(216 days)
The SteroScope® Sterilization Technology System is indicated for the terminal sterilization of cleaned reusable Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of:
- ID of 1.0 mm or larger and a length of 3580 mm or shorter and .
- ID of 1.2 mm or larger and a length of 4095 mm or shorter .
The SteroScope® Sterilization Technology System is a vaporized hydrogen peroxide based (VHP) sterilizer for the terminal sterilization of flexible endoscopes with the following characteristics: Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of: · ID of 1.0 mm or larger and a length of 3580 mm or shorter and · ID of 1.2 mm or larger and a length of 4095 mm or shorter. The SteroScope® Sterilization Technology System is a Gas Plasma VHP sterilization system designed specifically for flexible endoscope terminal sterilization, not for general surgical instrument loads. It is a self-contained stand-alone system of hardware and software system that uses technology to rapidly diffuse VHP into all the channels of the flexible endoscope to facilitate the sterilization of inner device surfaces, while being occupationally and environmentally safe to use. To enable the terminal sterilization of long multi-lumen endoscopes, while minimizing oxidation damage, the SteroScope® Sterilization Technology System incorporates a proprietary gas diffusion technology which creates a pressure differential in each internal endoscope lumen channel to actively pull hydrogen peroxide vapor from the chamber of the VHP sterilizer through the distal end of each endoscope channel, while the endoscope is in a sterile container. Utilizing a separate mechanism for the rapid diffusion of VHP from the chamber into the individual SteroScope® Sterilization Technology System allows the entire endoscope to be sterilized with less overall peroxide dose exposure.
The provided document is a 510(k) summary for the SteroScope® Sterilization Technology System. It outlines the non-clinical performance testing conducted to establish the device's safety and efficacy. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table (Table 3) listing various testing methods, their purpose, acceptance criteria, and results. All tests listed show a "Pass" result, indicating the device met the specified acceptance criteria.
| Testing Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| System Environmental Testing | System environmental testing under extreme conditions operating conditions | Internal Specification | Pass |
| SteroScope H2O2 Emissions Test | H2O2 emissions compliance to required OSHA safety levels | OSHA H2O2 SEL/PEL | Pass |
| System H2O2 Concentration Mapping | Peroxide concentration mapping during operation | Internal Specification | Pass |
| System Temperature Mapping | Temperature mapping during operation | Internal Specification | Pass |
| System Functional Test | Testing of system functional requirements to ensure conformance to system specifications | Internal Specification | Pass |
| SteroScope System Shipping | System shipping test for vibration, shock & drop to ensure system and packaging integrity | ISTA 2B | Pass |
| SteroScope Consumable Shipping | Consumable shipping test for vibration, shock & drop to ensure consumable and packaging integrity | ISTA 2A | Pass |
| EMC & Electrical Safety | The sterilizer was tested in accordance with IEC 60601-1-2 and IEC 61010-1 standards | IEC 60601-1-2 and IEC 61010-1 | Pass |
| Qualification of Pressure Limits | Validation of sterilizer operational pressure limits | Internal Specification | Pass |
| Human Factors | Validation of system ergonomics and human factors with clinical users | Internal Specification | Pass |
| Software Validation | Software verification and validation of software requirements | Internal Specification | Pass |
| Subsystem Design Verifications | Testing of each subsystem to ensure functional performance met design requirements | Internal Specification | Pass |
| H2O2 Consumable Shelf-life | Long term stability study of H2O2 consumable to establish shelf life | Internal Specification | Pass |
| H2O2 Consumable Storage | Stability testing of H2O2 consumable in extreme conditions | Internal Specification | Pass |
| Endoscope Temperature Mapping | Mapping of endoscope temperatures during cycle to verify the internal and external temperatures of a flexible endoscope | Internal Specification | Pass |
| Final Process Qualification | Operational process qualification with multiple systems | Internal Specification | Pass |
| Mated Surface Connector-Port | Half cycle connector efficacy test | No growth of Geobacillus stearothermophilus | Pass |
