(146 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria (if available) | Reported Device Performance |
|---|---|---|
| Visual Color Change | Changes color as designed | Changes color from pink to purple when exposed to steam in a temperature range of 121°C to 134°C (250°F to 273°F). |
| Conformity to Standard | Conforms to ANSI/AAMI ST60 requirements for Class I process indicators for steam sterilization. | Testing demonstrated conformity to applicable requirements of ANSI/AAMI ST60. |
| Response Time | (Implicitly, to confirm adequate exposure within a given cycle) | Changed color after approximately 2.5 minutes exposure to a 132°C autoclave processing cycle. |
| Shelf Life | Two-year shelf life | Data was provided to support a two-year shelf life. |
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.
§ 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).