(178 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 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 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.
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 diffusion-restricted 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 lbs 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 1 mm or larger and a length of 875 mm 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 lbs.
- 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 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 four cleared sterilization cycles: STANDARD, FLEX, EXPRESS, and DUO Cycles.
For the STANDARD and FLEX cycles, hydrogen peroxide (HoO2) vapor is generated by injecting aqueous hydrogen peroxide into an on-board vaporizer where the solution is heated and vaporized, thereby concentrating 59% H2O2 to 90% nominal H2O2. The H2O2 vapor is then introduced into the sterilization chamber under sub-ambient pressure and transformed into a gas-plasma using electrical energy. The sterilization process is a multiphase process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization.
For the EXPRESS cycle, the onboard concentration process utilized for STANDARD and FLEX cycles is not used: the subsystem receives hydrogen peroxide solution from the delivery system. vaporizes the liquid and delivers it to the chamber.
For the DUO Cycle, hydrogen peroxide from the STERRAD 100NX Cassette follows a different flow path through the delivery module. The hydrogen peroxide, when withdrawn from the cassette, is temporarily held in the accumulators of the delivery module, and a smaller quantity (1.55 mL, nominal value) of hydrogen peroxide is dispensed or metered into the vaporizer during each of the two half-cycles of the DUO cycle. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, and printer paper.
The hardware for the STERRAD 100NX 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, and printer paper.
The STERRAD 100NX Sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the pre-defined minimum concentration specification.
The modified STERRAD 100NX Sterilizer with ALLClear Technology described within this submission incorporates enhancements and new features to improve reliability and usability. as briefly described following:
- Load Conditioning Feature: Available for use with the STANDARD, FLEX, and . EXPRESS cycles. 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 technological characteristics associated with the sterilization process for the modified STERRAD 100NX Sterilizer ALLClear Technology are identical to those of the previously cleared STERRAD 100NX Sterilizer; the software and hardware changes associated with the described enhancements and new features do not modify the existing sterilization cycles.
This document describes the STERRAD® 100NX Sterilizer with ALLClear™ Technology, a low-temperature sterilization system using hydrogen peroxide gas plasma. The submission (K160903) concerns enhancements to reliability and usability of the previously cleared device, not changes to the core sterilization process.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative predefined "acceptance criteria" for the changes, but rather "Pass/Fail" results for various verification tests demonstrating compliance and functionality. The overall acceptance is implied by all tests yielding "Pass".
| Verification Testing Category | Description | Reported Performance (Pass/Fail) |
|---|---|---|
| Load Conditioning Feature | ||
| Load Check Design Verification | Device detects load out-gassing causing cycle cancellations. | Pass |
| Load Conditioning Design Verification | Load conditioning feature reduces load out-gassing. | Pass |
| Titer Enumeration of STERRAD CYCLESURE 24 BI | Load conditioning has no significant impact on BI. | Pass |
| Chemical Indicator Functionality Testing | Verified functionality of various CIs (Strip, Tape, Disc, pouches) following exposure to load conditioning. | Pass |
| Load Temperature Verification | Device with load conditioning does not exceed load temperature limits. | Pass |
| Final Process Qualification - STANDARD Cycle | Sterilizer performs consistently within process specifications with load conditioning. | Pass |
| Final Process Qualification - FLEX Cycle | Sterilizer performs within process specifications with load conditioning. | Pass |
| Final Process Qualification - EXPRESS Cycle | Sterilizer performs within process specifications with load conditioning. | Pass |
| Hardware Modifications | ||
| H2O2 Delivery System Design Verification | Cassette insertion modifications allow easier insertion and detect alignment. | Pass |
| Panel Subsystem Design Verification | New panels provide appropriate protection, access, and accommodate modifications. | Pass |
| Panel Subsystem Design Verification (Int. Temp) | Internal air temperature during operation at max ambient temperature is within allowed limits. | Pass |
| Panel Materials Testing | Effects of 70% isopropyl alcohol (IPA) and hydrogen peroxide on new panel material are within acceptable range. | Pass |
| Display Assembly Subsystem Design Verification | Characteristics of new display assembly and compatibility with modified system confirmed. | Pass |
| System & Compliance | ||
| System Verification | Verified new and related system requirements impacted by modifications. | Pass |
| System Tests (Environmental) | Modified device operates reliably and effectively at ambient conditions. | Pass |
| Summative Usability Testing | Assessed user interaction with the modified device. | Pass |
| Biocompatibility testing | Mean residual hydrogen peroxide level statistically significantly less than acceptable threshold on worst case materials after load conditioning and sterilization. | Pass |
| Electromagnetic compatibility (EMC) testing | Complies with IEC/EN 60601-1-2:2014 and EN 55011 Group I Class A limits. | Pass |
| Electrical Safety testing | Conforms to applicable sections of CAN/CSA-C22.2 No. 61010-1, CAN/CSA-C22.2 No. 61010-2-040, UL 61010-1/R:2008-10, IEC/EN 61010-1:2001, and IEC/EN 61010-2-40:2005. | Pass |
| Software Verification and Validation | Unit, Integration, and System level testing successfully completed per Guidance for Premarket Submissions for Software Contained in Medical Devices. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each verification test. It generally refers to "studies" or "testing" without detailing the number of units or cycles tested.
The data provenance is internal to Advanced Sterilization Products, as these are non-clinical verification tests conducted for regulatory submission. No information on country of origin of the data is provided beyond the submitting company's location (Irvine, CA, USA). The tests are prospective in nature, as they are specifically conducted to verify the changes in the device.
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 tests seem to be objective engineering and scientific evaluations rather than expert-driven ground truth establishment. For example, sterilizer performance is evaluated against defined physical and biological parameters, and usability testing is conducted with users, but the "ground truth" for the device's function is its validated performance.
4. Adjudication Method for the Test Set
Not applicable. The tests are presented as objective measurements and verifications, not requiring an adjudication panel.
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 device is a sterilizer, not an AI-powered diagnostic system that involves human readers or interpretation of medical images.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical sterilizer and does not involve AI algorithms in the context of diagnostic interpretation. Its performance is inherent to its mechanical, chemical, and software components operating in a standalone fashion.
7. The Type of Ground Truth Used
The ground truth for the performance of the sterilizer is based on established scientific principles of sterilization (e.g., microbial inactivation, hydrogen peroxide concentration, temperature, pressure), material compatibility, electrical safety standards, and software validation. For biological efficacy, this typically involves testing with biological indicators. For the improvements in this submission, the "ground truth" for the new features (e.g., load conditioning, new display) are that they perform their intended function (e.g., reduce out-gassing, display correctly) and do not compromise existing validated sterilization processes.
8. The Sample Size for the Training Set
Not applicable. This device does not employ machine learning or AI models that require a "training set" in the conventional sense. The "training" for the device's operation is its design, engineering tolerances, and validated parameters.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the AI sense for this device. The design and performance parameters are established through engineering specifications, regulatory standards, and scientific principles related to sterilization and medical device manufacturing.
§ 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).