(233 days)
The Aesculap SterilContainer System is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility for 360 days. The SterilContainer System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.
The Aesculap SterilContainer is designed as a container system that will allow for sterilization and storage of other medical devices. This system consists of full, three-quarter, half, quarter, and extra long and wide body container system. There are a variety of accessories also available for this container system. This container is designed to be compatible for use in pre-vacuum steam, pre-vacuum immediate use steam and EtO sterilization. The container bottom is manufactured in anodized aluminum and has stainless steel handles on each end. There are two types of lids for the container bottom. There are anodized aluminum lids that have removable retention plates to hold the filter and a stainless steel latch on each end to lock the lid only to the container bottom. There are also Prime Line lids available for use that are manufactured in the material commonly known as Radel R. The PrimeLine lids have a reusable filter system. The reusable filter is for Pre-vac steam and Immediate Use steam sterilization only.
The provided text describes the Aesculap SterilContainer System for sterilization. Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" with pass/fail thresholds in a formal table separate from the performance results. Instead, it presents the validated sterilization cycle parameters and states that the device was "fully validated" according to FDA and AAMI standards. The reported device performance is that it meets these validated parameters and achieves a 360-day event-related shelf life.
| Acceptance Criteria Category | Specific Criteria / Performance Target (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Must achieve sterilization under the stated parameters for: |
- Pre-vacuum steam (270°F, 4 min. exposure, 30 min. dry)
- Pre-vacuum immediate use steam (270°F, 3 min. (non-porous) / 4 min. (porous) exposure)
- Ethylene Oxide (130°F, 60 min exposure, ≥ 50% RH, 725 mg/L gas pressure) | Achieved: "fully validated for pre-vacuum steam, pre-vacuum immediate use steam, and EtO sterilization processes." |
| Shelf Life | Maintain sterility for 360 days. | Achieved: "360 days of event related shelf life testing has been conducted." |
| Compatibility | Compatible with specified lids, filters, and accessories for each sterilization method. | Achieved: Detailed tables provided for compatibility across various configurations and accessories. |
| Max Load Weight | Accommodate maximum load weights of 25 pounds or less (AAMI/AORN recommendation). | Achieved: "Max total weight 25 pounds." |
| Vent to Volume Ratio | Meet predetermined standards for the "worst case vent to volume ratio" to ensure sterilization. | Achieved: "This container represents the worst case vent to volume ratio for the SterilContainer System," and validation was successful. |
| Reuse Testing | Maintain performance after repeat sterilization cycles. | Achieved: "100 cycles minimum" for container, "2,200 cycles (lid)" for reusable filter. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample size used for the test set in terms of number of containers or cycles. However, it does state:
- "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' for Aesculap SterilContainer was completed on this new three-quarter size 8" (187mm) container of the worst case vent to volume ratio..."
- The testing was conducted by "a qualified testing laboratory."
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given that it's a 510(k) submission for a new device, the testing would inherently be prospective in nature, specifically designed to validate the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for sterilization efficacy is established through standardized biological and physical indicator tests, not expert consensus on medical images or patient outcomes. The testing was performed in a laboratory setting per established standards (FDA and AAMI).
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 refer to a process where multiple human reviewers independently assess data (e.g., medical images) and disagreements are resolved by an expert panel. Sterilization and shelf-life testing relies on objective, measurable scientific and engineering principles (e.g., microbial kill, barrier integrity), not subjective human interpretation 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
Not applicable. This is a medical device for sterilization, not an AI-powered diagnostic or assistive tool for human readers/clinicians, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of a device on its own, without human intervention in its function during testing. In this context, the device (the SterilContainer) was tested in a standalone manner as its primary function is to achieve and maintain sterility independently when subjected to specified sterilization cycles. The performance data presented (sterilization cycle parameters met, 360-day shelf-life) reflects the container's inherent capabilities.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for sterilization efficacy is typically established through:
- Biological Indicators (BIs): Contain a known number of highly resistant microorganisms (e.g., bacterial spores). A successful sterilization cycle renders the BI sterile, demonstrating microbial kill.
- Chemical Indicators (CIs): React to one or more sterilization parameters with a visible change in color or state.
- Physical Monitoring: Readings from sterilizer gauges, thermometers, pressure recorders, and timers confirm that the physical parameters (temperature, pressure, time) of the cycle were met.
- Barrier Integrity Testing: For shelf-life, tests ensure the container maintains a sterile barrier over time, often involving microbial ingress challenges or visual inspection for damage.
The document implicitly refers to these methods by stating: "These validations were conducted in accordance with FDA and AAMI standards by a qualified testing laboratory." These standards prescribe the use of BIs, CIs, and physical monitoring for sterilization efficacy, and specific tests for packaging integrity and shelf-life.
8. The Sample Size for the Training Set
Not applicable. Training sets are relevant for machine learning or AI models. This device is a physical container, and its performance is evaluated through conventional engineering and microbiological testing, not by training an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as 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).