ECG CHECK

K122184 · Cardiac Designs, LLC · DXH · Feb 14, 2013 · Cardiovascular

Device Facts

• Record ID: K122184
• Device Name: ECG CHECK
• Applicant: Cardiac Designs, LLC
• Product Code: DXH · Cardiovascular
• Decision Date: Feb 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Indications for Use

The ECG Check is intended for self-testing by patients at home. This 1-lead cardiac monitor allows remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server. Specifically, the ECG Check is indicated for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms: - Skipped Beats - Pounding Heart (Palpitations) - Heart Racing or Irregular Pulse - Lightheadedness or Faintness - History of Arrhythmias

Device Story

ECG Check (Model ECG01-4S) is a 1-lead personal ECG event monitor; records 30-second ECG segments. Device interfaces with iPhone via secure Bluetooth; transmits data to ECG Check web center. Intended for home use by patients to manage heart rate/rhythms. Web-based engine performs standard ECG analysis; provides objective assessment (Green/Yellow/Red stoplight output). With physician prescription, users view waveforms on iPhone app, trend results, and generate reports for caregivers. Without prescription, users cannot view waveforms. Facilitates remote monitoring of symptoms (palpitations, skipped beats, etc.) by medical professionals. Benefits include long-term rhythm management and improved communication between patients and caregivers/technicians.

Clinical Evidence

Bench testing only. Device demonstrated safety and essential performance per IEC 60601-1 and IEC 60601-2-47. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (maximization and intracutaneous reactivity). No clinical data provided.

Technological Characteristics

1-lead cardiac monitor; Bluetooth connectivity to iPhone; web-based analysis engine. Complies with IEC 60601-1, IEC 60601-2-47, ISO 10993-5, and ISO 10993-10. Class II device (21 CFR 870.2920).

Indications for Use

Indicated for patients at home concerned about heart rhythm experiencing symptoms including skipped beats, palpitations, racing/irregular pulse, lightheadedness, faintness, or history of arrhythmias.

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

• PMP4 SelfCheck™ ECG (K042254)

Submission Summary (Full Text)

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## SECTION 5: 510(k) SUMMARY

# FEB 1 4 2013

| | 510(k) Summary |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | January 13, 2013 |
| Submitter: | Cardiac Designs, LLC<br>3293 Niblick Drive<br>Park City, UT 84098<br>Phone: [phone]<br>Facsimile: 1 [phone] |
| Contact: | Karim Marrouche, Managing Director<br>1 [phone] |
| Trade/Proprietary<br>Name of Device: | ECG CHECK |
| Common Name<br>of Device: | Transmitters And Receivers, Electrocardiograph, Telephone |
| Classification: | Class II per 21 CFR 870.2920, Telephone<br>electrocardiograph transmitter and receiver, Product Code<br>DXH |
| Legally Marketed<br>Predicate<br>Device: | PMP4 SelfCheck™ ECG (K042254), manufactured by Card<br>Guard Scientific Survival, Ltd. |

## Description of New ECG CHECK Device:

rill

The ECG Check model ECG01-4S is a personal 1 lead ECG Event Monitor specifically designed to operate with an iPhone 4S handset and allows transmissions to the ECG Check web center. Future iterations will be designed for other handsets, but will not change the fundamental features and capabilities described herein. It will record a preselected amount of user ECG activity, as directed by the user. Typical configuration is to record 30 seconds of ECG per event.

The ECG Check is indicated for monitoring symptoms that may suggest irregular or abnormal heart rhythms. The ECG Check, when used in conjunction with the ECG Check web center, uses standard analysis of ECG by the web-based engine for objective assessment of the user in terms similar to a stoplight (Green, Yellow, Red). With a physician prescription, the user will be provided access to be able to trend their results and generate reports to provide to their physician or other caregivers. The symptoms may include: skipped beats, palpitations, racing

C.2.1

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heart, fainting, lightheadedness, irregular rate, or history of other related heart abnormalities.

