Search Results
Found 1 results
510(k) Data Aggregation
(101 days)
GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS
The Gyrus ACMI® Flexible Endoscope Storage-Sterilization Trays are intended to be used to enclose and protect Gyrus ACMI flexible endoscopes during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI endoscopes for which they are designed. Maintenance of sterility depends on the sterilization wrap, not the tray.
The trays are indicated for ETO sterilization of only of the following :
Gyrus ACMI Flexible Endoscopes ICN-0564, ICN-0565 ICN DUR-D DUR-D, DUR-DBA
ACN ACN-2T, ACN-2TBA DUR-8 DUR-8, DUR-8-BA, DUR-8E, DUR-8E-BA,DUR-8 Ultra AUR AUR AUR-7. AUR-735
EtO Sterilization parameters:
EtO Sterilize using 100% ethylene oxide
Temp: 55°C, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 725-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration: 12 hours @55 ℃
The Gyrus ACMI® Flexible Endoscope Storage-Sterilization trays are comprised of plastic lids and bottoms that contain numerous large holes (approximately 7mm in diameter) that permit ready ingress and egress of sterilization gases. The trays are designed to provide protection from physical damage to the flexible endoscope during sterilization and storage. The trays are constructed of biocompatible RADEL-R. The trays do not contact the patient. Radel-R is a polyphenylsulfone plastic that is widely used in medical devices. Radel-R meets the requirements for biocompatibility pursuant to ISO-10993 and is compatible with EtO sterilization.
The Gyrus ACMI Flexible Endoscope Storage-Sterilization Trays are designed to protect Gyrus ACMI flexible endoscopes during Ethylene Oxide (EtO) sterilization, using an FDA-cleared sterilization wrap. The key acceptance criterion is to ensure that the trays allow for effective EtO sterilization and maintain sterility through the wrap.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Effectiveness: The tray must permit effective EtO sterilization, demonstrating a Sterility Assurance Level (SAL) of $10^{-6}$ (6 log reduction capability). | The system was sterilized successfully in a 30-minute half cycle, demonstrating 6 log reduction capability (SAL of $10^{-6}$). |
| Residual EtO Levels: Ethylene oxide residuals must be within acceptable limits after aeration, as per ISO 10993-7. | Test systems were exposed to 60-minute full cycles and ethylene oxide residual testing was performed, with a 12-hour aeration time. Pursuant to ISO10993-7, residual concentrations were within acceptable limits. |
| Biocompatibility: The materials used in the trays must be biocompatible (Radel-R). | The trays are constructed of biocompatible RADEL-R. Radel-R meets the requirements for biocompatibility pursuant to ISO-10993. |
| Compatibility with EtO Sterilization: The tray material must be compatible with EtO sterilization. | Radel-R is compatible with EtO sterilization. |
| Protection of Endoscopes: The trays must provide protection from physical damage to the flexible endoscope during sterilization and storage. (This is a design feature rather than a quantifiable performance metric for this study, but implied by the intended use). | The trays are designed to provide protection from physical damage to the flexible endoscope during sterilization and storage. (This was assessed through the design and materials, and likely confirmed via visual inspection and functional testing of the endoscopes after processing, though specific data for this aspect isn't detailed in the provided text). |
2. Sample Size and Data Provenance:
- Sample Size for Test Set: The document mentions "PCDs (process challenge devices) were placed in the trays" and "Test systems were exposed to 60 minute full cycles". This implies multiple trays with PCDs were tested. However, a specific numerical sample size (e.g., number of trays, number of cycles per tray) for the sterilization effectiveness and residual testing is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin of the data. It is a submission to the U.S. FDA for regulatory clearance. The study appears to be prospective in nature, as new testing was conducted specifically for this device (e.g., "The PCDs...were placed in the trays and inoculated...").
3. Number of Experts and Qualifications for Ground Truth (Test Set):
- This study is a physical and chemical performance test rather than a diagnostic device that requires expert interpretation of results for ground truth.
- The "ground truth" for sterilization effectiveness (6 log reduction) is established by industrial standards and scientific principles related to biological indicators (e.g., spore-forming bacteria) and their inactivation kinetics. This does not involve human experts establishing a "ground truth" in the same way as, for example, radiologists interpreting images.
- For EtO residual testing, the "ground truth" is adherence to established chemical safety standards like ISO 10993-7, which are objective measurements.
4. Adjudication Method for the Test Set:
- No adjudication method (e.g., 2+1, 3+1) is applicable or mentioned, as this is not a study involving human interpretation or subjective assessment of results. The results are based on objective, quantifiable measurements of biological indicator inactivation and chemical residue levels.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Gyrus ACMI Flexible Endoscope Storage-Sterilization Trays are a medical device accessory for sterilization, not a diagnostic tool, and their performance is evaluated through physical and chemical testing.
6. Standalone Performance:
- A standalone performance study was done. The described testing, where PCDs and chemical indicators were placed in the trays and processed through sterilization cycles, is a direct assessment of the device's ability to facilitate effective sterilization without human intervention in the sterilization process itself (beyond loading and operating the sterilizer).
7. Type of Ground Truth Used:
- The ground truth for sterilization effectiveness was based on the inactivation of biological indicator organisms (demonstrating a 6 log reduction, or a sterility assurance level of $10^{-6}$), which is an objective, scientifically established method for validating sterilization processes.
- The ground truth for Ethylene Oxide residuals was based on compliance with ISO 10993-7, a recognized international standard for the biological evaluation of medical devices, specifically regarding acceptable limits for EtO residuals.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical accessory evaluated through performance testing, not an algorithm or AI system that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1