(260 days)
The Anprolene AN75 Ethylene Oxide Gas Sterilizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation.
The 12 hour cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer is for surface sterilization of medical devices, including mated surfaces.
The Anprolene AN75 Ethylene Oxide Gas Sterilizers, model numbers AN75i (AN75.64 and AN75.65), AN75iX (AN75.84 and AN75.85), and AN75J (AN75.74 and AN75.75), are intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag. Each sterilization cycle is monitored using cumulative gas exposure measurement (AN87 Dosimeter), as well as a Bacillus atrophaeus biological indicator (AN2203) inserted into a process challenge device (AN7508.14 Anprolene SteriTest) that is integrated into the sterilizer.
This document describes the Anprolene AN75 Ethylene Oxide Gas Sterilizer, its indications for use, and a comparison to predicate devices, along with performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Achieve a minimum sterility assurance level (SAL) of $10^{-6}$ for surfaces, including mated surfaces. | Successfully achieved a minimum SAL of $10^{-6}$ for surfaces, including mated surfaces, for all validated maximum loads. |
| Sterilize 24 lbs of metal instruments with or without mated surfaces. | Successfully sterilized 24 lbs of metal instruments with or without mated surfaces. |
| Sterilize 3.0 lbs of fabric. | Successfully sterilized 3.0 lbs of fabric. |
| Sterilize 3.5 lbs of plastic devices. | Successfully sterilized 3.5 lbs of plastic devices. |
| Meet requirements of AAMI/ANSI/ISO 10993-7 for EO residuals after recommended aeration. | EO residuals on the most absorbent materials met the requirements of AAMI/ANSI/ISO 10993-7 after recommended aeration. |
| Comply with requirements for electromagnetic compatibility and electrical safety. | Verified compliance for electromagnetic compatibility and electrical safety. |
| Gas cartridges and sterilization bags maintain performance specifications (physical characteristics, released EO amount, EO concentration, inactivation of biological indicators) throughout a 5-year shelf life. | AN7514 cartridges maintain performance specifications throughout the stated shelf life of 5 years. |
| Reproducibility and effectiveness of the 12-hour cycle at 20-29°C. | The 12-hour cycle at 20-29°C was repeatable and reliable under the indicated test load conditions. |
| Maintain critical cycle specifications (EO concentration, temperature, time, relative humidity). | The Anprolene AN75 sterilization system achieved and maintained the cycle specifications for EO concentration, temperature, time, and relative humidity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical sample size for the "test set" in terms of specific units tested. However, it indicates:
- "The maximum loads of metal, fabric, and plastic devices that may be routinely sterilized in the Anprolene AN75 Ethylene Oxide Gas Sterilizer were defined and validated."
- "All validated maximum loads were processed without additional devices in the sterilizer."
- "The validation testing demonstrated that exposure to EO gas under the defined loads and physical parameters achieved a minimum sterility assurance level (SAL) of $10^{-6}$ for surfaces, including mated surfaces."
- "The effectiveness of the sterilization process for the loads was confirmed by successful sterilization in simulated-use testing using instruments with mated surfaces."
The data provenance is not explicitly mentioned (e.g., country of origin). The study appears to be prospective validation testing conducted by the manufacturer to demonstrate the sterilizer's performance according to established guidelines.
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 sterilization effectiveness is typically established through recognized biological indicators and laboratory analyses, rather than expert human assessment for individual sterilization cycles.
4. Adjudication Method for the Test Set
This information is not applicable as the "test set" involves objective performance metrics (e.g., SAL achievement, residual levels, physical parameters) rather than subjective assessments 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
This is not applicable. The device is an ethylene oxide gas sterilizer, not an AI-assisted diagnostic or interpretative tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical sterilizer, not an algorithm. The performance evaluation focuses on the sterilizer's ability to achieve sterility without human intervention on a per-cycle basis, beyond loading and operating the device following instructions.
7. The Type of Ground Truth Used
The ground truth used for assessing the sterilization effectiveness primarily relies on:
- Sterility Assurance Level (SAL) of $10^{-6}$: This is a widely accepted microbiological standard for sterilization, achieved through the inactivation of biological indicators.
- Inactivation of an EZTest®- Gas Biological Indicator: Specifically, the document mentions "successful inactivation of an EZTest®- Gas Biological Indicator in the Anprolene SteriTest process challenge device."
- AAMI/ANSI/ISO 10993-7: For process residue analysis, ground truth is based on meeting the requirements of this standard for ethylene oxide residuals.
- Physical Performance Specifications: For the sterilizer components, cartridges, and bags, ground truth is adherence to predetermined physical performance specifications (e.g., EO amount, concentration, temperature, relative humidity, electrical safety).
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical sterilizer and not an AI/machine learning model, so there is no "training set" in that context. The validation involves testing the physical device's performance under various conditions and loads.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).