TSO3 125L Ozone Sterilizer is intended for use in the sterilization processing of reusable medical devices in health care facilities. TSO 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures.

TSO3 125L Ozone Sterilizer has the ability to sterilize successfully packaged rigid and flexible lumen medical devices, including single and multi channel flexible endoscopes such as fiberoptic and video endoscopes.

Device Description

TSO3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been previously cleaned.

The sterilization chamber has a capacity of 125 liters (4.3 cu. ft.).

It requires USP grade oxygen, water and electricity. TSO3 Sterilizer could be installed as a free standing unit or recessed behind the wall. No exhaust gas ventilation duct is required as long as the room is adequately ventilated. By-products are oxygen and low humidity water vapor.

Model 125L is equipped with a unique factory-programmed control system.

Non-woven wrapping material or pouches and anodized aluminum containers are used as packaging for medical devices to be sterilized.

OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) are recommended for use in evaluating cycle performance.

TSO3 Chemical Indicators are available for this process.

No aeration is needed following the sterilization cycle. The sterilized items are cool to the touch and can be removed immediately and used, or stored for future use.

AI/ML Overview

The provided text describes the TSO3 Ozone Sterilizer, Model 125L, and its validation for sterilizing flexible endoscopes. However, it does not contain a typical "acceptance criteria" table with specific quantitative metrics (like sensitivity, specificity, accuracy) and corresponding performance outcomes for an AI/device, as it's a sterilizer, not a diagnostic or AI-powered medical device.

Based on the information provided, here's a breakdown of the requested elements adapted for this type of device:

Acceptance Criteria and Study for TSO3 Ozone Sterilizer, Model 125L

The primary acceptance criterion for a sterilizer is to achieve a sufficient Sterility Assurance Level (SAL), typically 10^-6, meaning a one-in-a-million probability of a non-sterile item. The study demonstrates effectiveness through an "overkill" approach and validated test cycles.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Sterilizer Performance)	Reported Device Performance
Sterility Assurance Level (SAL)	Achieved an SAL of 10^-6 (10 to the power of -6)
Sterilization Efficacy for Flexible Endoscopes	Successfully sterilized packaged rigid and flexible lumen medical devices, including single and multi-channel flexible endoscopes (Colonoscope, Gastroscope, Broncho videoscope, Choledofiberscope, Ureteroscope).
Cycle Parameters	Items exposed to ozone at a concentration of 85 mg/liter for 15 minutes at a temperature of 30.8°C to 36.1°C (87.4°F to 97°F).
Load Configuration Efficacy	Demonstrated for a load comprising 2 multi-channel and 1 single-channel flexible endoscopes (total 14 channels) in the presence of other packaged medical devices (14 medical devices in TSO3 Sterilization Pouches and a Process Challenge Device). Total weight of the load was 49 lbs.
Biocompatibility and Material Compatibility	Demonstrated by processed device/material qualification testing, including material effects, functional compatibility, and biocompatibility evaluation.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of distinct "cases" in the way a diagnostic device would have patient samples. Instead, the study involved:
- Testing with flexible endoscopes: "single and multi channel flexible endoscopes such as fiberoptic and video endoscopes." Specific types evaluated include: Colonoscope, Gastroscope, Broncho videoscope, Choledofiberscope, and Ureteroscope.
- A specific test load configuration was used for qualification testing: 2 multi-channel and 1 single-channel flexible endoscope, plus 14 medical devices packaged in TSO3 Sterilization Pouches, and a Process Challenge Device.
- Biological Indicators (B. stearothermophilus) were used to evaluate cycle performance, though the number of indicators per test is not specified.
Data Provenance: The study was conducted as a validation of a medical device sterilizer, implying laboratory and simulated-use testing. The document is a 510(k) submission to the FDA for a device manufactured by TSO3 Inc. in Québec, Canada. The document itself does not specify a country of origin for the "data" in terms of patient population or retrospective/prospective clinical data, as this is a device effectiveness study, not a clinical trial. It is a prospective validation study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. For a sterilizer, "ground truth" is typically established by microbiological testing (e.g., negative growth of biological indicators after processing), not by expert consensus on visual or diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess a case and their disagreements need resolution. This is not applicable to a sterilizer performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and an AI system might assist them. The TSO3 Ozone Sterilizer is a medical device sterilizer, not an AI-powered diagnostic tool.

6. Standalone Performance Study

Yes, a standalone study was done. The "Effectiveness" section states that "Ozone Sterilizer validation testing... was performed using the 'overkill' approach to demonstrate the effectiveness of the process." This demonstrates the performance of the algorithm/device (the sterilizer itself) without human intervention in the sterilization process (beyond loading/unloading).
- The study included:
  - Full cycle validation testing in simulated use conditions.
  - Half-cycle validation testing.
  - In-use testing.

7. Type of Ground Truth Used

The ground truth used was microbiological evidence and validated laboratory sterility testing. This is inferred from:

The use of the "overkill" approach to demonstrate effectiveness.
The goal of achieving a Sterility Assurance Level (SAL) of 10^-6.
The recommendation for using OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) to evaluate cycle performance. This implies the absence of viable microorganisms is the ground truth.

