K113176 is an FDA 510(k) clearance for the MYSENSE HEART. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.
Submitted by Cardiac Science Corporation (Bothell, US). The FDA issued a Cleared decision on December 21, 2011 after a review of 54 days - a notably fast clearance cycle.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.
NCT01382953
Completed
Observational
The Simple ECG Monitoring Trial (Comparison of a Novel Recording System With a Standard Holter Monitor)
The Simple ECG Monitoring Trial (Comparison of a Simple ECG Recording System With a Standard ECG Recording System for Holter Monitoring)
| Condition studied |
Syncope; Pre-syncope; Atrial Fibrillation; Supraventricular Tachycardia |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Gust H. Bardy, MD |
| Sponsor |
Seattle Institute for Cardiac Research
|
Started 2011-08-01
→
Primary completion 2011-10-01
Primary outcome
To compare the *diagnostic yield and *ECG signal quality of the standard Holter with that of the Simple ECG Monitoring patch
Secondary outcome
Skin comfort or discomfort: Was skin irritated?
Study completed - no results published.
This trial concluded in 2011 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov