HEARTEVENT, MODEL AT

K072385 · Diagnostic Devices Pty, Ltd. · DXH · Jan 11, 2008 · Cardiovascular

Device Facts

• Record ID: K072385
• Device Name: HEARTEVENT, MODEL AT
• Applicant: Diagnostic Devices Pty, Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Jan 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The heartEVENT^T is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations. The HeartEVENT^] should be used in accordance with the instructions as indicated in the heartEVENTAT User Manual or as directed by a physician. The HeartEVENT^T is contraindicated for use in combination with external cardiac defibrillators or any other high frequency surgical equipment. The patient leads must be disconnected prior to performing any procedure utilizing this equipment.

Device Story

Battery-operated transtelephonic ECG event recorder; captures ECG signals via patient leads. Operates in manual or automatic trigger modes; manual mode records pre/post-event ECG upon button press; automatic mode detects bradycardia, pause, and atrial fibrillation. Stores up to 320 seconds of ECG data. Used by patients at home; data transmitted via telephone using acoustic coupling to a receiving system. Healthcare providers review transmitted ECGs to diagnose cardiac rhythm disturbances; facilitates clinical decision-making for transient symptoms. Benefits patients by enabling remote monitoring of intermittent cardiac events.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison of specifications/characteristics to the predicate device.

Technological Characteristics

Battery-operated transtelephonic ECG event recorder. Features manual and automatic trigger modes. Stores ECG data for transmission via acoustic coupling over telephone lines. Total recording capacity of 320 seconds. Class II device.

Indications for Use

Indicated for patients experiencing transient symptoms suggesting cardiac arrhythmia, conduction abnormalities, or rhythm disturbances (e.g., shortness of breath, pre-syncope, palpitations). Contraindicated for use with external cardiac defibrillators or high-frequency surgical equipment.

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

• KING OF HEARTS EXPRESS + AF MONITOR (K020825)

Submission Summary (Full Text)

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DIAGNOSTIC DEVICES
ACN 119 788 582

K072385

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

## The assigned 510(k) number is: K072385

Submitter Information (21 CFR 807.92(a)(l))

| Submitter's Name: | Diagnostic Devices Pty Ltd | |
|----------------------|------------------------------------------------------------------------|-------------|
| Submitter's Address: | Suite 405, Westfield Office Tower<br>Eastgardens NSW 2036<br>Australia | JAN 11 2008 |
| Contact Person: | Harry Platt | |
| Telephone: | [phone] Australia<br>203 654 7093 USA | |
| Fax: | [phone] Australia | |
| Date Prepared: | 21st August 2007 | |

## Name of Device and Classification (21 CFR 807.92(a)(2))

| Classification Name: | Telephone electrocardiograph transmitter and receiver |
|----------------------|-------------------------------------------------------|
| Common Name: | heartEVENT-AT ECG Recorder with Auto-Trigger |
| Proprietary Name: | heartEVENTAT |
| Product Code: | DXH |
| C.F.R. Section: | 870.2920 |
| Classification: | Class II - Performance Standards |

- Classification Panel: Cardiovascular
Diagnostic Devices Pty. Ltd. Suite 405 Office Tower Westfield Eastgardens Eastgardens N.S.W. 2036 Australia Tel [phone] Fax [phone]

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Image /page/1/Picture/1 description: The image shows the logo for Diagnostic Devices. The logo consists of the letters DD in a stylized font, with the word "DIAGNOSTIC DEVICES" written in all caps to the right of the letters. Below the company name is the text "ACN 119 781 532".

#### Identification of Legally Marketed Predicate Device (21 CFR 807.92 (a)(3))

- Predicate Name: KING OF HEARTS EXPRESS + AF MONITOR
- Predicate Manufacturer: CARD GUARD SCIENTIFIC SURVIVAL LTD.
- Predicate 510(k) Number: K020825

This legally marketed predicate device was used to determine substantial equivalence in accordance with 21 CFR 807.92(a)(3).

