(69 days)
The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide® 28 and Metricide Plus 300 Solutions (Browne Metrex 1.8% Glutaraldehyde Indicator) is a glutaraldehyde concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration of 1.8% glutaraldehyde.
The Browne Metrex 1.8% Glutaraldehyde Indicator is dedicated for use with Metricide® 28 and Metricide Plus 30® Solutions.
The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and The Drownload Solution and the substantially equivalent device are chemical indicator strips intended to monitor the concentration of glutaraldehyde in glutaraldehyde-containing germicide solutions. The devices indicate, via a color change, if the germicide concentration exceeds the MEC for the solution.
The Browne Metrex 1.8% Glutaraldehyde Indicator consists of a polypropylene The Drowns 110ward results of pad on one end. The indicator pad is impregnated with an indicator solution that changes color from yellow to purple in liquid chemical germicides with a glutaraldehyde concentration above the MEC of 1.8%.
The provided text describes a 510(k) summary for the Browne Metrex 1.8% Glutaraldehyde Indicator. It outlines the device's intended use and performance testing.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the intended use and the specific glutaraldehyde concentration thresholds. The reported performance refers to the device's ability to meet these thresholds.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accurately indicate glutaraldehyde concentration = 2.1% | Strip exhibits a uniform purple color (at 60 secs) |
| Accurately indicate glutaraldehyde concentration between 1.8-2.1% | Strip may appear yellow, purple/yellow, or purple (at 60 secs) |
| No false positives in solutions containing 1.8% glutaraldehyde (when used according to IFU) | "No false positives were recorded in solutions containing 1.8% glutaraldehyde, when the testing was performed according to the Instructions for Use." |
| Effective monitor for glutaraldehyde component of Metricide 28 and Metricide Plus 30 Solution with a MEC of 1.8%. | "The data demonstrates that the Browne Metrex 1.8% Glutaraldehyde Indicator is an effective monitor for the glutaraldehyde component of the Metricide 28 and Metricide Plus 30 Solution with a glutaraldehyde MEC of 1.8%." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that testing was performed in "solutions containing 1.8% and 2.1% glutaraldehyde." However, it does not specify the exact number of indicators tested or the number of solution samples used for the test set.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) submission, it is highly likely that this was a prospective, in-house laboratory study conducted by the manufacturer (Albert Browne Ltd., located in the United Kingdom).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (a chemical indicator strip) does not typically involve human expert interpretation for "ground truth" establishment in the same way, for example, a medical imaging AI would. The "ground truth" for the test set is the actual, measured glutaraldehyde concentration of the solutions used.
- Number of Experts: Not applicable in the context of expert interpretation. The ground truth is established by chemical analysis of the solutions.
- Qualifications of Experts: Not applicable for establishing ground truth for this device type. The accuracy of the glutaraldehyde concentration would rely on standard chemical laboratory practices and equipment.
4. Adjudication Method for the Test Set
Not applicable. The color change of the indicator is a direct chemical reaction, not a subjective interpretation requiring adjudication among human readers. The "reading" of the indicator is a comparison to a color chart or a visual assessment based on specific color descriptions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This device is a chemical indicator, not a diagnostic imaging or interpretive device that requires human readers. Therefore, an MRMC comparative effectiveness study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The device itself is a standalone chemical indicator. Its performance is measured by its intrinsic chemical reaction and the resulting color change, without human-in-the-loop performance influencing the primary "reading" (though a human must visually interpret the color change against the provided guidance). The performance described ("No false positives were recorded...") is the standalone performance of the indicator.
7. The Type of Ground Truth Used
The ground truth used is the known, measured glutaraldehyde concentration of the germicide solutions. This would be established through a separate, calibrated chemical assay method.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. This is a chemical indicator, not an AI/ML device that requires a training set. The performance is based on the inherent chemical properties of the indicator.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of chemical indicator. The device's mechanism is based on established chemical principles.
§ 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).