(139 days)
The OK Plus indicator is a chemical indicator designed for monitoring the efficacy of steam sterlization process. The indicator responds to all critical sterilization parameters. The OK Plus indicator changes color from off-white to black to indicate that the conditions of the cycle have been met. The indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
*Gravity: 121 C/250 F - 30 minutes
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Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes
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Vacuum assisted (prevacuum): 132 C/270 F - 10 minutes
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Vacuum assisted (prevacuum): 134 C/273 F - 3.5 minutes
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Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes
- *Vacuum assisted (prevacuum): 135 C/275 F 3 minutes
The OK Plus indicator has the following Stated Values determined in Resistometer:
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121 C/250 F - 15 minutes
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132 C/270 F - 4 minutes
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134 C/273 F - 3 minutes
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135 C/275 F - 2.9 minutes
The OK Plus indicator is a single use chemical indicator designed for steam sterilization monitoring. Each indicator consists of reactive steam indicator ink printed on a 4" x 9/16" substrate paper strip. It can be also printed on other substrate sizes, for example 8" x 9/16" paper. OK Plus indicators are sold in boxes of 250 strips.
The indicator responds to all critical parameters of a steam sterilization cycle: exposure time, temperature, and presence of saturated steam sterilization process indicator ink chemicals react forming a black compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from off-white to black. If the parameters do not achieve the required level, the indicator color will be light brown or brown.
The provided text describes the acceptance criteria and the results of a study for the "OK Plus Indicator" device, a chemical indicator for steam sterilization monitoring.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Performance testing in Steam BIER vessel | Demonstrate conformance with half-cycle requirements. Indicator should show end-point color when bacteria/spores are deactivated. | Color changes - end-point colors: 121°C - 15 min 00 s - black; 132°C - 4 min 00 s - black; 134°C - 3 min 00 s - black; 135°C - 2 min 54 s - black | Passed |
| Testing in Dry Heat oven | Confirm that indicator does not change color in absence of steam. | When tested in cycles at 140°C+/-2°C and time 30+/1 min as per ANSI/AAMI/ISO 11140-1:2014, the indicator should not achieve end color. Also, should not demonstrate color change to end point in 180°C - 60 min dry heat typical cycle. | Passed |
| Testing against biological indicator | Establish correlation between performance of OK Plus indicator and Steam Biological indicator. | The OK Plus indicator should not achieve end-point color before the biological indicator is inactivated. | Passed |
| Single parameter variation testing | Confirm that OK Plus indicator is sensitive to critical sterilization parameters. | Variation of one parameter while other ones are maintained steady. OK Plus indicator should not reach specified end-point black color. | Passed |
| Testing in cycles typical for healthcare | Demonstrate OK Plus indicator achieves specified end color in typical hospital-size and table-top sterilizers. | Color change from off-white to black. | Passed |
| Biocompatibility study and ink transfer | Demonstrate that the indicator does not create biocompatibility issues and no ink transfer occurs. | Evaluation of individual components for biocompatibility and review of biocompatibility of indicators with similar formulation. Testing according to ISO 11140-1:2014 (Requirement: 6.2.2. No ink transfer should be observed on unprocessed and Steam processed samples). | Passed |
| End-point stability and shelf-life study | Confirm acceptable stability after processing ("Pass" and "Fail" conditions) and maintenance of performance over shelf life. | OK Plus indicators processed in Pass and Fail cycles at various time points after production and at the end of shelf life should demonstrate stable color for at least 6 months. Meet specifications after real-time 48 months shelf-life exposure. | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each individual test in the "Summary of non-clinical testing" section. It broadly discusses "testing" and "cycles" without providing numerical quantities for the indicators tested in each scenario. No information on data provenance (e.g., country of origin, retrospective/prospective) is provided.
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 device's performance is assessed based on objective color changes and correlation with established standards (like biological indicators), rather than expert interpretation of a ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. The assessment of the indicator's performance is based on a clear, objective color change (off-white to black) as per pre-defined criteria, not subjective human adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. This type of study is typically for diagnostic imaging devices where human interpretation is a key component. The OK Plus indicator is a chemical indicator with an objective color change.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The studies described are inherently "standalone" in the context of the device's function. The OK Plus indicator's performance is evaluated based on its chemical reaction and color change under specific conditions, without requiring human intervention for its primary function of indicating sterilization efficacy. The "result" column indicates whether the indicator "Passed" or "Failed" specific criteria, demonstrating its inherent performance.
7. Type of Ground Truth Used:
The ground truth used for these tests is based on:
- Physical/Chemical Standards: Defined temperature, time, and steam conditions (e.g., 121°C - 15 min 00 s for black color).
- ANSI/AAMI/ISO 11140-1:2014: International standards for chemical indicators.
- FDA Guidance: "Pre-market Notification [510(k)] Submissions for Chemical Indicators, 2003."
- Correlation with Biological Indicators: The "inactivation" of biological indicators serves as a biological ground truth for sterilization efficacy.
8. Sample Size for the Training Set:
This information is not provided. Chemical indicators are typically not "trained" in the same way machine learning algorithms are. Their performance is inherent to their chemical formulation, and verification is done through rigorous testing, not a training/validation split.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of this chemical indicator, the establishment of ground truth for a training set is not applicable. The device's efficacy is proven by meeting the predetermined performance criteria against established chemical and biological standards.
§ 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).