← Product Code [JOJ](/productcode/JOJ) · K021161 # TSO3 OZONE CHEMICAL INDICATOR (K021161) _Technologies of Sterilization With Oxone, Tso3, Inc. · JOJ · Aug 27, 2003 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K021161 ## Device Facts - **Applicant:** Technologies of Sterilization With Oxone, Tso3, Inc. - **Product Code:** [JOJ](/productcode/JOJ.md) - **Decision Date:** Aug 27, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.2800 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for 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 TSO3 Model 125L 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. ## Device Story TSO3 Chemical Indicator is a single-use paper strip used by healthcare providers to verify exposure to ozone in the TSO3 Model 125L Sterilizer. The strip features a red indicator ink circle within a peach-colored reference square. During the sterilization cycle, exposure to ozone (minimum 70 mg/L) causes the red ink to change to a color lighter than the reference square. This provides visual confirmation that the item has been processed through the ozone sterilizer. It does not confirm terminal sterilization or cycle completion. The device is intended to complement biological indicator monitoring programs. The strip is protected by a clear finish to prevent damage from handling or abrasion. ## Clinical Evidence Bench testing only. Performance testing included incremental ozone exposure (endpoint at 70 mg/L), color stability testing against acid/basic vapors, UV exposure (up to 12 months), and cross-process testing (EtO and Steam). Cytotoxicity testing confirmed no residues are released when in contact with LDPE, stainless steel, or silicone. ## Technological Characteristics Paper strip with reactant chemical indicator ink and clear protective finish. Single-use. Dimensions/form factor: strip on adhesive roll. No energy source. No software. Sterilization: intended for use in ozone sterilization environment. ## Regulatory Identification Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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. ## Predicate Devices - STERRAD® Chemical Indicator ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a date stamp and some text. The date stamp reads "AUG 2 7 2003", indicating August 27, 2003. Below the date stamp, there is the text "T SKS", which appears to be some kind of identifier or abbreviation. ## 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "K021161" in the upper left corner. Below that is the text "TSO" in a sans-serif font. There are some artifacts around the text "TSO", which may be due to the image quality. The text is black on a white background. ## INDICATIONS-FOR-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. ## Description of Device 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 Indicator Strip 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. ## 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings. 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a chemical structure diagram. The diagram includes the letters "TSO" on the left side. To the right of the letters, there is a chemical structure with dashed lines indicating bonds or connections between atoms. The structure appears to represent a molecule or a chemical compound. ## 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 S . ( --- **Source:** [https://fda-staging.innolitics.com/device/K021161](https://fda-staging.innolitics.com/device/K021161) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com