(397 days)
Raven ProTest - Steam is a self-contained Biological Indicator inoculated with Geobacillus stearothermophilus spores and is intended for monitoring the efficacy of steam sterilization cycles (10 minute 132°C gravity displacement and 3 minute 132°C flash gravity displacement cycles). Raven ProTest has a validated reduced incubation time of 24 hours.
The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube. ProTest - Steam is intended for use in 10 minute 132°C gravity displacement and 3 minute 132°C flash gravity displacement cycles.
This document describes a 510(k) submission (K082756) for the Raven ProTest - Steam Biological Indicator, which is intended for monitoring steam sterilization cycles. The submission seeks to expand the label claims to include 132°C gravity/flash gravity cycles. The key information is structured as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Characteristic) | Reported Device Performance |
|---|---|
| Resistance to sterilization processes (efficacy in high-temperature gravity cycles) | Demonstrated per AAMI/ISO 11138-1:2006 |
| Spore population | Demonstrated per AAMI/ISO 11138-1:2006 |
| Recovery of low numbers of injured spores | Demonstrated per AAMI/ISO 11138-1:2006 |
| Reduced incubation period (24 hours) | Validated 24-hour reduced incubation time |
| Overall effectiveness in monitoring routine steam sterilization cycles | Demonstrated for all lots tested |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Testing was performed on "three separate lots of product manufactured from three different primary spore crops." The exact number of individual biological indicators tested within these lots is not specified.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Raven Biological Laboratories. The data is retrospective in relation to the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a biological indicator, and its function is to change color in the presence or absence of viable spores after a sterilization cycle. The "ground truth" is determined by the biological activity of the Geobacillus stearothermophilus spores and the effectiveness of the sterilization process itself, not by human expert opinion interpreting an output.
4. Adjudication Method for the Test Set
Not applicable. The outcome of the biological indicator (color change, turbidity) is a direct biological and chemical reaction, not subject to human adjudication in the context of establishing ground truth for the device's performance. The "ground truth" for each test condition (e.g., sterilization or no sterilization) would be established by physical/chemical parameters of the sterilizer or deliberate under-processing. A "control unit" is used to confirm spore viability.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a biological indicator, not an imaging or diagnostic device requiring human interpretation of complex data. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes. The described testing focuses solely on the performance of the biological indicator itself, independent of a human interpreter's direct involvement in its primary function. The indicator's performance (color change, spore recovery, resistance) is intrinsic to the device.
7. The Type of Ground Truth Used
The ground truth is based on:
- Biological Activity: The viability and growth of Geobacillus stearothermophilus spores, indicated by metabolic activity leading to a pH change.
- Chemical Change: The color change of the bromocresol purple indicator from purple to yellow, signifying acid production from spore metabolism.
- Physical Parameters of Sterilization: The conditions of the 132°C gravity displacement and 132°C flash gravity displacement steam sterilization cycles, which are designed to kill microorganisms. A successful cycle should result in no growth, while an unsuccessful one should (ideally) show growth.
8. The Sample Size for the Training Set
Not applicable in the typical sense of machine learning training sets. This device is a biological indicator, not an AI/ML algorithm that requires a training set. Its "training" is in its design and manufacturing process to consistently meet biological and chemical specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8). The "ground truth" for manufacturing control and device specification adherence would be established through a robust Quality Management System and adherence to relevant standards (e.g., AAMI/ISO 11138-1:2006). For example, spore counts and D-values (decimal reduction time) are verified during the manufacturing of biological indicators.
§ 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).