HEARTRAK SMART ECAT

K083535 · Universal Medical, Inc. · DXH · Dec 15, 2008 · Cardiovascular

Device Facts

• Record ID: K083535
• Device Name: HEARTRAK SMART ECAT
• Applicant: Universal Medical, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Dec 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. Heartrak Smart ECAT registers symptomatic and asymptomatic cardiac events triggered by a patient manually or autotriggered by embedded arrhythmia detection algorithms. Using wireless technology, Heartrak Smart ECAT, when placed within range of a compatible RF receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center. Heartrak Smart ECAT does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life. Heartrak Smart ECAT is for prescription use only.

Device Story

Heartrak Smart ECAT is a portable, hand-held, externally applied cardiac event recorder. It continuously scans and captures ECG signals via a 3-lead patient cable. The device features embedded arrhythmia detection algorithms that auto-trigger recording for events like bradycardia, tachycardia, and atrial fibrillation; patients can also manually trigger recordings. It stores up to 30 days of ECG data. When within 10 meters of an RF-compatible receiver, the device wirelessly uploads recorded waveforms and parameters. Data is subsequently reviewed by clinicians at a physician's office, clinic, or monitoring center to assist in arrhythmia assessment. The device does not provide automated diagnosis or life-sustaining functions. It is intended for prescription use to aid in the detection of infrequent or illusive cardiac arrhythmias.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including electrical characteristics, RF transmission performance, and verification of arrhythmia detection algorithm functionality.

Technological Characteristics

Hand-held, portable, 3-lead ECG event recorder. Dimensions: 7.4 cm x 5.3 cm x 1.8 cm; Weight: 90g. Power: Internal 3.6V Li-Ion rechargeable battery. Connectivity: RF wireless (Bluetooth 2.0 SPP profile, 10m range). Bandwidth: 0.05-30 Hz. Input impedance: 2 MOhm. CMRR: 60 dB. Features: Lead-off detection, auto-triggering for bradycardia/tachycardia/AF, and 30-day storage.

Indications for Use

Indicated for patients requiring ambulatory, multi-channel, continuous ECG monitoring to capture symptomatic and asymptomatic cardiac events. Contraindications: None stated.

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

• Heartrak Smart AF (K071130)
• Cg-6108 Arrhythmia ECG Event Recorder (K060911)

Submission Summary (Full Text)

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**HeartCare**
Corporation of America
Cardiac Monitoring Services

Image /page/0/Picture/3 description: The image shows a logo for Universal Medical Incorporated. The logo features a heart shape on the left side, with the words "Universal Medical" stacked on top of each other to the right of the heart. Below the words "Universal Medical" is the word "Incorporated" in a smaller font. The logo is simple and professional, and it is likely used to represent a medical company.

# 5. 510(k) Summary or 510(k) Statement

K083535

# DEC 1 5 2008

Date: October 30, 2008

Universal Medical, Inc. Submitter/Owner:

Official Contact Person Authorized by the Submitter:

Mark Job, Third-Party Reviewer Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313 Telephone: [phone] FAX: [phone] Email: [e-mail]

cardiac event recorder; electrocardiograph transmitter Device Type:

Device Class: ==============================================================================================================================================================================

Regulation Number 870.2920

Review Panel: Cardiovascular

Basis for the

new design incorporating wireless technology. Submission:

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HeartCare
Corporation of America
Cardiac Monitoring Services

Image /page/1/Picture/2 description: The image shows the logo for Universal Medical Incorporated. The logo features a heart shape on the left side, with the words "Universal medical" stacked on top of each other. Below the words, it says "INCORPORATED" in smaller letters. Underneath that, it says "An ISO13485 Certified Company".

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# Predicate Devices

Predicate devices for which Universal Medical, Inc. is claiming equivalence:

| 510(k)<br>Number | Trade or Model<br>Name | Manufacturer | Classification<br>Name | Product<br>Code |
|------------------|---------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------|-----------------|
| K071130 | Heartrak Smart<br>AF | Universal Medical,<br>Inc | transmitters and<br>receivers,<br>electrocardiograph,<br>telephone [phone] | DXH |
| K060911 | Cg-6108<br>Arrhythmia ECG<br>Event Recorder | Card Guard Scientific<br>Survival, Ltd. | transmitters and<br>receivers,<br>electrocardiograph,<br>telephone<br>870.2920 | DXH |

## Device Description

Heartrak Smart ECAT is a cardiac event recorder that is used to continuously scan and capture ECG signals. Patients can use Heartrak Smart ECAT to capture ECG data both before and after they experience a cardiac symptom. Heartrak Smart ECAT can capture and automatically record asymptomatic, infrequent, or illusive arrhythmia events such as Bradycardia, and Atrial Fibrillation.

