(187 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*
Note: With the exception of the 1 x 850 mm flexible endoscopes, validation studies were performed using a validation load consisting of one instrument tray weighing 10.7 bs. The 1 x 850 mm flexible endoscope was validated without any additional load.
- The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. *Only one flexible endoscope can be processed per sterilization cycle with or without a silicone mat. No additional load.
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 a 59% aqueous hydrogen peroxide into the vaporizer subassembly where the solution is heated and vaporized and relatively low temperatures through a process that utilizes a combination of heating and sub-ambient pressures created by an on-board vacuum pump. The vaporized hydrogen peroxide is then introduced into the chamber under sub-ambient pressure to allow perfusion of the hydrogen peroxide throughout the chamber and facilitate hydrogen peroxide contact with the surfaces to be sterilized. The vapor in the chamber is transformed into gas plasma using electrical energy. The chamber is then vented to allow the sterilization chamber to return to atmospheric pressure. This process is repeated an additional time to complete a full STERRAD NX Sterilization cycle (i.e., the full sterilization cycle is composed of two identical half-cvcles). The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles, both of which follow the general process described here.
The hardware for the STERRAD NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. Other major components of the system are constructed from passivated stainless steel, Viton (a copolymer of vinylidene fluoride and hexafluoropropylene), Ultem (polyetherimide), injection molding, and structural foam. The sterilizer also uses accessories such as reusable instrument trays, printer paper, and an optional movable cart. The STERRAD NX Sterilizer can be placed directly on a table, counter top, or on the movable STERRAD NX cart.
The STERRAD NX Sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. As previously described, the hydrogen peroxide is concentrated before introduction into the sterilizer chamber and its concentration is monitored during the cycle. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the pre-defined minimum concentration specification.
The STERRAD NX Sterilizer with ALLClear Technology incorporates enhancements and new features to improve reliability and usability, as briefly described following:
- . Load Conditioning Feature: Reduces canceled cycles by performing load and system checks and executing a load conditioning step prior to starting a sterilization cycle.
- . Enhanced Graphical User Interface (GUI): Added information to the error messages enabling users to take actions related to that error message. GUI enhancement also provides more intuitive navigation.
- Improved cassette insertion.
- New Touchscreen Display: Larger, higher resolution, and wider viewing angle. ●
- . New External Panels: Enhance aesthetic appearance and accommodate the larger display.
- . Capability for future "ecosystem" connectivity: Will allow communication and integration with future ASP biological indicator reader(s), as well as other potential future communication features.
The provided document is a 510(k) Premarket Notification for the STERRAD NX® Sterilizer with ALLClear™ Technology, a low-temperature sterilization device. The document describes the device, its intended use, and provides a summary of non-clinical data to demonstrate substantial equivalence to previously cleared predicate devices.
1. A table of acceptance criteria and the reported device performance
The document presents verification testing results in a table, demonstrating that the device meets its acceptance criteria, which appear to be related to various functional and safety aspects of the sterilizer. The acceptance criterion for each test is implied to be "Pass."
| Verification Testing | Description | Reported Device Performance |
|---|---|---|
| Load Check Design Verification | Study demonstrated that the modified device, with load conditioning feature enabled, is able to detect load out-gassing from moisture that has been absorbed into the load materials. | Pass |
| Load Conditioning Design Verification | Study demonstrated that the modified device with load conditioning feature enabled is effective in correcting load out-gassing. | Pass |
| Titer Enumeration of STERRAD CYCLESURE® 24 BI With and Without Load Conditioning Feature | Study verified that the load conditioning has no significant impact on the CYCLESURE 24 BI. | Pass |
| Chemical Indicator Functionality Testing | Study verified the functionality of the STERRAD Chemical Indicator (CI) Strip, SEALSURE® Chemical Indicator Tape, Chemical Indicator Disc on the CYCLESURE BI, and Tyvek® self-seal and heat-seal pouches with STERRAD Chemical Indicator following exposure to the load conditioning feature. | Pass |
| Load Temperature Verification | Study demonstrated that the modified STERRAD NX system, with load conditioning feature enabled, does not exceed the load temperature limit. | Pass |
| Final Process Qualification - STANDARD Cycle | Testing demonstrated that the sterilizer performs consistently within its process specifications with the load conditioning feature enabled. | Pass |
| Final Process Qualification - ADVANCED Cycle | Testing demonstrated that the sterilizer performs within its process specifications with the load conditioning feature enabled. | Pass |
| H2O2 Delivery System Design Verification | Study demonstrated that the cassette insertion modifications allow easier insertion and also detect cassette alignment. | Pass |
| Panel Subsystem Design Verification | Study verified that the new panels consist of all the parts to enclose the sterilizer functional subsystems and control user-access to only appropriate areas. | Pass |
| Panel Subsystem Design Verification for Internal Enclosure Air Temperature | Study verified that internal air temperature during operation at maximum ambient temperature is within the temperature allowed for sterilizer operation. | Pass |
