(66 days)
The Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121℃ to 135℃ (250°F to 275°F) or an ethylene oxide sterilization process.
The proposed VERIFY® STEAM and EO Load Record Card is a 5"x3" card containing space for recording information regarding the load to be processed and two indicator ink strips applied to the card using a rotary screen printing method. The indicator ink strips are steam and ethylene oxide-sensitive indicators that change color following exposure to the appropriate sterilant.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| For Steam Sterilization: | |
| Visual color change when exposed to steam (121°C to 135°C) | Undergoes a visual color change from Blue to Black when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F). |
| Indicator inks and substrate perform as intended. | The indicator inks (identical to K060103) and substrate perform as intended based on testing provided in K060103. |
| For Ethylene Oxide (EO) Sterilization: | |
| Visual color change when exposed to an ethylene oxide process. | Undergoes a visual color change from Orange to Red when exposed to an ethylene oxide sterilization process. |
| Indicator inks and substrate perform as intended. | The indicator inks (identical to K991418) and substrate perform as intended based on testing provided in K991418. |
| Overall performance under "in use conditions" | Albert Browne Ltd. has performed testing which demonstrates that the indicators perform as intended under in use conditions. (Specific results for "in use conditions" are not detailed in this summary, but the overall statement implies satisfactory performance). |
| Manufacturing process (rotary screen printing) performs as intended | The printing process used for application of the indicator inks to the substrate is identical to that used for the predicate devices (K991418 and K060103), implying consistent manufacturing quality. |
Explanation of Implied Acceptance Criteria: The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than explicitly stating quantitative acceptance criteria. Therefore, the acceptance criteria are inferred from the device's intended use and the performance characteristics described for both the proposed and predicate devices. The core criterion is the reliable and accurate visual color change upon exposure to the specified sterilization processes within the defined temperature ranges.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for the test set.
- Data Provenance: The studies referenced (K991418 and K060103) were conducted by Albert Browne Ltd., a UK-based company. This suggests the data provenance is likely from United Kingdom laboratories/facilities. The studies were retrospective in the sense that the results from previous submissions were used to support the current device. However, the current submission also states that Albert Browne Ltd. performed additional testing for "in use conditions," which would be more prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. Given that the device is a chemical indicator with a clear visual output, ground truth would likely be established through physical/chemical laboratory testing and adherence to recognized standards, rather than expert interpretation of complex images or clinical outcomes.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For a chemical indicator with a distinct color change, adjudication (in the sense of resolving conflicting interpretations) is usually not applicable. The assessment would likely involve objective observation of the color change against a reference and/or instrumental analysis to confirm the chemical reaction, rather than subjective human interpretation requiring consensus.
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 used for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance, to assess the impact of AI on diagnostic accuracy. The VERIFY® STEAM and EO Load Record Card is a chemical process indicator, not a diagnostic imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The concept of "standalone performance" for this device is not directly applicable in the way it is used for AI algorithms. The device itself is standalone in its function as a chemical indicator. Its performance is evaluated by observing the chemical reaction (color change) to a sterilization process. There is no "algorithm" in the conventional AI sense for this mechanical/chemical device. The performance data comes from laboratory tests validating the chemical reaction to sterilant exposure.
7. The Type of Ground Truth Used
The ground truth used for this device would be based on physical and chemical validation against established sterilization parameters. This means:
- Known sterilization conditions: Exposing the indicators to precisely controlled steam (at specified temperature and time) or ethylene oxide (at specified concentration, humidity, temperature, and time) processes.
- Failure conditions: Exposing the indicators to suboptimal or failed sterilization cycles to ensure they do not change color or show an inappropriate change.
- Reference standards: Comparing the observed color change to a known standard representing a successful sterilization.
Essentially, the "ground truth" is the objective physical and chemical reality of whether adequate sterilization conditions were met.
8. The Sample Size for the Training Set
The concept of a "training set" is not directly applicable to this device. This product is a chemical indicator, not an AI/machine learning algorithm that requires data for training. The performance of the indicator is based on its inherent chemical properties, validated through laboratory experiments, not on a machine-learning model trained on data.
9. How the Ground Truth for the Training Set Was Established
As stated above, there is no "training set" in the context of AI/machine learning for this device. The chemical properties of the indicator inks were developed and tested based on established scientific principles of chemical reactions to heat, steam, and ethylene oxide. The ground truth for their performance was established through rigorous physical and chemical laboratory testing as described in point 7.
§ 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).