← Product Code [DXH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH) · K083535 # HEARTRAK SMART ECAT (K083535) _Universal Medical, Inc. · DXH · Dec 15, 2008 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K083535 ## Device Facts - **Applicant:** Universal Medical, Inc. - **Product Code:** [DXH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH.md) - **Decision Date:** Dec 15, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2920 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** 3rd-Party Reviewed ## 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 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. ## Regulatory 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](/device/K071130.md)) - Cg-6108 Arrhythmia ECG Event Recorder ([K060911](/device/K060911.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo in black and white. The logo features a stylized heart shape at the top. Below the heart shape, there is a letter 't' in a bold, sans-serif font. Underneath the letter 't', the letters 'INC' are written in smaller font size. **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: 763 682 4139 FAX: 763 682 4420 Email: mark@markjob.com 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: Page 1 of 9 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Mednet Healthcare Technologies Inc. The word "mednet" is written in bold, black letters. Below the word "mednet" is the phrase "HEALTHCARE TECHNOLOGIES INC." in smaller, black letters. To the right of the word "mednet" is a stylized heart shape. 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". ### rvice bevond the cal # Predicate Devices Predicate devices for which Universal Medical, Inc. is claiming equivalence: | 510(k)
Number | Trade or Model
Name | Manufacturer | Classification
Name | Product
Code | |------------------|---------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------|-----------------| | K071130 | Heartrak Smart
AF | Universal Medical,
Inc | transmitters and
receivers,
electrocardiograph,
telephone 870.2920 | DXH | | K060911 | Cg-6108
Arrhythmia ECG
Event Recorder | Card Guard Scientific
Survival, Ltd. | transmitters and
receivers,
electrocardiograph,
telephone
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. page 2 of 9 tel 800.606.5511 ・ fax 800.889.5415 ・ 275 Phillips Blvd., Ewing, NJ 08618 ・ www.mednethealth.net {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Mednet Healthcare Technologies Inc. The word "mednet" is written in bold, black letters. Below the word "mednet" is the phrase "HEALTHCARE TECHNOLOGIES INC." in smaller, black letters. To the right of the word "mednet" is a graphic that looks like two overlapping hearts. 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. Page 3 OF 9 tel 800.606.5511 · fax 800.889.5415 · 275 Phillips Blvd., Ewing, NJ 08618 · www.medneth.net {3}------------------------------------------------ mednet ervice beyond the call HeartCarporation of Amer Image /page/3/Picture/2 description: The image shows the logo for Universal Medical Incorporated. The logo has the words "Universal Medical" in a vertical orientation. To the right of the words is the phrase "Incorporated, An ROI Health Company" in a smaller font. echnological Claracteristics (Subsatial Equivalers) Table) In the belows the the technologics of Heartel Co. In art ECAT ae subsentially equivalent othe prodicated deviral, L 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
Recorder (K060911) | Heartrak Smart AF
(K071130) | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | Universal Medical, Inc.
Heartrak Smart ECAT is a
hand-held, portable, externally
applied, cardiac event
recorder; electrocardiograph
transmitter. | Card Guard Scientific Survival,
Ltd.
Intended for use by patients who
experience transient symptoms that
may suggest cardiac arrhythmia. | Universal Medical, Inc.
Heartrak Smart AF is a hand-
held, portable, externally
applied, cardiac event recorder
that is intended for
transtelephonic use. | | 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 | The CG-6108 system is an Arrhythmia
ECG Event Recorder designed for self-
testing by patients at home and for
analysis by medical professionals at a
remote monitoring center.

It comprises a chest-worn ECG sensor
and a handheld device with a
proprietary application, configured to
process and transmit the ECG
recordings. | Heartrak Smart AF is a hand-
held, portable, externally
applied, cardiac event
recorder that is intended for
transtelephonic use. Patient
calls a receiving center at the
hospital or physicians office
from the patient's home to
play back the recording.
Heartrak Smart AF converts
electrocardiogram (ECG)
signals into audio tones which | el 800.606.5511 ・ fax 800.889.5415 ・ 275 Phillips Blvd., Ewing, NJ 08618 ・ www.mednethealth.ne 4 OF 9 Page {4}------------------------------------------------ mednét 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
Recorder (K060911)
Card Guard Scientific Survival, Ltd. | Heartrak Smart AF
(K071130) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Universal Medical, Inc.
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. | The chest-worn unit includes 3
electrodes on a harness and it houses a
battery, an ASIC and a Bluetooth
transceiver for the acquisition,
recording, and transmission of the ECG
signal. The ECG signals are transmitted
via Bluetooth to the handheld device.
When an event is detected, it is
wirelessly transmitted to the CG
Monitoring Center for professional
analysis. The handheld device is
equipped with shared memory used to
record the signal received from the
sensor and to allow pre- and post-
processing options through the use of
this memory in a dual memory loop
configuration, both running in parallel.
One loop is auto-triggered, with
programmable thresholds, which starts
recording based on specific rhythms
and arrhythmias detected or manually
activated by the patient. The second,
and longer, recording loop is controlled
remotely to provide the physician with
more information, when requested by | Universal Medical, Inc.
are transmitted over the
telephone lines.

Heartrak Smart AF does not
deliver any energy, administer
any drugs, or control a
patient's life. Heartrak Smart
AF is not a diagnostic tool and
performs no diagnostic
functions. | | | 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. | | | | | | Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event
Recorder (K060911)
Card Guard Scientific Survival,
Ltd. | Heartrak Smart AF
(K071130) | | | Universal Medical, Inc. | | Universal Medical, Inc. | | | | the CG Monitoring Center. | | | | | The handheld device automatically
transmits the recorded ECG, via
cellular link, to the Monitoring Center.
When cellular service is unavailable the
patient can transmit via landline
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
of a compatible RF receiver, the monitor
automatically uploads recorded
ECG data to the receiver.) | (When User puts monitor within range
of a compatible RF receiver, the
monitor automatically uploads recorded
ECG data to the receiver.) | Yes | | Reset Button | No | No | Yes | | Unintentional Erase Data
Protection | Yes | Unknown | Yes | | | Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event
Recorder (K060911)
Card Guard Scientific Survival, Ltd. | Heartrak Smart AF
(K071130) | | | Universal Medical, Inc. | Unknown | Universal Medical, Inc. | | Power Loss Data Protection | Yes | | Yes | | Programming/Configuration
Options | Available | | | | Programmable pre/post
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
set range for rate) | Yes (configuration option to
set range for rate) | Yes (configuration option to
set range for rate) | | Tachycardia | Yes (configuration option to
set range for rate) | Yes (configuration option to set
range for rate) | Yes (configuration option to
set range for rate) | | Atrial Fibrillation | Yes | Yes | Yes | | Auto-Trigger On/OFF
Capability | Yes | Unknown | Yes | | Monitor Physical
Characteristics | | | | | Dimensions | 7.4 cm length x 5.3 cm wide x
1.8 cm thick
Weight with batteries 90 gm | 75 x 58 x 23 mm (max.)
Net weight 54 gm | 7.4 cm length x 5.3 cm wide x
1.8 cm thick
Weight with batteries 90 gm | | | Heartrak Smart ECAT | CG-6108 Arrhythmia ECG Event
Recorder (K060911)
Card Guard Scientific Survival, Ltd. | Heartrak Smart AF
(K071130)
Universal Medical, Inc. | | Monitor Technical
Characteristics | Universal Medical, Inc. | | | | Transmission Mode
(Bluetooth 2.0 SPP
Profile) | Yes | Yes | N/A | | RF transmission range… --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K083535](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K083535) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com