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510(k) Data Aggregation
K Number
K970352Device Name
SMARTVAC SMOKE EVACUATION SYSTEM
Manufacturer
Date Cleared
1997-11-04
(278 days)
Product Code
Regulation Number
878.5070Why did this record match?
Applicant Name (Manufacturer) :
ISOMEDIX OPERATIONS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SmartVac is intended to be used for the evacuation of plume from the use of electrocautery, laser or other plume producing devices. It is intended to be used during both open surgery or endoscopic surgical procedures performed in the operating room or procedure room of hospitals, ambulatory surgery centers, clinics or in a physician's office.
The SmartVac Smoke Evacuation System is indicated for the evacuation of plume from electrocautery, laser or other plume generating devices.
Device Description
The SmartVac operates by collecting air containing smoke/plume from the site of origin, filtering the biological and chemical components, and returning the filtered, odor-free air to the room.
The SmartVac functions by creating a partial vacuum, near the smoke source, which pulls the smoke into a collection accessory and through a filtration system. After filtration, the air moves through the motor/blower and exits the cabinet.
The major components of the SmartVac are:
- 1) collection devices which consist of plain tubing or tubing with a procedure specific Collection Tip on the distal end;
- 2) a filtration system which includes a First Filter which is a combination High Efficiency Particulate (HEPA) and carbon filter intended for limited, multiprocedure usage;
- 3) a second Filter which is a large Ultra Low Penetration Air (ULPA) filter;
- 4) a pressure sensor monitors the pressure differential across the filter and activates the Change ULPA light when a filter nears occlusion; and
- 5) a vacuum system which consists of a motor/blower designed to pull a partial vacuum in the Filtration System and its various controls.
In use, the distal end of the Collection Accessory is positioned close to the surgical site. When electrocautery or laser usage produces smoke, the user activates the SmartVac. Air, pulled from in front of the Collection Tip or end of the Tubing, flows through the First Filter which removes most biological particulates and noxious gases. It then passes through the Second Filter for ULPA filtration before it goes through the motor/blower and exits the rear of the cabinet. Pressure sensors monitor the pressure differential across both filters. Those monitoring the First Filter control the three lights of the Filter Status Indicator ULPA light. The sensors on the First Filter also sense any sudden increase in pressure from invagination of either tissue or a foreign object.
The Collection Accessories offered in the SmartVac Evacuation System include corrugated tubing, electrosurgical shrouds, smaller tubing and/or connectors, laser resistant wands, replacement filters and a remote switch.
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