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510(k) Data Aggregation
(372 days)
The AESCULAP Aicon™ Container is a reusable rigid sterilization container 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 of the enclosed device during transport and until used. This container is compatible for use in the following sterilization modalities in the configurations listed below:
- Ethylene Oxide (EtO)
- STERIS V-PRO maX/maX 2: Lumen, Non-Lumen, Flex
- STERIS V-PRO 60: Lumen, Non- Lumen, Flex
- STERRAD 100NX: Standard, Express, Flex, Duo
- STERRAD NX: Standard, Advanced
- STERRAD 100S
- STERIZONE VP4
- PreVac Steam
The AESCULAP Aicon™ consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container.
The AESCULAP Aicon Container is a reusable container system intended for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities:
- Ethylene Oxide
- STERIS VPRO maX/ maX 2: Lumen, Non- Lumen, Flex,
- STERIS VPRO 60: Lumen, Non-Lumen, Flex
- STERRAD 100NX: Standard, Express, Flex, Duo
- STERRAD NX: Standard, Advanced
- STERRAD 100S
- STERIZONE VP4
- PreVac Steam
The containers are perforated and made from anodized aluminum and utilize a single-use filter.
This document describes the premarket notification (510(k)) for the Aesculap AICON™ Container, a reusable rigid sterilization container. The following information is extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Testing | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Efficacy | To determine sterilization effectiveness of test device after processing in a sterilization cycle. | A sterility assurance level (SAL) 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 | To determine the proper drying time required for the Aesculap Aicon Container. | The system shall demonstrate an average pre and post sterilization weight difference of less than 0.2% within five 5 minutes of cycle completion using final validated parameters and be free of visible moisture following a cooling period. | Pass |
| Microbial Aerosol Challenge | To analyze the package integrity and microbial barrier properties of the test device. | The container load maintains sterility after exposure to a defined amount of aerosol microorganisms. No presence of growth after incubation period. | Pass |
| Simulated Use | To determine the effective sterilization of flexible scopes when used with the test device. | A minimum of 1.0 x 10^6 spores contained within organic soil representative of actual use conditions are killed during defined sterilization cycle. | Pass |
| Material Compatibility | To assess effects of full use cycles on device components and their intended functionality. | No impact to functionality at the completion multiple sterilization cycles. | Pass |
| Cytotoxicity | To determine the potential of a test device to cause cytotoxicity. | Testing completed in accordance with ISO 10993-5: 2009 to 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 | To demonstrate that a processed test device can maintain a sterile barrier for a defined period of time. | 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 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "testing conducted in accordance with applicable FDA guidance and standards." For example, for "Sterilization Efficacy" and "Sterility Maintenance," it mentions using "Biological Indicators" (BI), implying an appropriate number of BIs were used to validate the SAL.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The tests described are primarily in vitro/laboratory-based performance tests for a sterilization container, rather than clinical studies requiring expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. The tests described are objective, measurable performance tests with clear pass/fail criteria, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. Such studies are typically conducted for devices that involve human interpretation of diagnostic or screening results, which is not the function of a sterilization container. The studies performed are directed at the physical and biological effectiveness of the container in sterilization and maintaining sterility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable to a physical medical device like a sterilization container. The performance tests are inherently "standalone" in the sense that they evaluate the device itself.
7. The Type of Ground Truth Used:
The ground truth for the performance tests is established by:
- Sterility Assurance Level (SAL) of 10^-6: This is a widely accepted standard for sterilization efficacy, and is verified using biological indicators (containing resistant bacterial spores).
- Weight difference and visible moisture: For dry time, objective measurements and visual inspection define the ground truth for adequate drying.
- Absence of microbial growth: For microbial aerosol challenge and sterility maintenance, the absence of bacterial growth from cultures of the container contents confirms sterility.
- Killing of spores in organic soil: For simulated use, the elimination of a specified number of spores in a challenging environment serves as the ground truth for effective sterilization of internal lumens.
- Functional integrity: For material compatibility, maintained functionality after multiple cycles serves as the ground truth.
- Cytotoxicity (mild reactivity): Defined by ISO 10993-5: 2009 standards, where a response not greater than 2 (mild reactivity) indicates acceptable biocompatibility.
8. The Sample Size for the Training Set:
This information is not provided and is not applicable. The device is a physical sterilization container, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is not applicable, as there is no training set for this device.
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