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.

AI/ML Overview

Acceptance Criteria and Device Performance for TSO3 Chemical Indicator

This document summarizes the acceptance criteria and study findings for the TSO3 Chemical Indicator, as presented in the provided 510(k) summary (K021161).

1. Acceptance Criteria and Reported Device Performance

The TSO3 Chemical Indicator is a process indicator intended to differentiate between unprocessed and processed items within the TSO3 Model 125L Ozone Sterilizer.

Acceptance Criteria	Reported Device Performance
Primary Function: Differentiate between unprocessed and processed items.	The TSO3 Chemical Indicator successfully changes color from red to lighter than the peach reference color when exposed to ozone. This color change indicates the presence of ozone, differentiating processed from unprocessed items.
Ozone Exposure Threshold: Reach its endpoint when the ozone dose is at least 70 mg/L.	Performance testing for incremental exposures to ozone confirmed that the CI reaches its end point when the ozone dose injected into the sterilization chamber (ozone concentration) is at least 70 mg/L.
Color Stability against Chemicals (excluding strong liquids/alkaline vapors): Maintain color integrity pre and post ozone exposure.	Tests showed that, generally, with the exception of liquids and very strong alkaline vapors, the color stability was not affected by acid and basic vapors and solutions.
Color Stability against UV Exposure (unprocessed CI): Unprocessed CIs should not be affected by UV exposure up to 2 months.	Unprocessed CIs exposed to UV for 15, 30, 45, and 60 days (up to 2 months) did not show color affectation.
Color Stability against UV Exposure (processed CI): Processed CIs should exhibit stable color for a certain period.	The color of CIs processed in a partial sterilization cycle is stable to UV up to 2 months. A slight color difference is observed for CIs processed to a partial sterilization cycle when exposed to UV between 3 to 12 months.
Inertness to Other Sterilization Processes (EtO): CI color should not be affected by EtO sterilization.	CIs processed to an EtO sterilization cycle showed no effect on the CI color.
Inertness to Other Sterilization Processes (Steam - porous load): CI color should not be affected by porous load steam sterilization.	CIs processed to a porous load Steam sterilization cycle showed no effect on the CI color.
Inertness to Other Sterilization Processes (Steam - liquid cycle): CI color may be affected by liquid cycle steam sterilization.	Results indicated that the CI color is affected by a liquid cycle in an autoclave. (This implies it's acceptable for the CI to be affected, as it's specifically for ozone sterilization).
Cytotoxicity: Not release residues that induce cytotoxicity when exposed to sterilization cycle.	Cytotoxicity tests conducted with CIs in contact with polymer, Stainless Steel, and medical grade silicone showed that the CI does not induce cytotoxicity.

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes for each test conducted for the performance criteria. However, it mentions "Tests were conducted" and "CIs were processed" for various evaluations. The data provenance is not specified in terms of country of origin, but the applicant's address is in Quebec, Canada, and the contact agent is in New York, USA. The studies appear to be retrospective in the sense that they were conducted to demonstrate the performance of a developed device for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of external experts for establishing ground truth regarding the performance of the chemical indicator. The evaluation of color change and other effects would have likely been performed by trained internal personnel (e.g., laboratory technicians, chemists, quality control staff) responsible for and knowledgeable in chemical indicator performance evaluation. No specific number or qualifications are provided.

4. Adjudication Method

No adjudication method is described. The assessment of color change and other physical/chemical properties would typically be objective measurements or visual assessments against a defined standard (e.g., the peach reference color).

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

No MRMC comparative effectiveness study was mentioned. This device is a chemical indicator, not an AI-powered diagnostic tool, so such a study would not be applicable.

6. Standalone (Algorithm Only) Performance

This question is not applicable. The TSO3 Chemical Indicator is a physical device that reacts to ozone exposure, not a software algorithm. Its performance is inherent to its physical and chemical properties in a standalone manner (without human interpretation beyond reading the color change).

7. Type of Ground Truth Used

The ground truth for the performance tests was based on:

Physical/Chemical Reaction: The inherent property of the indicator ink to change color in the presence of a specific concentration of ozone.
Established Test Protocols: Standardized laboratory tests to evaluate color stability under various conditions (chemical exposure, UV exposure, other sterilization methods) and cytotoxicity.
Measurement of Ozone Concentration: Direct measurement of ozone dose (e.g., 70 mg/L) in the sterilization chamber.

