Who is the manufacturer of MOBCARDIO SYSTEM?

Mobhealth Incorporation filed the 510(k) submission for MOBCARDIO SYSTEM (K113234).

What is the FDA product code for MOBCARDIO SYSTEM?

DPS. It is classified under 21 CFR 870.2340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for MOBCARDIO SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MOBCARDIO SYSTEM?

ARS-EKG 12K Electrocardiography System (K914206); Cardioline AR600 (K051534); Midmark IQecg (K103640).

Who can help prepare an FDA 510(k) submission like MOBCARDIO SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MOBCARDIO SYSTEM

K113234 · Mobhealth Incorporation · DPS · Nov 17, 2011 · Cardiovascular

Device Facts

Record ID	K113234
Device Name	MOBCARDIO SYSTEM
Applicant	Mobhealth Incorporation
Product Code	DPS · Cardiovascular
Decision Date	Nov 17, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2340
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended 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.

Device Story

System comprises EKG acquisition module, 12-lead patient cable, medical-grade laptop, and software. Inputs: electrical signals from patient via disposable electrodes. Operation: module connects to PC via USB; software collects, transmits, and displays resting 12-lead EKG data. Used in healthcare facilities/hospitals by trained operators. Output: visual display and printout of EKG waveforms. No automated interpretation provided; physician performs clinical/diagnostic evaluation. Benefits: enables acquisition and review of resting EKG data for clinical decision-making.

Clinical Evidence

Bench testing only. Device components underwent safety and functional performance testing. No clinical data provided.

Technological Characteristics

PC-USB based EKG acquisition module; 12-lead patient cable; medical-grade laptop. Standards: IEC 60601-1:2006, IEC 60601-1-2:2007, IEC 60601-2-25:1999, IEC 60601-2-51:2005, AAMI EC11:2007. Type BF applied part. Connectivity: USB 1.0 or higher. Software-based display and printing.

Indications for Use

Indicated for adult patients. Used by trained operators under direct supervision of licensed healthcare practitioner for collection, transmission, and display of resting 12-lead EKG data. No contraindications specified.

Regulatory Classification

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.

Predicate Devices

ARS-EKG 12K Electrocardiography System (K914206)
Cardioline AR600 (K051534)
Midmark IQecg (K103640)

Related Devices

K963578 — PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) · Intl. Products, Inc. · Jun 30, 1997
K050674 — PHYSIOGLOVE ES · Commwell , Ltd. · Apr 25, 2006
K111805 — ECG SERIES ELECTROCARDIOGRAPH · Advanced Instrumentations, Inc. · Aug 24, 2011
K133985 — DIGITAL ELECTROCARDIOGRAPH · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · Jan 22, 2015
K030535 — EKGCARD SYSTEM · Qrs Diagnostic, LLC · Jun 11, 2003

Submission Summary (Full Text)

{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. K113234 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 /