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510(k) Data Aggregation
K Number
K021161Device Name
TSO3 OZONE CHEMICAL INDICATOR
Manufacturer
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC
Date Cleared
2003-08-27
(503 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TSO3 Chemical Indicator is a process indicator intended for use by healthcare providers to accompany sterilization packs, containers, or trays intended to be sterilized in the TSO, Model 125L Sterilizer. It is intended to differentiate between unprocessed items and processed items. The color of the TSO; Chemical Indicator changes from a red to lighter than the peach reference color when exposed to ozone, a critical component of the TSO3 Model 125L Sterlizer sterilization process.
Device Description
The TSO1 Chemical Indicator is a process indicalor strip intended to be used in the TSO--125L Ozone Sterilizer. The TSO3-125L Ozone Sterilizer uses Ozone vapor at low temperature and high humidity to destroy both spore-forming and nonspore-forming microorganisms. The routine use of CI's is considered to complement the employment of a biological indicator monitoring program. The TSO3 Chemical Indicator can be used to identify that an item has been processed through the TSO:-125L Ozone Sterilizer and that the Ozone was present. It does not imply that terminal sterilization occurred or to assure that the sterilization cvcle has been completed.
The TSO3 Chemical Indicator is comprised of a paper strip upon which a reactant chemical indicator ink is printed which is then overcoated with a clear finish to prevent the indicator ink from being damaged by handling or abrasion before, during or after use. The imprint consists of a red indicating ink circle located within a peach colored reference square. When the color of the indicator circle has changed to a color lighter than that of the surrounding peach colored reference square, the appropriate exposure to Ozone has taken place.
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K Number
K020875Device Name
TSO3 OZONE STERILIZER, MODEL 125L
Manufacturer
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC
Date Cleared
2003-08-26
(526 days)
Product Code
FLF, FRC
Regulation Number
880.6860Why did this record match?
Applicant Name (Manufacturer) :
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TSO1-Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in Health Care Facilities. The TSO3 Model 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures. The sterilization cycle operates at very low pressure and low temperatures, consequently it is suitable for processing medical devices sensitive to heat and moisture.
The TSO-125L Ocone Sterilizer is designed to sterilize instruments and devices with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
The TSO--125L Ozone Sterilizer is also designed to process medical devices having a single stainless steel lumen with:
- an inside diameter of 2 mm or larger and a length of 250 mm or shorter;
- an inside diameter of 3 min or larger and a length of 470 mm or shorter;
- an inside diameter of 4 mm or larger and a length of 600 mm or shorter.
Note: Testing conducted employing half cycle with a SAL of 10 with no survivors.
The packaging compatible with the TSO3-Model 125L Ozone Sterilizer are TSO3 sterilization pouch and rigid anodized aluminum containers using disposable cellulose filter paper.
Device Description
TSO model 125L Ozone Sterilizer is intended to sterilize reusable medical devices that have been previously cleaned. Ozone is generated within the sterilizer to provide an efficient sterilant without the concerns for transporting, handling and disposing of toxic chemicals. The sterilization chamber has a capacity of 125 liters (4 cu. ft.). It requires medical grade oxygen, water and clectricity.
The Model 125L is equipped with a unique factory-programmed control system for processing reusable medical devices.
Processed medical instruments requires no aeration time at the end of the sterilization cycle. The TSO3 sterilization pouch and anodized aluminum sterilization containers are used as packaging for medical devices to be sterilized.
The TSO3 OZO-TEST™ self-contained Biological Indicator (B. stearothermophilus) is recommended for use in evaluating cycle performance. TSO3 Chemical Indicator is recommended for use to differentiate between processed and unprocessed loads and to indicate that the load has been exposed to the sterilization process.
Model 125L could be installed as a free standing unit or recessed behind a wall. No exhaust gas ventilation duct is required in a room that is adequately ventilated.
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