(261 days)
AN87 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 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc.
The AN87 Dosimeter is a single-use chemical indicator for cumulative ethylene oxide exposure. It is an accessory for the Anprolene AN75 Ethylene Oxide Gas Sterilizer.
The AN87 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 20-29°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 AN87 Dosimeter. The AN87 Dosimeter is not a replacement for a biological indicator.
The provided text describes the AN87 Dosimeter, a single-use chemical indicator for verifying adequate cumulative ethylene oxide exposure in the Anprolene AN75 Ethylene Oxide Gas sterilizer. The device is claimed to be substantially equivalent to the predicate AN1087 Dosimeter (K150645).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the performance testing described in section 5.9 of the 510(k) summary, specifically from Table 5-3.
| Acceptance Criteria (Test Description) | Reported Device Performance (Result) |
|---|---|
| Functionality: | Pass: |
| 1. Critical parameters include temperature, time, and gas concentration at a relative humidity of 35-90%. | Performance characterized in an Andersen Chemical Indicator Evaluator Resistometer and in an Anprolene AN75 Ethylene Oxide Gas Sterilizer using the 12-hour cycle at 20-29°C. The critical parameters to which the AN87 responds include temperature, time, and gas concentration in a relative humidity controlled environment. |
| 2. Performance parallels that of a biological indicator. | The AN87 indicates adequate cumulative EO exposure in the cycle for all validated loads in the Anprolene AN75 sterilizer. The AN87 performance parallels the performance of a 6-Log Bacillus atrophaeus biological indicator. |
| 3. A correlation exists between the extent the blue color travels and cumulative EO exposure. | A strong correlation is observed between cumulative EO exposure and the distance the blue color travels in the AN87 Dosimeter. |
| Biocompatibility: Not direct or indirect patient-contacting devices; Non-toxic ingredients; Provides reasonable assurance for safety. | Pass: Not direct or indirect patient-contacting devices; Non-toxic ingredients; Provides reasonable assurance for safety. (This is a statement of compliance rather than a test result.) |
| Endpoint Color Stability: Stable for at least 28 days at 20-25°C; Stability demonstrates reasonable assurance for effectiveness. | Pass: Using the AN87 Dosimeter at various stages of shelf life, the distance the blue line travels is stable for a minimum of 28 days after the sterilization cycle when AN87 Dosimeters are stored at room temperature (20-25°C). |
| Shelf Life: Maintains performance specifications throughout the stated shelf life of 3 years. | Pass: Real-time shelf stability testing with the AN87 Dosimeter supports a shelf life of 3 years. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set for any of the performance tests. It also does not explicitly state the data provenance (e.g., country of origin). The testing was conducted by Andersen Sterilizers, Inc., the manufacturer, implying internal data collection. The tests sound like prospective laboratory experiments rather than retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set.
4. Adjudication method for the test set
The document does not describe any adjudication method for the test set.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a chemical indicator, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, standalone performance testing was done. The device itself (the AN87 Dosimeter, which is a chemical indicator and not an algorithm in the typical software sense) provides a direct visual indication (color change). The performance tests described characterize the device's ability to accurately reflect cumulative EO exposure without human interpretation beyond observing the color change against a calibration mark. The "algorithm" here is the chemical reaction itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the functionality testing was established by correlating the AN87 Dosimeter's color change with:
- The critical process parameters of the sterilization cycle (temperature, time, gas concentration, humidity).
- The performance of a 6-Log Bacillus atrophaeus biological indicator, which is a widely accepted standard for demonstrating sterilization efficacy. This acts as the direct ground truth for sterilization effectiveness.
8. The sample size for the training set
The concept of a "training set" is not applicable in the context of this chemical indicator. Chemical indicators operate based on predetermined chemical reactions and calibration, not machine learning or AI models that require training data.
9. How the ground truth for the training set was established
As there is no training set for this device, this question is not applicable. The device's calibration and performance are validated against physical and biological standards.
§ 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).