DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300

K081603 · Heartforce Medical, Inc. · DXR · Jul 24, 2009 · Cardiovascular

Device Facts

• Record ID: K081603
• Device Name: DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
• Applicant: Heartforce Medical, Inc.
• Product Code: DXR · Cardiovascular
• Decision Date: Jul 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2320
• Device Class: Class 2

Intended Use

The dBG 300 records vibrational waveforms produced by the hearts contractions and transmitted to the chest wall. The dBG 300 may be used as a tool to measure the timing of the events in the cardiac cycle.

Device Story

dBG 300 records vibrational waveforms of heart contractions transmitted to chest wall; utilizes single-lead ECG and miniature tri-axial electronic accelerometer. Device transmits data via Bluetooth to PC-based software. Clinician operates system to visualize synchronized ECG and 3-axis (X, Y, Z) ballistocardiograph (BCG) waveforms. Software allows user to apply markers to identify cardiac events (e.g., mitral valve close/open, aortic valve open/close, early diastole). System calculates timing intervals between these events (e.g., systolic ejection period, isovolumic contraction time). Output assists clinicians in assessing cardiac cycle timing. Benefits include non-invasive measurement of mechanical heart motion.

Clinical Evidence

Clinical data collected to compare the device's measurement of cardiac event timing (e.g., aortic valve opening/closing) against echocardiography. Bench testing also performed.

Technological Characteristics

Portable hand-held unit with tri-axial electronic accelerometer and single-lead ECG. Connectivity via Bluetooth to PC. Software runs on Windows XP/Vista. Features include signal averaging, waveform markers, and automated timing interval calculations. Battery powered.

Indications for Use

Indicated for use as a tool to measure the timing of cardiac cycle events by recording vibrational waveforms produced by heart contractions and transmitted to the chest wall.

Regulatory Classification

Identification

A ballistocardiograph is a device, including a supporting structure on which the patient is placed, that moves in response to blood ejection from the heart. The device often provides a visual display.

Predicate Devices

• Modified Seismocardiograph - Seismed Instruments, Inc (K910994)

Submission Summary (Full Text)

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# 510(K) SUMMARY - K 081603 (as required by 807.92(c))

Regulatory Correspondent

Submitter of 510(k):

AJW Technology Consultants Inc. 962 Allegro Lane Apollo Beach, FL 33572

JUL 9 4 2009

HeartForce Medical, Inc Suite 200-100 Park Royal South Vancouver, BC V7T 1A2 Canada Phone: [phone] Fax: [phone] . . . .

Adrian Somers

Date of Summary:

Contact Person:

Trade/Proprictary Name:

Classification Name:

Product Code:

Intended Use: .

Device Description:

Predicate Device:

Substantial Equivalence:

07/21/09

dBG Digital Ballistocardiograph

Ballistocardiograph

## DXR

The dBG 300 records vibrational waveforms produced by the hearts contractions and transmitted to the chest wall. The dBG 300 may be used as a tool to measure the timing of the events in the cardiac cycle.

The Heart Force Ballistocardiograph senses and analyzes the mechanical movement of the heart. This is accomplished with 2 or 3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motion.

K910994 Modified Seismocardiograph - Seismed Instruments, Inc

Heart Force claims the proposed device to be substantially equivalent to the previously cleared device by FDA in K910994. Heart Force claims this equivalence because the proposed device has an equivalent intended use, manufacturing materials, operating principles, physical and operational specifications as compared to the predicate device.

In addition to bench data, the submittal includes clinical data collected to compare the subjects device's finding of the times of occurrence of cardiac events such as aortic valve opening or closing with that of an echocardiograph.

