(231 days)
The Sonicision Sterilization Tray (SCST) is intended to encase and protect reusable battery packs (SCB) and generators (SCG) 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 STERRAD® 100S model and pre-set (non-adjustable) Standard cycle. The tray within its sterile barrier is intended to maintain sterility for up to 30 days.
The Sonicision™ Sterilization Tray (SCST) 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. The tray containing the intented content/load must be wrapped with an FDA-cleared STERRAD® sterilizer-compatible polypropylene sterilization wrap (not supplied by Covidien) and sterilized as instructed by the labeling. Handles on the sides of the base facilitate transfer of the sterilized components, and the contoured inserts secure the contents within the tray.
The provided text describes a 510(k) summary for the Sonicision Sterilization Tray (SCST). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in a table format as requested for AI/software-based medical devices.
Therefore, much of the requested information, particularly quantitative performance metrics, sample sizes for training/test sets, ground truth establishment, and details of comparative effectiveness studies (MRMC, standalone), is not applicable or available within this document, as it pertains to a physical sterilization tray and its clearance is based on non-clinical performance and equivalence to a predicate device.
However, I can extract the relevant information and indicate where data is not available or applicable based on the nature of the device and the submission type.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterility Assurance Level (SAL) | Achieves a sterility assurance level of at least 10^-6 for its content when used as instructed with an FDA-cleared STERRAD® sterilizer-compatible polypropylene sterilization wrap. | Both the Sonicision tray and the predicate device achieve a sterility assurance level of at least 10^-6. The Sonicision tray assures adequate sterility of its content when used as instructed. |
| Latching Mechanism Performance | The latching mechanism must adequately secure the lid to the base to protect the contents during sterilization and storage. | The Sonicision tray's latching mechanism performs adequately to secure the lid to the base. |
| Material Compatibility | Materials (polysulfone, silicone inserts) must be compatible with the sterilization process (STERRAD® 100S with Standard cycle) and intended use. | Both trays are comprised of polysulfone. Cleaning and sterilization processes are very similar. Conforms to ISO 10993-1:2003 (Biological evaluation of medical devices), suggesting biocompatibility and material safety. |
| Protection of Contents | Intended to encase and protect reusable battery packs (SCB) and generators (SCG) of the Sonicision system during sterilization and storage. The contoured inserts must secure the contents. | The tray is intended to hold and protect Sonicision generators and battery packs. Contoured inserts secure the contents within the tray. |
| Sterility Maintenance | Intended to maintain sterility for up to 30 days within its sterile barrier (when wrapped in FDA-cleared sterilization wrap). | The tray within its sterile barrier is intended to maintain sterility for up to 30 days. |
| Conformance to Standards & Guidance | Conforms to applicable clauses of FDA-recognized consensus standard AAMI ST77:2006 and draft FDA Guidance Document, "Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA" (March 7, 2002). | Declarations of Conformity to AAMI ST77:2006, the draft FDA Guidance document, ISO 10993-1:2003, AAMI ST81:2004, ISO 14937:2000, and ISO 14971:2007 were provided. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of controlled clinical trials for device performance. The evaluation appears to be based on engineering tests, material compatibility, and adherence to recognized standards, usually involving a limited number of samples or representative units to demonstrate conformity.
- Data Provenance: The data provenance is from non-clinical performance testing conducted by the manufacturer, Covidien, to demonstrate conformance to standards and substantial equivalence. This is not a human clinical study, so concepts like "country of origin of the data" or "retrospective/prospective" do not directly apply in the same way.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For a physical device like a sterilization tray, "ground truth" is established through standardized engineering tests, material science evaluations, and conformity to recognized consensus standards by qualified testing personnel and regulatory affair experts, rather than expert consensus on interpretive data (e.g., radiology reads).
- Qualifications of Experts: Not specified. Testing would be conducted by laboratory technicians, engineers, and quality assurance personnel with expertise in sterility testing, material science, and medical device standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. The evaluation relies on direct measurement of physical properties (e.g., integrity of latching mechanism, material compatibility, bacterial challenge tests to confirm SAL) and comparison to established technical specifications and standards, not on interpretive judgments requiring adjudication.
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
- MRMC Comparative Effectiveness Study: No. This is a physical medical device (sterilization tray), not an AI/software-based diagnostic or assistive system. Therefore, MRMC studies are not relevant.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" is established by adherence to pre-defined technical specifications, performance standards as outlined in AAMI ST77:2006 and other ISO standards (e.g., SAL of 10^-6), and documented engineering test results. For example, the sterility assurance level (SAL) is a measurable and objective "ground truth" for sterilization efficacy, and the latching mechanism's performance would be assessed against its functional design requirements.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a physical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. No training set is used for this type of 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).