(103 days)
The AMSCO 600 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles (Table 1):
| Cycles | Sterilize
Temperature | Sterilize Time | Dry Time | Maximum Recommended Load |
|-----------------|--------------------------|----------------|------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Prevac | 270°F (132°C) | 4 minutes | 20 minutes | Fabric Packs. Refer to Table 2 for
recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg)
each and Fabric Packs. Refer to
Table 2 for recommended
quantities. |
| Prevac | 270°F (132°C) | 10 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3
kg) each . Refer to Table 2 for
recommended quantities. |
| Prevac | 270°F (132°C) | 4 minutes | 5 minutes | Single Fabric Pack. |
| Prevac | 275°F (135°C) | 3 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg)
each. Refer to Table 2 for
recommended quantities. |
| Prevac-
IUSS | 270°F (132°C) | 4 minutes | 1 minutes | Immediate use - single
unwrapped tray |
| Gravity | 250°F (121°C) | 30 minutes | 30 minutes | Double wrapped instrument trays,
maximum weight 25 lbs. (11.3 kg)
each. Refer to Table 2 for
recommended quantities. |
| Warm-Up | 270°F (132°C) | 3 minutes | 1 minute | N/A |
| DART | 270°F (132°C) | 3.5 minutes | 1 minute | Bowie-Dick Test Pack, DART |
| Leak
Test | N/A | N/A | N/A | N/A |
The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 600 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.
The AMSCO 600 Steam Sterilizer uses saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products. The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump. The ALUS is used with the AMSCO 600 Steam Sterilizer's existing transfer carriages and loading carts. It consists of a conveyor system which attaches to the load and/or unload ends of the steam sterilizer. It has a series of barcode labels which correspond to pre-programmed cycles and an optional scanner which when fitted to the system will communicate to the sterilizer which cycle to initiate.
The STERIS AMSCO 600 Steam Sterilizer (K211500) is being assessed. Based on the provided information, here's a breakdown of the acceptance criteria and the supporting study:
Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilizer Performance (ST 8) | Temperature distribution: 0 to +6 °F | 0 to +4.3 °F |
| Air removal: Chemical Indicator (CI) pass, 270 - 276 °F | CI pass, 271 - 273 °F | |
| Moisture retention: ≤ 20% mass increase | ≤ 16% mass increase | |
| Biological performance: F0 ≥ 12, Biological Indicator (BI) pass | F0 ≥ 87, BI pass | |
| Electrical Safety | Meets IEC 61010-1:2012, IEC 61010-2-040:2016 and IEC 61326-1:2012 requirements for electrical safety | Conforms with: IEC 61010-1:2012, IEC 61010-2-040:2016, IEC 61326-1:2012 |
| Software Validation | Meets documented software specifications | Software meets specifications |
| ALUS Function | Meets documented performance specifications | Properly loads and unloads (from Table 6. Summary of Nonclinical Tests). |
| Cycles | The new 10-minute, 270F prevacuum cycle demonstrates proper performance per AAMI ST8 | Testing performed per AAMI ST8 demonstrates proper performance |
| Automated Loading System | Proper performance via software validation | Software validation demonstrates proper performance (for the added automated loading system accessory) |
Note: The document refers to the predicate device K183410 AMSCO 600 Steam Sterilizer and indicates that the subject device (K211500) has the same intended use and technological characteristics with modifications. The primary modifications are the addition of a 10-minute, 270°F (132°C) prevacuum, steam sterilization cycle and an automated loading and unloading system (ALUS).
Study Details
The provided document describes nonclinical tests to demonstrate the substantial equivalence of the modified device to its predicate. This is typical for a 510(k) submission, not a study evaluating human reader performance with AI. Therefore, several of the requested categories are not applicable.
-
Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each test mentioned (e.g., how many cycles run for temperature distribution, moisture retention, or biological performance). This information would typically be detailed in the full test reports, which are not included in this summary.
- Data Provenance: The tests were conducted internally by the manufacturer (STERIS Corporation) as part of their device validation process. The origin of the raw data (e.g., country of origin) is not specified but is implicitly part of their internal testing protocols. The nature of the tests (performance, electrical safety, software, ALUS function) indicates this is prospective testing carried out specifically for this submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as this is a device performance test, not a diagnostic imaging or AI-assisted clinical interpretation study where expert ground truth is typically established. The "ground truth" for these tests comes from objective measurements against established engineering and sterilization standards (e.g., ST 8, IEC standards, F0 values, BI pass/fail).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for this type of device performance testing. Adjudication methods are relevant when human interpretation or clinical outcomes are subject to variability and require consensus.
-
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:
- No, an MRMC comparative effectiveness study was not done. This device is a steam sterilizer and an automated loading system, not an AI-powered diagnostic tool. Therefore, human readers or AI assistance in interpretation are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable in the context of an "algorithm only" study for diagnostic purposes. However, the performance tests are a "standalone" evaluation of the device's ability to meet its specifications and regulatory standards without human intervention in the sterilization process, other than loading/unloading (which the ALUS automates). For instance, the Biological performance – F0 ≥ 12, BI pass test directly evaluates the sterilizer's effectiveness independently. The ALUS function test also assesses its "standalone" functionality.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the sterilizer performance tests is based on objective physical and biological measurements against established industry standards and scientific principles of sterilization.
- Temperature distribution, air removal, moisture retention: Measured against physical thresholds defined in standards like ANSI/AAMI ST8.
- Biological performance (F0, BI pass): Measured against the inactivation of a resistant microorganism (Biological Indicator) under controlled conditions, demonstrating a Sterility Assurance Level (SAL) required by standards.
- Electrical Safety: Compliance with international electrical safety standards (IEC).
- Software Validation: Comparison against documented software specifications and requirements.
- ALUS Function: Comparison against documented performance specifications (e.g., proper loading and unloading).
- The "ground truth" for the sterilizer performance tests is based on objective physical and biological measurements against established industry standards and scientific principles of sterilization.
-
The sample size for the training set:
- This is not applicable. This is a hardware device (sterilizer) and its associated automated loading system, not a machine learning or AI model that requires a training set. The term "training set" is not relevant in this context.
-
How the ground truth for the training set was established:
- This is not applicable as there is no training set for this device.
§ 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).