(452 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; in the United States, this is for a period of 30 days.
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 of 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® Sterilization 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, 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 yellow (or lighter) when exposed to hydrogen peroxide.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Tyvek® Pouch/Roll with STERRAD® Chemical Indicator:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense (e.g., "must achieve X% accuracy"). Instead, it outlines a series of performance tests that the device passed. The implicit acceptance criterion for each study is "Pass."
| Study | Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilant Penetration | Pass | Passed |
| Package Integrity | Pass | Passed |
| Maintenance of Package Integrity | Pass | Passed |
| Material Compatibility | Pass | Passed |
| Chemical Indicator Functionality | Pass | Passed |
| End Point / Post Processing Color Stability | Pass | Passed |
| Shelf Life | Pass | Passed |
| Biocompatibility | Pass | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each of the performance tests (e.g., how many pouches were tested for sterilant penetration, how many were tested for shelf life, etc.).
It also does not directly state the data provenance (e.g., country of origin). However, given the submission is to the U.S. FDA, it is highly probable the testing was conducted to U.S. standards or by labs that meet U.S. regulatory requirements. It is a prospective study in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate the device's performance.
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 a physical device like a sterilization pouch with a chemical indicator, "ground truth" for many of these tests (e.g., Sterilant Penetration, Package Integrity, Shelf Life, Biocompatibility) would typically be established by standardized laboratory methods and measurements rather than expert consensus on interpretation. For the chemical indicator's functionality and color stability, visual assessment would be involved, but the number and qualifications of individuals assessing the color change are not specified.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the tests (laboratory measurements and visual assessment against a defined color change), formal adjudication methods like 2+1 or 3+1 are less likely to be explicitly called out as they would be for image interpretation. The "Pass" result implies that the observations met the predefined criteria.
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:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic/interpretive devices where human performance with and without AI assistance is being compared. The device in question is a sterilization pouch with a chemical indicator, not an AI-driven image analysis or diagnostic system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:
Not applicable. As stated above, this is a physical device, not an algorithm. The chemical indicator's function is standalone in the sense that it changes color without human intervention during the sterilization process, but "standalone performance" in the context of AI refers to the algorithm's performance without a human in the loop, which doesn't apply here.
7. The Type of Ground Truth Used:
The ground truth for most of these tests would be established by:
- Laboratory measurements and observations: For sterilant penetration, package integrity (e.g., burst strength, seal strength), material compatibility (e.g., degradation over time), and biocompatibility (e.g., toxicity tests). These are objective, quantitative or qualitative assessments based on established test methodologies.
- Visual observation against defined criteria: For "Chemical Indicator Functionality" and "End Point / Post Processing Color Stability," the ground truth is whether the indicator changed from red to yellow (or lighter) as specified. This is a direct observation compared to a known expected outcome.
- Time-based observation: For "Shelf Life" and "Maintenance of Package Integrity," the ground truth involves monitoring the device's characteristics over specific time periods under defined storage conditions.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve a "training set" as it is not an AI/machine learning model. The chemical indicator's behavior is based on chemical reactions, not learned patterns from data.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set for this device, there is no ground truth to establish for it.
§ 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).