(241 days)
The Verify® 275F Gravity Indicators are chemical integrators which meet ANSVAAMI 1140-1:2005 for emulating indicators intended for use in steam sterilization. The Verify® 275F Gravity Indicators change color from yellow to blue/purple when exposed to 275°F (135°C) and to the appropriate cycle type and duration. The Verify® 275F Indicators models and their cycle types and times are:
| MODEL | TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|---|
| Verify 275F 3-10 | 275°F (135°C) | Gravity flash steam | 3 and 10 minutes |
| Verify 275F 10 | 275°F (135°C) | Gravity steam | 10 minutes |
The proposed Verify® 275F Gravity Indicators consist of:
- A 22 mm x 143 mm polypropylene strip with two 12 mm chemical indicator . ink spots (for Verify® 275F 3-10 Indicator).
- A 22 mm x 143 mm polypropylene strip with one 12 mm chemical indicator . ink spots (for Verify® 275F 10 Indicator).
The indicator ink spots are located on each end of the strip (or one end if it is just one ink spot), adjacent to a reference block exhibiting the endpoint color. The indicator ink on the proposed Verify® 275F Gravity Indicators changes from yellow to blue/purple color when the steam sterilization cycle is complete.
The Verify® 275F Gravity Indicators can be used to monitor 275ºF (135ºC) sterilization cycles as follows:
- The Verify® 275F 3-10 Indicator can be used to monitor a 3 and 10 minute . 275°F (135°C) gravity flash steam sterilization cycle.
- The Verify® 275F 10 Indicator can be used to monitor a 10 minute 2759F . (135℃) gravity steam sterilization cycle.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The Verify® 275F Gravity Indicators are chemical indicators intended to meet the requirements for emulating Class 6 chemical steam indicators as defined in ANSI/AAMI/ISO 11140-1:2005. The primary performance criterion is the color change from yellow to blue/purple when exposed to saturated steam at 275°F (135°C) for the specified period of time.
| Criteria (Standard: ANSI/AAMI/ISO 11140-1:2005 for Class 6) | Reported Device Performance |
|---|---|
| Color change from yellow to blue/purple | Achieved |
| Exposure to 275°F (135°C) saturated steam at cycle type and duration | Achieved |
| Verify® 275F 3-10: Monitors 3 and 10 minute 275°F (135°C) gravity flash steam sterilization cycles | Meets requirements |
| Verify® 275F 10: Monitors 10 minute 275°F (135°C) gravity steam sterilization cycles | Meets requirements |
Study Proving Device Meets Acceptance Criteria
1. Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample size (i.e., number of indicators) used for the performance testing.
The data provenance is not specified beyond "Performance testing was conducted". It is assumed to be an internal laboratory study conducted by STERIS Corporation. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
2. Number of Experts and Qualifications:
The document does not mention the involvement of human experts for establishing ground truth or evaluating the test set. The evaluation of the chemical indicator's color change is likely objective and based on established color standards.
3. Adjudication Method:
Not applicable as human experts were not involved in establishing ground truth for the test set. The performance is assessed against the instrumental requirements of the standards.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices where human variability in reading is a factor. For chemical indicators, the assessment is based on a direct chemical reaction and color change, not human interpretation against a complex medical case.
5. Standalone Performance:
Yes, a standalone (algorithm only without human-in-the-loop performance) was effectively done. The performance testing "verified that the proposed Verify® 275F Gravity Indicators meet the requirements for emulating [Class 6] chemical indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSI/AAMI ISO 18472." This indicates an objective, instrument-based evaluation of the indicator's performance against the defined standard.
6. Type of Ground Truth Used:
The ground truth is established by the ANSI/AAMI/ISO 11140-1:2005 standard for Class 6 chemical indicators. The device's performance (color change in specific conditions) is directly compared against the engineering and performance specifications outlined in this standard. It's essentially a standards-based ground truth.
7. Sample Size for Training Set:
The document does not specify a separate training set or its sample size. For this type of chemical indicator, there isn't a "training set" in the machine learning sense. The device's formulation and design are developed and then validated against the standard.
8. How Ground Truth for Training Set Was Established:
Not applicable, as there isn't a "training set" in the traditional sense for this chemical indicator. The "ground truth" for the development and validation of such a device is inherently linked to the chemical properties, manufacturing processes, and the performance requirements specified by the and applicable standards (e.g., ANSI/AAMI/ISO 11140-1:2005).
§ 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).