(32 days)
The Bismuth Process Indicator Steam Sterilization Tape is in holding sterilization packs together and can be used in gravity sterilizers operating at 121°C for 30 minutes; 132 °C for 10 minutes; 132 °C for 15 minutes; 135 ℃ for 3 minutes and 135 ℃ for 10 minutes or pre-vacuum sterilizers operating at 132℃ for 3 minutes; 132 °C for 4 minutes; 134 °C for 3 minutes and 135°C for 3 minutes. The indicator lines turn dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.
The process indicator tape distinguishes between items processed and unprocessed in both gravity discharge and pre-vacuum steam sterilization cycles. The tape is made of a saturated crepe paper printed with beige indicator lines that turn to dark brown/black when proper levels of moisture and temperature have been achieved. The tape adheres on contact and stays in place through live steam pressure.
The provided text describes the acceptance criteria and study results for the Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape. This device is a chemical indicator designed to distinguish between sterilized and unsterilized items.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally qualitative "Passed" or "Failed" based on visual change or adherence.
| Test | Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Testing for a Type 1 Steam Process Indicator - ANSI/AAMI/ISO 11140-1 | Pass and fail testing in a steam resistometer according to Table 2 of ISO 11140-1:2014 | Pass - Visual Change as specified by manufacturer. Fail - No change or a change that is markedly different from change specified by the manufacturer. | Passed |
| Resistometer Performance Testing for a Type 1 Steam Process Indicator - FDA Chemical Indicator Guidance Document | Pass and fail testing in a steam resistometer according to the requirements in Table 3 of the FDA guidance document on Chemical Indicators | Pass - Visual Change as specified by manufacturer. Fail - No change or a change that is markedly different from change specified by the manufacturer. | Passed |
| In Use Testing in FDA 510k Cleared Steam Sterilizers - FDA Chemical Indicator Guidance Document | Pass and fail testing in cleared healthcare steam sterilizers according to the requirements in section VII "Performance Characteristics" of the FDA guidance document on Chemical Indicators | Pass - Visual Change as specified by manufacturer. Fail - No change or a change that is markedly different from change specified by the manufacturer. | Passed |
| Biocompatibility/Leach Off Testing - FDA Chemical Indicator Guidance Document | Cytotoxicity Testing to the requirements in section VIII "Biocompatibility” of the FDA guidance document on Chemical Indicators and Leach Off test in accordance with ISO 11140-1, section 6.4.2. | Biocompatibility - None of the cultures treated with the test article show greater than a Mild reactivity (Grade 2). Leach Off - The indicator agent shall not offset or bleed to the substrate to which it is applied, or materials in which it is in contact. | Passed |
| Endpoint Stability - ANSI/AAMI/ISO 11140-1 and FDA Chemical Indicator Guidance Document | End Point Stability was tested in accordance with ISO 11140-1, section 6.1.2. | Post processing, the endpoint color change shall remain unchanged for a period of not less than six months from the date of use, when stored under the conditions specified by the manufacturer. | Passed |
| Shelf Life - ANSI/AAMI/ISO 11140-1 and FDA Chemical Indicator Guidance Document | Pass and fail testing in a steam resistometer according to Table 2 of ISO 11140-1:2014 was performed in order to satisfy section X "Shelf Life" of the FDA guidance document on Chemical Indicators | Pass - Visual Change as specified by manufacturer. Fail - No change or a change that is markedly different from change specified by the manufacturer. | Passed |
| Pressure Sensitive Tape Council (PSTC) International Standards Test for Tape Adhesion - PSTC-101 and PSTC-131 Sterilization Tape Standards | Internal tape adhesion test performed in accordance with the PSTC-101 and PSTC-131 International Tape Standards | The average force and displacement values (in Newtons) of five tests shall meet the manufacturers' internal specification. | Passed |
| Post Processing Visual Adhesive Test for Wrapped Packages | Test performed in response to a request from the FDA in the predicate K140940 clearance | All test samples shall demonstrate proper adhesion by not lifting from sterilization wrap after steam sterilization and proper drying time. | Passed |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state a specific numerical "sample size" for the various tests. However, it indicates that testing was performed "in accordance with" established standards (ANSVAAMI/ISO 11140-1:2014, FDA Chemical Indicator Guidance Document, PSTC-101 and PSTC-131) which would specify the number of samples or replicates required for each test. For example, the PSTC adhesion test specifies "five tests".
The data provenance is not explicitly detailed in terms of country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by or on behalf of Intertape Polymer Inc. for regulatory submission to the FDA. The nature of these tests (performance, shelf-life, biocompatibility in controlled environments) suggests they are prospective laboratory and in-use studies.
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):
This information is not applicable and not provided. The "ground truth" for a chemical indicator like this is a direct physical or chemical change (color change due to exposure to steam sterilization conditions, or physical adherence). It does not involve human interpretation or expert consensus in the way a diagnostic imaging AI would, where radiologists establish ground truth for image classification. The "ground truth" is based on the physical parameters of the sterilization cycle and the expected reaction of the chemical indicator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As explained above, the assessment of the chemical indicator's performance is based on direct physical observation (color change, adhesion) relative to defined standards and manufacturer specifications, not subjective human opinion 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 process indicator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical/chemical indicator, not a software algorithm. Its "standalone performance" is its inherent reaction to steam sterilization conditions, which is what the performance testing evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth used is primarily based on controlled physical and chemical conditions (e.g., specific temperatures, times, and steam exposure levels in resistometers and actual sterilizers) as defined by established international and FDA standards (ANSVAAMI/ISO 11140-1:2014, FDA Chemical Indicator Guidance Document, PSTC standards). The expected "truth" is a specific visual change (dark brown/black color) upon exposure to these conditions and maintained physical properties (adhesion, lack of bleeding).
8. The sample size for the training set:
Not applicable. This device is a hardware chemical indicator, not a machine learning or AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 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).