Cleared Traditional

K090430 - BACKSTOP AND BACKSTOP INJECTOR

K090430 is an FDA 510(k) clearance for BACKSTOP AND BACKSTOP INJECTOR, manufactured by Pluromed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ONJ cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K090430 · Pluromed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
103d
Days
Class 2
Risk

K090430 is an FDA 510(k) clearance for the BACKSTOP AND BACKSTOP INJECTOR. Classified as Dissolvable Gel For Preventing Ureteral Stone Migration (product code ONJ), Class II - Special Controls.

Submitted by Pluromed, Inc. (Woburn, US). The FDA issued a Cleared decision on June 2, 2009 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - 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 Pluromed, Inc. devices

FDA 510(k) Submission Details - K090430

510(k) Number K090430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2009
Decision Date June 02, 2009
Days to Decision 103 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
28d faster than avg
Panel avg: 131d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

ONJ Device Classification - Class 2, Special Controls

Product Code ONJ Dissolvable Gel For Preventing Ureteral Stone Migration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
Definition For Use In The Ureter To Prevent The Migration Of Urinary Calculi And Their Fragments During Intracorporeal Lithotripsy Procedures.
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
NCT00893282 Completed Interventional Industry-sponsored

Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy

A Randomized, Controlled, Prospective, Single Blind Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy.

68
Patients (actual)
1
Site
Supportive_care
Purpose
Single blind
Masking
Condition studied Renal Calculi; Kidney Stones
Study design Parallel
Eligibility All sexes · 18 Years+
Sponsor Pluromed, Inc. (industry)
Started 2008-02-01 → Primary completion 2008-11-01 → Completed 2008-12-01
Primary outcome
Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no".
Secondary outcome
Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure.
Study completed - no results published. This trial concluded in 2008 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.
View full study on ClinicalTrials.gov