(71 days)
The Amsco Century Medium Steam Sterilizer 26" x 26" is designed for sterilization of heat and moisture-stabile materials used in healthcare facilities and is available in two configurations:
- Prevacuum is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles.
- Steam Flush Pressure-Pulse (SFPP) is equipped with SFPP, WRAP/SFPP, Prevacuum, Gravity, Leak Test and DART (Bowie-Dick) cycles.
The Amsco Century Medium Steam Sterilizer 26" x 26" is a Class II medical device as defined by 21 CFR 880.6880. This sterilizer is intended for the terminal sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Amsco Century Medium Steam Sterilizer 26" x 26" is substantially equivalent with the predicate device Amsco Century Medium Steam Sterilizer, K010865, cleared May 31, 2001.
The Amsco Century Medium Steam Sterilizer 26" x 26" is offered in the following configurations:
- 26" x 26" x 39" (660 mm x 660 mm x 991 mm)
- 26" x 26" x 49" (660 mm x 660 mm x 1245 mm)
- 26" x 26" x 61" (660 mm x 660 mm x 1520 mm)
Here's an analysis of the provided text regarding the acceptance criteria and study for the Amsco Century Medium Steam Sterilizer 26" x 26":
This document describes the validation of a medical device (a steam sterilizer), not an AI/ML powered device. Therefore, many of the typical questions for AI/ML device studies (like expert involvement, MRMC studies, or training/test set details) are not applicable in the context of this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by ANSI/AAMI ST8-1994) | Reported Device Performance (Amsco Century Medium Steam Sterilizer) |
|---|---|
| All Cycles (SFPP, Wrap/SFPP, Gravity, Prevac, Liquid): | All Cycles: Demonstrated a sterility assurance level (SAL) of at least 10⁻⁶ (or 10⁻⁴ for some cycles, 10th for LIQUID, specific values are inconsistently described in the text, but the general requirement is 10⁻⁶). This was achieved through: |
| For Fabric Test Packs (SFPP, Gravity, Prevac cycles): | |
| * Sterility Assurance Level (SAL) of at least 10⁻⁶ probability of survival | * Achieved an F₀ value of at least 12 (indicating sufficient time-at-temperature for sterilization and achieving a SAL of at least 10⁻⁶ or 10⁻⁴ depending on the cycle as inconsistently indicated). |
| * Moisture retention of less than 3% increase in pre-sterilization test pack weight | * Moisture retention of less than 3% increase in pre-sterilization test pack weight (for SFPP, Gravity, Prevac). |
| * No evidence of wet spots | * No evidence of wet spots (for SFPP, Gravity, Prevac). |
| For Full Load Instrument Trays (Wrap/SFPP, Prevac cycles): | |
| * Sterility Assurance Level (SAL) of at least 10⁻⁶ probability of survival | * Achieved a SAL of at least 10⁻⁶ using half-cycle analysis. |
| * Moisture retention of less than 20% increase in pre-sterilization weight of the towel | * Moisture retention of less than 20% increase in pre-sterilization weight of the towel. |
| * No evidence of wet spots on the outer wrapper | * No evidence of wet spots on the outer wrapper. |
| For Liquid Cycles (250°F (121°C), 45 minutes, 3 x 1000 mL flasks): | |
| * Sterility Assurance Level (SAL) of at least 10⁻⁶ (implied by "appropriate safety factor" and F₀ value) | * Achieved a SAL of at least "10th" (presumably 10⁻⁶ or 10⁻⁴, but the text literally says "10th" which is an error) through achievement of an F₀ value of at least 12. |
| * Water loss not exceeding 50 mL | * Water loss not exceeding 50 mL. |
| * Automatic sealing of the flask closure | * Automatic sealing of the flask closure. |
| For DART cycle (Bowie-Dick Test Pack): | |
| * Uniform color change throughout the test sheet, as described in ANSI/AAMI ST8 Section 5.6.1. | * Demonstrated a uniform color change throughout the test sheet. |
| Software Validation: | |
| * Meet FDA's moderate level of concern recommendations for software in medical devices (Guidance 5/29/98). | * Software validation for cycle operation was performed according to FDA's moderate level of concern recommendations. |
| Safety and Performance Requirements: | |
| * UL Electromedical Code 3101 | * Complies with UL Electromedical Code 3101 (certified by ITS). |
| * CSA Standard C22.2 No. 1010-1 | * Complies with CSA Standard C22.2 No. 1010-1 (certified by ITS). |
| * ASME, Section VIII, Division 1 for unfired pressure vessels | * Complies with ASME, Section VIII, Division 1 for unfired pressure vessels. |
| Overall Effectiveness: | |
| * Complete kill of biological indicators | * Effectiveness of sterilizer function and exposure time recommendations is demonstrated by complete kill of biological indicators. |
| * Verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10⁻⁶ probability of survival | * Demonstrated a sterility assurance level of at least 10⁻⁶ (or as specified for individual cycles, e.g., 10th for liquid, and 10⁻⁴ for some fabric pack cycles; there appears to be inconsistency in the reported SAL values, but the guiding principle is achieving a high SAL). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size in terms of the number of unique sterilization cycles performed for each test condition. Instead, it refers to the "verification studies" and indicates that "All [Cycle Type] cycles verified using..." were "qualified according to Section X.X.X ANSI/AAMI-ST8". The ANSI/AAMI ST8 standard would dictate the number of runs required for validation (e.g., typically 3 successful consecutive runs for each defined load and cycle).
- Data Provenance: The studies were "verification studies" conducted by STERIS as part of their product development and regulatory submission. This implies they are prospective studies performed in a controlled, laboratory-like setting using the actual device. The country of origin is not explicitly stated for the data, but given the company's US location and submission to FDA, it is highly likely the testing was conducted in the United States or under US quality standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
-
This information is not applicable in the context of a sterilizer validation study. The "ground truth" (i.e., whether sterilization was successful) is established through objective, scientific methods specified in the ANSI/AAMI ST8 standard, primarily:
- Biological Indicators (BIs): These contain resistant bacterial spores (e.g., Geobacillus stearothermophilus) that are cultured after the cycle. If there's no growth, it indicates a successful kill.
- Physical Parameters: Monitoring temperature, pressure, and time, and calculating F₀ values.
- Chemical Indicators/Dye Tests: Like the Bowie-Dick test, which shows uniform color change for successful air removal.
- Gravimetric Analysis: Measuring moisture retention.
Therefore, "experts" in the sense of radiologists reviewing images for ground truth are not involved. Instead, the "ground truth" is determined by the objective results of these standardized tests.
4. Adjudication Method for the Test Set
- Not Applicable. Since objective, quantifiable parameters and biological indicators, as per scientific standards (ANSI/AAMI ST8), determine success or failure, there is no need for an adjudication method by human observers for conflicting interpretations. The tests yield clear pass/fail results.
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
- Not Applicable. This is a physical device (sterilizer), not an AI/ML system that assists human readers with diagnostic or interpretive tasks. Therefore, no MRMC study was performed, and there is no "human reader improvement with AI."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device performing a physical process. The "algorithm" refers to the sterilizer's internal control software and the factory-programmed cycles, which operate autonomously to achieve sterilization. The performance of the sterilizer itself (as a "standalone" system) is what these validation studies demonstrate. There is no human intervention during the sterilization process itself, only in loading/unloading and selecting the appropriate cycle.
7. The Type of Ground Truth Used
- The ground truth used is primarily biological (complete kill of biological indicators) and physical/chemical (achievement of specified F₀ values, temperature/time profiles, moisture retention, water loss, uniform color change in Bowie-Dick tests, automatic flask seal), as defined by the ANSI/AAMI ST8 standard.
- The overall "ground truth" reflects the sterility assurance level (SAL), which is a statistically defined probability of a non-sterile item, directly measured or inferred from the efficacy of spore inactivation.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense. The device is designed, engineered, and then validated against a set of predetermined performance standards.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question does not apply. The performance parameters and criteria for the sterilizer were established by industry standards (ANSI/AAMI ST8) and scientific principles of sterilization.
§ 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).