K160899 is an FDA 510(k) clearance for the CoVa Monitoring System 2. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.
Submitted by Tosense, Inc. (San Diego, US). The FDA issued a Cleared decision on June 22, 2017 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.
NCT02337790
Completed
Observational
Industry-sponsored
Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals
Necklace-Shaped Sensor for Non-Invasive Monitoring of Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate in Patients With a Pacemaker, Implanted Cardioverter-Defibrillator, or Ventricular Assist Device
| Condition studied |
Heart Failure; Hypertension |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Matthew J Banet, PhD |
| Sponsor |
Baxter Healthcare Corporation
(industry)
|
Started 2015-01-01
→
Primary completion 2015-05-01
Primary outcome
Number of Patients with Interference between implanted devices and CoVa Monitoring System
Study completed - no results published.
This trial concluded in 2015 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510(k) Summary PDF or remain unpublished.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