Cleared Traditional

K153023 - Ablatherm Integrated Imaging

K153023 is an FDA 510(k) clearance for Ablatherm Integrated Imaging, manufactured by Edap Technomed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PLP cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K153023 · Edap Technomed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
22d
Days
Class 2
Risk

K153023 is an FDA 510(k) clearance for the Ablatherm Integrated Imaging. Classified as High Intensity Ultrasound System For Prostate Tissue Ablation (product code PLP), Class II - Special Controls.

Submitted by Edap Technomed, Inc. (Austin, US). The FDA issued a Cleared decision on November 6, 2015 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4340 - the FDA gastroenterology and urology device 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.

View all Edap Technomed, Inc. devices

FDA 510(k) Submission Details - K153023

510(k) Number K153023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2015
Decision Date November 06, 2015
Days to Decision 22 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 131d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

PLP Device Classification - Class 2, Special Controls

Product Code PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4340
Definition Prostate Tissue Ablation
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 Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00295802 Unknown Interventional Industry-sponsored

Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer

141
Patients (actual)
15
Sites
Treatment
Purpose
Open label
Masking
Condition studied Prostate Cancer
Study design Parallel
Eligibility Male only · 50 Years+
Principal investigator Carey Robertson, MD
Sponsor EDAP TMS S.A. (industry)
Started 2006-04-01 → Primary completion 2012-08-01 → Completed 2014-09-01
Primary outcome
Attainment achievement of prostate-specific antigen (PSA) nadir < 0.5 ng/ml and stability of PSA according to American Society for Therapeutic Radiology and Oncology (ASTRO) criteria through 24 month follow up without a positive biopsy
Secondary outcome
Achievement of a nadir PSA within 6 months < 0.5 ng/ml
View full study on ClinicalTrials.gov