(275 days)
AN1036 Dosimeter is a single-use color change chemical indicator. It is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in a 3-hour or 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc.
The AN1036 Dosimeter is a single-use chemical indicator for cumulative ethylene oxide exposure. It is an accessory for the EOGas 4 Ethylene Oxide Gas Sterilizer.
The AN1036 Dosimeter contains a proprietary pH indicator in a glass capillary tube that is sealed on one end and mounted on a plastic tray. It is calibrated for a 50℃ sterilization temperature and responds to ethylene oxide concentration and sterilization time. With exposure to ethylene oxide, the indicator turns from yellow-orange to a dark blue color from the open end toward the closed end. The extent of the color change is proportional to cumulative ethylene oxide exposure. The cycle-specific calibration marks represent adequate cumulative ethylene oxide exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator at the location of the AN1036 Dosimeter after 3-hour gas exposures or at the center of the endoscope lumens after 6-hour gas exposures. The AN1036 Dosimeter is not a replacement for a biological indicator.
Here's a summary of the acceptance criteria and study information for the AN1036 Dosimeter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Chemical Indicator | Critical parameters with pass/fail criteria; Able to correctly indicate pass/fail results from the EOGas 4 Sterilizer | AN1036 Dosimeters respond to EO concentration, sterilization time, and temperature, at a relative humidity of 35-90%. AN1036 Dosimeters correctly indicate pass/fail in various endoscope loads. A correlation exists between the extent the blue color travels and cumulative EO exposure. |
| Biocompatibility | Provides reasonable assurance for safety | AN1036 Dosimeter is not a direct or indirect patient-contacting device. None of the major ingredients is hazardous. No chemicals leach out of the AN1036 Dosimeters during the sterilization cycle. Without any additional aeration, the residual EO detected in Dosimeters met ISO 10993-7 requirements. |
| Endpoint Color Stability | Stability demonstrates reasonable assurance for effectiveness | Endpoint blue color is stable for 28 days at 20-25°C or 4 days at 50°C after 6-hour gas exposures. |
| Shelf Life | Maintains performance specifications throughout the stated shelf life | Data supports claimed shelf life of 3 years. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state a specific numerical sample size for the test set used in the "Chemical Indicator" performance evaluation. It mentions that "AN1036 Dosimeters correctly indicate pass/fail in various endoscope loads."
- Data Provenance: The studies were conducted by Andersen Sterilizers, Inc. as part of their 510(k) submission. The data is retrospective in the sense that it's a report of completed testing, but it's not specified if the data itself was collected retrospectively from past clinical cases or specifically generated for this submission through controlled laboratory experiments. Given the nature of a chemical indicator, it's highly likely it was generated through controlled laboratory testing. The country of origin for the data is implicitly the United States, as Andersen Sterilizers, Inc. is located in North Carolina, and the submission is to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The "ground truth" for a chemical indicator's performance would typically be established based on instrumental measurements of ethylene oxide concentration, temperature, and time parameters, and the known biological inactivation levels corresponding to those parameters, rather than expert interpretation of the indicator itself.
4. Adjudication method for the test set:
- This information is not explicitly provided. For a chemical indicator, the "adjudication" would likely involve objective measurements and comparison against established physical/chemical standards, rather than a human consensus process.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human interpretation is involved. The AN1036 Dosimeter is a chemical indicator, not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The AN1036 Dosimeter is a chemical indicator that works passively based on chemical reactions. It is not an algorithm or an AI system that performs independently.
7. The type of ground truth used:
- The ground truth for the "Chemical Indicator" test is based on the proper functioning of the EOGas 4 Ethylene Oxide Gas Sterilizer under specified critical parameters (Ethylene Oxide concentration, Temperature, Relative Humidity, EO Exposure Time, Total Cycle Time). The indicator's response (extent of color change) is correlated with "adequate cumulative EO exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator." This implies a biological indicator equivalency as the ultimate ground truth, verified under controlled physical and chemical parameters.
8. The sample size for the training set:
- This information is not applicable. The AN1036 Dosimeter is a physical chemical indicator, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- This information 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).