(119 days)
The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes. 135° C for 10 minutes;
Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes.
Minimum Stated Values as determined in a resistometer:
SV121°C/16.5 min., SV132°C/2.0min. SV134°C/1.4 min. SV135°C/1.2 min.
The True Indicating Chemical Indicator for Steam CSPN-15 consists of a white polyester substrate with acrylic adhesive married to a paper substrate. The paper substrate (with acrylic adhesive) has True Indicating water-based steam indicating ink, ISPN-01 (pink to dark brown/black), and general artwork printed. After printing, the top layer of the Type 5 Integrating Indicator strip is covered with a clear colorless polyester laminate with acrylic adhesive. The Integrating Indicators have been designed for Steam sterilization processes, ensuring the effectiveness of sterilization by monitoring all critical process variables (time, temperature and steam). The pink indicating ink was developed to turn to dark and conceal the word "NOT" when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of a 105 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer).
The provided document describes the acceptance criteria and study results for the True Indicating Type 5 Integrating Indicator for Steam (CSPN-15). This device is a chemical indicator designed to monitor steam sterilization cycles.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test | Acceptance Criteria | Subject Device Result |
|---|---|---|
| Steam Resistometer Testing | Pass result (end signal color achieved for all product codes) at the value for each temperature claimed: | |
| 121°C for 16.5 minutes | ||
| 132°C for 2.0 minutes | ||
| 134°C for 1.4 minutes | ||
| 135°C for 1.2 minutes | ||
| Fail result (end signal color not achieved) at the value for each temperature claimed: | ||
| 120°C for 14.025 minutes | ||
| 131°C for 1.7 minutes | ||
| 133°C for 1.19 minutes | ||
| 134°C for 1.02 minutes | ||
| Integrator temperature coefficient: 10 - 27 °C | ||
| Correlation coefficient: ≥ 0.9 | PASS | |
| Hospital Steam Sterilizer Testing | Pass result (signal color achieved for all product codes) at the value for each temperature claimed in combination of a sterilization load: | |
| Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes, 135° C for 10 minutes; | ||
| Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. | PASS | |
| Dry Heat Testing | Fail result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C) | PASS |
| End Point Stability | 6 Months | PASS |
| Side-by-Side Testing with a Biological Indicator | Chemical Integrator does not reach endpoint before BIs are inactivated. | PASS |
| Offset/Transference | The chemical indicators shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed. | PASS |
2. Sample size used for the test set and the data provenance
The document states that "Testing was performed for steam sterilization processes using multiple lots of True Indicating Chemical Indicator for Steam CSPN-15 over the range of the shelf-life". Specific numerical sample sizes for each test are not explicitly provided in this summary. The data provenance is derived from nonclinical tests conducted by or for True Indicating, LLC, following FDA and ISO guidelines. The context suggests prospective testing specific to the device's development and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is not an AI/imaging device requiring expert interpretation for ground truth. The ground truth for chemical indicators is established by objective physical and chemical measurements (e.g., specific temperatures, times, and presence/absence of steam for sterilization cycles, and color change observation). There is no mention of human experts being used to establish ground truth for this type of device.
4. Adjudication method for the test set
Not applicable. This device is a chemical indicator, and its performance is assessed by objective chemical/physical reactions and visual color changes, rather than 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 is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in a sense. The testing performed on the chemical indicator (Type 5 Integrating Indicator for Steam CSPN-15) is a standalone evaluation of its performance without human-in-the-loop interaction for interpretation, except for visual confirmation of the color change. The indicator itself is designed to provide a direct visual output.
7. The type of ground truth used
The ground truth used for this chemical indicator is based on:
- Physical and Chemical Parameters: Precisely controlled steam sterilization conditions (temperature, time, and steam presence) established in resistometers and hospital sterilizers.
- Biological Indicator Inactivation: For the "Side-by-Side Testing with a Biological Indicator," the ground truth for successful sterilization is the inactivation of biological indicators (BIs), which contain a known population of resistant bacterial spores. The chemical indicator's performance is compared against this biological standard.
- Color Change: The specific, objectively defined color change from pink to dark brown/black that indicates successful exposure to sterilization parameters.
8. The sample size for the training set
Not applicable. This is a chemical indicator, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As noted above, this device does not utilize a training set in the way an AI model would.
§ 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).