(486 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 safely sterilize medical instruments and materials without leaving toxic residue.
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:
-
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.
- It can sterilize instrument surfaces and instruments having diffusionrestricted spaces, such as the hinged portion of forceps and scissors
- It can sterilize rigid and semi-rigid endoscopes without lumens
Note: The validation studies for EXPRESS Cycle were performed using a validation load consisting of a single instrument tray weighing 10.7 Ibs placed on the bottom shelf.
The STERRAD® 100NX® DUO Cycle is an additional optional cycle designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions:
- Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1mm or larger and a length of 875mm or shorter
- Accessory devices that are normally connected to a flexible endoscope during use
- Flexible endoscopes without lumens
Note: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 Ibs.
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® 100NX® Sterilizer has three previously cleared cycles (STANDARD, FLEX, EXPRESS) and the new optional additional DUO 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, and printer paper.
The provided document describes the STERRAD® 100NX® Sterilizer with DUO Cycle, a low-temperature hydrogen peroxide gas plasma sterilization system. The document focuses on the nonclinical validation testing performed to demonstrate its safety and effectiveness for sterilizing medical devices.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Results from Validation Studies) |
|---|---|
| Dose Response with Biological Model (1 x 875 mm Flexible Endoscope) demonstrates effective sterilization. | Passed |
| Surface Sterilization demonstrates effective sterilization. | Passed |
| Mated Surface Sterilization demonstrates effective sterilization. | Passed |
| 1 x 875 mm Flexible Endoscope Validation demonstrates effective sterilization for the specified endoscopes. | Passed |
| Bacteriostasis Testing in the DUO Cycle demonstrates inhibition of bacterial growth. | Passed |
| In Use Testing – 1 x 875 mm Flexible Endoscopes and Accessories demonstrates effective sterilization under simulated use conditions. | Passed |
| Simulated Use Testing demonstrates effective sterilization under various simulated use conditions. | Passed |
| Toxicity Testing of Materials demonstrates that materials processed do not become toxic. | Passed |
| Device Functionality and Material Compatibility demonstrates proper system operation and material compatibility. | Passed |
| Process Reproducibility demonstrates consistent sterilization results across multiple cycles. | Passed |
Interpretation of Acceptance Criteria: The acceptance criteria are implicitly performance-based, requiring the sterilizer to effectively sterilize various types of medical devices and demonstrate safety and reliability. The "Passed" result for each study indicates the device met these implicit performance expectations for sterilization. The overarching acceptance criterion is that the STERRAD® 100NX® DUO Cycle is "safe and effective for sterilization of medical devices within the indications for use" and establishes "equivalence...to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes for each validation study beyond the following:
- Validation Load (General): "a validation load consisting of two instrument trays each weighing 10.7 lbs." (for Standard and Flex Scope cycles, excluding the 1x850mm endoscopes).
- 1 x 850 mm flexible endoscopes (Flex Scope cycle): "validated without any additional load."
- EXPRESS Cycle validation load: "a single instrument tray weighing 10.7 Ibs placed on the bottom shelf."
- DUO Cycle validation load: "two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs."
- 1 x 875 mm flexible endoscopes (DUO Cycle): This specific lumen type was used in several validation studies.
- Lumen counts: "A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle" and "A maximum of two flexible endoscopes, one per tray per sterilization cycle."
The data provenance is retrospective as the studies were performed specifically for regulatory submission of an existing device (STERRAD 100NX) with a new cycle (DUO Cycle). The country of origin of the data is not specified, but the applicant's address is Irvine, CA, suggesting studies conducted within the US or under US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The nature of the testing (sterilization efficacy using biological indicators) typically relies on laboratory results and microbiological analysis rather than expert human interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method as it relates to human review or consensus for the test set. The validation studies rely on objective criteria (e.g., elimination of G. stearothermophilus spores) for assessing sterilization effectiveness.
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
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices where human interpretation is involved. The STERRAD® 100NX® Sterilizer is a sterilization device, not an AI-assisted diagnostic or interpretive system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to the STERRAD® 100NX® Sterilizer. The device itself is a standalone sterlization system. Its performance is evaluated directly through its ability to sterilize, not through an algorithm's performance separate from human interaction in an interpretive setting. The "standalone" performance here refers to the sterilizer's ability to achieve sterility without human intervention in the sterilization process, which is the core of its validation.
7. The Type of Ground Truth Used
The primary ground truth used for proving sterilization effectiveness is biological indicator (BI) testing using G. stearothermophilus spores. This is an industry-standard method where the complete elimination of these highly resistant spores indicates successful sterilization. The document refers to this as the "overkill" approach.
Other ground truths include:
- Material compatibility: Testing to ensure the sterilization process does not damage the treated devices.
- Toxicity testing: Ensuring no toxic residues are left.
- Functionality testing: Confirming devices remain functional after sterilization.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is a physical medical device (sterilizer) undergoing performance validation, not a machine learning or AI algorithm that requires training data. The devices tested in the validation studies (e.g., flexible endoscopes, instrument trays, lumens) represent the types of items the sterilizer is designed to process, but they are not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI algorithm, this question is not applicable. The "ground truth" for evaluating the sterilizer's performance was established through the rigorous, standardized microbiological and physical testing methods described (e.g., biological indicator kill, material integrity checks).
§ 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).