8. Sample Size for the Training Set

This question is not applicable. The TSO3 Chemical Indicator is a physical device with a chemical reaction, not a machine learning model, so there is no "training set."

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

This question is not applicable as there is no training set for a chemical indicator.

Summary

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TSO3 Chemical Indicator 510(k) Summary - K021161

Applicant's Name and Address

TSO3 Inc. 2505, Dalton Avenue Sainte-Foy (Québec) GIP 385

Phone : (418) 651-0003 (418) 653-5726 Fax : Email :info@tso3.com

Contact United States Agent

Charles O. Hancock, RAC 33 Black Watch Trail Fairport, New York 14450

Phone 585-223-1850 Fax : 585-223-6855 Email : chancock(@frontiernet.net

Submission Date

April 5, 2002

Trade Name

TSO3 Chemical Indicator

Common Name

Chemical sterilization process indicator

Classification Name

Physical/chemical process indicator is classified as Class II under Sterilization Process Indicator in 21 CFR 880.2800 by the General Hospital and Personal Use Devices Panel.

Legally Marketed Equivalent Device Name(s)

STERRAD® Chemical Indicator

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INDICATIONS-FOR-USE

Description of Device

The Indicator Strip

Packaging

The TSO3 Chemical Indicator strips are packaged in rolls of 1000 indicators adhesively affixed to the roll to be peeled off for use. The rolls are packaged 2 per box for distribution.

Performance testing

The TSO3 Chemical Indicator is intended for one time, single use by health care workers to differentiate processed from unprocessed items.

Performance testing to support a substantial equivalence decision include the following :

Incremental exposures to ozone - For the CI to reach its end point, the ozone dose injected into the sterilization chamber (ozone concentration) must be at least 70 mg/L.

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K021161

TSO

Effects of other chemicals on the TSO3 Chemical Indicator color pre and post exposure to ozone :

Tests were conducted to determine the effect of acid and basic vapors and solutions on the color stability of the Chemical Indicators. Generally, with the exception of liquids and very strong alkaline vapors, the color stability was not effected.

The effect of UV exposure on color stability of the TSO3 Chemical Indicator was evaluated for pre and post exposure to ozone. Unprocessed CIs were exposed to UV for 15, 30, 45 and 60 days. The unprocessed CI's color was not affected by UV exposure. The color of the CI is stable to UV up to 2 months after being processed in a partial sterilization cycle. A slight color difference is observed for Cls processed to a partial sterilization cycle when exposed to UV between 3 to 12 months.

The effects of other sterilization processes on the color stability of the TSO3 Chemical Indicator were evaluated:

CIs were processed to an EtO sterilization cycle and the CI color is not affected by EtO sterilization process.

CIs were also processed to 2 different (liquid and porous load) Steam sterilization cycles. Results indicate that the CI color is effected by a liquid cycle in an autoclave but not affected by a porous load cycle.

Cytotoxicity tests were conducted to determine if residues could be released by the CI when exposed to the sterilization cycle. Cl's were processed in contact with polymer (LDPE), Stainless Steel coupons and medical grade silicone inside a sterilization pouch. Results showed that the CI does not induce cytotoxicity.

Conclusion

The results of the performance studies with the TSO, Chemical Indicator demonstrated that the TSO3 Chemical Indicator is appropriate for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2003

Technologies of Sterilization with Oxone, TSO3 Incorporation C/O Mr. Charles O. Hancock, RAC President Charles O. Hancock Associates, Incorporated 33 Black Watch Trail Fairport, New York 14450-3701

Re: K021161

Trade/Device Name: TOS3 Chemical Sterilization Process Indicator Regulation Number: 880.2800 (b) Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: August 18, 2003 Received: August 20, 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 (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.

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 Renner

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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Indication for Use Statement 510(k) Number K021161

Device Name : TSO3 Chemical Indicator

Indications for Use :

The TSO3 Chemical Indicator is a process indicator intended for use by health carc providers to accompany sterilization packs, containers, or trays to be sterilized in the TSO3 Model 125L Ozone Sterilizer. It is intended to differentiate between unprocessed items and processed items.

The color of the TSO3 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 Sterilizer sterilization process.

Olin S. Lim

(Division Sign-O Division of Anesthesiology, General Hospital. Infection Control, Dental

510(k) Number: K021161

. (

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).