(579 days)
The STERIS Eagle Century Steam Sterilizer is designed for efficient, sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities.
The AMSCO brand Eagle Century Steam Sterilizer is a Class II medical device as defined by 21 CFR §880.6880. The Eagle Century Steam Sterilizer is a sliding door sterilizer, offered in either a prevacuum or gravity configuration, intended for the terminal sterilization of heat and moisture-stabile materials.
The STERIS Eagle Century Steam Sterilizer is a Class II medical device used for the terminal sterilization of heat and moisture-stabile materials.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for sterilization is achieving a Sterility Assurance Level (SAL) of less than 10^-6 (probability of less than one chance out of one million of a non-sterile indicator). The device's performance is reported by demonstrating complete kill of biological indicators and verifying this SAL.
A summary of the device's performance against its intended cycles and loads is provided in the tables below. These tables represent the reported performance as validated by STERIS.
Prevacuum Configuration - Performance Summary
| CYCLES | STERILIZE TEMP. | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD |
|---|---|---|---|---|
| FLASH | 270°F (132°C) | 3 minutes | 1 minute | Unwrapped Instrument Tray with a Single Instrument |
| FLASH | 270°F (132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray with non-porous multiple instruments (maximum weight of 17lbs) |
| EXPRESS | 270°F (132°C) | 4 minutes | 3 minutes | Single Wrapped Instrument Tray with a single instrument. Non-porous goods only. |
| PREVAC | 270°F (132°C) | 4 minutes | 20 minutes* | Up to two double wrapped instrument trays (maximum weight of 17lbs. each). Up to six fabric packs. |
| *Note: Five minutes dry time can be used for processing a single fabric pack. |
Gravity Configuration - Performance Summary
| CYCLES | STERILIZE TEMP. | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD |
|---|---|---|---|---|
| FLASH | 270°F (132°C) | 3 minutes | 1 minute | Unwrapped Instrument tray with a single instrument |
| FLASH | 270°F (132°C) | 10 minutes | 1 minute | Unwrapped Instrument Tray with non-porous multiple instruments (maximum weight of 17 lbs.) |
| GRAVITY | 270°F (132°C) | 15 minutes | 30 minutes | Up to two double wrapped instrument trays (maximum weight of 17lbs. each) |
| GRAVITY* | 250°F (121°C) | 30 minutes | 15 minutes | Fabric Packs |
| *Note: A 270°F (132°C) cycle adjusted to 25 minute Sterilize Time can be used for processing Fabric Packs. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state a specific "sample size" for the test set in terms of number of sterilization cycles or tests performed. However, it does refer to "Validation Studies" which imply testing was conducted.
The data provenance is presented as internal validation studies conducted by STERIS Corporation to comply with U.S. standards (AAMI-ST8 and AAMI-ST37). This suggests the data is retrospective as it has been collected and analyzed for submission. The country of origin for the data is implicitly the United States, given the reference to U.S. standards and the company's location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not specify the number or qualifications of individual experts. However, it states that STERIS "validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI)." This indicates that the "ground truth" (the definition of effective sterilization) is established by widely recognized industry standards and guidance, rather than by a specific panel of individual experts for this particular submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe an adjudication method for the test set. The validation process relies on meeting established benchmarks (complete kill of biological indicators and SAL
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).