(30 days)
The Green Card Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.
The Green Card Bowie-Dick Test is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air as recommended by ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. The Green Card Bowie-Dick Test is a 3.5" X 1.91" card with the indicator ink printed on one side. Both sides of the card are laminated with a polyester film and an identification/record label is placed on the back side. The Green Card Bowie-Dick Test duplicates the resistance of a Bowie-Dick towel pack as described in ANSI/AAMI ST8 Hospital Steam Sterilizers.
The Green Card Bowie-Dick Test indicator areas will uniformly change color from purple to green when a passing Bowie-Dick test is performed. If a significant amount of air is present inside the sterilizer chamber during the sterilization cycle, it will be detected by the Green Card and displayed as a purple area on the indicator card, whereas the remainder of the indicator will have turned green. The non-uniform color change demonstrates the presence of air that would have created a 2°C temperature depression in a standard cloth Bowie-Dick pack.
The provided text describes the Green Card Bowie-Dick Test (BD115), a sterilization process indicator. The study detailed is a non-clinical performance test to verify the device meets applicable standards for Class 2 indicators for Bowie and Dick-type air removal tests.
Here's the breakdown of the acceptance criteria and study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Testing (of 3 manufactured lots) | Pre-Determined Acceptance Criteria | Results |
|---|---|---|
| Uniform Color Change (Pass Test) - ANSI/AAMI/ISO 11140-5 Annex B | The Standard Test Pack must demonstrate no greater than a 0.5°C difference between the inside of the Standard Test Pack and the drain temperature and shall remain so for the duration of the exposure time exclusive of a 15-second equilibration time. This should be demonstrated with a thermocouple graph. | |
| The SteriTec Green Card Bowie-Dick Test Card indicator cards must demonstrate a uniform color change to green. | PASS | |
| Non-Uniform Color Change (Fail Test) - ANSI/AAMI/ISO 11140-5 Annex F | The Standard Test Pack must demonstrate a 2°C (+1°/-0°C) temperature difference between the towel pack and the drain temperatures for the last one minute of the three and a half minute sterilization cycle. This should be demonstrated with a thermocouple graph. | |
| The SteriTec Green Card Bowie-Dick Test Card indicator cards must demonstrate a non-uniform color change with a purple area in the center and the rest of the indicator green. | PASS | |
| Dry Heat Testing - ANSI/AAMI/ISO 11140-5 Annex C | The SteriTec Green Card Bowie-Dick Test Card shall show either no change or a change that is markedly different from the change occurring after exposure to a steam sterilization process. | PASS |
| Color Density Test - ANSI/AAMI/ISO 11140-5 Annex A | Difference in color density between the substrate and indicator should be not less than 0.3. | PASS |
| Indicator Color Stability | Verify that the Green Card Indicator sample end color has not changed to any other color and has remained green after 18 months or longer from steam sterilization exposure. | |
| Verify that the Green Card Indicator sample fail point color has not changed to any other color and has remained purple in center of card after 18 months or longer from steam sterilization exposure. | PASS | |
| Shelf-Life Stability | The following tests will be performed at 24 months of shelf life or longer: | |
| ● The pass cycle samples shall exhibit complete color change to green. | ||
| ● The fail cycle samples shall exhibit incomplete color change. This presents as a purple spot in the center of the test card. | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The testing was conducted on 3 manufactured lots of the Green Card Bowie-Dick Test.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical device, it's highly likely to be prospective testing conducted by the manufacturer (SteriTec Products, Inc., located in Englewood, CO, USA).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This information is not provided in the document. The ground truth for this type of device (a chemical indicator for sterilization) is established through physical measurements of temperature and air presence in a controlled sterilization environment, not through expert interpretation of images. The criteria refer to thermocouple graphs for temperature verification.
4. Adjudication Method for the Test Set:
- Not applicable or not specified. The performance of this device is assessed against objective physical and chemical changes (color change, temperature differences) based on defined ANSI/AAMI/ISO standards, rather than subjective human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is not relevant for this device. An MRMC study is typically performed for AI/image analysis systems where human readers interpret medical images, and the AI assists in that interpretation. The Green Card Bowie-Dick Test is a chemical indicator that provides a direct visual result.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, effectively. The performance testing described is for the device itself to objectively meet specific physical and chemical criteria. The "algorithm" here is the chemical reaction of the indicator. The acceptance criteria are based on whether the indicator changes color as expected under specific sterilization conditions, without human interpretation influencing the measurement of those conditions (e.g., thermocouple readings). The visual interpretation of the color change by a human is the final step, but the "performance" of the device in demonstrating the condition is intrinsic to the device itself.
7. Type of Ground Truth Used:
- The ground truth is established through objective physical measurements in controlled sterilization environments, specifically:
- Temperature measurements using thermocouples within a "Standard Test Pack" and at the drain, to verify specific temperature differences (e.g., no greater than 0.5°C difference for pass, 2°C or greater for fail).
- Defined steam sterilization cycles (e.g., 270°F/132°C and 273°F/134°C for 3.5 minutes).
- Absence or presence of residual air engineered into the test conditions.
- Direct observation of color change (uniform green for pass, non-uniform with purple for fail) and color density as per ANSI/AAMI/ISO standards.
8. Sample Size for the Training Set:
- Not applicable/Not specified. This is a physical chemical indicator, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Its performance is inherent to its material composition and design, which is validated through a test set of manufactured lots.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As explained above, there is no "training set" for this device in the context of an AI/ML algorithm. The device's inherent chemical and physical properties are designed to react to specific sterilization conditions, and its performance is validated against established industry standards for those reactions, not "trained" on data.
§ 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).