(56 days)
The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is designed for testing air removal efficiency of 132- 134°C (270- 273°F) dynamic-air-removal steam sterilizers.
The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is equivalent in performance to the Bowie-Dick towel pack described in AAMI ST79. The test pack consists of a chemical indicator test sheet positioned within a pack of porous sheets. The test sheet contains a lead-free 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.
The provided text describes the 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack, which is a sterilization process indicator. However, it does not include detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the format requested (e.g., performance metrics like sensitivity, specificity, accuracy, or associated confidence intervals based on a clinical study).
Instead, the document is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for a new device.
Here's an attempt to answer the questions based on the available information, noting where information is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| Intended Use: For testing air removal efficiency of 132-134°C (270-273°F) dynamic-air-removal steam sterilizers. | The 3M™ Comply™ Bowie-Dick Type Lead Free Test Pack is designed for testing air removal efficiency of 132-134°C (270-273°F) dynamic-air-removal steam sterilizers. (Matches predicate's intended use). |
| Performance: Equivalent to the Bowie-Dick towel pack described in AAMI ST79, specifically in indicating air removal failures (lighter-colored area) vs. successful air removal (uniform dark brown/black color). | The test pack is equivalent in performance to the Bowie-Dick towel pack described in AAMI ST79. An air removal failure is indicated by a lighter-colored area in the indicator ink pattern, while successful removal results in a uniform dark brown/black color. |
| Material/Composition: Lead-free. | Contains a lead-free steam-sensitive chemical indicator ink. |
| Technological Characteristics: Similar to predicate (3M™ Comply™ 1233 Bowie-Dick Type Test Pack). | Information provided in the 510(k) submission shows substantial equivalence to the predicate "in terms of intended use, indications for use, composition, physical properties and technological characteristics." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document states "Comparative Data for Determining Substantial Equivalence," but it does not detail specific study sample sizes (e.g., number of test packs, number of sterilization cycles) or the provenance of this data. The submission focuses on demonstrating equivalence rather than reporting on a new performance study with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. This type of information is typically part of a clinical performance study involving human assessment. The device is a chemical indicator, which provides a direct visual output, rather than an imaging device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. As stated above, this device provides a direct visual result. Expert adjudication methods are not typically relevant for such chemical indicators.
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
- No. This is a chemical sterilization indicator, not a device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a passive chemical indicator, not an algorithm. Its "standalone" performance is its visual reaction to steam sterilization conditions. The document implies this performance was compared to AAMI ST79 standards and the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a Bowie-Dick test pack like this is the physical condition of the sterilizer's air removal efficiency, determined by whether steam penetration was successful or if air pockets remained. The AAMI ST79 standard defines the expected visual outcome (uniform dark coloration) for successful air removal. The "ground truth" against which the new device's performance is measured would be the performance of the predicate device and adherence to the AAMI ST79 standard.
8. The sample size for the training set
- Not applicable/Not provided. This is a physical chemical indicator, not a machine learning model, so there is no "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).