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510(k) Data Aggregation
K Number
K233762Device Name
SteroScope® Sterilization Technology System
Manufacturer
IDEATE Medical, Inc.
Date Cleared
2024-06-27
(216 days)
Product Code
MLR
Regulation Number
880.6860Why did this record match?
Applicant Name (Manufacturer) :
IDEATE Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SteroScope® Sterilization Technology System is indicated for the terminal sterilization of cleaned reusable Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of:
- ID of 1.0 mm or larger and a length of 3580 mm or shorter and .
- ID of 1.2 mm or larger and a length of 4095 mm or shorter .
Device Description
The SteroScope® Sterilization Technology System is a vaporized hydrogen peroxide based (VHP) sterilizer for the terminal sterilization of flexible endoscopes with the following characteristics: Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of: · ID of 1.0 mm or larger and a length of 3580 mm or shorter and · ID of 1.2 mm or larger and a length of 4095 mm or shorter. The SteroScope® Sterilization Technology System is a Gas Plasma VHP sterilization system designed specifically for flexible endoscope terminal sterilization, not for general surgical instrument loads. It is a self-contained stand-alone system of hardware and software system that uses technology to rapidly diffuse VHP into all the channels of the flexible endoscope to facilitate the sterilization of inner device surfaces, while being occupationally and environmentally safe to use. To enable the terminal sterilization of long multi-lumen endoscopes, while minimizing oxidation damage, the SteroScope® Sterilization Technology System incorporates a proprietary gas diffusion technology which creates a pressure differential in each internal endoscope lumen channel to actively pull hydrogen peroxide vapor from the chamber of the VHP sterilizer through the distal end of each endoscope channel, while the endoscope is in a sterile container. Utilizing a separate mechanism for the rapid diffusion of VHP from the chamber into the individual SteroScope® Sterilization Technology System allows the entire endoscope to be sterilized with less overall peroxide dose exposure.
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