(14 days)
The Amsco Century Steam Sterilizer is designed for efficient sterilization of non-porous and porous, heat and moisturestabile materials used in healthcare facilities. The Amsco Century Steam Sterilizer is available in the following configurations:
16" x 16" x 26" Single Door Gravity*
16" x 16" x 26" Double Door Gravity
20" x 20" x 38" Single Door Gravity
20" x 20" x 38" Double Door Gravity
16" x 16" x 26" Single Door Prevacuum
16" x 16" x 26" Double Door Prevacuum
20" x 20" x 38" Single Door Prevacuum
20" x 20" x 38" Double Door Prevacuum
*Note: No changes are being made to the gravity sterilizers program.
The Amsco Century Steam Sterilizer is equipped with the following factory-programmed set sterilization cycle values:
| Cycle | Recommended Loads | Sterilize Temp | Sterilize Time | Dry Time |
|---|---|---|---|---|
| Flash | Unwrapped instrument tray with a single instrument | 270°F (132°C) | 3 minutes | 1 minute |
| Flash | Unwrapped instrument tray with multiple non-porous instruments, maximum weight 17 pounds per tray. | 270°F (132°C) | 10 minutes | 1 minute |
| Express | Single wrapped instrument tray with a single instrument. Non-porous goods only. | 270°F (132°C) | 4 minutes | 3 minutes |
| Prevac | Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. Up to six fabric packs. | 270°F (132°C) | 4 minutes | 20 minutes¹ |
| Prevac | Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. | 275°F (135°C) | 3 minutes | 16 minutes |
Prevacuum Configuration
1Five minute dry time can be used for processing a single fabric pack.
Gravity Configuration
| Cycle | Recommended Loads | Sterilize Temp | Sterilize Time | Dry Time |
|---|---|---|---|---|
| Flash | Unwrapped instrument tray with a single | |||
| instrument | 270°F (132°C) | 3 minutes | 1 minute | |
| Flash | Unwrapped instrument tray with multiple | |||
| non-porous instruments, maximum weight 17 | ||||
| pounds per tray. | 270°F (132°C) | 10 minutes | 1 minute | |
| Gravity | Up to two double wrapped instrument trays, | |||
| maximum weight 17 pounds per tray. | 270°F (132°C) | 15 minutes | 30 minutes | |
| Gravity | Fabric Packs up to six Fabric Packs | 250°F (121°C) | 30 minutes2 | 15 minutes |
2 A 270°F (132°C) cycle adjusted to 25 minute Sterilize Time can be used for processing fabric packs.
The Amsco Century Steam Sterilizer is a Class II medical device as defined by 21 CFR 880.6880. This sterilizer is intended for the terminal sterilization of non-porous, heat and moisture-stabile materials used in healthcare facilities. The Amsco Century Steam Sterilizer is substantially equivalent with the predicate device Eagle Century Steam Sterilizer, K964332, cleared June 1, 1998 and also substantially equivalent to Castle 400HC/500HC Series Steam Sterilizer, K012573, cleared September 5, 2001 for the 135℃ (275°F) for 3 minutes prevac cycle claim.
The Amsco Century Prevaum Steam Sterlizer (16" x 26" x 20" x 38") is equipped with the following factory-programmed sterilization cycle values:
| Cycle | Recommended Loads | Sterilize Temp | Sterilize Time | Dry Time |
|---|---|---|---|---|
| Flash | Unwrapped instrument tray with a single instrument | 270°F (132°C) | 3 minutes | 1 minute |
| Flash | Unwrapped instrument tray with multiple non-porous instruments, maximum weight 17 pounds per tray. | 270°F (132°C) | 10 minutes | 1 minute |
| Express | Single wrapped instrument tray with a single instrument. Non-porous goods only. | 270°F (132°C) | 4 minutes | 3 minutes |
| Prevac | Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. Up to six fabric packs. | 270°F (132°C) | 4 minutes | 20 minutes¹ |
| Prevac | Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. | 275°F (135°C) | 3 minutes | 16 minutes |
Prevacuum Configuration
1Five minute dry time can be used for processing a single fabric pack.
