(89 days)
E-Z Chek® Residual Chlorine Test Strips (K100-0101B) provide accurate and convenient means of measuring the concentration of free chlorine remaining in water when rinsing out equipment following disinfection. A rapid screening qualitative method will detect levels above 0.5ppm (mg/L) while the 30 second semi-quantitative method allows interpolation of concentration between 0ppm and 5ppm. The qualitative method can be used to determine that chlorine has been adequately rinsed from the equipment. The semi-quantitative method may be useful when corrective measures are undertaken on equipment retaining higher levels of chlorine for extended periods and for testing any containers disinfected with free chlorine (bleach).
Reprocessing Products Corporation (RPC) E-Z Chek® Residual Chlorine Test Strips (K100-0101B) is semi-quantitative or qualitative, reagent test strip comprised of a pad impregnated with chemicals, which change color upon contact with free chlorine and combined chlorine (monochloramines). The pad is attached to a plastic strip for handling.
The Reprocessing Products Corporation (RPC) E-Z Chek® Residual Chlorine Test Strips (K100-0101B) are designed to provide an accurate and convenient method for measuring the concentration of free chlorine remaining in water after rinsing equipment following disinfection.
Here's an analysis of the acceptance criteria and the study conducted for the device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating that the subject device consistently generates color change that meets the color blocks for reference solution concentrations, similar to the predicate device. The performance is assessed qualitatively (for detecting levels above 0.5 ppm) and semi-quantitatively (for interpolating concentrations between 0 ppm and 5 ppm).
From the "Non-clinical Performance Data" section:
"The test data confirms the subject device and the predicate device consistently generates color change which meets the color block(s) for the reference solution concentrations tested. This data demonstrates appropriate performance for the detection of residual free chlorine in rinse water that was used in disinfection of hemodialysis equipment fluid pathways."
Given this, the table would look like this:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Consistently generate color change that meets reference color blocks for tested solution concentrations. | Achieved: The test data confirms the E-Z Chek® Residual Chlorine Test Strips consistently generate color change which meets the color blocks for the reference solution concentrations tested. |
| Appropriately perform for the detection of residual free chlorine in rinse water used in hemodialysis equipment disinfection. | Achieved: The data demonstrates appropriate performance for the detection of residual free chlorine in rinse water that was used in disinfection of hemodialysis equipment fluid pathways, indicating it functions as intended for both qualitative (detecting > 0.5 ppm) and semi-quantitative (interpolating 0-5 ppm) methods. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set. It mentions "reference solution concentrations tested" implicitly indicating multiple concentrations were used. The data provenance is not specified (e.g., country of origin, retrospective/prospective), but it is a non-clinical performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be established by using "reference solution concentrations," which implies a controlled laboratory setting where the actual chlorine concentrations are known.
4. Adjudication Method for the Test Set:
No adjudication method is described. The comparison is against "color block(s) for the reference solution concentrations tested," suggesting a direct visual comparison by the test personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study is a non-clinical performance evaluation comparing the subject device's color change against known reference solutions and its predicate device. This device is a test strip, 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:
No, a standalone (algorithm only) performance study was not done. This device is a manual test strip that requires human observation and interpretation of color change to determine chlorine levels. It does not involve an algorithm.
7. The Type of Ground Truth Used:
The ground truth used is based on known, controlled reference solution concentrations of free chlorine in water. These are prepared solutions with precisely measured amounts of chlorine.
8. The Sample Size for the Training Set:
This device is a chemical test strip, not a machine learning or AI-driven product. Therefore, there is no "training set" in the context of algorithm development. The performance data is generated through testing the strips against various known concentrations.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this chemical test strip, this question is not applicable. The device's performance is inherently based on its chemical reactivity and the visual interpretation of the resulting color change against a predefined color chart.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.