(88 days)
The Sterilucent SCBI is intended to be used as a standard method for frequent monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated into a test pack.
The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial installation, after relocation, major repairs or mal functions, or after sterilization process failures.
Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.
The Sterilucent Self-Contained Biological Indicator (SCBI) is a sterilization process indicator that conforms to ANSI/AAMI/ISO 11138-1, and is intended for use only with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. The HC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilization cycles ("Lumen" and “Flexible") which both utilize vaporized hydrogen peroxide (VHP) to rapidly sterilize a variety of reusable medical devices.
The Sterilucent SCBI is to be used in a test pack configuration, with a different test pack (Process Challenge Device) used for each sterilization cycle. Each Process Challenge Device (PCD) is designed to have greater resistance than the worst-case sterilization load, allowing for survival beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.
The Sterilucent SCBI provides information on whether necessary conditions were met to kill a specified number of microorganisms upon exposure to either cycle of the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer.
The document describes the acceptance criteria and study results for the Sterilucent Self-Contained Biological Indicator (SCBI) and Process Challenge Device (PCD).
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SCBI Resistance Evaluation (D-Value & Survival/Kill Window) | Meaningful value | Passed |
| SCBI Holding Time Assessment (24 hours) | Meaningful value | Passed |
| SCBI Reduced Incubation Time (24 hours) | Value less than seven (7) days based on FDA RIT protocol | Passed |
| SCBI Growth Inhibition (none allowed) | Spore growth | Passed |
| SCBI Population Stability & 12-month Shelf Life | Spore population remains between 1.0-4.0 x 10^6 throughout | Passed |
| SCBI Integrated Chemical Indicator Verification | ISO 11140-1 Section 8.7, Table 6 | Passed |
| PCD Resistance Characterization | Greater resistance as demonstrated by fractional kill | Passed |
| PCD Functionality | Fractional kill at half-cycle; all kill at full cycle | Passed |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test. The provenance of the data is not explicitly stated in terms of country of origin, but the submission is for the U.S. Food and Drug Administration (FDA), implying the testing was conducted to meet U.S. regulatory standards. The testing appears to be prospective as it was conducted to demonstrate the functionality of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a biological indicator and process challenge device for sterilization. Its performance is evaluated through biological and physical tests based on established standards, not through expert interpretation of data like in diagnostic imaging.
4. Adjudication method for the test set
This information is not applicable for this type of device and testing. The evaluation relies on quantitative measurements and adherence to predefined performance metrics rather than expert consensus on subjective outcomes.
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
This information is not applicable. This device is a sterilization indicator, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device itself is non-algorithmic and does not involve AI or human-in-the-loop performance in the conventional sense of software-as-a-medical-device. Its performance is inherent to its design and material properties.
7. The type of ground truth used
The ground truth for the SCBI and PCD testing is established by recognized international standards and methodologies for sterilization indicators. This includes:
- Biological inactivation: The absence or presence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
- Physical/chemical parameters: Measurements of D-value, survival/kill windows, spore population counts, pH changes, and color changes in chemical indicators.
- Compliance with standards: Adherence to ANSI/AAMI/ISO 11138-1, ANSI/AAMI/ISO 11140-1, and FDA Guidance documents.
8. The sample size for the training set
This information is not applicable. The Sterilucent SCBI and PCD are not AI/ML-based devices; therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable as the device does not utilize a training set in the AI/ML sense.
§ 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).