(482 days)
The SteriTec Chemical Integrator Challenge Pack-Steam is designed to be used to monitor sterilization cycles in pre-vacuum steam sterilizers operating at 132 "C. for 3 minutes or longer. It is to be used as a supplementary test to biological pack testing, not as a substitute.
The SteriTec Chemical Integrator Challenge Pack-Steam is designed specifically for load testing of steam sterilizers. The SteriTec Chemical Integrator Challenge Pack-Steam consists of a chemical integrator test sheet placed inside a package of porous and non porous material. This pack provides resistance to the penetration of steam during the sterilization cycle.
The provided document describes the SteriTec Chemical Integrator Challenge Pack-Steam, a device designed to monitor steam sterilization cycles. The performance testing section outlines its behavior under different temperature and exposure duration conditions.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SteriTec Chemical Integrator Challenge Pack-Steam are implicitly defined by its intended use and the performance characteristics of the predicate device. The performance data is presented as the device's response to specific temperature and time exposures.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalent performance to predicate device (ATI Disposable Test Pack for Steam K952408) | The laboratory test data showed that the performance of the SteriTec Chemical Integrator Challenge Pack-Steam is equivalent to the predicate. (Quantitative equivalence metrics are not provided in this summary). |
| Does not change color completely at insufficient sterilization conditions. | At 132 °C: Did not change color completely when exposed for 1, 2, and 3 minutes. |
| Changes color completely (PASS) at sufficient sterilization conditions for its intended use (132 °C for 3 minutes or longer). | At 132 °C: Did change color completely (PASS) between 3 and 4 minutes. (This indicates it would pass at 3 minutes or longer as intended). |
| Does not change color completely at insufficient sterilization conditions (lower temperatures/shorter times) | At 130 °C: Did not change when exposed for 1, 2, 3, or 4 minutes. |
| At 128 °C: Did not change when exposed for 1, 2, 3, 4, and 5 minutes. | |
| Changes color completely (PASS) at sufficient sterilization conditions (lower temperatures/longer times as expected). | At 130 °C: Did change between 4 and 5 minutes. |
| At 128 °C: Did change between 5 and 6 minutes. (These demonstrate appropriate responsiveness to varying conditions and correlation with expected sterilization times at lower temperatures, further supporting the product's reliability). | |
| Provides a sufficient load challenge to monitor steam sterilization cycles at 132 °C for 3 minutes or longer. | Results of performance testing indicate that the SteriTec Chemical Integrator Challenge Pack-Steam provides a sufficient load challenge to monitor steam sterilization cycles at 132 °C for 3 minutes or longer. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated. The document refers to "laboratory test data" but does not specify the number of individual challenge packs tested under each condition.
- Data Provenance: The study was conducted as "laboratory test data." The country of origin is implicitly the United States, given the submitter's address and the FDA submission. It is a retrospective study in the sense that the testing was performed to support a 510(k) submission for an already developed device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a chemical indicator where the "ground truth" is a physical chemical reaction (color change) to defined physical parameters (temperature and time of steam exposure). The ground truth is established by the known physics and chemistry of sterilization processes and the specific chemical formulation of the indicator, rather than by human expert consensus or clinical outcomes. The document does not mention any expert review of the color changes.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" is a direct chemical reaction. The outcome (color change or no color change) is a physical property, not subject to human adjudication for its primary determination in this context. It would be observed directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a standalone chemical indicator; its effectiveness is measured by its chemical response to sterilization conditions, not by how it improves human reader performance or diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The "performance testing" described is for the device itself, without human intervention in interpreting its primary function (color change at specific conditions). The statement "the performance of the SteriTec Chemical Integrator Challenge Pack-Steam is equivalent to the predicate" and the detailed description of color change under various temperature/time combinations are direct measurements of the device's standalone performance.
7. The Type of Ground Truth Used
The ground truth used is based on defined physical parameters and chemical reactions.
- Defined Physical Parameters: Specific temperature (132°C, 130°C, 128°C) and exposure durations (1, 2, 3, 4, 5, 6 minutes) for steam sterilization. These are objective and measurable.
- Chemical Reactions: The color change of the chemical integrator is a direct, observable outcome of the chemical reaction within the device when exposed to these physical conditions. The expectation of "passing" or "failing" at certain conditions is derived from established sterilization cycle parameters.
8. The Sample Size for the Training Set
Not applicable. This device is a passive chemical indicator, not an AI/algorithm-based system. Therefore, there is no "training set" in the machine learning sense. The device's design and chemical composition are developed through chemical engineering and testing, not through training on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The chemical formulation and physical design of the pack are developed based on established principles of chemical integration for sterilization monitoring, aiming to achieve the desired response profile.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).