(200 days)
The AirView™ II Bowie Dick Test Pack is intended for the daily air removal efficacy testing of prevacuum steam sterilizers. It may also be used after sterilizer installation, relocation, after major repairs and after sterilization process failures.
The AirView" II Bowie Dick Test Pack is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 134°C for 3.5 minutes. The indicator sheet within the AirView II Bowie Dick Test Pack will demonstrate a uniform color change from blue to dark brown black when proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C (+1° /-0°C) temperature difference between the center of the towel pack. as identified in ANSVAAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the AirView" II Bowie Dick Test Pack will demonstrate a non-uniform color change.
Functionality-The AirView™ II Bowie Dick Test Pack is designed for routine testing of 134°C ' (273°F) prevacuum steam sterilizers. The Bowie Dick test is part of the daily release criteria for any prevacuum steam sterilizer. It may also be used after sterilizer installation, relocation, malfunction, after major repairs and after sterilization process failures. The AirView™M II Bowie Dick Test Pack should always be run in an empty chamber.
Scientific Concepts-The Bowie Dick Test should be run only after the chamber has been preheated. It is a means of detecting air leaks in gaskets or chamber piping, poor air removal and subsequent steam penetration. The AirView™ II Bowie Dick Test Pack has proven safe and effective as a replacement for the standard Bowie Dick Towel Pack through validated performance testing.
Physical Characteristics-The AirView™ II Bowie Dick Test Pack consists of layers of paper with an air removal indicator placed in the center of the stack all placed within an exterior containment box. A process indicator label placed on the containment box alerts users if a pack has been exposed to the sterilization process. The approximate dimensions of the pack are 3-3/4" x 5/8" x 5". The air removal indicator within the AirView™ II Bowie Dick Test Pack should be retained as a permanent record while the remainder of the pack can be discarded with regular waste according to local legislation, recycling land filling or incineration. None of the AirView™ II Bowie Dick Test Packs components are made from lead.
Performance Characteristics-The AirView™ II Bowie Dick Test Pack performs substantially equivalent to the AAMI Standard Towel Pack when tested in conformance with the FDA guidance document for Chemical Indicators and ANSI/AAM1/ISO 11140-5.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Performance - Pass Cycle | Uniform dark brown/black color when subjected to a 134°C for 3.5 minutes prevacuum steam sterilizer cycle with a complete vacuum air removal phase and temperature limits of 0.5°C or less difference within the test pack compared to drain temperature. | The AirView™ II Bowie Dick Test Pack turns a uniform dark brown/black color when subjected to the standard pass cycle (134°C for 3.5 minutes, complete vacuum, ≤0.5°C temp difference). |
| Performance - Fail Cycle | Non-uniform color when subjected to a modified air removal phase (fault condition) resulting in residual air entrapped within the test pack, creating a 2-3°C lower temperature in the center of the test pack compared to the drain at the start of the last minute of the exposure phase. | The AirView™ II Bowie Dick Test Pack turns a non-uniform color when subjected to the standard fault condition (modified air removal, 2-3°C lower temperature in pack center). The indicator is sensitive enough to detect when enough air is left to create a 2°C or greater temperature difference in the test pack. |
| Performance - Dry Heat | Require the presence of steam molecules to turn to specified endpoint color (i.e., no color change in dry heat). | Indicators require the presence of steam molecules to turn to their specified endpoint color. (No color change in dry heat). |
| Indicator Porosity | Meet predetermined acceptance criteria for indicator material porosity. | Results documented the porosity of the indicator material which meet the predetermined acceptance criteria. |
| Biocompatibility | Non-toxic (despite being intended for an empty chamber). | Biocompatibility testing concluded the indicators to be non-toxic. |
| Interfering Substances | Not sensitive to acidic or basic environments (both unprocessed and processed form). | Testing verified that the indicators in their unprocessed form are not sensitive to an acidic or basic environment. Testing verified that the indicators in their processed form are not sensitive to an acidic or basic environment. |
| Shelf Life | Maintain effectiveness for three (3) years from the date of manufacture. | Maintains a shelf life of three (3) years from the date of manufacture when properly stored. |
| Post-Processing Stability | Maintain indicator stability for two (2) years or more post-processing. | Post processing indicator stability has been documented to exceed two (2) years when properly stored. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "multiple lots of indicators" were used for testing. However, it does not explicitly state a specific numerical sample size for the test set.
The provenance is implied to be laboratory-based testing conducted by the manufacturer (SPSmedical Supply Corp.) in the U.S.A., following FDA guidance. It's a prospective study designed to validate the device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a chemical indicator, and its "ground truth" is established through physical and chemical reactions under controlled sterilization conditions, rather than expert interpretation of complex data (like medical images). The "ground truth" for pass/fail cycles is defined by temperature differences and air removal efficacy within the sterilizer, measured by instrumentation, not human experts.
4. Adjudication Method for the Test Set:
Not applicable. The "adjudication" is based on the visual color change of the indicator and objective physical measurements (temperature, vacuum) within the sterilizer during the validation process. The determination of "uniform" vs. "non-uniform" color change for pass/fail conditions is a direct observation of the indicator's performance against predefined criteria, not a consensus among experts.
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 relevant for interpretative devices where human readers are involved (e.g., AI-assisted diagnosis). The AirView™ II Bowie Dick Test Pack is a chemical indicator that produces a direct visual result.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
Yes, the testing described is a standalone performance assessment of the device itself. The chemical indicator operates independently to display a visual outcome (color change) based on environmental conditions within the sterilizer. There is no "human-in-the-loop" component in its direct function, although a human is required to interpret the final visual output.
7. The Type of Ground Truth Used:
The ground truth used is primarily physical and chemical measurements under controlled conditions, established by:
- Defined sterilizer cycle parameters (e.g., 134°C for 3.5 minutes).
- Objective measurements of air removal and steam penetration (e.g., temperature differences within the test pack and at the drain, vacuum levels).
- Compliance with recognized standards (ANSI/AAMI/ISO 11140-5).
Specifically, "pass cycles" and "fail cycles" were experimentally created and defined by these physical conditions.
8. The Sample Size for the Training Set:
Not applicable. This device is a passive chemical indicator, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" or development of the indicator's chemical formulation would involve laboratory research and development, but not a data-driven training set like those for AI.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as explained in point 8. The "ground truth" for the development of such an indicator would be established through chemical principles and laboratory experiments to ensure the indicator ink responds predictably and accurately to specific sterilization parameters (temperature, steam, air presence).
§ 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).