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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the TSO3-125L Ozone Sterilizer. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, most of the requested information regarding AI device acceptance criteria, comparative effectiveness studies, and ground truth establishment for AI models cannot be extracted from this document.

However, I can provide information related to the device's effectiveness and safety as described in the document.

Acceptance Criteria and Device Performance (Based on provided document)

Acceptance Criteria Category	Reported Device Performance
Effectiveness (Sterilization)	Demonstrated by "overkill" approach. Effective on medical devices packaged in TSO3 sterilization pouch and rigid anodized aluminum sterilization containers using disposable cellulose filter paper.
Safety - Electrical & Mechanical	Complies with CSA C22.2 No 1010.1, UL 61010A-1, FCC Part 18 / EN 55011, and IEC 60601-1-2.
Safety - Risk Management	Fault Tree Analysis and Mitigation (FTA-MIT) and Failure Mode Effects and Criticality Analysis (FMECA) conducted.
Software Control	Factory-programmed control system designed for only intended operating cycles to function to completion. Unintended conditions abort the cycle and provide information.
Material/Device Compatibility (Lumen)	Sterilizes single stainless steel lumens with: - inside diameter of 2 mm or larger and a length of 250 mm or shorter - inside diameter of 3 mm or larger and a length of 470 mm or shorter - inside diameter of 4 mm or larger and a length of 600 mm or shorter
Biological Indicator Challenge	"Half cycle with a SAL of 10 with no survivors" using B. stearothermophilus (OZO-TEST™ self-contained Biological Indicator).

Information Not Applicable or Not Found in the Document:

Sample size used for the test set and the data provenance: Not applicable. This document describes a sterilizer, not an AI model validated with a test dataset of medical images or patient encounters. The effectiveness testing references an "overkill" approach, which is a common method for sterilizer validation, but it doesn't specify a "test set" in the context of an AI model's performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would refer to results of sterility testing, which doesn't involve medical image interpretation by experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a sterilizer and does not involve human readers interpreting data with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a sterilizer, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For sterility, the ground truth is typically the absence of viable microorganisms after processing. The document mentions using B. stearothermophilus biological indicators to evaluate cycle performance, implying a microbiological method for ground truth.
The sample size for the training set: Not applicable. No AI model is described.
How the ground truth for the training set was established: Not applicable. No AI model is described.

Summary of the Study:

The document describes the validation of the TSO3-125L Ozone Sterilizer. The primary "study" or validation approach mentioned for effectiveness is the "overkill" method, which is a standard microbiological approach for sterilizer validation to establish a Sterility Assurance Level (SAL). This method involves challenging the sterilizer with a high concentration of bacterial spores (specifically Geobacillus stearothermophilus, formerly Bacillus stearothermophilus, as per the OZO-TEST™ BI) to demonstrate its ability to sterilize across a wide range of conditions, thus ensuring a high probability of sterility for less challenging actual loads. The document states "half cycle with a SAL of 10 with no survivors," which is a common way to demonstrate a robust sterilization process.

The document emphasizes safety through compliance with electrical and mechanical standards and the use of risk analysis techniques (FTA-MIT and FMECA). Compatibility with specific medical device types (e.g., lumen dimensions) and packaging materials is also detailed through testing.

Summary

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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

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Description of Device

The Model 125L is equipped with a unique factory-programmed control system for processing reusable medical devices.

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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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 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

Regulation Number and Section

§ 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).