(145 days)
The Revital-Ox™ RESERT™ R60 Solution Test Strip is a high level disinfectant concentration monitor dedicated for use with Revital-Ox™ RESERT™ High Level Disinfectant. The purpose of the Revital-Ox™ RESERT™ R60 Solution Test Strip is to determine whether the concentration of hydrogen peroxide, the active ingredient in Revital-Ox™ RESERT™ High Level Disinfectant, is above the minimum recommended concentration (MRC) of 1.5%.
The Revital-Ox™ RESERT™ R60 Solution Test Strip is a chemical indicator strip consisting of an absorbent paper pad impregnated with reactive chemicals that is adhesively bonded to one end of a polymer film. The polymer strip has a window to facilitate viewing of the color change. The Revital-OxTM RESERT™ R60 Solution Test Strip has been developed to monitor Revital-Ox™ RESERT™ High Level Disinfectant solution (originally cleared as Resert XL HLD High Level Disinfectant) that has a minimum recommended concentration (MRC) of 1.5%. The Revital-Ox™ RESERTIM R60 Solution Test Strip is dipped into a working solution of Revital-Ox™ RESERT™ High Level Disinfectant and the resultant color reaction is viewed through the window to determine if the solution is above the MRC and thus still suitable for use.
The provided text describes the acceptance criteria and a summary of performance testing for the Revital-Ox™ RESERT™ R60 Solution Test Strip. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance | Equivalent performance to the predicate in pass and fail conditions for simulated use. | Equivalent |
| Specificity | Incomplete color change when exposed to tap water only or to Revital-Ox™ RESERT™ High Level Disinfectant solution with peroxide below MRC or no peroxide | The proposed strip does not change when exposed to the active ingredient (hydrogen peroxide) alone as the predicate does. The proposed strip requires the active ingredient of the disinfectant to be in its final form thus demonstrating greater specificity to the disinfectant solution than the predicate. The proposed strip performs equivalently to the predicate in water alone or in disinfectant without the active ingredient. |
| Contaminants | Equivalent performance to the predicate in pass and fail conditions in the presence of organic and inorganic contaminants in the test solution | Equivalent |
| Exposure to aggressive chemicals | Equivalent performance to the predicate in pass and fail conditions | The proposed strip demonstrated failing results under pass conditions after exposure to aggressive chemicals. The product labeling includes a warning to store away from aggressive chemicals. This same warning is in the labeling of the predicate device. |
| Blind study testing | Equivalent performance to the predicate in pass and fail conditions | Equivalent |
| Shelf life | Meet performance specifications at each time point after storage in different environments | Performance testing of the proposed device out to one year was performed. |
| In-use (open bottle) | Meet performance specifications at each time point after storage in different environments | Performance testing of the proposed device up to 11 days was performed. |
2. Sample size used for the test set and the data provenance:
The document summarizes "verification activities" and "performance testing" but does not explicitly state the sample sizes (e.g., number of test strips, number of solution samples) used for each test. It also does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document mentions "Blind study testing" and "Blind interpretation of exposed strips" but does not provide details on the number or qualifications of experts involved in establishing ground truth for these interpretations.
4. Adjudication method for the test set:
The document mentions "Blind study testing" and "Blind interpretation," but does not specify an adjudication method (e.g., 2+1, 3+1, none) used for the test set results.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:
No, an MRMC comparative effectiveness study was not done. This is a chemical indicator device, not an AI-assisted diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance tests described are standalone evaluations of the chemical indicator strip's ability to detect the hydrogen peroxide concentration. The device is a test strip, not an algorithm, and its performance is inherently standalone (without human-in-the-loop for its basic function of indicating concentration). Human interpretation is required to read the strip's color change, which is covered by the "blind study testing."
7. The type of ground truth used:
The ground truth for this device would be established by controlled chemical solutions with known concentrations of hydrogen peroxide, both above and below the Minimum Recommended Concentration (MRC) of 1.5%. For specificity, tap water and disinfectant solutions without the active ingredient would also serve as ground truth for negative controls.
8. The sample size for the training set:
Not applicable. This device is a chemical indicator strip, not a machine learning algorithm that requires a "training set." The development of the strip involves chemical formulation and optimization, not data-driven training.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 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).