(114 days)
The Signia™ sterilization tray is intended to provide storage for the Signia™ reusable insertion guide and Signia™ manual retraction tool during sterilization, storage and transportation within the hospital environment. The Signia™ sterilization tray is only intended to maintain sterility of the enclosed if it is used in coniunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration. The tray can contain at a maximum: one (1) Signia™ adapter, one (1) Signia™ reusable insertion guide and one (1) Signia™ manual retraction tool. The tray is intended to allow steam sterilization of the enclosed medical devices.
The Signia™ sterilization tray is an optional reusable accessory to the Signia™ stapling system, and is intended to provide storage of the Signia™ accessories during sterilization, as well as, storage and transportation within the hospital environment. The Signia™ sterilization tray can simultaneously accommodate at a maximum the following Signia™ accessories: One (1) Signia™ adapter One (1) Signia™ reusable insertion guide One (1) Signia™ manual retraction tool The Signia™ sterilization tray is composed of a lid and base made of stainless steel. Both the lid and base are perforated to allow penetration of steam during sterilization. There are two latches on the side to secure the lid to the base, and handles for holding or transporting the tray. Inside of the base, inserts and strips are placed to hold the respective Signia™ accessories along with the pre-printed layout of the accessory as a visual aid. Each corner has a protective cover for protection. The Signia™ sterilization tray is designed to facilitate the sterilization process when used in conjunction within the Central Supply Room (CSR) wrapping material (an FDA cleared sterilization wrap). The tray is intended to be reprocessed, which is first to be cleaned either manually or by an automatio washerdisinfector, and then sterilization. The tray is to be handled by medical personnel qualified in the transportation, cleaning, sterilization and use of surgical devices.
The document describes the Signia™ Sterilization Tray, a device intended to provide storage for specific medical accessories during sterilization, storage, and transportation within a hospital environment. It also facilitates steam sterilization of these enclosed medical devices.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What the device should achieve) | Reported Device Performance (What the studies showed) |
|---|---|
| Cleaning Efficacy: Device must be adequately cleaned. | Cleaning validation simulated worst-case scenarios, conforming to AAMI TIR30:2011 and FDA's 2015 reprocessing guidance. Cleanliness was assessed by carbohydrate, protein, and hemoglobin residuals. All residuals met predefined acceptance criteria, demonstrating adequate cleanliness. |
| Sterilization Efficacy: Achieve a minimum sterility assurance level (SAL) of 10⁻⁶ when following IFU. | Sterilization validation (based on AAMI/ANSI ST77:2013) demonstrated that a minimum SAL of 10⁻⁶ can be achieved if the sterilization instructions in the IFU are followed for the specified steam sterilization cycles (132 °C for 4 minutes and 134 °C for 3 minutes, both with 20-40 minutes vacuum dry time). |
| Biocompatibility/Safety (Cytotoxicity): Materials contacting enclosed accessories should be non-cytotoxic. | Materials that contact the enclosed Signia™ accessories during sterilization were evaluated for cytotoxicity. The testing results confirmed 'non-cytotoxic', indicating no release of toxic material constituents or leachable chemicals. |
| Material Durability/Reliability: Withstand repeated cleaning and sterilization processes without degradation. | Reliability evaluation concluded that the materials (primarily stainless steel) have been shown through use in other devices to withstand the cleaning and sterilization process without adverse reactions, and the tray will not undergo degradation due to environmental stresses during reprocessing. Repeated processing at listed temperatures has minimal effect. |
| Functional Use (Storage/Transportation): Provide storage for specified Signia™ accessories and allow steam sterilization. | The device description and intended use state it provides storage for one Signia™ adapter, one Signia™ reusable insertion guide, and one Signia™ manual retraction tool, and allows steam sterilization. This functional aspect is implicitly demonstrated by the successful cleaning and sterilization validations involving the loaded tray, and the device description itself. The tray is only intended to maintain sterility if used with an FDA cleared sterilization wrap and in a non-stacked configuration. No explicit "performance" for storage/transport is detailed beyond its structural integrity. |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: Not explicitly stated for each test. For example, the number of sterilization cycles or cleaning repetitions used in the validation studies is not provided in detail. "Worst-case scenario" is mentioned for cleaning validation, implying a robust test design, but specifics are absent.
- Data Provenance: The studies were non-clinical performance data conducted by the manufacturer (Covidien). The country of origin for the data is not specified, but the submission is to the US FDA, so the studies would adhere to relevant US regulatory standards (e.g., AAMI). The data is prospective in the sense that these were specific validation tests conducted for the purpose of this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable. This device is a sterilization tray, which is a physical medical device, not an AI/software device that generates diagnostic outputs or predictions requiring expert review for ground truth establishment. The ground truth for its performance is based on established engineering and microbiological standards for sterilization and cleaning (e.g., AAMI/ANSI ST77:2013, AAMI TIR30:2011, FDA reprocessing guidance).
4. Adjudication Method for Test Set:
- Not applicable. As this is a non-clinical device involving physical and microbiological performance metrics, not an interpretative AI tool, there is no need for expert adjudication of results in the way it would apply to image interpretation or diagnostic performance. The results are based on objective measurements against predefined criteria (e.g., residual levels, SAL).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is relevant for AI systems that aid human readers in diagnosis or interpretation. The Signia™ Sterilization Tray is a physical medical device and does not involve human readers for diagnostic interpretation; therefore, an MRMC comparative effectiveness study is not applicable.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This device is a physical sterilization tray, not an algorithm or software. Therefore, standalone algorithm performance is not a relevant concept for this product.
7. Type of Ground Truth Used:
- The ground truth for the performance of the sterilization tray is based on:
- Established industry standards and regulatory guidance: Such as AAMI/ANSI ST77:2013 (for sterilization), AAMI TIR30:2011, and FDA's 2015 reprocessing guidance (for cleaning).
- Objective scientific measurements: Such as sterility assurance levels (SAL), residual levels of carbohydrates, protein, and hemoglobin, and material properties.
8. Sample Size for Training Set:
- Not applicable. This device is a physical product and does not utilize machine learning or AI algorithms, thus there is no "training set."
9. How Ground Truth for Training Set Was Established:
- Not applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply.
§ 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).