(15 days)
Not Found
No
The summary describes a system for acquiring, transmitting, and displaying EKG data. It explicitly states that no clinical interpretation is provided and there is no mention of AI, ML, or any related technologies in the device description or performance studies.
No
The device is designed to collect, transmit, and display EKG data for diagnostic evaluation by a physician, not for therapeutic intervention. It explicitly states "No clinical interpretation of EKG is provided."
No
The device collects, transmits, and displays EKG data, but it explicitly states that "No clinical interpretation of EKG is provided" and the "clinical and diagnostic evaluation of acquired EKG signals should be made by a physician." This indicates it's a data acquisition and display tool, not a diagnostic device itself.
No
The device description explicitly states that the MobCardio System is comprised of an EKG acquisition module, a 12-lead EKG patient cable, a medical grade laptop, and the user software. This includes significant hardware components beyond just software.
Based on the provided information, the MobCardio System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The MobCardio System collects EKG data directly from the patient's body (external surface of chest and limbs) using electrodes. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is to collect, transmit, and display EKG data. This is a physiological measurement, not an in vitro analysis of a specimen.
- The device description focuses on hardware and software for acquiring and displaying electrical signals from the heart. It doesn't mention any reagents, calibrators, or other components typically associated with IVD testing.
The MobCardio System is a medical device used for physiological monitoring and data acquisition. It falls under the category of electrocardiographs, which are used to record the electrical activity of the heart.
N/A
Intended Use / Indications for Use
The MobCardio System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult populations. The device is designed to collect, transmit, and display resting 12 lead EKG data. The clinical and diagnostic evaluation of acquired EKG signals should be made by a physician, who has experience or is specialized in Cardiology. No clinical interpretation of EKG is provided.
Product codes
DPS
Device Description
The MobCardio System is comprised of an EKG acquisition module (connected via a PC-USB cable), a 12-lead EKG patient cable, a medical grade laptop, and the user software. The device is used to collect, transmit, and display resting 12-lead EKG data using FDA cleared disposable EKG electrodes and manufacturer supplied 12-lead EKG patient cable.
The user software is pre-installed for the user and provides necessary menus and user interfaces for displaying and printing the acquired 12-lead EKG data.
The MobCardio System is compatible with any desktop or notebook computer with a suitable USB port (1.0 or above) and Windows operating system. While we offer the EKG acquisition module and the medical grade laptop as a system, the user has the option to use a personal computer that fits the requirements listed in the device user manual. Without being connected to a computer, the EKG data acquired will not be displayed and no EKG prints out can be obtained.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
External surface of chest and limbs
Indicated Patient Age Range
Adult
Intended User / Care Setting
Trained operators under the direct supervision of a licensed healthcare practitioner.
Healthcare facilities/Hospitals
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
Device components underwent safety and bench testing on both hardware and software and demonstrated acceptable functional and performance results. No safety and effectiveness issues were raised.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
V. 510(k) Summary
This 510(k) summary is submitted in accordance to the requirements of 21 CFR 807.92.
The assigned 510(k) number is:
General Information
| Criteria | Information |
|---|---|
| Trade Name | MobCardio System |
| Model Name | MHC2011.1.0 |
| Common Name | Electrocardiography |
| Classification | Class II |
| 510(k) Submitter | MobHealth Corporation |
| 5227 Village Circle Dr. | |
| Temple City, CA 91780 | |
| Contact Person | Patricia Lin, Director of Technology Marketing |
| patricial@mobhealth.com | |
| Date Prepared | May 12th, 2011 |
Substantially Equivalent Devices
| Manufacturer | Substantially Equivalent Device | 510(k) |
|---|---|---|
| Kardiosis Ltd. | ARS-EKG 12K | |
| Electrocardiography System | K914206 | |
| ET Medical Devices Spa | Cardioline AR600 | K051534 |
| Midmark Diagnostic Group | Midmark IQecg | K103640 |
Predicate Device Comparison Summary:
The MobCardio System has in many instances, identical or nearly identical technological characteristics to the substantially equivalent devices. See device comparison table below:
| Device name | ARS-EKG 12K
ECG System
(K914206) | Cardioline
AR 600
(K051534) | Midmark
IQecg
(K103640) | MobCardio
System |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Acquisition and
display of resting
12-lead ECG; no
interpretation | Acquisition,
display, and
interpretation of
resting 12-lead ECG | Acquisition,
display, and
interpretation of
resting 12-lead
ECG | Acquisition and
display of resting
12-lead ECG; no
interpretation |
| Indications
for use | Prescription use by
trained physicians
and/or medical
personnel only | Prescription use by
trained physicians
and/or medical
personnel only | Prescription use by
trained physicians
and/or medical
personnel only | Prescription use by
trained physicians
and/or medical
personnel only |
| Target
population | Adult | For non interpretive
applications, no
limitations to age,
sex and race | Adult and pediatric | Adult |
| Device name | ARS-EKG 12K
ECG System