Heartrak Smart ECAT can store up to 30 days of ECG data in its memory. The physician can use a compatible wireless device to set event recording times and autotriggering parameters and then upload them to a patient's monitor.

Using wireless technology, Heartrak Smart ECAT, when placed within range (less than 10 meters) of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.

The physician is to instruct the patient on the proper use and care of the Heartrak Smart ECAT monitor. Patients should be told to contact their physician if they have any further questions.

## Intended Use

Heartrak ECAT is a hand-held, portable, externally applied, cardiac event recorder; electrocardiograph transmitter.

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tel [phone] ・ fax [phone] ・ 275 Phillips Blvd., Ewing, NJ 08618 ・ www.mednethealth.net

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Image /page/2/Picture/2 description: The image shows a logo for HeartCare Corporation of America Cardiac Monitoring Services. The logo is black and white and features the words "HeartCare" in a large, bold font. Below that, in a smaller font, are the words "Corporation of America" and "Cardiac Monitoring Services". To the left of the text is a graphic that resembles a heart rate monitor.

Image /page/2/Picture/3 description: The image shows a logo for Universal Medical Incorporated. The logo features the words "Universal Medical" in a bold, sans-serif font, with the word "Universal" stacked on top of "Medical". Below the words is a thin line, and below that is the word "Incorporated" in smaller letters. The text "An ISO13485 Certified Company" is at the bottom.

## Indications for Use

Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. Heartrak Smart ECAT registers symptomatic and asymptomatic cardiac events triggered by a patient manually or auto-triggered by embedded arrhythmia detection algorithms. Using wireless technology, Heartrak Smart ECAT, when placed within range of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.

Heartrak Smart ECAT does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life. Heartrak Smart ECAT is for prescription use only.

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echnological Claracteristics (Subsatial Equivalers) Table)
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CG-6108 Arrhythmia ECG Event Recorder (K060911) manufactured by Card Guard Scientific Survival, Ltd. in wireless communication

# ble 1 Substantial Equivalency Tabl

| | Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event<br>Recorder (K060911) | Heartrak Smart AF<br>(K071130) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Universal Medical, Inc.<br>Heartrak Smart ECAT is a<br>hand-held, portable, externally<br>applied, cardiac event<br>recorder; electrocardiograph<br>transmitter. | Card Guard Scientific Survival,<br>Ltd.<br>Intended for use by patients who<br>experience transient symptoms that<br>may suggest cardiac arrhythmia. | Universal Medical, Inc.<br>Heartrak Smart AF is a hand-<br>held, portable, externally<br>applied, cardiac event recorder<br>that is intended for<br>transtelephonic use. |
| Indications for use | Heartrak Smart ECAT is a<br>wireless ambulatory, multi-<br>channel, continuous ECG<br>event recorder with embedded<br>arrhythmia detection<br>algorithms. Heartrak Smart<br>ECAT registers symptomatic<br>and asymptomatic cardiac<br>events triggered by a patient<br>manually or auto-triggered by<br>embedded arrhythmia<br>detection algorithms. Using | The CG-6108 system is an Arrhythmia<br>ECG Event Recorder designed for self-<br>testing by patients at home and for<br>analysis by medical professionals at a<br>remote monitoring center.<br><br>It comprises a chest-worn ECG sensor<br>and a handheld device with a<br>proprietary application, configured to<br>process and transmit the ECG<br>recordings. | Heartrak Smart AF is a hand-<br>held, portable, externally<br>applied, cardiac event<br>recorder that is intended for<br>transtelephonic use. Patient<br>calls a receiving center at the<br>hospital or physicians office<br>from the patient's home to<br>play back the recording.<br>Heartrak Smart AF converts<br>electrocardiogram (ECG)<br>signals into audio tones which |

el 800.606.5511 ・ fax [phone] ・ 275 Phillips Blvd., Ewing, NJ 08618 ・ www.mednethealth.ne

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Image /page/4/Picture/7 description: The image shows the logo for HeartCare, a corporation of America. The text is vertically oriented and stacked on top of each other. Underneath the text is a graphic of a heart rate monitor.

