(180 days)
The Verify® Chemical Monitoring Strip for Resert Solutions Version 2 is a high level disinfectant concentration monitor dedicated for use with Resert® XL HLD High-Level Disinfectant. The purpose of the Verify Chemical Monitoring Strip for Resert Solutions Version 2 is to determine whether the concentration of a Resert® XL HLD High-Level Disinfectant solution is above the minimum recommended concentration (MRC) of 1.5%.
The Verify Chemical Monitoring Strip for Resert Solutions Version 2 is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals that is adhesively bonded to one end of a polymer film. The Verify Chemical Monitoring Strip for Resert Solutions Version 2 has been developed to monitor the Resert 11 XL HLD High-Level Disinfectant that has a minimum recommended concentration (MRC) of 1.5%.
The provided document describes the K102296 510(k) submission for the "Verify® Chemical Monitoring Strip for Resert Solutions Version 2". This is a chemical indicator device, not an AI/ML medical device. Therefore, many of the requested elements for AI/ML device studies (such as MRMC studies, human reader improvement, and training set details) are not applicable.
Below is a description of the acceptance criteria and study information that can be extracted from the provided text for this specific device type.
Device Name: Verify® Chemical Monitoring Strip for Resert Solutions Version 2
Description: A chemical indicator strip designed to monitor the concentration of Resert XL HLD High-Level Disinfectant to determine if it is above the minimum recommended concentration (MRC) of 1.5%.
1. Table of Acceptance Criteria and Reported Device Performance
| Test of 3 Lots | Acceptance Criteria @ 20° and 24°C | Reported Device Performance (Result) |
|---|---|---|
| Performance Testing | FAIL @ 1.5%, PASS @ 1.8% | Pass |
| Blind Study Testing | 100% | Pass |
| Simulated Use (Contaminants) Testing | ≥ 50% | Pass |
| Test Strip Life Outside the Bottle | 100% | Pass |
| Aggressive Chemical Stability Testing | ≥ 50% | Pass |
| Specificity Testing for hydrogen peroxide | 100% | Pass |
| Stability Testing in three storage environments through labeled shelf life | ≥ 50% | Pass |
| In-Use Stability Testing in three storage environments through labeled opened bottle shelf life | 100% | Pass |
| ≥ 50% |
Note on Performance Testing Acceptance Criteria: The row for "Performance Testing" includes two criteria: "FAIL @ 1.5%" and "PASS @ 1.8%". This implies that the device should indicate a "fail" when the concentration is at the MRC (1.5%) and a "pass" when it is above the MRC (1.8%), demonstrating its ability to distinguish between concentrations at or below the MRC and those above it. The "Result" for this test is simply "Pass", indicating that these criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
The document states that a "Test of 3 Lots" was performed for all listed verification activities. This implies that the testing was conducted on samples from three different manufacturing lots of the device.
- Sample Size (Test Set): Samples from 3 lots. Specific number of strips per lot is not provided.
- Data Provenance: Not explicitly stated, but based on the device type (chemical indicator) and the nature of the tests (laboratory testing of chemical reactions and stability), this would be considered prospective data generated in a controlled laboratory environment. The country of origin of the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a chemical indicator device, and its performance is determined by its chemical reaction to a specific concentration of a disinfectant solution. The "ground truth" is the known chemical concentration of the solution, not an expert assessment.
4. Adjudication Method for the Test Set
Not applicable. The performance is based on the chemical reaction of the strip, not on subjective human interpretation that would require adjudication. The "Blind Study Testing" mentioned in the table suggests that the evaluators were blinded to the expected outcome, which is a form of control, but not an adjudication method for ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement
Not applicable. This is not an AI/ML device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While this is a "standalone" device in the sense that it doesn't integrate with an algorithm, the term "standalone performance" typically refers to the performance of an AI algorithm without human input. This device's performance is intrinsically linked to its intended use by a human visually interpreting the result. Therefore, the concept of standalone algorithm performance does not apply. The performance testing described is the standalone performance of the device as a chemical indicator.
7. The Type of Ground Truth Used
The ground truth for this device is the known chemical concentration of the Resert XL HLD High-Level Disinfectant solutions. For example, for the "Performance Testing," the ground truth was solutions at 1.5% (expected FAIL) and 1.8% (expected PASS).
8. The Sample Size for the Training Set
Not applicable. This is a chemical indicator; its design is based on chemical principles and formulation, not on a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set as described for AI/ML devices.
§ 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).