Cleared Traditional

TULSA-PRO System (K191200) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K191200 · Profound Medical, Inc. · Gastroenterology & Urology device
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Aug 2019
Decision
101d
Days
Class 2
Risk

K191200 is an FDA 510(k) clearance for the TULSA-PRO System. Classified as High Intensity Ultrasound System For Prostate Tissue Ablation (product code PLP), Class II - Special Controls.

Submitted by Profound Medical, Inc. (Mississauga, CA). The FDA issued a Cleared decision on August 15, 2019 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Profound Medical, Inc. devices

Submission Details

510(k) Number K191200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2019
Decision Date August 15, 2019
Days to Decision 101 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
29d faster than avg
Panel avg: 130d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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
NCT01686958 Completed Interventional

Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer

Phase 1 Study: A Prospective, Multi-center, Single Arm Study - Evaluation of the Safety and Feasibility of MRI-guided Transurethral Ultrasound Therapy for the Ablation of Prostate Tissue in Patients With Localized Prostate Cancer

30
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Prostate Cancer
Study design Single group
Eligibility Male only · 65 Years+
Principal investigator Joseph Chin, MD
Sponsor Profound Medical Inc.
Started 2013-03-13 → Primary completion 2015-03-23 → Completed 2019-06-11
Primary outcome
Safety - Evaluate the Frequency of Treatment Related Adverse Events
Secondary outcome
Feasibility - Evaluate the Effectiveness of the Investigational System to Thermally Coagulate Prostate Tissue Conforming to the Target Volume With a High Degree of Accuracy and Precision
View full study on ClinicalTrials.gov