(222 days)
Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to enclose medical devices that are to be terminally sterilized in the STERRAD Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll is intended to maintain sterility of the enclosed device until used.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2014 [Type I]) that changes from red to the color indicated on the comparator bar included on the shelf pack (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD Sterilization Systems.
The pouches and rolls can be used in the STERRAD Sterilization Systems and Cycles shown in Table 1.
The modified Tyvek Pouch/Roll with STERRAD Chemical Indicator is constructed from Tyvek plastic films, with the STERRAD Chemical Indicator printed onto the Tyvek film. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD Sterilization Systems.
The modified Tyvek Pouch/Roll with STERRAD Chemical Indicator is intended to enclose medical devices to be terminally sterilized in the STERRAD Sterilization Systems in a single or double pouch configuration. The medical devices are inserted into the pouch/roll, sealed, and then sterilized in the STERRAD Sterilization System.
The only difference between the modified device and the predicate device, is the increased post-processing shelf-life to 12 months.
The STERRAD Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. STERRAD Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to the color indicated by the comparator bar included on the shelf pack (or lighter) when exposed to hydrogen peroxide.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Tyvek® Pouch/Roll with STERRAD® Chemical Indicator with Extended Post-Processing Shelf-Life."
It's important to note that this document is a 510(k) summary, which is a premarket notification to the FDA. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed scientific publication of an efficacy study. Therefore, some of the requested information (like specific sample sizes for training sets, number of experts for ground truth, or MRMC studies) is typically not included in such summaries.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for the modification is related to the shelf-life of the product.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Original Device (Predicate K141693): Maintain sterility of the enclosed medical device for 30 days post-sterilization. | Reported Performance: The predicate device maintained sterility for 30 days post-sterilization. (This is implied as it was the cleared shelf-life). |
| Modified Device (K163598): Maintain sterility of the enclosed medical device for 12 months post-sterilization across various STERRAD® Sterilization Systems and Cycles. | Reported Performance: "12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with STERRAD Chemical Indicator Post Processing using the STERRAD 100S Sterilization System" - Pass |
| "12 Months Sterility Maintenance of the Tyvek Pouches/Rolls with STERRAD Chemical Indicator Post Processing in the STERRAD 100S Sterilization System using LONG Cycle" - Pass | |
| ... (and similarly for other STERRAD® systems: NX Advanced, NX Standard, 100NX Standard, 100NX Express, 100NX Duo) - All Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., number of pouches/rolls tested for each condition) for the "Maintenance of Package Integrity" verification tests. It only lists the different STERRAD® systems and cycles that were tested to support the 12-month shelf-life.
- Data Provenance: The data appears to be prospective verification testing conducted by the manufacturer, Advanced Sterilization Products. The country of origin for the data is not specified, but given the FDA submission, it's typically conducted under US or international standards accepted by the FDA.
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 a 510(k) summary. The "ground truth" here is the objective measurement of sterility maintenance, likely performed by a microbiology lab, rather than an expert interpretation of data points.
4. Adjudication Method for the Test Set
- Not applicable as the "ground truth" is based on objective laboratory testing for sterility, not subjective expert assessment 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 device is a medical packaging with a chemical indicator, not an AI-powered diagnostic or assistive technology for human readers. There is no AI component or human reader involvement in interpreting its primary function (sterility maintenance).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm or AI system. The "performance" being evaluated is the physical and chemical properties of the packaging and indicator.
7. The Type of Ground Truth Used
- The ground truth for the "Maintenance of Package Integrity" tests is objective laboratory measurements of sterility over time, specifically for 12 months after processing in various STERRAD® sterilization systems. This would involve microbial ingress testing or similar methods to confirm the sealed package prevents contamination. The chemical indicator's functionality (color change) is also objectively evaluated.
8. The Sample Size for the Training Set
- Not applicable. This product is a physical device being evaluated for its material properties and performance, not a machine learning model that requires a training set. The "testing" referred to in the document is verification testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a machine learning model.
§ 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).