(251 days)
The AN85/AN86 EO Indicators are single-use Class 1 process indicators used to distinguish between processed and unprocessed packaged medical devices, through a visible color change from yellow-green to blue. They are intended for the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycle are summarized in Table 5-1.
AN85/AN86 EO Indicators are adhesive-backed Class 1 process indicators for ethylene oxide sterilization that conform to AAMI/ANSI/ISO 11140-1.
AN85/AN86 EO Indicators contain a pH indicator. The pH indicator ink is printed in dots on the AN85 and in stripes on the AN86. The indicator ink is laminated between two layers of plastic material and changes color from yellow-green to blue by chemical reactions when exposed to ethylene oxide.
Here's an analysis of the provided text regarding the AN85/AN86 EO Indicators, focusing on the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the "Functionality" test in Table 5-2, which refers to ISO 11140-1 Class 1 process indicator standards and the device's ability to indicate EO exposure under specific conditions. The reported performance is a simple "Pass" for all criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functionality: | |
| 1. Critical parameters include temperature, time, and gas concentration under a relative humidity of 35-90%. | Pass |
| 2. ISO 11140-1 Class 1 process indicator. | Pass |
| 3. Indicate EO exposure in the CIER (Chemical Indicator Evaluator Resistometer) and in the EOGas 4 sterilizer. | Pass |
| Biocompatibility: Not direct or indirect patient-contacting devices; Non-toxic ingredients; Provides reasonable assurance for safety. | Pass |
| Endpoint Color Stability: Stable for at least 12 months at 20-25°C and 3 months at 50°C; Stability demonstrates reasonable assurance for effectiveness. | Pass |
| Shelf Life: Maintains performance specifications throughout the shelf life (2 years from manufacture under specified storage conditions: away from EO/pH affecting products, 20-30°C, 30-50% RH). | Pass |
Study Details:
The information provided only describes "Performance Testing" which consists of "bench studies." There is no detailed study protocol, raw data, or statistical analysis provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document doesn't explicitly state the sample size (number of indicators) used for each test. It mentions "bench studies" and that the "AN85/AN86 EO Indicators perform as intended," but no specific counts are given for the number of devices tested in the CIER or EOGas 4 sterilizer.
- Data Provenance: The studies were conducted by Andersen Sterilizers, Inc., the manufacturer. They are described as "bench studies," implying prospective testing. The country of origin for the data is not explicitly stated but implied to be the US given the manufacturer's address and FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (chemical indicator) does not involve expert interpretation for ground truth. The "ground truth" is based on objective chemical reactions and physical changes (color change) when exposed to specific sterilization conditions. The assessment of whether the color change occurred and meets the Class 1 indicator definition is likely done by trained laboratory personnel following an established protocol, not by medical experts like radiologists.
4. Adjudication Method for the Test Set
Not applicable for this type of device. The assessment is objective (color change from yellow-green to blue) and does not involve subjective interpretation or multi-reader adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this type of device. This device is a chemical indicator that shows a visible color change, not an interpretive diagnostic tool requiring human reader assessment or comparison with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The device itself (the chemical indicator) performs as a standalone tool that changes color. There is no "algorithm" in the digital sense, but the chemical reaction within the indicator operates independently to display the result. Its performance is assessed directly (i.e., whether it correctly changes color under specified conditions and remains unchanged under others).
7. The Type of Ground Truth Used
The ground truth is established by the known exposure conditions to ethylene oxide within controlled environments (CIER and EOGas 4 sterilizer) and the expected chemical reaction/physical change (color change from yellow-green to blue) as defined by ISO 11140-1 for Class 1 process indicators. Essentially, it's a physical/chemical ground truth based on controlled experimental conditions.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical indicator, not a machine learning or AI model that requires a training set. Its performance is based on its inherent chemical and physical properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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).