The Amsco Century Graniy Steam Sterilizer (16'' x 26' and 20" x 20" x 38") is equipped with the following factory-programmed sterilization cycle values:
Gravity Configuration
| Cycle | Recommended Loads | Sterilize Temp | Sterilize Time | Dry Time |
|---|---|---|---|---|
| Flash | Unwrapped instrument tray with a single instrument | 270°F (132°C) | 3 minutes | 1 minute |
| Flash | Unwrapped instrument tray with multiple non-porous instruments, maximum weight 17 pounds per tray. | 270°F (132°C) | 10 minutes | 1 minute |
| Gravity | Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. | 270°F (132°C) | 15 minutes | 30 minutes |
| Gravity | Fabric Packs up to six Fabric Packs | 250°F (121°C) | 30 minutes2 | 15 minutes |
2A 270ºF (132ºC) cycle adjusted to 25 minute Sterilize Time can be used for processing fabric packs.
The provided text describes the Amsco Century Steam Sterilizer and its various sterilization cycles, along with information about its effectiveness and safety. However, it does not contain a study that describes device performance against specific acceptance criteria. Instead, it states that the device's effectiveness is demonstrated by compliance with industry standards and the complete kill of biological indicators.
Here's an analysis based on the information available:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly lay out "acceptance criteria" in a typical table format with corresponding "device performance" results for a comparative study. Instead, it outlines the standard for effectiveness and states that the device meets it.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Complete kill of biological indicators | Demonstrated by complete kill of biological indicators. |
| Sterility Assurance Level (SAL) no greater than 10⁻⁶ (implied by "appropriate safety factor" and alignment with AAMI standards) | Sterility assurance level (SAL) or probability of surviving micro-organism that is no greater than 10⁻⁶ (stated as 10⁻⁶ in the text, but often implied by "no greater than 10⁻⁴" in common sterilization standards; the text explicitly states "no greater than 10⁻⁶"). |
| Compliance with ANSI/AAMI ST8:2001, "Hospital Steam Sterilizers" | The Amsco Century 135°C (275°F) for 3-minute prevac steam sterilization cycle was validated to meet the requirements of ANSI/AAMI ST8:2001, "Hospital Steam Sterilizers", November 11, 2001. |
| Compliance with safety standards | - Underwriters Laboratory (UL) Electromedical Code 3101 as certified by Intertek Testing Services (ITS). |
- Canadian Standards Association (CSA) Standard C22.2 No. 1010-1 as certified by Intertek Testing Services.
- American Society of Mechanical Engineers (ASME), Section VIII, Division 1 for unfired pressure vessels. |
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 provide details on the specific sample size of biological indicators or test loads used in the validation study. The data provenance is not explicitly stated as a "country of origin" but implies internal testing by STERIS Corporation, which is based in Erie, Pennsylvania, USA. The validation is described as an "effectiveness" demonstration, which implicitly would be prospective testing using biological indicators and sterilization challenges.
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):
This information is not applicable and not provided. The ground truth for sterilization effectiveness is based on scientific principles of microbial inactivation and established by regulatory standards (like AAMI ST8) and verified by biological indicator testing, not expert consensus on image interpretation or similar diagnostic tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable to a sterilization validation study. Adjudication methods are typically used in studies involving subjective assessment (e.g., medical image interpretation) where multiple reviewers' opinions need to be reconciled.
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 a steam sterilizer, not an AI-assisted diagnostic tool or an imaging system that would involve human readers or cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is implicitly stated. The validation of the sterilizer's "effectiveness" (complete kill of biological indicators and SAL achievement) refers to the performance of the machine and its cycles without human "in-the-loop" performance during the sterilization process itself. The sterilizer operates autonomously once the cycle is initiated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for effectiveness is the complete kill of biological indicators and the achievement of a specified Sterility Assurance Level (SAL), which is a quantitative measure of the probability of a surviving microorganism. This is based on microbiological principles and validated against recognized international standards (ANSI/AAMI ST8:2001).
8. The sample size for the training set:
This is not applicable. Sterilization validation does not involve training sets in the context of machine learning or AI.
9. How the ground truth for the training set was established:
This is not applicable. As stated above, sterilization validation does not involve training sets in this context.
§ 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).