Cleared Traditional

PATCHASSIST (K101218) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101218 · Polytouch Medical, Ltd. · General & Plastic Surgery device
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Jun 2010
Decision
48d
Days
Class 2
Risk

K101218 is an FDA 510(k) clearance for the PATCHASSIST. Classified as Mesh, Surgical, Deployer (product code ORQ), Class II - Special Controls.

Submitted by Polytouch Medical, Ltd. (Providence, US). The FDA issued a Cleared decision on June 17, 2010 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery 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 Polytouch Medical, Ltd. devices

Submission Details

510(k) Number K101218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2010
Decision Date June 17, 2010
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ORQ Mesh, Surgical, Deployer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Intended To Be Used To Facilitate The Delivery Of Soft Tissue Prosthetics During The Laparoscopic Repair Of Soft Tissue Defects (e.g. Hernia Repair).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.