Cleared Traditional

K163608 - HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm

K163608 is an FDA 510(k) clearance for HAART 300 Aortic Annuloplasty Device 19mm, manufactured by Biostable Science & Engineering, Inc.. The device is a Class 2 Cardiovascular device with product code PST cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K163608 · Biostable Science & Engineering, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
90d
Days
Class 2
Risk

K163608 is an FDA 510(k) clearance for the HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Devi.... Classified as Aortic Annuloplasty Ring (product code PST), Class II - Special Controls.

Submitted by Biostable Science & Engineering, Inc. (Austin, US). The FDA issued a Cleared decision on March 21, 2017 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3800 - 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.

FDA 510(k) Submission Details - K163608

510(k) Number K163608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2016
Decision Date March 21, 2017
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

PST Device Classification - Class 2, Special Controls

Product Code PST Aortic Annuloplasty Ring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3800
Definition To Correct Annular Dilatation And/or Maintain Annular Geometry Of The Aortic Valve.
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
Janice M. Hogan

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
NCT01400841 Completed Interventional Industry-sponsored

HAART Model 300 Annuloplasty Ring

A Prospective, Non-randomized, Multi-center Trial to Evaluate the Safety and Effectiveness of the HAART Model 300 Annuloplasty Ring When Used to Surgically Repair a Leaking Aortic Valve Using a 3-D Intra-annular Mounting Frame

18
Patients (actual)
4
Sites
Treatment
Purpose
Open label
Masking
Condition studied Aortic Regurgitation
Study design Single group
Eligibility All sexes · 50 Years+
Principal investigator Christof Stamm, M.D.
Sponsor Biostable Science & Engineering (industry)
Started 2012-01-01 → Primary completion 2013-04-01 → Completed 2014-09-01
Primary outcome
Primary Safety Outcome Measure: Event-free Survival
Secondary outcome
Implant Procedure Success
View full study on ClinicalTrials.gov
K163608 · HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm
Download PDF FDA Summary Biostable Science & E…