The KING OF HEARTS EXPRESS + AF MONITOR (K020825) is a transtelephonic cardiac event recorder. When an ECG is recorded on the King of Hearts Express AF, the stored ECG it can be transmitted via telephone. Along with being able to record patient-activated events, the recorder also has the ability to detect asymptomatic events with auto-triggers capable of automatically capturing atrial fibrillation, tachycardia and bradycardia.

#### Device Description (21 CFR 807.92 (a)(4))

#### Device Description Summary:

The heartEVENT* is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms. The transmission of these recordings is by telephone to a receiving system.

The heartEVENTAT has two operating modes – manual and automatic trigger.

In the manual mode, the heartEVENT^T stores the ECG before and after the 'record' button is depressed. The recording period is preset up to 80 seconds with 2 manually activated recordings stored.

The heartEVENTAT also has an automatic triggering function where recording is automatically activated when the user experiences a cardiac symptom. Cardiac symptoms captured by the auto-trigger function include bradycardia, pause and atrial fibrillation.

The heartEVENT^T is configured with 'pre' and 'post' event memories with a total ECG recording time for up to 320 sec.

The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the heartEVENTAT by manually depressing the 'send' button.

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Image /page/2/Picture/1 description: The image shows the logo for Diagnostic Devices. The logo consists of a stylized "DD" symbol on the left, followed by the words "DIAGNOSTIC DEVICES" in a sans-serif font. Below the words "DIAGNOSTIC DEVICES" is the text "ACN 119 788 582". There is also some text in the upper right corner that is difficult to read.

## Intended Use (21 CFR 807.92 (a)(5))

## Intended Use:

The heartEVENT^T is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.

## Precautions and Contraindications for Use:

The HeartEVENT^] should be used in accordance with the instructions as indicated in the heartEVENTAT User Manual or as directed by a physician.

The HeartEVENT^T is contraindicated for use in combination with external cardiac defibrillators or any other high frequency surgical equipment. The patient leads must be disconnected prior to performing any procedure utilizing this equipment.

## Similarities to the Predicate (21 CFR 807.92 (a)(6))

#### Substantial Equivalence:

The KING OF HEARTS EXPRESS + AF MONITOR (K020825) legally marketed predicate device was used to determine substantial equivalence in accordance with 21 CFR 807.92(a)(3).

The specifications and characteristics of the predicate device, KING OF HEARTS EXPRESS + AF MONITOR (K020825), were compared to the heartEVENTAT

The results of this comparison indicate that the heartEVENTAT has the same or better specifications and characteristics and is substantially equivalent to the KING OF HEARTS EXPRESS + AF MONITOR (K020825).

#### Safety and Effectiveness:

The heartEVENTAT utilises similar technology currently found in the legally marketed predicate device. Based on testing and comparison with the predicate device, the heartEVENTAT indicated no adverse indications or results.

It is our determination that the heartEVENTAT is safe and effective, performing within its design specifications and is substantially equivalent to the predicate device.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

JAN 1 1 2008

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

Diagnostic Devices, PTY, Ltd., c/o Mr. Harry Platt Project Manager Suite 405, Office Tower Westfield Eastgardens Eastgardens, NSW 2306 AUSTRALIA

Re: K072385

Trade/Device Name: HeartEVENTAT ECG Event Recorder with Auto-Trigger Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: January 2, 2008 Received: January 7, 2008

Dear Mr. Platt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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#### Page 2 -- Mr. Harry Platt

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Bhimmeron fr

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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#### 4. INDICATIONS FOR USE STATEMENT

## INDICATIONS FOR USE STATEMENT

Applicant: Diagnostic Devices Pty Ltd

K072385 510(k) Number (if known):

Device Name: heartEVENTAT

Indications for Use:

The heartEVENT^T is indicated for use by patents as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, presyncope or palpitations.

#### Contraindications for Use:

The HeartEVENT^ is contraindicated for use in combination with external cardiac defibrillators or any other high frequency surgical equipment. The patient leads must be disconnected prior to performing any procedure utilizing this equipment.

Prescription Use > (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blommers