(213 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® 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
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
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® and 100NX® Sterilizers are self-contained stand-alone systems of hardware and software designed to sterilize medical instruments and devices using a hydrogen peroxide 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 and transforming the vapor into a gas plasma using electrical energy. 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 network connectivity software revision that is the basis for this 510(k) premarket notification 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. The software has been designed for ease of configuration using Dynamic Host Configuration Protocol (DHCP). The cycle information will be available in Portable Document Format (PDF) and Comma Separated Values (CSV) formats and transmitted using Transmission Control Protocol/Internet Protocol (TCP/IP). The network digital information will be identical to the existing cycle information printed out by the devices after each cycle (PDF file) and the existing electronic delimited data (CSV file) that can be downloaded through the USB port.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
It's important to note that this document is a 510(k) summary for a medical device (sterilizer), and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against new, specific clinical acceptance criteria. The "acceptance criteria" here are primarily based on established standards for safety, electromagnetic compatibility, and software validation, aligning with regulatory requirements for demonstrating equivalence for a modification to an existing device.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria/Standard | Reported Device Performance |
|---|---|---|
| I. Biocompatibility | Not required (due to changes not affecting design or materials) | Not applicable |
| II. Electrical Safety & Electromagnetic Compatibility (EMC) | Radiated Emissions: | |
| - CISPR 11:2009 (Amended by A1:2010) Class A | Pass | |
| - EN 60601-1-2:2007 Class A | Pass | |
| Conducted Emissions: | ||
| - CISPR 11:2009 (Amended by A1:2010) Class A | Pass | |
| - EN 60601-1-2:2007 Class A | Pass | |
| Safety Standards: | ||
| - CAN/CSA-C22.2 No.:61010-1/R: 2009 | Evaluated (standardized level of assurance achieved) | |
| - UL 61010-1/R: 2008-10 | Evaluated (standardized level of assurance achieved) | |
| - IEC/EN 61010-1: 2001 | Evaluated (standardized level of assurance achieved) | |
| - IEC/EN 61010-2-240 First Ed., 2005 | Evaluated (standardized level of assurance achieved) | |
| - IEC/EN 60601-1-2: 2007 CLASS A | Evaluated (standardized level of assurance achieved) | |
| - EN 55011, Group I Class A limits (subset of EN 60601-1-2) | Evaluated (standardized level of assurance achieved) | |
| III. Software Verification and Validation | Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Software considered "moderate" level of concern, meaning a failure could result in Minor Injury). | Software verification and validation testing conducted, and documentation provided. Devices perform as intended under specified use conditions. |
| IV. Mechanical and Acoustic | No additional testing required (due to changes limited to CPU, controller board, and software). | Not applicable |
| V. Animal Study | Not required | Not applicable |
| VI. Clinical Studies | Not required | Not applicable |
Study Details:
Given the nature of this 510(k) submission, the "study" primarily consists of engineering and software testing to demonstrate that the modifications (software revision, upgraded CPU, and controller board) to the existing STERRAD® sterilizers do not negatively impact their performance and that the modified devices remain substantially equivalent to their predicates. This is not a typical clinical performance study of a diagnostic AI device.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of typical clinical "samples" (e.g., patients or images). For the electrical and EMC testing, entire STERRAD® NX® and 100NX® Sterilizer units with the upgraded CPU and controller board were tested. For software, the "test set" would refer to software validation test cases, which are not quantified here.
- Data Provenance: The testing was conducted by the manufacturer (Advanced Sterilization Products) or their designated testing facilities. This is internal testing, not external patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this submission. "Ground truth" in a clinical sense (e.g., expert labels on medical images or pathology reports) is not relevant for electrical, EMC, and software validation of a sterilizer. The "ground truth" for these tests are the specifications and requirements of the referenced standards.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth from expert opinions. Here, the "truth" is determined by meeting objective engineering and software standards.
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:
- No MRMC or comparative effectiveness study was performed. This device is a sterilizer, not a diagnostic AI tool that assists human readers. The changes are to its internal computing and networking capabilities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not directly applicable in the terms of a diagnostic algorithm. However, the electrical, EMC, and software validation tests are essentially "standalone" in that they evaluate the device's adherence to technical standards without human intervention in its primary operation during these tests. The software itself is a standalone component within the sterilizer, and its functionality (like network connectivity) was validated independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For electrical safety and EMC, the ground truth is defined by the requirements of the referenced international and national standards (e.g., CISPR 11, EN 60601-1-2, UL 61010-1).
- For software validation, the ground truth is adherence to the software requirements specification and meeting safety and functionality expectations outlined in the FDA's guidance document for medical device software.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI algorithm in the context of diagnostic imaging that requires a "training set" of data. The software is deterministic control software.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set."
§ 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).