| BI & CI Functionality | BI & CI functionality under worst case conditions | No Growth in BI & color change in CI | Pass |
| AOAC Sporicidal Test | Process and sterilant efficacy for multiple organisms | AOAC Official Method 966.04 | Pass |
| Mated Surface Sterilization | Half cycle mated material efficacy using material coupons | No growth of Geobacillus stearothermophilus | Pass |
| Material Surface Sterilization | Half cycle surface efficacy using material coupons | No growth of Geobacillus stearothermophilus | Pass |
| Uniformity Microbial Inactivation | Dosing study to assess uniformity of microbial inactivation | Uniformity in inactivation kinetics based on SLR | Pass |
| Endoscope Dose Response Curves | Dosing study with various flexible endoscopes | Internal Specification | Pass |
| Material Bacteriostasis Validation | Confirmation that there are no bacteriostatic effects that inhibit growth for material coupons | No bacteriostatic effect after sterilization with growth of defined micro-organisms | Pass |
| Bacteriostasis & Fungistasis Validation | Confirmation that there are no bacteriostatic effects that inhibit growth for flexible endoscopes | No bacteriostatic effect after sterilization with growth of defined micro-organisms | Pass |
| Simulated Use Testing | Worst-case testing with unwashed flexible endoscopes inoculated with test culture challenge | 6-log reduction in Geobacillus stearothermophilus | Pass |
| In-Use Testing | Worst-case testing with clinically used flexible endoscopes. | No growth upon recovery after sterilization | Pass |
| Functionality & Material Compatibility | Worst-case material compatibility testing of multiple flexible endoscopes with back to back cycles | Internal Specification | Pass |
| Biocompatibility Coupons | Worst-case residual and cytotoxicity (MTT) testing with material coupons | ISO 10993-5 | Pass |
| Biocompatibility Flexible Endoscopes | Worst-case residual and cytotoxicity (MTT) testing with flexible endoscopes | ISO 10993-5 | Pass |
2. Sample sized used for the test set and the data provenance:
The document describes non-clinical performance testing. It doesn't explicitly state sample sizes for each test in a numerical format that would typically be used for a clinical study (e.g., N=X patients). However, it mentions "multiple systems" for "Final Process Qualification," "multiple organisms" for "AOAC Sporicidal Test," "various flexible endoscopes" for "Endoscope Dose Response Curves," and "multiple flexible endoscopes" for "Functionality & Material Compatibility."
The data provenance is from non-clinical laboratory testing of the device, not from human subjects. The country of origin for the data is not specified, nor is whether the data is retrospective or prospective. Given it's non-clinical testing for a new device, it is inherently prospective data generation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are primarily performance-based tests against established standards and internal specifications, not expert-driven diagnostic interpretations. For example, for sterilization efficacy, the ground truth is "no growth" of specified microorganisms or a "6-log reduction," which are objective laboratory measurements, not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the tests are non-clinical performance evaluations, not human reader-based assessments requiring adjudication of interpretations.
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:
This information is not applicable as this is a non-clinical 510(k) submission for a sterilization system, not a diagnostic imaging device utilizing AI that would involve human reader performance studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a physical sterilization system, not an algorithm or AI. Therefore, standalone algorithm performance is not applicable. The tests performed are essentially "standalone" device performance evaluations in a controlled environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the non-clinical performance testing is based on established scientific and engineering principles, industry standards (e.g., ISO, IEC, AAMI, ASTM, AOAC, USP-NF, ISTA, OSHA), and internal specifications. For sterilization efficacy tests, the ground truth is a specific microbial reduction (e.g., 6-log reduction) or absence of microbial growth, which is a definitively measurable biological outcome. For other tests, it's adherence to specified physical, electrical, or chemical parameters.
8. The sample size for the training set:
This information is not applicable. The device is a physical sterilization system, not a machine learning model that requires a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
§ 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).