(135 days)
The Steri-Pak LF Bowie Dick Test Pack manufactured by SteriTec Products Mfg. Co., Inc. is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 132 °C. It is designed to be used for daily Bowie Dick testing of hospital sterilizers as described in AAMI/ANSI ST46 section 7.7. It contains no Lead.
The Steri-Pak LF Bowie-Dick Test Pack is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air. The test pack is approximately 3%" x 5/4" x2/" in size consisting of a stack of 25 layers of porous blotter paper with a plastic laminated layer at the bottom. Embedded within the pack is an indicator sheet with steam sensitive ink printed on it. The indicator sheet changes to black during a typical Bowie-Dick test and will have a lighter, blue color in the center if a significant amount of air is present during the test.
The provided text describes a 510(k) submission for the Steri-Pak LF Bowie-Dick Test Pack. While it mentions "laboratory tests" for comparison to a predicate device, it does not explicitly detail acceptance criteria or a specific study that proves the device meets those criteria in a format that would allow for a direct fill-in of all your requested fields. The provided document is a summary for regulatory approval, not a detailed scientific study report.
However, I can extract the information that is present and indicate where information is not provided based on your specific questions:
Acceptance Criteria and Study Details for the Steri-Pak LF Bowie-Dick Test Pack
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Bowie-Dick Test Functionality: Detect the presence of residual air in prevacuum steam sterilizers operating at 132°C. | The indicator sheet changes to black during a typical Bowie-Dick test and will have a lighter, blue color in the center if a significant amount of air is present during the test. Performance is stated to be "substantially equivalent" to predicate device (SteriTec Steri-Pak Bowie Dick Test Pack 510(k) 982188). |
| Intended Use: Daily monitoring of pre-vacuum steam sterilizers to detect residual air. | "Laboratory tests show the Steri-Pak LF Bowie-Dick Test Pack and the above named predicate device have the same intended use." |
| Material Composition: Contains no Lead. | Stated in the device description and indications for use. |
| Physical Dimensions: Approximately 3¾" x 5¾" x 2" in size. | Stated in the device description. |
| Comparison to Predicate Device: Substantial equivalence to SteriTec Steri-Pak Bowie Dick Test Pack (K982188). | "Based on the results of laboratory tests, the Steri-Pak LF Bowie-Dick Test Pack is substantially equivalent to the SteriTec Steri-Pak Bowie Dick Test Pack 510(k) 982188." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only mentions "laboratory tests."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It is implied to be internal testing by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. Bowie-Dick tests are physical/chemical indicators; their performance is assessed by color change under specific conditions, not typically by expert human interpretation in the same way an AI algorithm for medical imaging would be. The "ground truth" for a Bowie-Dick test is the successful removal of air in a sterilizer (resulting in a uniform color change) or the presence of residual air (resulting in an incomplete color change).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This is a physical/chemical indicator, not a diagnostic device requiring human interpretation and adjudication for "ground truth."
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 standalone chemical indicator, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, effectively. The device itself is the standalone "algorithm" (or chemical reaction) that produces a result (color change pattern) without human intervention in its function. The "performance" mentioned in the summary is the performance of this standalone indicator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for a Bowie-Dick test is the physical conditions within the sterilizer, specifically the presence or absence of residual air. This is established by observing whether the indicator achieves a uniform color change (absence of air) or an incomplete color change (presence of air). This would be validated against calibrated sterilization equipment and known air leaks.
8. The sample size for the training set
- Not applicable/Not provided. This is a physical/chemical indicator, not an AI/machine learning device 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).