Search Results

The Browne Packaging and Label Steam Process Indicator is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 134°C (250°F to 273°F).

The Packaging and Label Steam Indicator is a chemical indicator consisting of indicator ink applied to a suitable substrate. The indicator ink changes color from pink to purple in a steam autoclave in a temperature range of 121°C to 134°C (250°F to 273°F).

The purpose of this submission is to:
. Replace the process indicator on the outer wrapper of the Browne TST Single Use Bowie Dick Type Test Pack (Browne Bowie Dick Test Pack, K971971) with the Packaging and Label Steam Indicator;
Market the Packaging and Label Steam Indicator, consisting of indicator ink . printed onto clay-coated label stock with permanent or peelable adhesive and a siliconized backing.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Browne Packaging and Label Steam Process Indicator:

Upon reviewing the provided 510(k) summary, it's important to note that this document describes a physical/chemical sterilization process indicator (Class II), not a diagnostic medical device that would typically involve a "device performance" metric like sensitivity or specificity. Therefore, many of the requested categories in your prompt that pertain to diagnostic performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not directly applicable or reported in the context of this type of device submission.

The "device performance" for this process indicator is its ability to reliably change color when exposed to specific steam sterilization conditions and to maintain its properties over its shelf life.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated in the provided document. The term "testing" is used generally.
• Data Provenance: Not explicitly stated, but the manufacturer is Albert Browne Ltd., located in the United Kingdom. Given the nature of a product test, it can be inferred that the testing was conducted prospectively on samples of the device being submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in the context of this device. The "ground truth" for a chemical indicator is the physical state of the indicator itself (color change) after being subjected to a defined physical environment (steam sterilization cycle). This is a direct physical observation, not an interpretation requiring expert consensus.

4. Adjudication method for the test set

Not applicable. As noted above, the outcome (color change) is an objective physical observation, not a subjective interpretation requiring adjudication among experts.

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

Not applicable. This is a chemical process indicator, not a diagnostic device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical chemical indicator, not an algorithm or AI system.

7. The type of ground truth used

The ground truth used is the physical state determined by exposure to known sterilization parameters. For example:

• Exposure to a 132°C autoclave for 2.5 minutes should result in a color change.
• Exposure to conditions below the threshold (e.g., lower temperature, shorter time) should not result in a complete color change.
• The color change observed is the direct physical "truth" of the indicator's performance under those conditions.

8. The sample size for the training set

Not applicable. This is a physical chemical indicator, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Ask a specific question about this device