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| Features and Functions | Seismed SCG- 2000<br>Seismocardiograph | Heartforce<br>dBG 300 |
|-----------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------|
| dBG Software | | |
| Record Management and Platform | | |
| Tests Stored as individual files | Yes | Yes |
| Save Test | Yes | Yes |
| File Retrieval | From 3.5" floppy disk | From Hard Drive or external drive |
| Operating System | Proprietary | Windows XP, Windows Vista |
| PC-Based Software | No, Proprietary<br>software on<br>proprietary operating | Yes |
| Printing | Yes | Yes |
| Networked | No | No |
| Modem Data Transfer | Yes | No |
| Security | | |
| Printer | Yes | No (may use standard Windows<br>Printers) |
| Patient Demographics | | |
| Patient Name | Yes | Yes |
| Gender | No | Yes |
| Date of Birth | No | Yes |
| Comments | Yes | Yes |
| Patient ID | Yes | No |
| Physician Demographics (for Modem<br>Transfer) | Yes | Yes |
| Recording Test | | |
| ECG - BCG Syncrhonized Stacked Display | Yes | Yes (ECG & 3 Axis X, Y, Z BCG) |
| Rhythm Strip | No | Yes |
| ECG | 3 Lead | No, Single Lead Rhythm Strip |
| X Axis BCG | No | Yes |
| Y Axis BCG | No | Yes |
| Z Axis BCG | Yes | Yes |
| Preset Recording time | 30 Secs | User Configurable 10 secs, 30 secs,<br>60 Secs |
| Pre Exercise Test | Yes | Yes |
| Post Exercise Test | Yes | Yes |
| Recovery Test | Yes | No |
| ECG - BCG Review | | |
| Waveform Markers | No | Yes, User Applies Markers for ACC |
| | | recognized waves (Mitral Valve |
| | | Close, J, Mitral Valve Open, Aortic |
| | | Value Open, Aortic Valve Close, Early<br>Diastole) |
| Scroll BCG | Yes | Yes |
| Zoom BCG | No | Yes |
| Measurements | No | Yes |
| Signal Averaging | Yes | Yes |
| Reports | | |
| BCG Complex | Yes | Yes |
| MVC to AVO: Shows the Mitral Valve<br>Close to Aortic Valve Open time | No | Yes |
| AVO to AVC: Shows the systolic ejection<br>period | No | Yes |
| AVC to MVC: Shows the isovolumic | No | Yes |
| MVO to ED: Shows the Mitral Valve Open<br>to Early Diastole time | No | Yes |
| AVO: Aortic Valve Opening | No | Yes |
| MVO: Mitral Valve Opening | No | Yes |
| dBG Hardware | | |
| Portable Unit | Semi Portable Beside<br>Unit | Portable hand held unit, |
| Battery Power | No | Yes |
| Tri-axial Accelerometer | No (2 Axis) | Yes |
| Detachable Patient Cable (ECG, BCG) | Yes | Yes |
| ECG Lead Wires | Yes | No (ECG adhesive patches applied to<br>sensor and patient) |
| Data Transmission | Built in unit | Wireless Bluetooth transmission<br>from dBG 300 device to dBG<br>Software on a PC |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HeartForce Medical, Inc. c/o Mr. Arthur Ward AJW Technology Consultants, Inc. 962 Allegro Lane Apollo Beach, FL 33572

# JUL 2 4 2009

Re: K081603

Trade/Device Name: dBG 300 Digital Ballistocardiograph Regulatory Number: 21 CFR 870.2320 Regulation Name: Ballistocardiograph Regulatory Class: Class II (Two) Product Code: DXR, DSB Dated: May 27, 2009 Received: May 28, 2009

### Dear Mr. Ward:

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. Arthur Ward

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

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: K 081603

Device Name: dBG 300 Digital Ballistocardiograph

Indications for Use:

The dBG 300 records vibrational waveforms produced by the hearts contractions and transmitted to the chest wall. The dBG 300 may be used as a tool to measure the timing of the events in the cardiac cycle.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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for B Zuckerman(Division Sign-Off) 7124189 Division of Cardiovascular Devices 510(k) Number KO81603

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