While performing the recording, the results are continuously sent to the iPhone by secure Bluetooth connection technology and, with a physician prescription, displayed for quality and observation purposes on the iPhone ECG Check application. Users without a physician prescription will not be able to view the waveform. The data can then be stored locally and/or transmitted to the ECG Check web center for analysis and assessment by qualified professionals. The ECG Check web center provides privacy and protection for user medical information and the ability to interact with Cardiac Designs, LLC technicians and engineers, as well as with their own caregivers.

The ECG Check Model ECG01-4S is intended for users that seek to manage their heart rate and rhythms over long periods of time. Additional features will be added to involve health care professionals in the service, with the intent to ensure that the device remains consumer focused and non-diagnostic.

### Indications for Use of the New Device:

The ECG CHECK is intended for self-testing by patients at home. This 1-lead cardiac monitor allows remote patients to display and transmit their FCG data to medical professionals via a communication device to a remote server.

Specifically, the ECG CHECK is indicated for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms:

- Skipped Beats .
માં આવેલું એ તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે આવેલું એક ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે આવેલું એક ગામનાં લોકોનો મુખ્ય વ

- Pounding Heart (Palpatations)
- Heart Racing or Irregular Pulse
- Lightheadedness or Faintness
- History of Arrhythmias .

### Comparison of the Technological Features of the New (Modified) Device and Predicate Device:

The new ECG CHECK indications for use are equivalent to the predicate PMP4 SelfCheck™ ECG device. The new ECG CHECK and the predicate PMP4 SelfCheck™ ECG device have identical patient populations and places of use. In addition, the parameters that are measured by the new ECG CHECK device are identical to those measured by the predicate PMP4 SelfCheck™ ECG device.

There are few differences between the new ECG CHECK device and the predicate PMP4 SelfCheck™ ECG device. The main difference is as follows:

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#### Leads:

The new ECG CHECK device operates with 1 lead. The predicate PMP4 SelfCheck™ ECG device can operate with 1 lead or with 12 leads. Cardiac Designs, LLC seeks substantial equivalence only to the 1 lead functionality of the predicate PMP4 SelfCheck™ ECG device. Comparisons, testing, and conclusions will be drawn based only on the 1 lead configuration.

#### Testing:

The ECG CHECK device successfully passed safety and essential performance testing as required by:

IEC 60601-1

IEC 60601-2-47 - Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems. ISO 10993-5:2009 Cytotoxicity - MEM Elution Test

ISO 10993-10:2010 Maximization Test for Delayed Hypersensitivity

ISO 10993-10:2010 Intracutaneous (Intradermal) Reactivity Test

#### Conclusion:

The conclusions drawn from the specifications and performance testing of the new ECG CHECK device demonstrate that the new ECG CHECK device is at least as safe and as effective and performs as well as or better than the Card Guard Scientific Survival, Ltd. predicate PMP4 SelfCheck™ ECG (K012254). For these reasons, we believe the new ECG CHECK device is substantially equivalent to the predicate device.

Signed,

Karin. Marranaka . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Karim Marrouche Managing Director

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

### February 14, 2013

Cardiac Designs, LLC c/o Mr. Karim Marrouche Managing Director 3293 Niblick Drive Park City, UT 80498

Re: K122184

> Trade/Device Name: ECG Check Regulatory Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitters and Receivers Regulatory Class: II (two) Product Code: 74 DXH Dated: January 18, 2013 Received: January 22, 2013

Dear Mr. Marrouche:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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Page 2 - Mr. Karim Marrouche

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.htm 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

for

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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## SECTION 4: INDICATIONS FOR USE

K122184 510(k) Number (if known): _

Device Name: ECG CHECK

#### Indications for Use:

The ECG Check is intended for self-testing by patients at home. This 1-lead cardiac monitor allows remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server.

Specifically, the ECG Check is indicated for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms:

- . Skipped Beats
- . Pounding Heart (Palpitations)
- . Heart Racing or Irregular Pulse
- Lightheadedness or Faintness .
- . History of Arrhythmias

Prescription Use X (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)

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