(270 days)
The TST Control Integrator for Steam Autoclave is a steam sterilization process indicator designed to indicate, through a yellow to blue color change, when a combination of parameters necessary for sterilization (270°F for 3 minutes) have been achieved.
Albert Browne Ltd. received clearance for a TST Control Integrator for Steam Autoclave, K902958, which monitored sterilization cycles with a holding temperature/time combinations of 250°F (121°C)/15 min. The purpose of this submission is to expand the process parameter combinations to include a cycle of 270°F/3 min.
Like the integrator described in K902958, the TST steam integrator discussed in this amendment changes color from yellow to blue when a specific set of process parameters required for steam sterilization to occur have been met. The parameters of the sterilization cycle monitored by the proposed integrator - time, temperature and the presence of steam - are equivalent to those monitored by the integrators described in K902958. Albert Browne Ltd. is amending K902958 in order to increase the combinations of parameters which produce a color change to include additional temperatures. The time-temperature combinations in sterilization cycles which will induce TST Control Integrators to change color from vellow to blue are presented in Table 1.
The TST steam integrator consists of a paper strip with the chemical indicator ink located on one end. The color change is pH based. The time and temperature required for the color change to occur is precisely controlled through manipulation of the chemical composition of the ink.
{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": "The TST Control Integrator for Steam Autoclave is designed to indicate, through a yellow to blue color change, when a combination of parameters (270°F for 3 minutes and the presence of steam) necessary for sterilization have been achieved.",
"Reported Device Performance": {
"Exposure in partial cycles": "The strips did NOT change color.",
"Exposure in full cycles (270°F for 3 minutes, saturated steam)": "The strips changed color (yellow to blue).",
"Safety margin": "The temperature/time required for color change to occur provides a wide safety margin over that necessary to kill spores on a biological indicator.",
"Color change stability": "Color change was stable for at least 5 years after exposure.",
"Expiration date validity": "Testing with strips ≥3 years from manufacture date demonstrated accurate, reproducible performance, confirming the 3-year expiration date is adequate."
},
"Table 1: Performance Characteristics for the TST Control Integrator for Steam Autoclave": {
"Temperature": ["250°F", "270°F"],
"Time (minutes)": ["15", "3"],
"Presence of Steam": ["yes", "yes"],
"Regulatory Status": ["[K902958](https://510k.innolitics.com/search/K902958)", "proposed"]
}
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document does not explicitly state the sample size used for the test set (number of strips tested). It mentions \"All strips used for testing were all ≥3 years from the date of manufacture,\" implying a prospective-like evaluation of aged product. The country of origin for the data is not specified beyond Albert Browne Ltd. being a UK company and the testing being conducted to U.S. standards (ANSI/AAMI ST45-1992).",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. The ground truth for this device is based on physical/chemical properties and the efficacy of sterilization parameters against biological indicators, not on human expert interpretation of an image or signal. The performance is assessed against established sterilization standards (e.g., biological kill rates, specific temperature/time/steam combinations) rather than expert consensus.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The color change is a direct read-out of a chemical reaction, not subject to individual interpretation requiring adjudication.",
"5. 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 is a physical/chemical sterilization process indicator, not an AI-based diagnostic or assistive device that would involve human readers.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, this study is a standalone performance test of the device (integrator) itself. Its function is to perform a specific chemical reaction (color change) based on exposure to sterilization parameters, without human interpretation of complex outputs.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth is established by: \n- **Defined physical parameters:** Specific temperature (270°F), time (3 minutes), and presence of saturated steam, as required for sterilization. \n- **Biological kill rates:** Comparison to biological indicators (BIs) to ensure the conditions for color change provide a wide safety margin beyond what is necessary to kill spores.",
"8. The sample size for the training set": "Not applicable. This is a physical/chemical device, not an AI/machine learning model that requires a training set.",
"9. How the ground truth for the training set was established": "Not applicable. This is a physical/chemical device, not an AI/machine learning model that requires a training set."
}
§ 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).