(54 days)
Not Found
No
The summary describes a standard ECG recorder and processing software for technician/clinician analysis, with no mention of AI or ML capabilities.
No
The device is described as a cardiac monitor for collecting ECG data, which is a diagnostic function, not therapeutic. It helps in the analysis of symptoms but does not treat them.
Yes
The device is designed to collect electrocardiographic (ECG) data from patients experiencing transient symptoms like syncope and palpitations. This data is then analyzed by ECG technicians/clinicians to facilitate diagnosis of cardiac conditions. The description explicitly states its purpose is for "ambulatory collection of electrocardiographic (ECG) data continuously for up to 24 hours" and that the data "will be downloaded for subsequent analysis by ECG technicians/clinicians," indicating its role in the diagnostic process.
No
The device description explicitly states that the system is composed of a "Recorder" which is a physical, patch-style cardiac monitor with electrodes and an adhesive pad. This is a hardware component, not solely software.
Based on the provided information, the mySense Heart is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- mySense Heart Function: The mySense Heart is a wearable cardiac monitor that collects electrocardiographic (ECG) data directly from the patient's skin. It measures electrical activity of the heart within the body (in vivo).
- Intended Use: The intended use is to monitor patients experiencing transient symptoms related to heart activity, not to analyze samples taken from the body.
- Device Description: The description clearly states it's a patch-style cardiac monitor with electrodes that attach to the skin for ECG collection.
Therefore, the mySense Heart falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DSH
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:
- . 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ECG technicians/clinicians
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)
- 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.
All testing demonstrated acceptable results.
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
§ 870.2800 Medical magnetic tape recorder.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 |
| recorder | |
| Class II; product code: DSH | |
| 510(k) Submitter | Cardiac Science Corporation |
| 3303 Monte Villa Parkway | |
| Bothell, WA 98021 USA | |
| Contact Person | Neil Sheller |
| Senior Regulatory Affairs Engineer | |
| Cardiac Science Corporation | |
| nsheller@cardiacscience.com | |
| 425-402-2156 (phone) 425-402-2017 (fax) |
Substantially Equivalent Devices
| Manufacturer | Substantially equivalent devices | 510(k) |
|---|---|---|
| iRhythm Technologies, Inc. | ||
| San Francisco, CA | Zio patch | |
| Example model: Z100 | K090363 | |
| Braemar Corporation | ||
| Burnsville, MN | Holter recorder | |
| Example model: Model DXP1000 | ||
| (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
1
- . 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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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle, with its wings forming three distinct lines. The eagle is facing to the right.
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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
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)
page 1 of 1
510(k) Notification - mySense Heart Cardiac Science Corporation