(201 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.
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.
The STERRAD 100NX EXPRESS Cycle is an additional 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.
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.
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 cleared sterilization cycles, the Standard and Advanced Cycles. The sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. The hydrogen peroxide is concentrated before introducing 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 specification. 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. 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 cart.
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). The sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. For the Standard and Flex Cycles, the hydrogen peroxide is concentrated before into the sterilizer chamber. For the EXPRESS and DUO Cycles, the concentration process is not used. For all four cycles, the hydrogen peroxide concentration is monitored during the cycle and the sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the specification. 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 STERRAD NX and 100NX are controlled by software running on an onboard microprocessor. The software is designed to control the sterilizer and provide an interface for user interaction with the sterilizer. The software has the network connectivity feature that allows the Hospital IT Department to connect the STERRAD NX or STERRAD 100NX to a Hospital Local Area Network (LAN) for transfer of cycle parameters to a server and then, if desired, to an Instrument Tracking System.
This document describes the regulatory submission for a software revision to the STERRAD NX and STERRAD 100NX Sterilizers, primarily enabling network connectivity. The core functionality of sterilization remains unchanged from the predicate device. Therefore, the "device performance" in this context refers to the performance of the software and the electrical safety and electromagnetic compatibility (EMC) of the overall system with the new software.
No human reader studies (MRMC) or standalone algorithm performance studies were conducted as this is not an AI/ML powered diagnostic device. The ground truth for the training set is not applicable as this is a software update for a sterilizer, not a machine learning model requiring training data.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for the software revision and overall system) | Reported Device Performance |
|---|---|
| Electrical Safety and EMC | |
| Radiated Emissions (CISPR 11:2009 +A1:2010 Class A) | Pass |
| Radiated Emissions (EN 60601-1-2:2007 Class A) | Pass |
| Conducted Emissions (CISPR 11:2009 +A1:2010 Class A) | Pass |
| Conducted Emissions (EN 60601-1-2:2007 Class A) | Pass |
| Electrical Safety (CAN/CSA-C22.2 No.: 61010-1 (R2009)) | System is electrically safe |
| Electrical Safety (UL 61010-1 (R2008)) | System is electrically safe |
| Electrical Safety (IEC/EN 61010-1:2001) | System is electrically safe |
| Electrical Safety (IEC/EN 61010-2-040:2005) | System is electrically safe |
| Electrical Safety (IEC/EN 60601-1-2:2007, CLASS A) | System is electrically safe |
| Electrical Safety (EN 55011:2009 +A1:2010) | System is electrically safe |
| Software Verification and Validation Testing | |
| All testing met predefined acceptance criteria | All testing met predefined acceptance criteria |
| Software functionality (network connectivity) | |
| Configurable automatically or manually | Yes |
| Activated only upon user request | Yes |
| User can turn it off and back on after activation | Yes |
| Diagnostic tools for network troubleshooting | Yes |
| Notification of unsuccessful transmission | Yes |
| Digital information identical to existing printout/USB download | Yes |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the traditional sense of a dataset for algorithm evaluation. Instead, the testing pertains to the hardware and software functionality of the sterilizer.
- Electrical Safety and EMC Testing: Performed on the STERRAD NX and 100NX Sterilizers themselves. The sample size would be the units of sterilizers tested, which is typically a limited number of physical devices (e.g., one or a few units for compliance testing).
- Software Verification and Validation Testing: Implies testing performed on the software code and integrated system. The "sample size" here would be the extent of the test cases executed to verify software requirements.
- Data Provenance: Not applicable in the context of data used for algorithm training or evaluation, but rather for testing the manufacturing of the physical device and its updated software. This is likely internal testing by the manufacturer, Advanced Sterilization Products.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this device primarily pertains to engineering specifications, safety standards, and software requirements, not expert interpretation of outputs like images. The "ground truth" for electrical safety and EMC is defined by established international and national standards (e.g., CISPR, EN, CAN/CSA, UL, IEC).
4. Adjudication Method for the Test Set
Not applicable. This type of device testing relies on objective measurements against predefined engineering and regulatory standards, not subjective expert adjudication. For instance, an EMC test result is a "pass" or "fail" based on quantitative limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a sterilizer with a software update for network connectivity, not a diagnostic or screening tool that would involve human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in essence, the software verification and validation testing, along with the electrical safety and EMC testing, represents a form of standalone performance evaluation for the updated system. The network connectivity feature itself operates without human intervention once configured, sending cycle parameters automatically. The "algorithm" here is the sterilizer's control software and the new networking software. Its performance is assessed against its functional requirements and regulatory standards.
7. The Type of Ground Truth Used
- For Electrical Safety and EMC: Regulatory and industry standards (e.g., CISPR 11, EN 60601-1-2, CAN/CSA-C22.2 No.: 61010-1, UL 61010-1, IEC/EN 61010-1, IEC/EN 61010-2-040, EN 55011). These standards define the acceptable limits for emissions and safety parameters.
- For Software Verification and Validation: Predetermined software requirements specifications and functional design documents. The "ground truth" is whether the software correctly implements its intended functions (e.g., network configuration, data transmission, error notifications) according to these documented specifications.
8. The Sample Size for the Training Set
Not applicable. This device is a sterilizer system with a software update, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 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).