Cleared Traditional

ID-Cap System (K183052) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K183052 · Etectrx, Inc. · Cardiovascular device
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Dec 2019
Decision
399d
Days
Class 2
Risk

K183052 is an FDA 510(k) clearance for the ID-Cap System. Classified as Ingestible Event Marker (product code OZW), Class II - Special Controls.

Submitted by Etectrx, Inc. (Gainesville, US). The FDA issued a Cleared decision on December 6, 2019 after a review of 399 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 880.6305 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Etectrx, Inc. devices

Submission Details

510(k) Number K183052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2018
Decision Date December 06, 2019
Days to Decision 399 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
274d slower than avg
Panel avg: 125d · This submission: 399d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OZW Ingestible Event Marker
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6305
Definition To Provide Confirmation Of An Event Co-ingested Or Coincident With The Ingestible Component Of The Device. The Wearable Component Of The Device Incorporates Wireless Communication To Display The Event And Other Information On A General Computing Device
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02344238 Completed Interventional

Smart Capsule for Automatic Adherence Monitoring

60
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Medication Adherence
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Aimee McRae-Clark, PharmD, BCPP
Sponsor Medical University of South Carolina
Started 2015-07-01 → Primary completion 2016-04-01 → Completed 2016-06-01
Primary outcome
Medication Adherence
Secondary outcome
Number of Participants Reporting Adverse Events
View full study on ClinicalTrials.gov