(260 days)
The STERRAD® NX 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® NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with the following materials and dimensions can be processed in the STERRAD® NX Sterilizer Standard cycle:
Single channel stainless steel lumens with
- An inside diameter of 1 mm or larger and a length of 150 mm or shorter
- An inside diameter of 2 mm or larger and a length of 400 mm or shorter
Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD® NX Sterilizer Advanced cycle:
Single channel stainless steel lumens with
- An inside diameter of 1 mm or larger and a length of 500 mm or shorter
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with - An inside diameter of 1 mm or larger and length of 850 mm or shorter
The STERRAD® NX 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® NX Sterilizer has two different sterilization cycles, the Standard cycle and the Advanced cycle.
The hardware for the STERRAD® NX 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 system and an optional movable cart. The STERRAD® NX Sterilizer can be placed directly on a table, counter top, or on the movable cart.
The document describes the validation testing for the STERRAD® NX Sterilizer. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each study type are implied as "Passed," meaning the sterilization process successfully rendered the tested items sterile. The document does not provide specific quantitative thresholds for passing (e.g., spore kill percentages), but "Passed" indicates the criteria were met.
| Study Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dose Response with 1 x 500mm Stainless Steel Lumens | Sterile | Passed |
| Surface Sterilization | Sterile | Passed |
| Mated Surface Sterilization | Sterile | Passed |
| 1 x 500mm Stainless Steel Lumen Validation | Sterile | Passed |
| 1 x 150 Stainless Steel Lumen Validation | Sterile | Passed |
| 2 x 400mm Stainless Steel Lumen Validation | Sterile | Passed |
| 1 x 850mm Flexible Endoscope Validation | Sterile | Passed |
| Pouched 1 x 500mm Stainless Steel Lumen Validation | Sterile | Passed |
| Bacteriostasis Testing in Standard and Advanced Cycles | No bacterial growth | Passed |
| Sporicidal Testing | Kill spores | Passed |
| In Use Testing | Sterile | Passed |
| Bacteriostasis/Fungistasis Testing | No microbial growth | Passed |
| Simulated Use Testing | Sterile | Passed |
| Toxicity Testing of Materials | Non-toxic | Passed |
| Chemical Indicator Functionality | Proper indication | Passed |
| Biological Indicator Functionality | Proper indication | Passed |
| Bacteriostasis Testing of CycleSure Biological Indicator | No bacterial growth | Passed |
| Device Functionality and Material Compatibility | Functional, Compatible | Passed |
| Process Reproducibility | Consistent sterilization | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state a total number of samples for the entire test set. However, it provides details for specific validations:
- 1 x 850mm flexible endoscope validation: Tested with only one flexible endoscope per sterilization cycle.
- 1 mm diameter or larger and 500 mm or shorter lumens: Maximum of 10 lumens per load.
- Other validations: The "Note" implies that with the exception of the 1 x 850mm flexible endoscopes, the validation studies were performed using a "validation load consisting of one instrument tray weighing 10.7 lbs." This suggests that for many tests, the sample size per cycle was consistent with a single instrument tray load.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission for a medical device cleared in the U.S. in 2005, it is highly likely that these were prospective validation studies conducted in a controlled laboratory environment to demonstrate the sterilizer's efficacy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The ground truth for sterilization efficacy studies is typically determined empirically through microbiological testing (e.g., culturing biological indicators or test organisms) rather than expert interpretation of results.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is established objectively through microbiological methods, not through expert review and adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a sterilizer, and its performance is evaluated in terms of its ability to kill microorganisms, not by human reader interpretation of images or other data. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance Study
While "standalone" is often used in the context of AI algorithms, this refers to the performance of the sterilizer itself. The document comprehensively details numerous validation studies performed to demonstrate the sterilizer's standalone efficacy in achieving sterilization. The entire "SUMMARY OF NONCLINICAL TESTS" section (5.0) describes the standalone performance without human intervention during the sterilization cycle.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth used for these sterilization validation studies is primarily microbiological/biological evidence. Specifically, the "overkill" approach utilizes G. stearothermophilus spores, which are highly resistant biological indicators. The "Passed" result for each study indicates the complete inactivation of these spores and other tested microorganisms, demonstrating sterility.
8. Sample Size for the Training Set
Not applicable. This device is a physical sterilizer and not an AI or software device that relies on a "training set" in the machine learning sense. The validation studies demonstrate the sterilizer's inherent physical and chemical process efficacy.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (in the machine learning context) was used.
§ 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).