(148 days)
U&U Bowie-Dick Test Pack are designed for testing air removal efficiency of dynamic-air-removal prevacuum steam sterilizers operating at 134 degree C (273 degree F) for 3.5 minutes. The U&U Bowie-Dick Test Pack is for single use and will demonstrate a uniform color change from yellow to dark brown/black when proper sterilization are met and no air is present. If enough air is present to create a 2°C (+1°C /-0°C) temperature difference between the center of the Bowie-Dick Test Pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the U&U Bowie-Dick Test Pack will demonstrate a non-uniform color change
The U&U Bowie-Dick Test Pack is equivalent in performance to the Bowie-Dick towel pack described in AAMI ST66. The test pack consists of a chemical indicator test sheet positioned within a pack of porous sheets. The test sheet contains a steam-sensitive chemical indicator ink printed on paper as a yellow-colored pattern. The test sheet will turn a uniform dark brown/black color except when air removal failures such as air leaks occur. An air removal failure is indicated by a lighter-colored area in the indicator ink pattern of an otherwise dark-colored test sheet.
Here's an analysis of the provided text regarding the U&U Bowie-Dick Test Pack, focusing on acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Item | Code Requirement | Reported Device Performance |
|---|---|---|
| Visual inspection | Inspect the Cleanliness of Bowie-dick test pack. | PASS |
| Dimensions | Width: 140±1mm | |
| Length: 140±1mm | ||
| Height: 18±1mm | PASS | |
| Endpoint Color | Dark brown/black | Black |
| Indicator Format | The bowie-dick internal indicator ink shall be | |
| uniformly distributed on its substrate paper to | ||
| cover not less than 30 % of the test area of the | ||
| substrate paper. the indicator ink printed / the | ||
| substrate paper ≥ 30% | 66% | |
| Indicator Color Change Performance | The bowie-dick internal indicator system shall | |
| show a uniform color after exposure to saturated | ||
| steam at 134°C for 3.5 min. | PASS | |
| Internal Indicator Color Change Fault Performance | Color change fault condition (the temperature at | |
| the center of the bowie-dick test pack is 2°C | ||
| lower than the temperature of the chamber drain | ||
| at the beginning of the final 1 min of a 3.5 min | ||
| cycle at 134 °C). After exposure to conditions | ||
| used to produce a color change fault condition in | ||
| the bowie-dick test pack. the internal indicator | ||
| shall show a non-uniform color change. | PASS | |
| Air Permeance Performance | The bowie-dick test pack shall have an air | |
| porosity not less than 1.7 µm/(Pa·s) when tested | ||
| in accordance with ISO 5636-3 at an air pressure | ||
| of 1.47 kPa | PASS | |
| Toxicity (In Vitro Cytotoxicity - MTT cytotoxicity test) | Under the conditions of cytotoxicity study, the viability of 100% extract of the test article was 76 %. It can be considered that the article extracts had not a cytotoxic potential. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size (number of Bowie-Dick test packs) used for each performance test condition (e.g., number of units tested for temperature difference, number for steam exposure, etc.). It generally refers to "performance testing in dynamic-air-removal steam sterilizer, biocompatibility, storage condition, shelf life."
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to have been generated internally by the manufacturer during "validation studies."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable and therefore not provided in the document. The device (Bowie-Dick Test Pack) is a chemical indicator designed to demonstrate a physical change (color change) based on specific sterilization conditions. The ground truth is established by the physical and chemical properties of the indicator and its interaction with steam and air, not by expert human interpretation of a complex image or data set. The "PASS" result for each test indicates objective measurement against a defined standard.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is based on physical and chemical reactions observable against defined criteria, not on subjective interpretation requiring adjudication.
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 device is a chemical indicator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study is not relevant.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device. Its performance is inherent to its physical and chemical design.
7. The Type of Ground Truth Used
The ground truth used is primarily based on objective measurement against established physical and chemical standards and conditions. Specifically:
- Engineering and Material Specifications: Dimensions, air permeance, indicator format (ink coverage).
- Defined Sterilization Parameters: Saturated steam at 134°C for 3.5 minutes.
- Defined Fault Conditions: 2°C (+1°C /-0°C) temperature difference between the center of the Bowie-Dick Test Pack and the drain temperature.
- Biocompatibility Standards: In vitro cytotoxicity results (e.g., cell viability percentage).
- Visual Color Change: Objective observation of color change to dark brown/black or non-uniform change.
These are derived from internationally recognized standards such as ANSI/AAMI/ISO 11140-5, AAMI ST66, and ISO 5636-3.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML model that requires a training set. The performance is based on its physical design and chemical properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set and therefore no ground truth established for a training set.
§ 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).