(189 days)
The STERRAD® 200 Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. Because the cycle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture.
The STERRAD® 200 Sterilizer can sterilize instruments which have diffusion-restricted spaces. such as the hinged portion of forceps and scissors.
Medical devices with only a single stainless steel lumen with the following dimensions can be processed in the STERRAD® 200 Sterilizer.
- An inside diameter of 1 mm or larger and a length of 125 mm or shorter* .
- An inside diameter of 2 mm or larger and a length of 250 mm or shorter* .
- An inside diameter of 3 mm or larger and a length of 400 mm or shorter .
Teflon® and polyethylene luments with inside diameters of 6 mm or larger and lengths of 310 mm or shorter can be processed in the STERRAD® 200 Sterilizer.
*The validation testing for this lumen size was conducted using a maximum of 12 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
Note: The validation studies for this sterilizer were performed using the STERRAD cycle consisting of a 6-minute 45-second injection phase followed by a 2-minute diffusion phase and a 2-minute plasma phase. The validation studies were performed using a validation load consisting of four instrument trays each weighing 9.12 lbs. (the total weight of the load was 36.48 lbs.).
The STERRAD® 200 Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices, using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer bowl where the solution is heated and transformed into a vapor, introducing the vapor into the process chamber under negative pressure and transforming the vapor into a gas plasma with electrical energy.
The equipment (hardware) for the STERRAD® 200 Sterilizer is the same as that of the predicate device, the STERRAD® 100S Sterilizer. (Note: The STERRAD® 200 Sterilizer is available in either a one-door or two-door model, depending on customer preference). The hardware consists of a sterilization chamber onto which is mounted a variety of instruments and components, housed in a covered frame. The system also uses accessories such as a movable carriage for transport of the cart, disposable sterilant cassettes, reusable instrument trays, printer paper and ink cartridges.
The STERRAD® 200 Sterilizer is a medical device designed for the sterilization of both metal and non-metal medical devices at low temperatures. It uses a hydrogen peroxide gas plasma process.
Here's an analysis of its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Sterilization for 1x125mm Lumens | Passed Dose Response and Lumen Validation Studies |
| Sterilization for 2x250mm Lumens | Passed Dose Response and Lumen Validation Studies |
| Sterilization for 3x400mm Lumens | Passed Dose Response and Lumen Validation Studies |
| Sterilization for 6x310mm Teflon® and polyethylene lumens | Passed 6x310mm Lumen Validation Study |
| Surface Sterilization | Passed Surface Sterilization Study |
| Mated Surface Sterilization | Passed Mated Surface Sterilization Study |
| Sterilization for Pouched 1x125mm Lumens | Passed Pouched 1x125mm Lumen Validation Study |
| Sterilization for Pouched 2x250mm Lumens | Passed Pouched 2x250mm Lumen Validation Study |
| Sterilization for Pouched 3x400mm Lumens | Passed Pouched 3x400mm Lumen Validation Study |
| Prevention of Bacteriostasis in Carrier Materials | Passed Bacteriostasis Testing of Carrier Materials |
| Sporicidal Efficacy | Passed Sporicidal Testing |
| Efficacy in "In Use" conditions | Passed In Use Testing |
| Prevention of Bacteriostasis/Fungistasis | Passed Bacteriostasis/Fungistasis Testing |
| Efficacy in simulated use conditions | Passed Simulated Use Testing |
| Material Biocompatibility / Absence of Toxicity for Materials | Passed Toxicity Testing of Materials |
| Proper Functionality of Chemical Indicator | Passed Chemical Indicator Functionality |
| Prevention of Bacteriostasis of CycleSure Biological Indicator | Passed Bacteriostasis Testing of CycleSure Biological Indicator |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes (e.g., number of lumens, surfaces, or biological indicators) used for each validation study. However, it notes that for the lumen sizes, "The validation testing for this lumen size was conducted using a maximum of 12 lumens per load." This implies at least 12 lumens were used for these specific tests.
The data provenance is not explicitly stated in terms of country of origin. The studies are described as "nonclinical tests" and "validation studies," indicating they were conducted in a controlled environment, likely by the manufacturer or a contracted testing facility, to evaluate the device's performance. The nature of the tests (e.g., "Dose Response," "Lumen Validation") suggests a prospective design, where tests were specifically set up to challenge the sterilizer's capabilities under defined conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing ground truth. Sterilization validation often relies on established industrial and microbiological standards, rather than expert human interpretation in the same way a medical imaging AI might. The "ground truth" for sterilization is typically determined by the absence or presence of viable microbial spores after the sterilization process, which is a quantitative, laboratory-based assessment.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the context of human expert review. Given that the validation involves "overkill" approach utilizing B. stearothermophilus spores and subsequent laboratory analysis, the "adjudication" is inherent in the microbiological results (e.g., growth or no growth of spores). This is a objective, scientific measurement rather than a subjective human interpretation requiring consensus.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically relevant for diagnostic devices where human interpretation is a key component, and the AI aims to assist human readers. The STERRAD® 200 Sterilizer is a standalone sterilization device, and its effectiveness is measured directly through its ability to kill microorganisms, not by how it influences human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The entire suite of "Validation Testing" listed in Table 1 represents the standalone performance of the STERRAD® 200 Sterilizer. The device's ability to sterilize was evaluated directly, independent of human intervention beyond loading and operating the machine.
7. The Type of Ground Truth Used
The primary type of ground truth used is microbiological outcome data/biological indicators. Specifically, the "overkill" approach utilizing B. stearothermophilus spores was employed. This method involves challenging the sterilization process with a high concentration of highly resistant microorganisms (biological indicators) within test devices. The "ground truth" for successful sterilization is the complete inactivation of these spores, indicated by no growth in subsequent laboratory incubation.
8. The Sample Size for the Training Set
The document does not mention a traditional "training set" in the context of machine learning or AI. This device is a physical sterilizer, not a software algorithm that learns from data. Its performance is based on its engineered design and process, which is validated through the nonclinical tests described.
9. How the Ground Truth for the Training Set Was Established
As there is no traditional "training set" for an AI or machine learning model, this question is not applicable. The device's design and operational parameters were established through engineering principles and prior research (implied by the predicate device), with the validation studies serving to confirm its efficacy.
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).