(503 days)
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.
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.
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.
§ 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).