Master Caution Device MCD

K142476 · Healthwatch , Ltd. · DXH · Feb 17, 2015 · Cardiovascular

Device Facts

• Record ID: K142476
• Device Name: Master Caution Device MCD
• Applicant: Healthwatch , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Feb 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

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 Story

Personal, hand-held, battery-powered ECG device; connects to 10 standard electrodes for 12-lead ECG acquisition. Device includes embedded processor, accelerometers, respiration sensor, and IR skin temperature sensor. Inputs: physiological signals (ECG, motion, respiration, temperature). Transformation: signal conditioning and digitization; transmission via Bluetooth to external communication device (cellphone, computer, modem). Output: near real-time data forwarded via Wi-Fi/cellular to remote medical receiving center. Used by patients; reviewed by physicians/medical staff. Output enables remote monitoring and clinical decision-making regarding cardiac status and patient activity. Benefits: facilitates remote patient management and timely professional review.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and reliance on existing clinical literature for predicate technologies.

Technological Characteristics

Hand-held, battery-powered; 12-lead ECG configuration via 10 electrodes. Sensors: ECG, accelerometer (posture/motion), respiration, IR (skin temperature). Connectivity: Bluetooth Class II. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, ISO 62304, ISO 14971, ISO 15223-1, ASTM D4169.

Indications for Use

Indicated for adults >21 years old for transmission of 12-lead ECG, posture, motion, respiration, and skin temperature signals to remote medical centers for professional review.

Regulatory Classification

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.

Predicate Devices

• SHL Smartheart (K113514)
• MotionWatch and Pro-Diary (K132764)
• Avivo Mobile Patient Management System (K083287)
• Hospira vital Signs wireless monitoring system (K090610)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known) K142476

Device Name Master Caution Device (MCD™)

#### Indications for Use (Describe)

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.

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)

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

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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.<br>6 Hasadna Street<br>Kfar Saba, Israel 4442405<br>Tel: [phone]<br>Fax: [phone] |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite<br>31 Haavoda Street<br>Binyamina, Israel 30500<br>Tel [phone]; Fax [phone]<br>[e-mail] |
| Trade Name: | Master Caution Device MCDTM |
| Summary<br>Preparation Date: | February 09, 2015 |
| Classification: | Name: Telephone electrocardiograph transmitter and receiver<br>Product Code: DXH<br>Regulation No: 21 CFR 870.2920<br>Class: II<br>Classification Panel: Cardiovascular |

#### 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

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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.

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.

#### Intended Use Statement:

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.

### 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 Patient<br>Management System | K083287 | February 3, 2009 |
| Hospira vital Signs wireless<br>monitoring 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.

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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 | HealthWatch<br>Master Caution<br>Device | SHL<br>Smartheart<br>(K113514) | AVIVO Mobile<br>patient<br>management<br>system<br>(K083287) | Hospira vital<br>Signs wireless<br>monitoring<br>system<br>(K090610) | MotionWatch<br>(K132764) |
|-----------------------------------------|-----------------------------------------|--------------------------------|--------------------------------------------------------------|----------------------------------------------------------------------|--------------------------|
| Physiological<br>parameters<br>transfer | Bluetooth | Bluetooth | Bluetooth | Bluetooth | Bluetooth |
| Bluetooth<br>class | Class II | Class II | Class II | Class II | Class II |
| ECG<br>measures | Yes | Yes | Yes | Yes | N/A |
| Acceleration<br>sensor | Yes | N/A | Yes | N/A | Yes |
| Respiration<br>sensor | Yes | N/A | Yes | N/A | N/A |
| Skin<br>temperature<br>sensor | 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.

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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)

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HealthWatch Master Caution Device (MCD™) 510k Submission