(K914206) | Cardioline
AR 600
(K051534) | Midmark
IQecg
(K103640) | MobCardio
System |
| Anatomical
sites | External surface of
chest and limbs | External surface of
chest and limbs | External surface of
chest and limbs | External surface of
chest and limbs |
| Where used | Healthcare
facilities/Hospitals | Healthcare
facilities/Hospitals | Healthcare
facilities/Hospitals | Healthcare
facilities/Hospitals |
| Energy used
and/or
delivered | PC powered (PC
EKG add-on card) | AC Main/External
battery power | External battery
power/PC-USB
powered | USB powered/AC
adapter and
rechargeable
battery for medical
grade laptop |
| Design | EKG data
acquisition module
(PC-ISA) with
software for data
processing,
display, storage,
and print | EKG data
acquisition, storage
and print device
(infrared serial)
with software for
interpretation,
display, storage, and
print | EKG data
acquisition module
(USB/RS232) with
software for data
processing,
interpretation,
display, storage,
and print | EKG data
acquisition module
(PC-USB) AND
medical grade PC
with software for
data processing,
display, storage,
and print |
| Standards
met | • IEC 60601-
1:1990
• AAMI
EC11:1982
• AAMI
ES1:1985 | • IEC 60601-
1:2006
• IEC 60601-1-
2:1993
• IEC 60601-2-
25:1995
• IEC 60601-2-
51:2003 | • IEC 60601-
1:2006
• IEC 60601-1-
2:2007
• IEC 60601-2-
25:1999
• AAMI
EC11:2007 | • IEC 60601-
1:2006
• IEC 60601-1-
2:2007
• IEC 60601-2-
25:1999
• IEC 60601-2-
51:2005
• AAMI
EC11:2007 |
| Bio-
compatibility | Not applicable | Not applicable | Not applicable | Not applicable |
| Sterility | Not applicable | Not applicable | Not applicable | Not applicable |
| Electrical/Co
mpatibility
w/environme
nt & other
devices | Passed EMC test -
met IEC 60601-1,
AAMI ES11 and
ES1 requirements | Passed EMC and
LVD tests - met
IEC 60601-1, IEC
60601-1-2, IEC
60601-2-25
requirements | Passed EMC and
LVD tests - met
IEC 60601-1, IEC
60601-1-2, IEC
60601-2-25
requirements | Passed EMC and
LVD tests - met
IEC 60601-1, IEC
60601-1-2, IEC
60601-2-25
requirements |
| Mechanical
safety | ECG amplifiers
(e.g. input
protection against
defibrillation
shocks, type BF
applied part) | ECG amplifiers
(e.g. input
protection against
defibrillation
shocks, type CF
applied part) | ECG amplifiers
(e.g. input
protection against
defibrillation
shocks, type CF
applied part) | ECG amplifiers
(e.g. input
protection against
defibrillation
shocks, type BF
applied part) |
1
..............................................................................................................................................................................
Summary of Substantial Equivalence
After comparing the indications for use, technology, and performance specifications of the listed predicate devices and the MobCardio System, we have concluded that the proposed device does not raise any new safety or effectiveness issues and is substantially equivalent to the listed predicate devices.
2
Device Description
The MobCardio System is comprised of an EKG acquisition module (connected via a PC-USB cable), a 12-lead EKG patient cable, a medical grade laptop, and the user software. The device is used to collect, transmit, and display resting 12-lead EKG data using FDA cleared disposable EKG electrodes and manufacturer supplied 12-lead EKG patient cable.
The user software is pre-installed for the user and provides necessary menus and user interfaces for displaying and printing the acquired 12-lead EKG data.
The MobCardio System is compatible with any desktop or notebook computer with a suitable USB port (1.0 or above) and Windows operating system. While we offer the EKG acquisition module and the medical grade laptop as a system, the user has the option to use a personal computer that fits the requirements listed in the device user manual. Without being connected to a computer, the EKG data acquired will not be displayed and no EKG prints out can be obtained.
Indications for Use
The MobCardio System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult populations. The device is designed to collect, transmit, and display resting 12 lead EKG data. The clinical and diagnostic evaluation of acquired EKG signals should be made by a physician, who has experience or is specialized in Cardiology. No clinical interpretation of EKG is provided.
Functional and Safety Testing
Device components underwent safety and bench testing on both hardware and software and demonstrated acceptable functional and performance results. No safety and effectiveness issues were raised.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002
NOV 1 7 2011
MobHealth Corporation c/o Mr. Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 53313
Re: K113234
Trade/Device Name: MobCardio System Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: November 1, 2011 Received: November 2, 2011
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined honice 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 (Act (Act to not require approval of a proval 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 misbillions and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Mark Job
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation -Center for Devices and Radiological Health
Enclosure
5
IV. Indications for Use Statement
510(k) Number (if known):
Device Name: MobCardio System
Indications For Use:
The MobCardio System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult populations. The device is designed to collect, transmit, and display resting 12 lead EKG data. The clinical and diagnostic evaluation of acquired EKG signals should be made by a physician, who has experience or is specialized in Cardiology. No clinical interpretation of EKG is provided.
Prescription Use X (21 CFR Part 801 Subpart D) AND/OR
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division d Cardiovasc I Devices 5 ! Onk) Nümber
Page 1 of /