Search Results

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
• STERIS V-PRO S2 Non-Lumen
• 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 enhance drying system (EDS) container.

The AESCULAP Aicon® Container is compatible with accessories such as baskets, trays, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags. Prevac cycles without dry times are Immediate Use Sterilization Cycles (IUSS).

The AESCULAP Aicon® Container System is a reusable rigid container system used for the packaging, transportation, and storage of instruments prior to, during, and after sterilization. It consists of the various sizes of container bottoms, container lid, and basket options, and should only be used with designated Aesculap® filters, locks and indicator cards identified in this IFU.

The AESCULAP Aicon® Container System is provided non-sterile and will undergo sterilization by the end user. The AESCULAP Aicon® Container System can be identified by its JJ Series part number.

• The first digit of the model number designates the container length.
• The second digit designates the height.
• The last digit identifies the model and features.
  • Standard solid bottom container, designated by the "0" at the end of the product number.
  • Enhanced Drying System (EDS) solid bottom container, designated by the "1" at the end of the product number. The EDS container can also be identified by the Enhanced Drying Module, item 14 in the Product Component Diagram.

The JJ Series uses the same lids for the Standard and the EDS container bottoms.

The AESCULAP Aicon® Container System lid latches should remain in the closed position at all times except when installing on and removing the lid from the container bottom.

The JJ Series can be used with the perforated baskets and trays of both the AESCULAP Aicon® Container System and Aesculap® SterilContainer™ System. Non-Aesculap® pre-configured baskets that meet the clearance requirements, and can be properly aseptically presented may also be used. Medical device and container IFUs parameters (time and temperature) should be reconciled. Steam sterilization dry time performance may vary by facility based on water and steam quality and/or sterilization performance. Ensure you can achieve the same end result as identified in the instrument IFU. Follow facilities policies and procedures.

Notes:

• Thoroughly clean all Aesculap® container products, baskets, accessories and replacement parts prior to first use and after container repair service has been performed.
• Aesculap® baskets and accessories can be cleaned and sterilized following accepted industry guidelines and by using the same processes as Aesculap® sterile container bottoms.
• AESCULAP Aicon® Container System has ONLY been validated with Aesculap® filters, locks and indicator cards.
• Aesculap® only performed container testing with baskets and does not recommend using containers without baskets or with only mats.

Here's an analysis of the provided FDA 510(k) clearance letter for the Aesculap Aicon® Series Container System, focusing on the acceptance criteria and the studies that prove the device meets them.

It's important to note that this document is a 510(k) summary, which provides a high-level overview. Detailed study protocols, raw data, and comprehensive reports would be found in the full 510(k) submission, which is not publicly available here. The summary focuses on non-clinical performance data and does not involve AI or human readers for diagnostic interpretation, as this is a medical device for sterilization. Therefore, sections related to AI, multi-reader multi-case studies, and expert adjudication for ground truth are not applicable to this type of device and will be marked as "Not Applicable".

Acceptance Criteria and Reported Device Performance

Device: Aesculap Aicon® Series Container System (Sterilization Container Wrap)

Purpose of Studies: To demonstrate that the Aesculap Aicon® Series Container System is safe, effective, and performs as well as, or better than, the predicate device for its intended use of enclosing medical devices for sterilization and maintaining sterility.

Detailed Study Information

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of containers, number of sterilization cycles, number of biological indicators) for each test. For medical device sterilization studies, sample sizes are typically determined by relevant standards (e.g., AAMI, ISO) to achieve statistically significant results for sterility assurance. The phrasing "biological indicators must be negative for growth" implies that multiple indicators were used.
• Data Provenance: The document explicitly states "non-clinical tests" and does not mention clinical trials or human data. The tests are laboratory-based performance studies compliant with international and national standards (AAMI, ISO, EN). The country of origin of the data is not specified, but it would typically be from the manufacturer's labs or contracted testing facilities. The studies are prospective in nature, as they involve testing the device under controlled conditions to determine its performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is a medical device for sterilization, not an AI or diagnostic device that requires expert human interpretation of data for ground truth establishment. The ground truth for these performance tests is based on objective, measurable criteria defined by international and national technical standards (e.g., presence/absence of microbial growth, weight difference, visible moisture, protein/hemoglobin levels).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As there are no human experts establishing ground truth for diagnostic purposes, there is no adjudication method involved. The evaluation of test results against predefined, objective acceptance criteria constitutes the assessment mechanism.

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 physical medical device (sterilization container) and does not involve AI, human readers, or diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device (sterilization container) and does not involve an algorithm or AI.

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 objective, measurable physical and biological outcomes as defined by recognized standards (AAMI ST-77, ISO 10993-5:2009, TIR30, TIR17, ISO 11167-1). Examples include:
  • Absence of microbial growth in biological indicators (for sterilization efficacy and sterility maintenance).
  • Specific quantitative thresholds for weight difference (for dry time).
  • Absence of visible moisture.
  • Quantitative levels of protein or hemoglobin below predetermined amounts (for cleaning validation).
  • No degradation or impact to functionality (for material compatibility).
  • Cellular reactivity levels below a certain threshold (for cytotoxicity).

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set. The development of such devices relies on engineering design, material science, and iterative physical testing.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for a training set does not apply here.

Ask a specific question about this device