(239 days)
The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.
Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.
Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.
Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.
The Genesis Reusable Rigid Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards. The container system houses baskets of varying depths and organizing.
Here's a summary of the acceptance criteria and study information for the Genesis Reusable Rigid Container System, based on the provided text:
Acceptance Criteria and Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy (Pre-Vacuum Steam; and 100% Ethylene Oxide) | 12 log reduction and sterility assurance level (SAL) of 10⁻⁶ | Testing demonstrated a 12 log reduction and sterility assurance level (SAL) of 10⁻⁶ using biological (BI) overkill method and half-cycle validation. |
| 180 Day Event Related Shelf Life | Maintenance of sterility for all sterilization modalities for 180 days. | 180 Day Event Related Shelf life studies demonstrated sterility maintenance for all sterilization modalities. |
| Microbial Challenge | Negative growth after exposure to a minimum of 1 x 10⁶ Bacillus atrophaeus colony forming units (CFU) | Whole package microbial challenge test exposing a container to a minimum of 1 x 10⁶ Bacillus atrophaeus colony forming units (CFU) via an aerosol challenge demonstrating 100% negative growth. |
Study Information
The provided document describes non-clinical performance testing for the Genesis Reusable Rigid Container System.
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "Testing" and "studies" but does not quantify the number of units or cycles tested for each characteristic.
- Data Provenance: The studies are described as "non-clinical tests" and "Performance Test Summary-New Device". The manufacturer is CareFusion, based in McGaw Park, IL, USA. This suggests the data is likely from internal laboratory testing conducted by the manufacturer. It is prospective testing for the purpose of validating the new/modified device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the ground truth appears to be established through standardized methods for sterilization efficacy (biological indicators, microbial challenges) rather than expert consensus on observational data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable as the ground truth is determined by objective laboratory measurements and standardized biological/microbial tests, not by human adjudication of subjective assessments.
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If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers assessing cases with and without AI assistance for diagnostic accuracy. The Genesis Reusable Rigid Container System is a sterilization container, not a diagnostic imaging device, so such a study would not be relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The reported performance data for sterilization efficacy, shelf life, and microbial challenge are "standalone" in the sense that they are objective measurements of the device's ability to perform its intended function (sterilization and maintaining sterility) without human intervention in the outcome assessment (beyond setting up the tests). The device itself is not an algorithm, but its function is evaluated without a human-in-the-loop interacting with its core sterilizing mechanism.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is established through objective biological and microbiological testing standards. Specifically:
- Sterilization Efficacy: Achieved a 12 log reduction and SAL of 10⁻⁶ using biological indicators (BI) and an overkill method, as per ST 77:2006.
- Microbial Challenge: Demonstrated 100% negative growth following exposure to a specified concentration of Bacillus atrophaeus CFU via aerosol, also as per ST 77:2006.
- Shelf Life: Sterility maintenance demonstrated over 180 days.
- The ground truth is established through objective biological and microbiological testing standards. Specifically:
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The sample size for the training set:
- This information is not applicable. The device is a physical sterilization container, not a software algorithm that requires a training set. The performance is validated through physical and biological testing.
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How the ground truth for the training set was established:
- This information is 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).