(73 days)
The Reliance™ CI Process Indicator is intended for routine monitoring of the Reliance™ EPS Endoscope Processing System employing Reliance™ DG Dry Germicide. The Reliance™ CI Process Indicator is a peracetic acid dose indicator that changes color from orange to white (colorless) upon exposure to an effective dose of peracetic acid.
The Reliance CI is a single-use chemical indicator with indicator ink printed on one end that was developed to monitor the peracetic acid (PAA) dose at the point of use in a Reliance™ EPS Endoscope Processing System employing Reliance™ DG Dry Germicide. The Reliance CI shows an incomplete color change when exposed to peracetic acid at a dose of 9,000 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle. The Reliance CI changes color from orange to white (colorless) when exposed to peracetic acid at a dose of 11,500 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle.
The document provides a 510(k) summary for the Reliance™ CI Process Indicator, a chemical indicator for monitoring peracetic acid dose in endoscope processing systems.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance (Reliance™ CI) |
|---|---|---|
| Color Change (Pass) | Colorless (white) at ≥11,500 mg/L PAA min. | Changes from orange to white (colorless) at ≥11,500 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle. |
| Color Change (Fail) | Incomplete color change (any shade of orange or other than reference pass color) at ≤ 9,000 mg/L PAA min. | Shows an incomplete color change when exposed to peracetic acid at a dose of 9,000 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle. |
| Unprocessed State | Orange | Orange |
2. Sample size used for the test set and the data provenance
The document indicates that "Performance testing was conducted to demonstrate that the Reliance CI is an effective monitor for the circulating peracetic acid dose." However, it does not specify the sample size used for this performance testing.
Regarding data provenance, the testing was conducted in the context of the device's development by Albert Browne Ltd., a subsidiary of STERIS Corporation, which is based in the United Kingdom. The exact location of the testing facility is not explicitly stated, but it would presumably be within the company's research and development arm. The testing described is inherent to the development and validation of the device, making it prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for chemical indicators like this is typically established by controlled laboratory conditions where the concentration of the active chemical (peracetic acid in this case) is precisely known and measured by analytical methods, rather than by human expert consensus or pathology. The assessment of color change is likely objective based on defined reference colors.
4. Adjudication method for the test set
This information is not provided. Given that the "ground truth" for a chemical indicator's color change is typically based on objective chemical concentrations and predefined color references, a formal adjudication method by experts (like 2+1, 3+1) is usually not applicable in the same way it would be for image-based diagnostic devices. The assessment is likely based on comparing the indicator's color to a standard color chart or reference after exposure to known concentrations.
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 indicator, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
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 an algorithm. Its performance is inherent in its chemical reaction and visible color change, which is then interpreted by a human user (by observing the color). There is no "algorithm only" performance separate from its physical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the Reliance™ CI Process Indicator is based on precisely measured and controlled concentrations of peracetic acid (PAA) dose (specifically, 9,000 mg/L PAA min. and 11,500 mg/L PAA min.) within the specified Reliance™ EPS Endoscope Processing System. The efficacy of the indicator is determined by its ability to accurately reflect these known chemical concentrations through its defined color change.
8. The sample size for the training set
Not applicable. This document describes a chemical indicator, not a machine learning or AI-based device that requires a training set. The performance is based on chemical and physical properties, not trained algorithms.
9. How the ground truth for the training set was established
Not applicable. As stated above, this is not an AI/machine learning device, so there is no "training set" or establishment of ground truth for such a set.
§ 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).