(54 days)
The mySense Heart is indicated for use with patients who experience transient symptoms such as syncope, palpitations, shortness of breath or chest pains.
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.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It generally states that "All testing demonstrated acceptable results." The primary method for demonstrating "acceptability" appears to be equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Safety | Electrical Safety (IEC 60601-1) | Demonstrated acceptable results |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Demonstrated acceptable results | |
| Biocompatibility (ISO 10993-1) | Demonstrated acceptable results | |
| Adhesive Performance (ANSI/AAMI EC12) | Demonstrated acceptable results in a clinical trial | |
| Effectiveness/Functionality | Design Verification | Demonstrated acceptable results |
| Software Verification and Validation | Demonstrated acceptable results | |
| Ambulatory ECG Data Collection (Equivalence to predicate) | "Substantially equivalent" to commercially available Holter ECG monitor (predicate) | |
| Clinical Performance | Comparative performance against a predicate device in cardiac subjects for ECG data collection accuracy | "Acceptable results" in a clinical trial of 50 cardiac subjects |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: 50 cardiac subjects.
- Data Provenance: The document does not explicitly state the country of origin. It describes it as a "Clinical trial Comparative testing against a commercially available Holter ECG monitor (predicate device) in 50 cardiac subjects." This suggests a prospective clinical study setup.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not provide this information. It mentions "subsequent analysis by ECG technicians/clinicians" for the downloaded data, but it doesn't specify how ground truth for comparative testing was established (e.g., number of expert cardiologists interpreting the predicate device's data to serve as truth).
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size Improvements:
The document describes "Clinical trial Comparative testing against a commercially available Holter ECG monitor (predicate device) in 50 cardiac subjects," but this appears to compare the device's performance to a predicate device, not the human reader's performance with and without AI assistance. Therefore, an MRMC study related to AI assistance was not done, and no effect size for human reader improvement is stated. This device is a data acquisition device, not an AI-powered diagnostic tool in the sense of image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a recorder that collects ECG data. The "Recorder Processing Software (RPS)" is mentioned for "subsequent analysis by ECG technicians/clinicians." This implies that the device's primary function is data acquisition, and human review is part of the intended workflow. The "testing" section focuses on the device's ability to accurately record data and its adherence to various safety and design standards. While the RPS might have some automated processing, the core "performance" being evaluated seems to be the recording capability and equivalence to a Holter. Therefore, a standalone diagnostic algorithm performance study in the absence of human review does not appear to be the focus or explicitly detailed here.
7. The Type of Ground Truth Used:
The ground truth for the clinical comparative testing is implicitly the ECG data recorded by the predicate Holter monitor, which is considered the "gold standard" for ambulatory ECG recording in this context. The study compares the mySense™ Heart's recorded data to this established truth.
8. The Sample Size for the Training Set:
This information is not provided in the document. The device is a hardware recorder with associated software for processing, not a machine learning model that requires a "training set" in the conventional sense for deep learning. If there are internal algorithms within the RPS for artifact detection or basic rhythm classification, the training of such might not be detailed here.
9. How the Ground Truth for the Training Set was Established:
As no explicit "training set" and associated machine learning model development are described, this information is not applicable/provided.
{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 taperecorderClass II; product code: DSH |
| 510(k) Submitter | Cardiac Science Corporation3303 Monte Villa ParkwayBothell, WA 98021 USA |
| Contact Person | Neil ShellerSenior Regulatory Affairs EngineerCardiac Science Corporationnsheller@cardiacscience.com425-402-2156 (phone) 425-402-2017 (fax) |
Substantially Equivalent Devices
| Manufacturer | Substantially equivalent devices | 510(k) |
|---|---|---|
| iRhythm Technologies, Inc.San Francisco, CA | Zio patchExample model: Z100 | K090363 |
| Braemar CorporationBurnsville, MN | Holter recorderExample 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.
PAGE 2 OF 2
{2}------------------------------------------------
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
§ 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).