(239 days)
The Aesculap JJ Series Container System is a reusable rigid 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 of the enclosed device during transport and until used. This container system is compatible for use in steam sterilization according to the configurations listed in the tables below.
The JJ Series Container System container styles: a solid bottom container and enhanced drying system (EDS) container.
The Aesculap JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags.
The attached tables identifies the load configurations.
The Aesculap JJ Series Container System is a reusable rigid 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 of the enclosed device until used. This container system is compatible for use in Prevac steam with and without dry time.
The JJ Series Container System consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container.
The containers are made from anodized aluminum and utilize a single-use filter. The JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags.
The provided text is a 510(k) Summary for the Aesculap JJ Series Container System. This document focuses on demonstrating substantial equivalence to a predicate device based on nonclinical performance data, rather than on a comparative effectiveness study with human readers (MRMC) or a standalone AI algorithm. Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document as they are specific to studies involving AI or human interpretation of data, which is not the nature of this device (a sterilization container system).
However, I can provide the acceptance criteria and reported device performance from the nonclinical testing, as well as general information about the device and its testing.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and the Reported Device Performance
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | A sterility assurance level (SAL) of 10-6 will be achieved post sterilization using the BI overkill method and half cycle validation indicated in section 5.6 of AAMI ST-77. Biological indicators must be negative for growth after incubation period. | Pass |
| Dry Time | Per AAMI ST-77 section 4.4.2, (in association with EN868-8 section G.3/G.4 and EN 285 section G20.3), 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 | The container load maintains sterility after exposure to a defined amount of aerosol microorganisms per ST-77 sections 5.9.1.1 & 5.9.1.2. No presence of growth after incubation period. | Pass |
| Sterility Maintenance | Sterility of container contents is maintained under conditions which simulate hospital sterile package handling and storage conditions and were tested per ISO 11167-1 section 6.4. Test articles stored for their post processing shelf life. Biological indicators must be negative for growth after incubation period. | Pass |
| Material Compatibility | No degradation or impact to functionality at the completion of multiple sterilization cycles according to section 5.0 of TIR17. | Pass |
| Cytotoxicity | Testing completed in accordance with ISO 10993-5:2009. Using the ISO Elution Method, the response to the article must not be greater than 2 (mild reactivity). | Pass |
| Cleaning Validation | In accordance with Annex A and section 7.5 of TIR30, test samples shall show no visible soil after cleaning and shall have protein or hemoglobin levels less than the predetermined amounts. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes the acceptance criteria for various performance tests, but does not specify the sample sizes used for these tests or the data provenance. It states "Testing was conducted in accordance with applicable FDA guidance and standards," which implies a prospective testing approach conducted by the manufacturer to meet regulatory requirements.
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)
This information is not applicable/provided. The device is a sterilization container. The "ground truth" for the performance tests listed (e.g., sterility, dry time, material compatibility) is established through standardized laboratory testing protocols and objective measurements, not by expert consensus or interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies where human judgment is involved in establishing ground truth (e.g., reading medical images) and disagreements need to be resolved. This is not relevant for the type of objective performance testing described for a sterilization container.
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
This information is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools with human readers. The Aesculap JJ Series Container System is a physical medical device (sterilization container), not an AI diagnostic tool, so such a study was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This question pertains to the performance of an AI algorithm in isolation. The Aesculap JJ Series Container System is a physical product and does not involve an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed on the Aesculap JJ Series Container System is established through objective, standardized laboratory measurements and scientific principles as defined by recognized standards (e.g., AAMI ST-77, EN868-8, EN 285, ISO 11167-1, TIR17, ISO 10993-5:2009, TIR30). For example:
- Sterilization Efficacy: Achieved Sterility Assurance Level (SAL) of 10-6, confirmed by negative biological indicators.
- Dry Time: Measured weight difference and absence of visible moisture.
- Microbial Aerosol Challenge: Absence of microbial growth after exposure.
- Sterility Maintenance: Absence of microbial growth in stored test articles.
- Material Compatibility: Absence of degradation or impact on functionality.
- Cytotoxicity: Response to article not greater than 2 (mild reactivity) via ISO Elution Method.
- Cleaning Validation: Absence of visible soil and protein/hemoglobin levels below predetermined amounts.
8. The sample size for the training set
This information is not applicable/provided. A "training set" refers to data used to train machine learning models. This device is a physical product, not an AI algorithm, so there is no training set in this context.
9. How the ground truth for the training set was established
This information is not applicable/provided 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).