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510(k) Data Aggregation
(407 days)
BOARD OF DIRECTORS, ALBERT BROWNE LTD.
The Browne TST Single Use Bowie-Dick Type Test Pack is a chemical sterilization process monitor which demonstrates adequate air removal and steam penetration during a 132°C (270°F) or 134°C (273°F) autoclave processing cycle by means of a yellow to blue color change.
The Browne TST Single Use Bowie Dick Type Test Pack is a paper sheet containing an indicator figure wrapped in multiple layers of paper which is designed to monitor air removal and steam penetration during a 132 °C (270°F) or 134°C (273°F) steam autoclave processing cycle with a hold time of 3-4 minutes. The device changes color from yellow to blue when air removal during the cycle is sufficient to allow complete, even, steam penetration.
This document describes the Browne TST Single Use Bowie-Dick Type Test Pack, a chemical sterilization process monitor. Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Air Removal & Steam Penetration during Autoclave Processing: Demonstrates adequate air removal and steam penetration during a 132°C (270°F) or 134°C (273°F) autoclave processing cycle. | The device changes color from yellow to blue when air removal during the cycle is sufficient to allow complete, even, steam penetration. |
| Temperature Depression Sensitivity: Detects a ≥2℃ temperature depression at 132°C (270°F) or 134°C (273°F) in a test cycle of 3-4 minutes duration. | Performance testing showed that the sensitivity of the Test Packs is sufficient to detect a ≥2℃ temperature depression at 132°C (270°F) or 134°C (273°F) in a test cycle of 3-4 minutes duration. |
| Performance in Loaded Chamber: Sensitivity of the Test Pack is not affected by the presence of a loaded chamber. | Additional testing conducted in a loaded chamber demonstrated that the sensitivity of the Test Pack was not affected by the presence of the load. |
| Color Change Mechanism: Yellow to blue color change. | Achieves a yellow to blue color change. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the performance testing. It refers to "performance testing" and "additional testing" without quantifying the number of tests conducted.
The data provenance is not explicitly stated as country of origin, retrospective or prospective. However, the submitter is from the United Kingdom, and the device is being submitted to the FDA in the US, suggesting the testing likely occurred in a calibrated lab environment for regulatory submission. The testing appears to be prospective, demonstrating the device's function under specified conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of human experts to establish ground truth for this device. This is a chemical indicator, where the "ground truth" is determined by the known physical conditions within the autoclave (e.g., successful steam penetration, specific temperature depression). The color change of the indicator itself is the output, and its accuracy is validated against the controlled physical parameters, not against human interpretation of an image or condition.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the "ground truth" for a chemical indicator is the physical state of the autoclave, not an interpretation by human experts that would require adjudication. The color change is a direct physical response.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. The Browne TST Single Use Bowie-Dick Type Test Pack is a chemical indicator, not a diagnostic imaging device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance assessment was conducted. The performance testing described evaluates the device's ability to accurately reflect the autoclave conditions (air removal, steam penetration, temperature depression) independently. The color change is a direct output of the device's chemical properties reacting to the environment, not requiring human interpretation as part of its primary function.
7. The Type of Ground Truth Used:
The ground truth used is based on physical parameters and controlled conditions within an autoclave. This includes:
- Adequate air removal and steam penetration: Established by controlling the autoclave cycle to ensure these conditions are met.
- Specific temperature depression: Artificially creating a ≥2℃ temperature depression to test the device's sensitivity.
- Loaded vs. Unloaded Chamber: Testing under both conditions to see if the device's performance is affected.
The color change of the indicator then correlates with these known physical states.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable here. This device is a passive chemical indicator, not an AI/machine learning algorithm that requires training data. Its function is based on fixed chemical properties.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for a chemical indicator.
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(104 days)
BOARD OF DIRECTORS, ALBERT BROWNE LTD.
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.
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