(107 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) | 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 minute | 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 Test
Pack |
| Leak Test | N/A | N/A | N/A | N/A |
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 provided FDA 510(k) summary describes the AMSCO 600 Steam Sterilizer and its nonclinical testing. This document is a premarket notification for a medical device and thus the "acceptance criteria" here refers to the performance standards and regulatory requirements the device must meet to be deemed substantially equivalent to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance: Meets requirements of ANSI/AAMI ST8 | Meets requirements of ANSI/AAMI ST8 |
| General Electrical Safety: Meets requirements of IEC 61010-1 | Meets requirements of IEC 61010-1 |
| Sterilizer Electrical Safety: Meets requirements of IEC 61010-2-40 | Meets requirements of IEC 61010-2-40 |
| Electromagnetic Compatibility: Meets requirements of FCC 47 CFR Part 15 - Subpart B | Meets requirements of FCC 47 CFR Part 15 - Subpart B |
| Pressure Vessel Safety: Meets requirements of ASME Boiler Pressure Vessel Code, Section VIII (Division 1) | Meets requirements of ASME Boiler Pressure Vessel Code, Section VIII (Division 1) |
| Sterility Assurance Level (SAL): 10^-6 | 10^-6 |
| Ability to sterilize heat and moisture-stable materials: As defined by factory-programmed cycles (various temperatures, times, and dry times for different loads like fabric packs and instrument trays) | The device is designed for sterilization of heat and moisture-stable materials and includes the specified factory-programmed cycles (Table 1 and 2 in the document). The "Performance" test (meeting ANSI/AAMI ST8) would encompass validation of these cycles. |
| Full Loads: The ability to sterilize specified maximum loads for different sterilizer sizes (e.g., 39", 51", 63" models for wrapped instrument trays and fabric packs). | Proposed sterilizer can sterilize larger loads, and maximum load configurations validated per ANSI/AAMI ST8 (as stated in the comparison table under "Full Loads"). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes nonclinical testing and references compliance with standards like ANSI/AAMI ST8, IEC 61010-1, IEC 61010-2-40, FCC 47 CFR Part 15 - Subpart B, and ASME Boiler Pressure Vessel Code, Section VIII (Division 1).
- Sample Size: The document does not specify the sample size for these nonclinical tests in terms of specific units tested (e.g., number of sterilizers, number of loads processed). It states that "The testing demonstrated that subject device met the acceptance criteria described in these standards."
- Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. Nonclinical testing typically involves laboratory or in-house validation rather than patient data.
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. For nonclinical tests of a steam sterilizer, "ground truth" would typically be established by established engineering standards and methodologies, rather than expert human consensus on clinical images or outcomes.
4. Adjudication Method for the Test Set
This information is not provided and is generally not applicable to nonclinical engineering and performance testing of a steam sterilizer. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of results (e.g., by multiple radiologists).
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human interpretation is involved. The AMSCO 600 Steam Sterilizer is an automated sterilization device and does not involve human readers for interpretation in the context of its primary function.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to the AMSCO 600 Steam Sterilizer. It is a physical device that performs a function (sterilization) based on programmed cycles, not an algorithm that interprets data. Its performance is inherent in its operation and validated against physical and microbiological standards.
7. The Type of Ground Truth Used
The ground truth used for proving the device meets the acceptance criteria is based on:
- Engineering and Performance Standards: Compliance with recognized international and national standards (ANSI/AAMI ST8, IEC 61010-1, IEC 61010-2-40, FCC 47 CFR Part 15 - Subpart B, ASME Boiler Pressure Vessel Code, Section VIII (Division 1)). These standards define acceptable performance metrics for sterilization, electrical safety, EMC, and pressure vessel integrity.
- Microbiological Sterility Assurance: The specification of a Sterility Assurance Level (SAL) of 10^-6 implies that the ground truth for sterilization efficacy is the reduction of microbial population to a probability of 1 in a million, which is typically demonstrated through biological indicator challenges and physical parameter monitoring.
8. The Sample Size for the Training Set
This information is not applicable as the AMSCO 600 Steam Sterilizer is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the AMSCO 600 Steam Sterilizer is not an AI/ML device that requires a training set and associated ground truth.
§ 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).