(252 days)
AN1087 Dosimeter is a single-use color change chemical indicator that is calibrated for sterilization temperature and used to verify adequate cumulative ethylene oxide exposure in the 3 hour sterilization cycle at 50°C in the Andersen Sterilizers EOGas 4 Ethylene Oxide Gas Sterilizer.
The AN1087 Dosimeter is a single-use chemical indicator for cumulative ethylene oxide exposure. It is an accessory for the EOGas 40 Ethylene Oxide Gas Sterilizer.
The AN1087 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°C 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 the cumulative ethylene oxide exposure. The calibration mark represents adequate cumulative ethylene oxide exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator at the location of the AN1087 Dosimeter. The AN1087 Dosimeter is not a replacement for a biological indicator.
The provided text describes a 510(k) premarket notification for the AN1087 Dosimeter. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative thresholds in the document, but rather as "Pass" for each test. The performance is described qualitatively.
| Test | Acceptance Criteria (Implied) | Reported Performance |
|---|---|---|
| Functionality | 1. Critical parameters include temperature, time, and gas concentration under a relative humidity of 35-90%. |
- Performance parallels that of a biological indicator.
- A correlation between the extent of the blue color formed and the cumulative EO exposure.
- A correlation between the measured vs. calculated EO exposure. | Pass |
| Biocompatibility | Non-toxic ingredients; Provides reasonable assurance for safety. (Implies no adverse biological reactions as a non-patient-contacting device). | Pass |
| Endpoint Color Stability | Stable for at least 28 days at 20-25°C and 3 days at 50°C; Stability demonstrates reasonable assurance for effectiveness. | Pass |
| Shelf Life | Maintains performance specifications throughout the stated shelf life of 3 years. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for individual tests. The studies were performed in an "Andersen Chemical Indicator Evaluator Resistometer" and an "EOGas 4 Ethylene Oxide Gas Sterilizer." The provenance of the data is not specified beyond being generated by the manufacturer, Andersen Sterilizers, Inc. It's a regulatory submission, so likely pre-market testing. The document does not specify if the studies were retrospective or prospective, but given the context of a 510(k) submission, they would typically be prospective pre-market validation studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for the dosimeter's performance appears to be based on its intended function to "verify adequate cumulative ethylene oxide exposure" in relation to a 6-Log Bacillus atrophaeus biological indicator (though the dosimeter is not a replacement for it). The assessment of "Pass" for functionality, stability, and shelf life would likely be based on internal criteria and measured physical/chemical properties, not expert human interpretation in the sense of medical image analysis.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of a chemical indicator, the "adjudication" is likely based on objective chemical and physical measurements rather than human consensus or clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This is not applicable to the AN1087 Dosimeter. This device is a chemical indicator, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related improvement in human readers would be relevant or performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable to the AN1087 Dosimeter. It is a physical chemical indicator, not an algorithm. Its "standalone" performance is its intrinsic ability to change color in response to EO exposure, which is what the functionality tests evaluate.
7. The Type of Ground Truth Used
The ground truth used for evaluating the AN1087 Dosimeter's performance is primarily physical and chemical measurements related to ethylene oxide exposure, temperature, time, and relative humidity. The document mentions that the dosimeter's calibration mark "represents adequate cumulative ethylene oxide exposure to inactivate a 6-Log Bacillus atrophaeus biological indicator." This implies that the effectiveness of sterilization (as measured by a biological indicator) serves as a benchmark for the dosimeter's "ground truth" for adequate exposure, even though the dosimeter itself is not a biological indicator. For other tests like stability and shelf life, the ground truth is the maintenance of its calibrated color change properties over time and under specified conditions.
8. The Sample Size for the Training Set
This is not applicable in the context of machine learning. The AN1087 Dosimeter is a chemical indicator that operates based on a direct chemical reaction, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for this chemical indicator. The "calibration" of the dosimeter for a 50°C sterilization temperature and its response to EO concentration and time would have been established through a series of experiments and measurements by the manufacturer.
§ 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).