(555 days)
The STERRAD® 100NX™ Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization.
The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusionrestricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with the following materials and dimensions can be processed in the STERRAD® 100NX™ Sterilizer Standard cycle:
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Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter*
Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD® 100NX™ Sterilizer Flex Scope cycle: -
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 850 mm or shorter**
Note: With the exception of the 1 x 850 mm flexible endoscopes, the validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 lbs. The 1 x 850 mm flexible endoscopes were validated without any additional load.
*A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.
** A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.
The STERRAD® 100NX™ EXPRESS Cycle is an additional optional cycle designed for surface sterilization of both metal and nonmetal medical devices at low temperatures.
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It can sterilize instrument surfaces and instruments having diffusionrestricted spaces, such as the hinged portion of forceps and scissors
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It can sterilize rigid and semi-rigid endoscopes without lumens
The validation studies for EXPRESS Cycle were performed using a validation load Note: consisting of a single instrument tray weighing 10.7 Ibs placed on the bottom shelf.
The STERRAD® 100NX™ 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 where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas-plasma using electrical energy. The STERRAD® 100NXTM Sterilizer has three different sterilization cycles, the Standard cycle, the Flex cycle, and the new optional additional EXPRESS cycle.
The hardware for the STERRAD® 100NX™ Sterilizer consists of a sterilization chamber and a variety of instruments and components which are housed in a covered frame. The sterilizer system also uses accessories such as a disposable sterilant cassette, reusable instrument trays, printer paper, and an optional movable cart. The STERRAD® 100NXTM Sterilizer can be placed directly on a table, counter top, or on the movable cart.
Here's a breakdown of the acceptance criteria and the study information for the STERRAD® 100NX™ Sterilizer with EXPRESS Cycle, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria (e.g., "sterility assurance level of X"). Instead, it describes a "Passed" outcome for various validation studies, implying that the device met pre-defined success metrics for each study. The overarching acceptance criterion is achieving sterilization and demonstrating equivalence to predicate devices.
| Study | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dose Response with Anodized Aluminum Surfaces | Demonstrated effective sterilization on anodized aluminum surfaces. | Passed |
| Surface Sterilization | Achieved effective surface sterilization. | Passed |
| Mated Surface Sterilization | Achieved effective sterilization of mated surfaces. | Passed |
| Bacteriostasis Testing in the EXPRESS Cycle | No inhibition of bacterial growth attributed to the process. | Passed |
| In Use Testing - General Medical Devices | Sterilized general medical devices as intended. | Passed |
| Simulated Use Testing | Sterilized devices under simulated use conditions. | Passed |
| Toxicity Testing of Materials | Demonstrated material compatibility and non-toxicity post-process. | Passed |
| Chemical Indicator Functionality | Chemical indicators accurately reflected sterilization conditions. | Passed |
| CycleSure Biological Indicator Qualification | Biological indicators performed as expected, confirming sterility. | Passed |
| Bacteriostasis Testing of CycleSure Biological Indicator | No inhibition of biological indicator growth. | Passed |
| Device Functionality and Material Compatibility | Maintained device functionality and material integrity. | Passed |
| Process Reproducibility | Consistently achieved sterilization across multiple cycles. | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state a total numerical sample size for the "test set" in terms of how many individual items were sterilized across all tests. However, it does provide specific load configurations used for validation studies:
- Standard Cycle Validation Load: Two instrument trays, each weighing 10.7 lbs. (for 0.7 mm x 500 mm lumens). A maximum of ten single-channel stainless steel lumens (five per tray per cycle).
- Flex Scope Cycle Validation Load: Two flexible endoscopes (one per tray per cycle) for 1 mm x 850 mm flexible endoscopes. For other flexible endoscopes, the load was two instrument trays, each weighing 10.7 lbs.
- EXPRESS Cycle Validation Load: A single instrument tray weighing 10.7 lbs placed on the bottom shelf.
- Data Provenance: The document does not specify the country of origin of the data. It implies the studies were conducted by Advanced Sterilization Products (division of Ethicon, Inc.), based in Irvine, CA, USA.
- Retrospective or Prospective: The studies described ("Validation Testing") are inherently prospective, as they were conducted to validate the performance of the new EXPRESS cycle.
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. The document primarily focuses on microbiological "overkill" methods using G. stearothermophilus spores and physical testing, which don't typically involve human expert adjudication for ground truth in the same way as, for example, medical imaging diagnostics.
4. Adjudication Method for the Test Set:
This information is not provided as the ground truth establishment method (microbiological challenge and physical testing) does not involve adjudication by multiple experts. The "ground truth" for sterilization is typically measured by the inactivation of biological indicators.
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 done. This type of study is relevant for diagnostic devices where human interpretation is involved. The STERRAD® 100NX™ Sterilizer is a sterilization device, and its effectiveness is determined by its ability to kill microorganisms, not by human interpretation of images or data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone system (the sterilizer). The validation studies presented evaluate the performance of the sterilizer operating on its own; there is no "human-in-the-loop" performance being measured in the context of the device's primary function (sterilization). Therefore, in a sense, the evaluations are entirely of the "algorithm only" (the sterilization process) without human interpretive intervention.
7. The Type of Ground Truth Used:
The primary ground truth used is the inactivation of biological indicators, specifically G. stearothermophilus spores, using an "overkill" approach. This is a well-established and accepted method for demonstrating sterilization efficacy. Additional ground truth elements include:
- Physical/Chemical measurements: Ensuring appropriate levels of hydrogen peroxide and plasma are achieved.
- Bacteriostasis testing: Confirming that materials or residues do not inhibit microbial growth.
- Functionality and material compatibility assessments: Ensuring the devices being sterilized are not damaged and remain functional.
8. The Sample Size for the Training Set:
This document does not refer to a "training set" in the context of an algorithm or AI. The STERRAD® 100NX™ Sterilizer is a physical device with a defined process, not a machine learning model that undergoes a training phase. The validation studies demonstrate the performance of the finalized device.
9. How the Ground Truth for the Training Set was Established:
As there is no "training set" in the machine learning sense, this question is not applicable. The device's design and parameters would have been developed based on scientific principles of sterilization and iterative testing, not by training an algorithm on a dataset with pre-established ground truth.
§ 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).