(104 days)
The Browne Steam Indicator is a process indicator to be used in a steam autoclave with a working range of 121-134°C to distinguish between processed and unprocessed units.
The Browne Steam Indicator is a paper strip with indicator ink pads on each end. The indicator ink pads change color from white to black through a brown intermediate in a steam autoclave working at 121-134°C (250-273°F).
The Browne Steam Indicator is a physical/chemical sterilization process indicator. Its intended use is to distinguish between processed and unprocessed units in a steam autoclave operating within a range of 121-134°C.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance Statement |
|---|---|
| Color Change | The strips should change color from white to black through a brown intermediate. |
| Response Time at 121°C | The time required for complete development of an end-point response at 121°C should meet an undefined threshold for effective sterilization. |
| Response Time at 134°C | The time required for complete development of an end-point response at 134°C should meet an undefined threshold for effective sterilization. |
| Distinguish Processed/Unprocessed | The device should be able to confirm exposure to a processing cycle in a steam autoclave with a working range of 121-134°C. |
| Equivalence to Predicate Device | The performance of the Browne Steam Indicator should be equivalent to that of the predicate device (3M Comply 1250 Steam Integrator Strips). |
| Expiration Date Adequacy | The 2-year expiration date should be adequate to ensure accurate, reproducible performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set (i.e., how many strips were tested). It mentions that "All strips used for testing were ≥2 years from the date of manufacture," which implies a sample was used, but the quantity is not provided.
The data provenance is retrospective in the sense that the strips tested had already been manufactured and aged for at least two years. The testing itself would then be prospective on these aged strips.
The country of origin for the data is implicitly United States, as the testing was conducted for submission to the FDA. The manufacturer is based in the United Kingdom, but the testing environment (BIER vessel conforming to ANSI/AAMI ST45-1992) suggests adherence to US standards for medical device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (chemical indicator for sterilization) does not typically involve human expert interpretation of results to establish ground truth in the same way an AI diagnostic imaging system would. The "ground truth" for these indicators is objective chemical color change based on exposure to specific conditions. Therefore, no experts were explicitly used in a consensus or adjudication process for establishing the ground truth of the color change. The color change itself, and its timing, are the measurable outcomes.
4. Adjudication Method
Not applicable. As described above, the "ground truth" for this device is based on objective chemical reactions and physical measurements (time to color change), not subjective interpretation requiring adjudication among experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is not applicable to a physical/chemical sterilization process indicator. This type of study is typically used for diagnostic or screening devices where human readers interpret output (e.g., medical images) and their performance is compared with and without AI assistance. This device's function is a direct chemical reaction.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The "performance testing" described is a standalone evaluation of the device's chemical reaction and color change properties under controlled conditions in a BIER vessel. There is no "human-in-the-loop" component to the inherent function of the indicator itself, only observation of its final state (color change or lack thereof). The device functions autonomously based on chemical properties.
7. The Type of Ground Truth Used
The ground truth used is objective physical/chemical reaction data. Specifically, it's the observed color change (from white to black through brown) and the measured time required for this change to reach an end-point response at specified temperatures (121°C and 134°C). The absence of the expected color change under specific conditions also serves as a ground truth for "unprocessed."
8. The Sample Size for the Training Set
Not applicable. This device is a physical/chemical indicator, not a machine learning or AI-based device that requires a training set. Its function is based on chemical engineering and physical properties, not on 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 type of device.
§ 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).