(126 days)
The Sonicision Sterilization Tray is intended to be used to encase and protect reusable battery packs and generators of the Sonicision system during sterilization and storage. The tray containing up to one generator and one battery pack (maximum load) can be used with the following models and pre-set (non-adjustable) cycles.
| Model | Cycle |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® NX® | Standard |
| STERRAD® 100NX® | Standard |
| STERIS Amsco® V-PRO® 1 | Lumen |
| STERIS Amsco® V-PRO® 1 Plus | Lumen |
| STERIS Amsco® V-PRO® maX | Lumen |
Maintenance of sterility of the content within the tray is based on demonstrated performance of the sterilization wrap or pouch used to encase the tray.
The Sonicision™ Sterilization Tray is intended to hold and protect Sonicision generators and battery packs during sterilization and storage, as indicated. It is comprised of a polysulfone base containing silicone inserts and a removable/latching polysulfone lid. The tray is reusable and provided to the customer in a non-sterile condition. Perforations on the lid and base permit exposure of the sterilant. Handles on the sides of the base facilitate transfer of the sterilized components, and the contoured inserts secure the contents within the tray.
The Sonicision™ Sterilization Tray does not contain gaskets, filters, or valves to act as a barrier to microorganisms during storage, handling, and transport. The tray containing its intended content (load) must be wrapped with an FDA-cleared STERRAD or STERIS V-PRO-compatible polypropylene sterilization wrap or pouched with an FDA-cleared STERRAD or STERIS V-PRO-compatible Tyvek® pouch (note: the wrap and pouch are not supplied by Covidien) and sterilized as instructed by the labeling.
Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Achieve a six-log reduction of Geobacillus stearothermophilus in designated worst-case areas of the loaded tray after exposure to specified STERRAD and STERIS "half cycles." | The results show that the indicated STERRAD and STERIS "half cycles" provided a six-log reduction of the indicator organism (Geobacillus stearothermophilus) at the worst-case locations (battery pack, generator, and sterilization tray). |
| Sterilant Residuals | Adequate dissipation of hydrogen peroxide from the load, comparable to a reference predicate tray. | The results show that the Sonicision Sterilization Tray permits adequate dissipation of hydrogen peroxide on the load when compared to the predicate devices used in the study. |
| Use Life (Material Compatibility) | Maintenance of key functional/performance specifications after repeated reprocessing (340 cycles) using worst-case sterilization systems (STERRAD 100NX with Standard cycle, STERIS V-Pro with Lumen cycle) as per labeling instructions. | The results show the tray meets its performance specifications when reprocessed repeatedly (340 cycles) in accordance with the labeling. |
| Biocompatibility | Pass all applicable requirements for cytotoxicity as per ISO 10993-5:2009, Part 5: Tests for In Vitro Cytotoxicity, following exposure to intended sterilization systems. | The results show that the Sonicision Sterilization Tray passes all applicable biocompatibility requirements and is, therefore, considered non-cytotoxic following exposure to the intended sterilization systems. Samples were prepared in accordance with ISO 10993-12:2007 (Part 12). |
| Mechanical/Bench | Meet all applicable clauses/criteria specified in AAMI ST77:2006. | The results show that all requirements (specified in AAMI ST77:2006) were met. |
Study Details:
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Sample Size used for the test set and the data provenance:
- Sterilization Efficacy: The trays were loaded with the "intended maximum load (one reusable battery pack and one reusable generator)." The number of trays or replicates is not explicitly stated, but the mention of "the sterilization trays were either wrapped... or pouched" implies multiple test items. The biological indicator used was Geobacillus stearothermophilus. The data provenance is from non-clinical performance studies conducted by Covidien. The location of the testing is not specified, but it's internal company testing supporting a US FDA submission.
- Sterilant Residuals: "Three runs of loaded (one battery pack and one generator), wrapped, or pouched Sonicision trays placed in STERRAD or STERIS systems." Testing of the reference predicate tray involved "at least one run." Provenance is also internal non-clinical testing.
- Use Life (Material Compatibility): The study involved "repeatedly (340 cycles)" of reprocessing the tray. This implies testing on at least one (and likely more) trays. Provenance is internal non-clinical testing.
- Biocompatibility: "Test samples were prepared in accordance with ISO 10993-12:2007, Part 12: Sample Preparation and Reference Materials." The Sonicision Sterilization Tray was exposed to "two full cycles (as indicated) of the STERRAD and STERIS systems." "All biocompatibility assays were performed on neat extracts." The specific number of samples or replicates is not explicitly given, but the methodology suggests controlled lab-based testing. Provenance is internal non-clinical testing.
- Mechanical/Bench: The text does not explicitly state the sample size for mechanical testing beyond "The Sonicision Sterilization Tray was evaluated." Provenance is internal non-clinical testing.
All studies appear to be prospective in nature, designed specifically to test the device's performance against defined criteria. The origin is internal non-clinical testing for the purpose of a 510(k) submission to the US FDA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The studies described are non-clinical performance studies involving laboratory testing, not human expert evaluations of clinical data. Therefore, this question is not applicable in the context of this submission. The "ground truth" for these tests comes from established scientific and engineering principles, accepted standards (e.g., AAMI ST77, ISO 10993), and the documented efficacy of sterilization methods and biological indicators. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The studies are non-clinical, laboratory-based performance tests, not clinical evaluations requiring expert adjudication. -
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:
Not applicable. This device is a medical device accessory (sterilization tray), not an AI-assisted diagnostic or imaging device used by human readers. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical medical device accessory, not an algorithm. The performance described is "standalone" in the sense that the tray's performance is measured directly through physical and biological tests without human intervention in the performance aspect, but rather human designers and users are integral to its intended use and reprocessing. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For these non-clinical studies, the "ground truth" is established by:- Sterilization Efficacy: Gold standard biological indicators (Geobacillus stearothermophilus) and their known reduction kinetics represent the ground truth for microbial inactivation.
- Sterilant Residuals: Chemical analytical methods (UV/VIS spectroscopy) with established reference values from predicate devices.
- Use Life (Material Compatibility) & Mechanical/Bench: Adherence to material specifications, functional performance requirements, and conformity to recognized industry standards (AAMI ST77).
- Biocompatibility: In vitro cytotoxicity assays conforming to ISO 10993-5, where the absence of cytotoxic effects is the ground truth.
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The sample size for the training set:
Not applicable. This is a physical medical device accessory, not an AI/ML-based device that requires a training set. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
§ 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).