MYSENSE HEART

K113176 · Cardiac Science Corporation · DSH · Dec 21, 2011 · Cardiovascular

Device Facts

• Record ID: K113176
• Device Name: MYSENSE HEART
• Applicant: Cardiac Science Corporation
• Product Code: DSH · Cardiovascular
• Decision Date: Dec 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The mySense Heart is indicated for use with patients who experience transient symptoms such as syncope, palpitations, shortness of breath or chest pains.

Device Story

mySense Heart is a small, lightweight, patch-style ambulatory ECG monitor; collects continuous ECG data for up to 24 hours. Device consists of a recorder with two electrodes and an adhesive pad for chest attachment; Recorder Processing Software (RPS) installed on a computer for data download. Used in clinical settings; operated by ECG technicians or clinicians. Data is downloaded from the recorder to the RPS for subsequent analysis by healthcare providers. Output allows clinicians to review cardiac activity to evaluate transient symptoms, potentially aiding in diagnosis and patient management.

Clinical Evidence

Clinical trial conducted with 50 cardiac subjects. Comparative testing performed against a commercially available Holter ECG monitor (predicate device). All testing, including design verification and software validation, demonstrated acceptable results.

Technological Characteristics

Patch-style ambulatory ECG monitor; two-electrode sensing; adhesive attachment. Dimensions: size of a large band-aid. Connectivity: data download to computer via RPS. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility), ANSI/AAMI EC12 (disposable electrodes).

Indications for Use

Indicated for patients experiencing transient symptoms including syncope, palpitations, shortness of breath, or chest pains.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• Zio patch (K090363)
• Holter recorder Model DXP1000 (K993618)

Submission Summary (Full Text)

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#### K113174 510(k) Summary of Safety and Effectiveness ll.

# mySense™ Heart

### General Information

| Criteria | Information |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | mySense™ Heart |
| Model Number | none assigned |
| Common Name | Ambulatory electrocardiograph (ECG) |
| Classification | 21 CFR 870.2800 - Medical magnetic tape<br>recorder<br>Class II; product code: DSH |
| 510(k) Submitter | Cardiac Science Corporation<br>3303 Monte Villa Parkway<br>Bothell, WA 98021 USA |
| Contact Person | Neil Sheller<br>Senior Regulatory Affairs Engineer<br>Cardiac Science Corporation<br>[e-mail]<br>425-402-2156 (phone) 425-402-2017 (fax) |

## Substantially Equivalent Devices

| Manufacturer | Substantially equivalent devices | 510(k) |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------|---------|
| iRhythm Technologies, Inc.<br>San Francisco, CA | Zio patch<br><i>Example model:</i> Z100 | K090363 |
| Braemar Corporation<br>Burnsville, MN | Holter recorder<br><i>Example model:</i> Model DXP1000<br>(model is now called the Vision 5L) | K993618 |

## Device Description

The mySense™ Heart, developed by Cardiac Science Corporation (CSC), is small, lightweight, patch-style cardiac monitor, designed for ambulatory collection of electrocardiographic (ECG) data continuously for up to 24 hours. The device system is composed of 2 main components:

510(k) Notification - *mySense Heart*
Cardiac Science Corporation

PAGE 10F2

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- . Recorder - The mySense Heart recorder is about the size of a large band-aid and contains 2 electrodes that are used for sensing and detecting a patient's ECG. The recorder has an adhesive pad so that it can be attached to the patient's skin in the chest region for ECG collection.
- Recorder Processing Software (RPS) The RPS is installed on a . computer where the patient's ECG data on the recorder will be downloaded for subsequent analysis by ECG technicians/clinicians.

## Indications for Use

The mySense Heart is indicated for use with patients who experience transient symptoms such as syncope, palpitations, shortness of breath or chest pains.

## Testing

The mySense Heart device underwent extensive testing, including testing listed below. All testing demonstrated acceptable results.

- Design verification testing
- Software verification and validation testing
- IEC 60601-1 testing (Electrical safety)
- IEC 60601-1-2 testing (EMC)
- ISO 10993-1 testing (biocompatibility)
- ANSI/AAMI EC12 testing (disposable ECG electrodes), including adhesive testing in humans in a clinical trial.
- Clinical trial Comparative testing against a commercially available Holter ECG monitor (predicate device) in 50 cardiac subjects.

## Summary of Substantial Equivalence

Based on the information contained in this 510(k) Notification, Cardiac Science Corporation determined that the mySense Heart does not raise any new safety or effectiveness issues and is substantially equivalent to legally marketed electrocardiographs that are in commercial distribution, and have been determined to be substantially equivalent to devices in commercial distribution. prior to May 28, 1976.

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

DEC 2 1 2011

Cardiac Science Corporation c/o Mr. Neil Sheller Senior Regulatory Affairs Engineer 3303 Monte Villa Parkway Bothell, WA 98021

K113176 Re:

> Trade/Device Names: mySense™ Heart Regulatory Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (Two) Product Code: DSH Dated: October 25, 2011 Received: October 28, 2011

Dear Mr. Sheller:

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 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. Neil Sheller

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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Munh Jale for

Zuckerman, M.D. Bram D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K//3176

Device Name:

mySense™ Heart

Indications for Use:

The mySense Heart is indicated for use with patients who experience transient symptoms such as syncope, palpitations, shortness of breath or chest pains.

shill for Bram Zuckerman
(Division Sign-Off) Director DCD
Division of Cardiovascular Devices
510(k) Number K113176

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Notification - mySense Heart Cardiac Science Corporation