Cleared Traditional

K213657 - DEEPVESSEL FFR (FDA 510(k) Clearance)

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

K213657 · Keyamed Na, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2022
Decision
133d
Days
Class 2
Risk

K213657 is an FDA 510(k) clearance for the DEEPVESSEL FFR. Classified as Coronary Vascular Physiologic Simulation Software (product code PJA), Class II - Special Controls.

Submitted by Keyamed Na, Inc. (Seattle, US). The FDA issued a Cleared decision on April 1, 2022 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1415 - 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. Standard predicate reliance. 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 Keyamed Na, Inc. devices

Submission Details

510(k) Number K213657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2021
Decision Date April 01, 2022
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PJA Coronary Vascular Physiologic Simulation Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1415
Definition A Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease.
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.

Regulatory Consultant

Hogan Lovells US LLP
Kelliann Payne

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT04828590 Completed Observational Industry-sponsored

The ADAPT Study: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease

Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease

302
Patients (actual)
10
Sites
Condition studied Coronary Artery Disease; Myocardial Ischemia
Eligibility All sexes · 18 Years+
Principal investigator Joseph Schoepf, MD
Sponsor Keya Medical (industry)
Started 2020-08-10 → Primary completion 2021-12-01 → Completed 2021-12-31
Primary outcome
Sensitivity of DVFFR at the vessel level in identifying ischemic lesions, i.e. DVFFR value≤0.80, from coronary CTA images, using ICA-FFR measurement as a reference standard.
Secondary outcome
Diagnostic accuracy, positive predictive value (PPV) and negative predictive value (NPV) of DVFFR at the vessel level
Study completed - no results published. This trial concluded in 2021 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. Individual participant data will not be shared.
View full study on ClinicalTrials.gov