(195 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 medical "devices" at 2011" withing a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization.
The STERRAD® 100NX™ 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 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 Modical as nocessed 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 Ibs. 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® 100NXTM 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 two different sterilization cycles, the Standard cycle and the Flex 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.
The provided text is a 510(k) summary for the STERRAD® 100NX™ Sterilizer. It describes the device's indications for use, its predicate device, a general description, and a summary of nonclinical tests. However, the document does not contain specific acceptance criteria, reported device performance metrics in a table format, sample sizes or provenance for test sets, details on ground truth establishment (number of experts, qualifications, adjudication methods), information about MRMC studies, or standalone algorithm performance.
The text focuses on the validation testing performed, which used an "overkill" approach with G. stearothermophilus spores to demonstrate the sterilizer's effectiveness.
Based only on the provided input, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria:
- The primary acceptance criterion for a sterilizer is usually the complete inactivation of a specified biological indicator (e.g., G. stearothermophilus spores). The "overkill" approach implies demonstrating sterility under challenging conditions (e.g., high spore populations). The document states "Testing was performed using the 'overkill' approach utilizing G. stearothermophilus spores."
- Specific performance metrics (e.g., Sterility Assurance Level (SAL) of 10^-6 or better) are implied by the overkill method but not explicitly stated as quantitative acceptance criteria in this document.
- The ability to sterilize specific types of lumens and endoscopes of certain dimensions is also an implicit acceptance criterion.
- Reported Device Performance: The document only states "Table 8-1 on the following page identifies the validation studies performed and the results obtained." This table is not provided in the given text, so specific performance results are unavailable.
| Acceptance Criteria (Implied/Stated) | Reported Device Performance (Not explicitly provided in text) |
|---|---|
| Complete inactivation of G. stearothermophilus spores ("overkill" approach) | "results obtained" (details in missing Table 8-1) |
| Sterilization of single channel stainless steel lumens (0.7mm ID, 500mm length, 10 max) | (Details in missing Table 8-1) |
| Sterilization of flexible endoscopes (polyethylene/Teflon, 1mm ID, 850mm length, 2 max) | (Details in missing Table 8-1) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "a validation load consisting of two instrument trays each weighing 10.7 lbs" for most studies. For the 1 x 850 mm flexible endoscopes, they "were validated without any additional load." It also specifies "A maximum of ten lumens, five per tray" and "A maximum of two flexible endoscopes, one per tray." These describe the loading configurations for the tests, but not the total 'sample size' in terms of the number of sterilization cycles or the total number of biological indicators tested.
- Data Provenance: Not specified. This is a nonclinical, device performance study, not a clinical study on human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a study involving human interpretation of data where expert ground truth would be established. The "ground truth" for a sterilizer is the proven inactivation of biological indicators, which is a laboratory measurement.
4. Adjudication method for the test set:
- Not Applicable. There is no human adjudication component for this type of device performance study.
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:
- Not Applicable. This is a sterilization device, not an AI-powered diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware and software system for sterilization, not an algorithm being tested for standalone performance. The sterilizer operates autonomously to perform the sterilization cycle.
7. The type of ground truth used:
- The ground truth for the sterilization efficacy tests was the inactivation of G. stearothermophilus spores. This is a biological indicator common in sterilization validation, typically confirmed by culture methods to ensure no viable spores remain after processing.
8. The sample size for the training set:
- Not Applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. The "training" for a sterilizer system is its design and engineering parameters.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set in this context.
§ 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).