(259 days)
The Aesculap Sterilcontainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and disposable polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container has been validated with stainless steel lumens, hinged, and knurled instruments. 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 with the STERRAD 200, STERRAD NX (Standard cycle and Advanced cycle), and STERRAD 100NX (Standard cycle and Flex cycle). The Sterilcontainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
The Sterilcontainer S is recommended for surface and lumens:
STERRAD 200, stainless steel lumens ≥ 3mm I.D. x ≤ 400mm L STERRAD NX standard cycle, stainless steel lumens ≥ 2mm I.D. x ≤ 400mm L STERRAD NX advanced cycle, stainless steel lumens ≥ 1mm I.D. x ≤ 500mm L STERRAD 100NX standard cycle, stainless steel lumens ≥ 0.7mm I.D. x ≤ 500mm L STERRAD 100NX flex cycle, porous lumens (flexible endoscope) ≥ 1mm I.D. x ≤ 850mm L
30 days of shelf life testing has been conducted for the Sterilicontainer S.
The attached tables identify which products may be sterilized in which STERRAD sterilization cycle.
The Aesculap Sterilcontainer S is designed as a container system that will allow for sterilization and storage of other medical devices. This container is designed to be compatible for use with the STERRAD sterilization processes [200, NX (Standard cycle and Advanced cycle), and 100NX (Standard cycle and Flex cycle). The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter. The Sterilcontainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
Here's an analysis of the acceptance criteria and study information for the Aesculap Sterilcontainer S, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Sterilization Compatibility (STERRAD 200): Maintain sterility for enclosed devices and allow sterilization for lumens: ≥ 3mm I.D. x ≤ 400mm L (stainless steel). | The SterilContainer S has been "fully validated" for STERRAD 200. |
| Validated for full, ¾, ½, and ¼ size containers with 5 stainless steel lumens per system. | |
| Validated for Extra Long Mini container with 2 stainless steel lumens per system. | |
| Sterilization Compatibility (STERRAD NX Standard Cycle): Maintain sterility for enclosed devices and allow sterilization for lumens: ≥ 2mm I.D. x ≤ 400mm L (stainless steel). | The SterilContainer S has been "fully validated" for STERRAD NX (Standard cycle). |
| Validated for full, ¾, ½, and ¼ size containers with 5 stainless steel lumens per system. | |
| Validated for Extra Long Mini container with 2 stainless steel lumens per system. | |
| Sterilization Compatibility (STERRAD NX Advanced Cycle): Maintain sterility for enclosed devices and allow sterilization for lumens: ≥ 1mm I.D. x ≤ 500mm L (stainless steel). | The SterilContainer S has been "fully validated" for STERRAD NX (Advanced cycle). |
| Validated for full, ¾, ½, and ¼ size containers with 5 stainless steel lumens per system. | |
| Validated for Extra Long Mini container with 2 stainless steel lumens per system. | |
| Sterilization Compatibility (STERRAD 100NX Standard Cycle): Maintain sterility for enclosed devices and allow sterilization for lumens: ≥ 0.7mm I.D. x ≤ 500mm L (stainless steel). | The SterilContainer S has been "fully validated" for STERRAD 100NX (Standard cycle). |
| Validated for full, ¾, ½, and ¼ size containers with 5 stainless steel lumens per system. | |
| Validated for Extra Long Mini container with 2 stainless steel lumens per system. (Note in text seems to have a typo for Extra Long Mini, but it's likely intended to be 2 lumens like other cycles) | |
| Sterilization Compatibility (STERRAD 100NX Flex Cycle): Maintain sterility for enclosed devices and allow sterilization for porous lumens (flexible endoscope): ≥ 1mm I.D. x ≤ 850mm L. | The SterilContainer S has been "fully validated" for STERRAD 100NX (Flex cycle). |
| Validated for full, ¾, and ½ size containers with 1 PTFE/PE lumen per system. | |
| Sterility Maintenance (Shelf Life): Maintain sterility of the enclosed device until used for a specified duration. | "30 days of shelf life testing has been conducted for the Sterilicontainer S." (No explicit pass/fail criteria and result provided beyond simply stating it was conducted). |
| Compatibility with various instruments: Validate with stainless steel lumens, hinged, and knurled instruments. | "This container has been validated with stainless steel lumens, hinged, and knurled instruments." |
| Overall Performance: Meet "all required testing" per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for sterilization containers. | "All required testing...was completed." |
| "This validation was conducted in accordance with FDA guidance and available AAMI standards by a qualified testing laboratory." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state a numerical sample size for the "test set" in terms of how many containers or sterilization cycles were performed. Instead, it refers to "validation" of various container sizes with a specific number of lumens per container system (e.g., "5 stainless steel lumens per container system" for full, ¾, ½, and ¼ sizes, and "2 stainless steel lumens per container system" for Extra Long Mini). For the 100NX flex cycle, it states "1 PTFE/PE lumen per container system." This suggests that the "sample size" is the combination of container types and the specified number of lumens.
- Data Provenance: The document explicitly states the validation was conducted by "a qualified testing laboratory." The country of origin for the data is not specified. The study is implicitly prospective as it's a validation study for a new device to demonstrate its performance against predefined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The validation appears to rely on objective measures of sterilization efficacy rather than expert subjective assessment.
4. Adjudication Method for the Test Set
- This information is not applicable as the nature of the study (sterilization container validation) does not involve human expert adjudication of results but rather objective measurements of sterility and physical compatibility.
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. The device is a sterilization container, not an AI-powered diagnostic tool, so an MRMC study related to human reader performance with or without AI is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable. The device is a physical sterilization container, not an algorithm.
7. The Type of Ground Truth Used
- The ground truth in this context would be objective laboratory measurements of sterility (e.g., absence of microbial growth on biological indicators, successful chemical indicator changes, maintenance of barrier properties, and lumen patency) and physical compatibility (e.g., fitness for use within the specified STERRAD sterilizers). The document implies validation against "FDA guidance and available AAMI standards," which would define the methods and criteria for establishing sterility.
8. The Sample Size for the Training Set
- This information is not applicable. The Aesculap Sterilcontainer S is a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is 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).