8. Sample Size for the Training Set

This information is not applicable / not provided. Sterilizers are not "trained" in the way AI algorithms are. Their design and validation are based on engineering principles and microbiological test standards.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable / not provided for the same reason as point 8. The device's operational parameters are factory-programmed based on scientific validation and engineering design, not through a "training set" with established ground truth.

Summary

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TSO

RILIZATION OF FLEXIBLE ENDOSCOPES INTO HE TSO2 OZONE STERILIZER. MODEL 125L

JC090636

510(k) Summary

DEC - 2 2009

Applicant's Name and Address

TSO3 Inc. 2505 avenue Dalton Québec, Qc Canada G1P 3S5

Contact Person, Telephone, FAX

Marc Chaunet, Director of Quality Assurance and Regulatory Affairs Tel : (418) 651-0003 FAX : (418) 653-5726 E-mail : mchaunet@tso3.com

U.S. Agent

Charles O. Hancock Inc. Contact person: Charles O. Hancock, RAC Tel : (585) 223-1850 FAX : (585) 223-6855 E-mail : chancock@rochester.rr.com

Submission Date

March 4, 2009

Trade Name

TSO3 STERIZONE® 125L Sterilizer

Common Name

TSO3 125L Ozone Sterilizer

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STERILIZATION OF FLEXIBLE EN E TSO3 OZONE STERILIZER. MODEL 125/

Classification Name

Sterilizer, Chemical

Class II (as per 21CFR, part 880.6860 equivalent device)

Legally Marketed Equivalent Device Name(s)

TSO3 Ozone Sterilizer, model 125L (K020875) (K051595)

Description of Device

TSO3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been previously cleaned.

The sterilization chamber has a capacity of 125 liters (4.3 cu. ft.).

Model 125L is equipped with a unique factory-programmed control system.

Non-woven wrapping material or pouches and anodized aluminum containers are used as packaging for medical devices to be sterilized.

OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) are recommended for use in evaluating cycle performance.

TSO3 Chemical Indicators are available for this process.

No aeration is needed following the sterilization cycle. The sterilized items are cool to the touch and can be removed immediately and used, or stored for future use.

Effectiveness

Ozone Sterilizer validation testing for sterilization of flexible endoscopes was performed using the « overkill » approach to demonstrate the effectiveness of the process.

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STERILIZATION OF FLEXIBLE ENDOSCOPES INTO THE TSO3 OZONE STERILIZER, MODEL 125L

The effectiveness of the ozone sterilization process in sterilization of flexible endoscopes is demonstrated by the full cycle validation testing in simulated use conditions, half-cycle validation testing and in-use testing.

Safety

Safety of the TSO3 Ozone Sterilizer, model 125L was demonstrated into the original 510(k) submission (K020875). The content of the actual submittal does not compromise the safety of the device.

The safety of the ozone sterilization process in sterilization of flexible endoscopes is demonstrated by the processed device/material qualification testing which includes material effects, functional compatibility and biocompatibility evaluation.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle or bird-like figure with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

TSO3 Incorporated C/O Mr. Charles O. Hancock Regulatory Affairs Consultant Charles O. Hancock Associates, Incorporated 33 Black Watch Trail Fairport. New York 14450

DEC - 2 2009

Re: K090636

Trade/Device Name: TSO3 Ozone Sterilizer, Model 125L Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: II Product Code: FLF Dated: November 12, 2009 Received: November 12, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Antman Q. muster for

Susan Runner, D.D.S., M.A. Acting 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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Indications for Use

510(k) Number (if known): K090636

Device Name: TSO3 Ozone Sterilizer, model 125L

Indications for Use:

Notes:

· Testing on flexible endoscopes was conducted employing half cycle to demonstrate achievement of a sterility assurance level (SAL) of 10°.
· During the sterilization cycle, items are exposed to ozone at a concentration of 85 milligrams per liter for 15 minutes at a temperature of 30.8℃ to 36.1℃ (87.4 F to 97 F).
· Sterilization efficacy was demonstrated for a load comprising packaged multi channel (2) and single channel (1) flexible endoscopes having a total of 14 channels in the presence of other packaged medical devices. The load configuration used for qualification testing contained 2 multi channel and one single channel flexible endoscope, plus 14 medical devices packaged in TSO3 Sterliization Pouches and a Process Challenge Device. Total weight of the load was 49 lbs.

· For the purpose of this submission:

· Single channel flexible endoscopes refer to medical devices having only one channel.
· Multi channel flexible endoscopes refer to medical devices that may have two or more channels such as: Working channel (biopsy); Water jet; Air feeding; Water feeding; Suction;
· Endoscopes evaluated include: Colonoscope, Gastroscope, Broncho videoscope, Choledofiberscope and Ureteroscope.

AND/OR

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Anesthesiology, General Hospital Infection Control, Dental Devices

(Division Sign-Off)

510(k) Number: 19063600

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).