Image /page/4/Picture/2 description: The image shows the logo for Universal Medical. The logo has the words "Universal Medical" stacked vertically. To the right of the words are some smaller words that are illegible.

| Service |
|----------|
| beyond |
| the call |

| Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event<br>Recorder (K060911)<br>Card Guard Scientific Survival, Ltd. | Heartrak Smart AF<br>(K071130) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Universal Medical, Inc.<br>wireless technology, Heartrak<br>Smart ECAT, when placed<br>within range of a compatible<br>RF receiver, uploads recorded<br>ECG waveform and ECG<br>parameter data to the receiver.<br>When data upload is complete,<br>data can be reviewed and<br>analyzed at a physician's<br>office, clinic, or monitoring<br>center. | The chest-worn unit includes 3<br>electrodes on a harness and it houses a<br>battery, an ASIC and a Bluetooth<br>transceiver for the acquisition,<br>recording, and transmission of the ECG<br>signal. The ECG signals are transmitted<br>via Bluetooth to the handheld device.<br>When an event is detected, it is<br>wirelessly transmitted to the CG<br>Monitoring Center for professional<br>analysis. The handheld device is<br>equipped with shared memory used to<br>record the signal received from the<br>sensor and to allow pre- and post-<br>processing options through the use of<br>this memory in a dual memory loop<br>configuration, both running in parallel.<br>One loop is auto-triggered, with<br>programmable thresholds, which starts<br>recording based on specific rhythms<br>and arrhythmias detected or manually<br>activated by the patient. The second,<br>and longer, recording loop is controlled<br>remotely to provide the physician with<br>more information, when requested by | Universal Medical, Inc.<br>are transmitted over the<br>telephone lines.<br><br>Heartrak Smart AF does not<br>deliver any energy, administer<br>any drugs, or control a<br>patient's life. Heartrak Smart<br>AF is not a diagnostic tool and<br>performs no diagnostic<br>functions. | |
| Heartrak Smart ECAT does<br>not deliver any energy,<br>administer any drugs, make<br>any diagnosis, or control a<br>patient's life. Heartrak Smart<br>ECAT is for prescription use<br>only. | | | |
| | Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event<br>Recorder (K060911)<br>Card Guard Scientific Survival,<br>Ltd. | Heartrak Smart AF<br>(K071130) |
| | Universal Medical, Inc. | | Universal Medical, Inc. |
| | | the CG Monitoring Center. | |
| | | The handheld device automatically<br>transmits the recorded ECG, via<br>cellular link, to the Monitoring Center.<br>When cellular service is unavailable the<br>patient can transmit via landline<br>telephone. | |
| Monitor Features | | | |
| Patient Cable | 3-lead patient cable | 3-lead patient cable | 2-lead patient cable |
| Lead off Detection | Yes | Unknown | No |
| Channel Recording | 3 | 3 | 1 |
| Monitoring Mode | Continuous | Continuous | Loop |
| Data Transmission | Radio Frequency (RF) | Radio Frequency (RF) | Transtelephonic FM |
| Recording Button | Yes | Yes | Yes |
| | No | No | Yes |
| Playback Button | (When User puts monitor within range<br>of a compatible RF receiver, the monitor<br>automatically uploads recorded<br>ECG data to the receiver.) | (When User puts monitor within range<br>of a compatible RF receiver, the<br>monitor automatically uploads recorded<br>ECG data to the receiver.) | Yes |
| Reset Button | No | No | Yes |
| Unintentional Erase Data<br>Protection | Yes | Unknown | Yes |
| | Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event<br>Recorder (K060911)<br>Card Guard Scientific Survival, Ltd. | Heartrak Smart AF<br>(K071130) |
| | Universal Medical, Inc. | Unknown | Universal Medical, Inc. |
| Power Loss Data Protection | Yes | | Yes |
| Programming/Configuration<br>Options | Available | | |
| Programmable pre/post<br>recording times | Multiple | Yes | Multiple (Total memory 10 minutes) |
| Number of events | Multiple | Multiple | Multiple |
| Patient Manual Activation | Yes | Yes | Yes |
| Silent Recording | Yes | Unknown | Yes |
| Auto-Triggering | Yes | Yes | Yes |
| Bradycardia | Yes (configuration option to<br>set range for rate) | Yes (configuration option to<br>set range for rate) | Yes (configuration option to<br>set range for rate) |
| Tachycardia | Yes (configuration option to<br>set range for rate) | Yes (configuration option to set<br>range for rate) | Yes (configuration option to<br>set range for rate) |
| Atrial Fibrillation | Yes | Yes | Yes |
| Auto-Trigger On/OFF<br>Capability | Yes | Unknown | Yes |
| Monitor Physical<br>Characteristics | | | |
| Dimensions | 7.4 cm length x 5.3 cm wide x<br>1.8 cm thick<br>Weight with batteries 90 gm | 75 x 58 x 23 mm (max.)<br>Net weight 54 gm | 7.4 cm length x 5.3 cm wide x<br>1.8 cm thick<br>Weight with batteries 90 gm |
| | Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event<br>Recorder (K060911)<br>Card Guard Scientific Survival, Ltd. | Heartrak Smart AF<br>(K071130)<br>Universal Medical, Inc. |
| Monitor Technical<br>Characteristics | Universal Medical, Inc. | | |
| Transmission Mode<br>(Bluetooth 2.0 SPP<br>Profile) | Yes | Yes | N/A |
| RF transmission range…