(489 days)
STERRAD® SEALSURE® Chemical Indicator Tape (PN 14202) is a process indicator (ISO 11140-1:2005) intended for use by healthcare providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems. The color of the STERRAD® SEALSURE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.
STERRAD® SEALSURE® Chemical Indicator Tape is a process indicator intended for use by healthcare providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems. The color of the STERRAD® SEALSURE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.
Here's a breakdown of the acceptance criteria and study information for the STERRAD® SEALSURE® Chemical Indicator Tape, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Chemical Indicator Functionality | Passed |
| Tape Adhesion Strength | Passed |
| End Point / Post Processing Color Stability | Passed |
| Biocompatibility | Passed |
| Shelf life | Passed |
Study Details
- Sample Size for Test Set: Not explicitly stated in the provided text.
- Data Provenance (Test Set): Not explicitly stated in the provided text.
- Number of Experts for Ground Truth (Test Set): Not applicable. This device is a chemical indicator, not an AI or diagnostic device requiring expert interpretation for ground truth.
- Qualifications of Experts (Test Set): Not applicable.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not conducted as the device is a chemical indicator, not a diagnostic or AI-assisted tool for human readers.
- Effect Size of Human Readers with vs. without AI Assistance: Not applicable.
- Standalone (Algorithm Only) Performance Study: Not applicable. The device's performance is intrinsically linked to its chemical reaction, not an algorithm.
- Type of Ground Truth Used: The ground truth for the "Chemical Indicator Functionality" and "End Point / Post Processing Color Stability" would be based on the intended color change (red to gold or lighter) upon exposure to a specific sterilization cycle (hydrogen peroxide). "Tape Adhesion Strength" and "Biocompatibility" would have their own established pass/fail criteria from material science and safety testing. "Shelf life" would be determined by remaining functional over time.
- Sample Size for Training Set: Not applicable. This is a physical chemical indicator, not an AI model that requires a training set.
- How Ground Truth for Training Set was Established: Not applicable.
§ 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).