(226 days)
The Gyrus ACMI Cyber Wand™ Sterilization Trays are intended to be used to enclose and protect only CyberWand™ transducers and accessories during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the CyberWand™ transducers and accessories for which they are designed.
The trays are indicated for ETO sterilization of only the following (maximum load) per tray: 2 CyberWand Transducers, 2 CyberWand Probe sets, 1 Wrench, 1 Cleaning stylet.
EtO Sterilization parameters: EtO Sterilize using 100% ethylene oxide: Temp 55 ℃, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 735-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration 12 hours @55°C.
The Gyrus ACMI® Cyber wand 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 transducer and accessories during EtO 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 E1O sterilization. The trays are locked shut with stainless steel clips on each end.
The provided text describes the acceptance criteria and study for the Gyrus ACMI CyberWand Transducer and Accessories Storage-Sterilization Trays.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| EtO Sterilization Efficacy: Achieve a 6 log reduction in biological indicator organisms. | System was sterilized successfully by EtO, demonstrating 6 log reduction capabilities (SAL of 10⁻⁶). |
| EtO Residual Concentrations: Residual concentrations of EtO should be within acceptable limits after aeration, pursuant to ISO10993-7. | EtO residual testing was performed, with a 12 hour aeration time. Pursuant to ISO10993-7, residual concentrations were within acceptable limits. |
| Biocompatibility: Constructed from biocompatible materials meeting requirements of ISO-10993. | Trays are constructed of biocompatible RADEL-R, which meets the requirements for biocompatibility pursuant to ISO-10993. |
| Compatibility with Sterilization Modality: Compatible with EtO sterilization. | Radel-R is compatible with EtO sterilization. |
| Protection from Physical Damage: Designed to provide protection from physical damage to the transducer and accessories during EtO sterilization and storage. | The trays are designed to provide protection from physical damage to the transducer and accessories during EtO sterilization and storage. |
| Ingress and Egress of Sterilization Gases: Design to permit ready ingress and egress of sterilization gases. | Trays are comprised of plastic lids and bottoms containing numerous large holes (approximately 7mm in diameter) that permit ready ingress and egress of sterilization gases. |
| Intended Use Conditions (Maximum Load): Successfully sterilize a maximum load per tray: 2 CyberWand Transducers, 2 CyberWand Probe sets, 1 Wrench, 1 Cleaning stylet, using specified EtO parameters (Temp: 55 ℃, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 735-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration: 12 hours @55 ℃). | The maximum load was placed in the tray, inoculated with FDA cleared biological indicator organisms, and chemical indicators were placed. The system was sterilized successfully by EtO, demonstrating 6 log reduction capabilities (SAL of 10⁻⁶). |
Study Details
The provided document describes a performance study to demonstrate the effectiveness of the sterilization trays.
1. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state a precise numerical sample size (e.g., number of trays or sterilization cycles tested). However, it mentions that "The maximum load was placed in the tray and inoculated with FDA cleared biological indicator organisms, and chemical indicators were placed. . The trays were wrapped with two layers of FDA approved sterilization wrap and placed into ethylene oxide sterilizer for processing." This implies testing was conducted on at least one tray with the maximum specified load.
- Data Provenance: Not explicitly stated, but the submission is to the FDA for a US market, suggesting the testing was likely conducted in a controlled laboratory setting. It is a retrospective study in the context of the 510(k) submission, meaning the data was collected prior to the submission for regulatory approval.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the study relates to terminal sterilization efficacy and chemical residual limits, not diagnostic interpretation or clinical decision-making that would require expert consensus. The "ground truth" for sterilization efficacy is objectively measured via biological indicators (6-log reduction) and chemical residual testing (ISO10993-7 compliance) by laboratory analysis.
3. Adjudication method for the test set:
- Not applicable. The performance evaluation involved objective laboratory tests (biological indicator growth via incubation, chemical residue analysis) rather than subjective assessments requiring adjudication among experts.
4. 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. This type of study is entirely irrelevant to the evaluation of a sterilization tray. MRMC studies are typically used for evaluating diagnostic imaging devices or AI algorithms in clinical settings.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The study evaluated the standalone performance of the sterilization tray system (tray + wrap + sterilization process) in achieving sterilization and managing residuals. There is no "algorithm" or "human-in-the-loop" aspect to the function of a sterilization tray itself; its performance is purely mechanical/chemical.
6. The type of ground truth used:
- Biological indicator log reduction: The primary ground truth for sterilization efficacy was the "6 log reduction capabilities (SAL of 10⁻⁶)" demonstrated by the FDA cleared biological indicator organisms.
- ISO10993-7 standard for residuals: The ground truth for EtO residual concentrations was compliance with the limits specified in the ISO10993-7 standard.
7. The sample size for the training set:
- Not applicable. This device is a passive sterilization tray, not an AI or machine learning algorithm. Therefore, there is no "training set."
8. How the ground truth for the training set was established:
- Not applicable. As there is no training set for this type of device, ground truth establishment for a training set is not relevant.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).