| Panel Materials Testing | Study verified that the effects of 70% isopropyl alcohol (IPA) and hydrogen peroxide on the new panel material are within the acceptable range. | Pass |
| Display Assembly Subsystem Design Verification | Study verified that the characteristics of the new display assembly and confirmed compatibility with the modified STERRAD NX system. | Pass |
| System Verification | Study verified new and related system requirements which were not tested at the subsystem level. | Pass |
| System Tests (Environmental) | Study verified that the modified device operates reliably and effectively at ambient conditions. | Pass |
| Summative Usability Testing | Usability testing assessed user interaction with the modified device. | Pass |
| Biocompatibility testing | An additional study was performed to assess residual hydrogen peroxide on worst case medical device materials following load conditioning in conjunction with an ADVANCED sterilization cycle. This study demonstrated that mean residual hydrogen peroxide level was statistically significantly less than the acceptable threshold level. | Pass |
| Electromagnetic compatibility (EMC) testing | Demonstrated that the modified STERRAD NX complies with the requirements for radiated and conducted emissions in accordance with specified standards (IEC/EN 60601-1-2:2014, EN 55011, CISPR 11). | Pass |
| Electrical Safety testing | Undertaken to demonstrate that the modified STERRAD NX is electrically and mechanically safe when operated and maintained in accordance with the User's Guide, conforming to specified standards (CAN/CSA-C22.2 No. 61010-1, CAN/CSA-C22.2 No. 61010-2-040, UL 61010-1, IEC/EN 61010-1, IEC/EN 61010-2-40). | Pass |
| Software verification and validation testing | Unit, Integration, and System level testing were successfully completed, and documentation was provided as recommended by FDA guidance. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each individual test or the data provenance (country of origin, retrospective/prospective). The studies are referred to as "Verification testing" and "Design Verification" which typically implies prospective testing conducted by the manufacturer.
For the lumen validation studies (mentioned in the Indications for Use on page 2 and 6):
- For the 1 x 850 mm flexible endoscope, it "was validated without any additional load."
- For other lumen sizes, "validation studies were performed using a validation load consisting of one instrument tray weighing 10.7 lbs."
- "The validation testing for this lumen size was conducted using a maximum of 10 lumens per load."
- "Only one flexible endoscope can be processed per sterilization cycle with or without a silicone mat. No additional load."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document is for a sterilization device, not an AI/diagnostic imaging device. Therefore, the concept of "ground truth established by experts" in the context of medical image interpretation by radiologists is not applicable here. The "ground truth" for the performance of this sterilizer would be established through scientific and engineering principles, such as microbiological testing (e.g., sterilization of biological indicators), chemical indicators meeting specifications, temperature and pressure monitoring, and physical measurements. The document does not specify the number or qualifications of experts involved in these engineering and biological ground truth determinations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable to a sterilization device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert readers interpreting medical images, where discrepancies need to be resolved. The "test set" here refers to the various physical, chemical, and biological tests conducted on the sterilizer, where the outcome is objectively measured against predefined specifications.
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 a diagnostic imaging device with an AI component for human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the typical sense of "standalone AI performance." The device itself operates in a standalone manner to perform sterilization cycles. Its performance is evaluated independently of human intervention during the sterilization cycle, meaning the sterilizer's ability to achieve sterilization endpoints is assessed on its own. The "Summative Usability Testing" (page 7) does assess user interaction, but this is about the human interface with the device, not about the device's diagnostic or interpretative accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the STERRAD NX Sterilizer with ALLClear™ Technology is primarily established through:
- Microbiological testing: Using biological indicators (e.g., STERRAD CYCLESURE®), where the ground truth is the complete inactivation of target microorganisms. The "Titer Enumeration of STERRAD CYCLESURE® 24 BI" study supports this.
- Chemical/Physical measurements: Ensuring parameters like hydrogen peroxide concentration, temperature, pressure, and cycle times meet predefined specifications. This includes "Final Process Qualification" (STANDARD and ADVANCED cycles), "Load Temperature Verification," and "H2O2 Delivery System Design Verification."
- Safety standards compliance: Meeting established electrical safety (e.g., UL, CSA, IEC/EN standards) and electromagnetic compatibility (EMC) standards (e.g., IEC/EN 60601-1-2).
- Biocompatibility testing: Demonstrating that residual sterilant levels are below acceptable thresholds.
8. The sample size for the training set
Not applicable to this type of medical device which is a sterilizer, implying no machine learning training set as conventionally understood for AI devices. The device's operational parameters and safety features are based on engineering design and validation, not on a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this sterilization device. The device operates based on predefined physical and chemical processes, validated through scientific and engineering experiments against established industry standards for sterilization.
§ 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).