(217 days)
Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® 100NX™ Sterilizer and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll maintains sterility until the seal of the pouch/roll is opened.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization Systems.
The Tyvek® Pouch/Roll with STERRAD® Chemical Indicator is intended to be used to contain medical devices to be terminally sterilized in the STERRAD® Sterilization Systems. The medical devices are inserted into the pouch/roll, sealed, and then sterilized in the STERRAD® Sterilization System. After completion and the sterilization process, the pouch/roll maintains sterility of the enclosed medical devices until the seal is opened. The pouch/roll is printed with a chemical indicator bar that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during the sterilization process in the STERRAD® Sterillization Systems.
The proposed pouches are 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 STERRAD® Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to smot in place of, the biological indicator. STERRAD® Chemical Indicators no 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 yellow (or lighter) when exposed to hydrogen peroxide.
Here's a breakdown of the acceptance criteria and study information for the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with specific numerical thresholds for each test. Instead, it lists performance tests and their results, which are all reported as "Passed." This implies that the device met predetermined internal acceptance criteria for each test.
| Study | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilant Penetration | Adequate sterilant penetration | Passed |
| Package Integrity | Maintenance of package integrity | Passed |
| Maintenance of Package Integrity | Maintenance of package integrity after sterilization | Passed |
| Material Compatibility | Compatibility with sterilization process and medical devices | Passed |
| Chemical Indicator Functionality | Color change from red to yellow (or lighter) upon exposure to H2O2 | Passed |
| End Point / Post Processing Color Stability | Stable color change after processing | Passed |
| Shelf Life | Maintenance of performance characteristics for claimed shelf life | Passed |
| Biocompatibility | Biocompatible with intended use | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample sizes used for any of the performance tests.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a sterilization device, the studies would typically be prospective and conducted under controlled laboratory conditions, implying an internal company setting (likely in the US, where the company is based).
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. For these types of tests, "ground truth" would typically be established by established scientific methods and instrumentation (e.g., spectrophotometers for color changes, microbial challenge tests for sterility), rather than expert consensus on subjective observations. The results ("Passed") are likely based on direct measurements against predefined specifications.
4. Adjudication Method for the Test Set:
This information is not provided in the document. Given the objective nature of the performance tests (e.g., color change, integrity tests), an adjudication method in the sense of reconciling conflicting expert opinions is unlikely to have been relevant or formalized in the way it might be for diagnostic image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study is primarily relevant for diagnostic devices where human interpretation is a critical component. The Tyvek® Pouch/Roll and its chemical indicator are
functional components of a sterilization process, not a diagnostic tool requiring human reader comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are inherently standalone (algorithm only) in the context of device performance testing. The "device" in this instance is a physical product (pouch/roll with a chemical indicator), not a software algorithm. The performance tests ("Sterilant Penetration," "Chemical Indicator Functionality," etc.) evaluate the inherent physical and chemical properties and behavior of the device itself, without human intervention in the primary measurement or function. The human "in-the-loop" only interprets the result of the indicator (red to yellow), but the indicator's function is standalone.
7. The Type of Ground Truth Used:
The ground truth for these performance tests is based on objective measurements and predefined specifications for the physical and chemical properties and performance of a sterilization packaging system and chemical indicator. Examples include:
- Chemical Indicator Functionality: Exposure to hydrogen peroxide vapor is the "ground truth" event, and the color change (red to yellow) is the observable outcome, validated against known chemical reactions.
- Sterilant Penetration/Package Integrity/Shelf Life: Ground truth would be established through accredited laboratory methods and instrumentation to verify the absence of microbial contamination or the maintenance of physical barrier properties.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set" in the context of artificial intelligence or statistical modeling.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and therefore not provided. As mentioned above, there is no "training set" for this type of device.
§ 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).