk management to medical devices
· ISO 15223-1 Medical Devices- Symbols to be used with medical device labels, labeling and information to be supplied- Part 1.
· ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems

Performance Bench Tests

Bench testing demonstrated that the HealthWatch Master Caution Device (MCD™) is as safe and effective as the cleared predicate device.

Summary of Pre-Clinical and clinical study

The HealthWatch Master Caution Device (MCD™) implies the exact same intended use, clinical indication and technology as its predicate device. The substantial equivalence o fthe HealthWatch Master Caution Device (MCD™) is shown by the predicate devices using the same parameters. Due to the comprehensive clinical studies already performed by the predicate and other devices, published in scientific literature, and since the performance testing shows its substantial equivalence, HealthWatch believes that animal and clinical studies are not necessary to determine the substantial equivalence of the

HealthWatch Master Caution Device (MCDTM)

2-4

HealthWatch Master Caution Device (MCD™) 510k Submission

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).