(115 days)
The ONE TRAY® Container is a reusable rigid sterilization container intended to be used to enclose reusable medical devices that are to be steam sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and maintenance of sterility of the enclosed devices during storage, transport and until used. This container is compatible for use in the following sterilization modalities in the configuration listed below:
- Prevac Steam
- 270°F, 4 min exposure
- 15-minute dry time
ONE TRAY® is validated to process a twenty five pound (25 lb) gross weight load (single container plus contents). This includes sterilization of lumens (Stainless Steel and Titanium) 1 mm in diameter or larger with lengths of up to 500 mm.
DO NOT STACK ONE TRAY® CONTAINERS DURING STERILIZATION
Examples of validated materials that can be processed within the ONE TRAY®- Metals: Stainless Steel, Titanium, Aluminum, Thermoplastics: PEEK, Polypropylene, Radel, Thermosetting Polymers: Silicone, Phenolic
The ONE TRAY® sealed sterilization container consists of a line of rigid reusable containers listed in the table below. Healthcare Facilities should follow steam sterilization cycle and storage guidelines as stated in AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
The ONE TRAY® Sealed Sterilization Container is a sealed rigid container with a lid and base containing a rectangular patterned group of perforations to permit steam penetration of sterilant. Single use SMS filters cover each vented area and are held firmly in place by a perforated stainless steel filter cover. This assembly permits the penetration of steam during the sterilization process and serves as a bacterial and fluid barrier at the conclusion of the sterilization cycle.
ONE TRAY® Sealed Sterilization Containers are a reusable device whose base and lid are composed of anodized aluminum to prevent corrosion.
The gaskets used in the ONE TRAY® Sealed Sterilization Containers are made from medical grade silicone material identical to that used by predicate containers. The lid is firmly secured to the base with a cam-locking latch at each end.
The provided FDA 510(k) clearance letter and summary describe a physical medical device (sterilization container) and its performance, not an AI/software-as-a-medical-device (SaMD) or diagnostic device that would typically involve a "test set," "ground truth," expert adjudication, or MRMC studies.
Therefore, many of the requested details about acceptance criteria and study design (especially those related to AI/SW performance) are not applicable to this type of device and the information presented in this document.
However, I can extract the relevant acceptance criteria and study information provided for the physical sterilization container.
Analysis of Acceptance Criteria and Study for ONE TRAY® Sealed Sterilization Container System
The device under review is the ONE TRAY® Sealed Sterilization Container System, a reusable rigid sterilization container. The studies described are nonclinical tests to demonstrate the safety and effectiveness of the container in maintaining sterility of enclosed medical devices during steam sterilization, storage, and transport. The criteria and studies are designed for a physical device, not an AI/SW product.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | A sterility assurance level of 10-6 will be achieved post sterilization using the BI overkill method and half cycle validation. Biological indicators must be negative for growth after incubation period. | Pass |
| Dry Time | The system shall demonstrate an average pre and post sterilization weight difference of less than 0.2% within five 15 minute cycle completion using final validated parameters and be free of visible moisture. | Pass |
| Microbial Aerosol Challenge | The container load maintains sterility after exposure to a defined amount of aerosol microorganisms. No presence of growth after incubation period. | Pass |
| Material Compatibility | No impact to functionality at the completion of multiple cleaning and sterilization cycles. | Pass |
| Cytotoxicity | Demonstrate no significant cytotoxic reaction after exposure to sterilant. Using the ISO Elution Method, the response to the article is not greater than 2 (mild reactivity). | Pass |
| Sterility Maintenance | Sterility of container contents is maintained after processing for 365 days under conditions which simulate hospital sterile package handling and storage conditions. Biological indicators must be negative for growth after incubation period. | Pass |
Information Not Applicable/Not Provided (due to the nature of the device)
The following points are typically relevant for AI/SW performance studies, but the provided document describes a physical medical device (sterilization container). Therefore, the information for these points is not applicable (N/A) in this context, or the details are not explicitly provided as they would be for an AI/SW submission.
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2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in terms of "test set" for data-driven models. The studies involve multiple sterilization cycles, microbial challenges, and material compatibility tests, but the exact number of cycles/samples for each test is not detailed in this summary.
- Data provenance: N/A for a physical device. These are laboratory performance tests.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth is established by objective scientific measurements (e.g., biological indicator growth, weight difference, visual inspection, cytotoxicity assays), not expert readers.
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4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Adjudication is not relevant for these types of objective performance tests.
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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: N/A. This is not an AI/SW device.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a physical device, and its function is standalone in terms of sterilizing/maintaining sterility.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device's performance studies is based on established sterilization efficacy standards (e.g., biological indicator sterility/growth, physical measurements like weight change, absence of moisture, and material biocompatibility testing). It is objective performance data, not subjective human assessment or pathology.
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8. The sample size for the training set: N/A. This is a physical device, not an AI/ML model that requires a training set.
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9. How the ground truth for the training set was established: N/A. See point 8.
§ 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).