(526 days)
STERRAD® 100S Sterilization System
Not Found
No
The summary describes a standard ozone sterilization system with a factory-programmed control system. There is no mention of AI, ML, or any features that would suggest the use of such technologies for tasks like image processing, data analysis for cycle optimization, or adaptive control based on complex inputs.
No
The device is an ozone sterilizer used to process reusable medical devices, not a device used to treat or diagnose patients.
No
The device is an ozone sterilizer used for processing reusable medical devices, not for diagnosing medical conditions.
No
The device description clearly describes a physical sterilizer unit with a sterilization chamber, requiring oxygen, water, and electricity. It also mentions packaging and biological/chemical indicators, all of which are hardware components. While it has a "factory-programmed control system," this is part of the overall hardware device, not a standalone software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "sterilization processing of reusable medical devices in Health Care Facilities." This is a process applied to medical devices themselves, not a test performed on biological samples to diagnose or monitor a condition.
- Device Description: The description focuses on the mechanism of sterilization using ozone and the physical characteristics of the sterilizer. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Using reagents or assays
The device is a sterilizer, which is a type of medical device used to prepare other medical devices for use. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
FLF, FRC
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.
The software controls of the Model 125L have been designed providing safeguards that only intended operating cycles function to completion. An unintended condition will abort the cycle . and provide appropriate information identifying the source of the condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Care Facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
STERRAD® 100S Sterilization System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).
0
AUG 2 6 2003
TS().
K020875 TSO3-125L Ozone Sterilizer
510(k) Summary
Applicant's Name and Address TSO3 Inc. 2505 Dalton Avenue Sainte-Foy (Quebec) GIP 3SS
Phone : (418) 651-0003 (418) 653-5726 Fax : Email :info(@tso3.com
Contact Person, Telephone, FAX
Marc Chaunet, Quality Assurance and Regulatory Affairs Tel : (418) 653-0003 ext. : 242 FAX : (418) 653-5726 E-mail : mchaunet@tso3.com
U.S. Agent
Charles O. Hancock inc. Contact person: Charles O. Hancock, RAC Tel : (716) 223-1850 FAX : (716) 223-6855 E-mail : chancock@frontiemet.net
Submission Date
March 15" 2002
Trade Name
TSO3 Ozone Sterilizer, model 125L
Common Name
TSO3-125L Ozone Sterilizer
Classification Name
Sterilizer, Chemical Class II (as per 21CFR, part 880.6860 equivalent device)
Legally Marketed Equivalent Device Name(s) STERRAD® 100S Sterilization System
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K020875 TSO3-125L Ozone Sterilizer
Image /page/1/Picture/1 description: The image shows the letters 'TS' followed by an open parenthesis. The letters are in a simple, sans-serif font and appear to be handwritten or drawn. The parenthesis is slightly offset from the letters, suggesting it might be a separate element or added later.
Description of Device
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.
Effectiveness
Model 125L Validation testing was performed using the « overkill » approach to demonstrate the effectiveness of the process.
This process has been demonstrated to be effective on medical devices packaged in the TSO3 sterilization pouch and in rigid anodized aluminum sterilization containers using disposable cellulose filter paper.
Safety
Model 125L sterilizer have been designed, constructed and tested to meet the safety and performance requirements of various North American safety codes and standards. The TSO3-125L sterilizer complies with the applicable portions of the following standards:
- Canadian Standard Association (CSA) Standard C22.2 No 1010.1 ●
- Underwriters Laboratory Standard UL 61010A-1 .
- Federal Communication Commission (FCC) Part 18 / EN 55011
- . International Electrotechnical Commisssion (IEC) Standard IEC 60601-1-2
A Fault Tree Analysis and Mitigation (FTA-MIT) and a Failure Mode Effects and Criticality Analysis (FMECA) has been conducted on the Model 125L entire system to ensure safety features and control redundancies has been implemented in the design and will be maintained during the manufacturing, installation, maintenance and servicing of the sterilizers.
To ensure optimum performance, the user must ensure the materials, instruments and devices to be sterilized are thoroughly cleaned, that the instrument manufacturer's instructions are followed, and that each sterilization load is monitored with biological and chemical sterilization process indicators.
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K020875 TSO3-125L Ozone Sterilizer
The software controls of the Model 125L have been designed providing safeguards that only intended operating cycles function to completion. An unintended condition will abort the cycle . and provide appropriate information identifying the source of the condition.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2003
Technologies of Sterilization with Oxone, TSO3 Incorporation C/O Charles O. Hancock, RAC President Charles O. Hancock Associates, Incorporated 33 Black Watch Trail Fairport, New York 14450-3701
Re: K020875
Trade/Device Name: TSO3 Ozone Sterilizer, Model 1251L Regulation Number: 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: FLF, FRC Dated: June 11, 2003 Received: June 13, 2003
Dear Mr. Hancock:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Hancock
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Runge
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of 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.
Rhin S. Lim
510(k) Number. K020875