(413 days)
Not Found
No
The summary describes a device that senses and analyzes mechanical movement and ECG signals, comparing its findings to an echocardiograph. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is described as a tool to measure the timing of events in the cardiac cycle and records vibrational waveforms, which is a diagnostic or monitoring function, not a therapeutic one. It analyzes mechanical movement and compares its findings with an echocardiograph, further supporting its diagnostic role.
Yes
The device records vibrational waveforms produced by the heart's contractions and is used to measure the timing of events in the cardiac cycle. This physiological measurement provides information about cardiac function, which is a diagnostic purpose. The comparison with an echocardiograph in performance studies further supports its diagnostic intent.
No
The device description explicitly states it uses "standard ECG electrodes" and a "miniature electronic accelerometer," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device function: The dBG 300 records vibrational waveforms from the chest wall, which are external measurements of the heart's mechanical activity. It does not analyze biological samples taken from the body.
- Intended Use: The intended use is to measure the timing of events in the cardiac cycle based on these external vibrations.
- Device Description: The description confirms it senses and analyzes mechanical movement, not biological samples.
Therefore, the dBG 300 falls under the category of a non-IVD medical device that measures physiological signals from the body's surface.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DXR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2320 Ballistocardiograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: (604)-566-8200 Fax: (604)-566-8201 . . . .
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
Seismocardiograph | Heartforce
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
software on
proprietary operating | Yes |
| Printing | Yes | Yes |
| Networked | No | No |
| Modem Data Transfer | Yes | No |
| Security | | |
| Printer | Yes | No (may use standard Windows
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
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,
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
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
Close to Aortic Valve Open time | No | Yes |
| AVO to AVC: Shows the systolic ejection
period | No | Yes |
| AVC to MVC: Shows the isovolumic | No | Yes |
| MVO to ED: Shows the Mitral Valve Open
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
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
sensor and patient) |
| Data Transmission | Built in unit | Wireless Bluetooth transmission
from dBG 300 device to dBG
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.
4
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
5
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) |
|---|
for B Zuckerman(Division Sign-Off) 7124189 Division of Cardiovascular Devices 510(k) Number KO81603
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