(54 days)
SERIM® HiSENSE ULTRA 0.1 TM Test Strips provide a convenient means for indicating the concentration of residual chlorine (chlorine bleach) detected in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. HiSENSE ULTRA 0.1 also provides a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in water used to prepare dialysate.
The device is a semi-quantitative or qualitative, single use, reagent test strip made up of a 0.20 inch square reagent pad that has been chemically treated to detect total chlorine (free chlorine/chloramines) in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
This document is a 510(k) summary for the SERIM® HiSENSE ULTRA 0.1™ Test for Total Chlorine. It describes the device, its intended use, technological characteristics, and performance evaluation.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detect total chlorine concentrations | Reliably detect concentrations of 0.1 ppm total chlorine. Device detects concentrations between 0 and 3 ppm. |
| Substantial equivalence to predicate device (SteriChek Sensitive Total Chlorine Reagent Strips) | Performance is substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical sample size for the test set. It mentions: "The performance of the Serim HiSENSE ULTRA 0.1 Test Strips were evaluated using water samples in which either sodium hypochlorite or chloramines were added to give a range of total chlorine (free chlorine/chloramines) levels."
- Sample Size: Not explicitly stated as a number of samples. The evaluation used "water samples."
- Data Provenance: The water samples were prepared by adding sodium hypochlorite or chloramines to achieve varying total chlorine levels. While the country of origin isn't specified, it's implied to be an in-house laboratory evaluation based on the nature of the test. It is a prospective evaluation, as samples were prepared for the purpose of testing the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth for the prepared water samples would typically be established by precise chemical measurements (e.g., using a reference method or analytical chemistry techniques) rather than human experts interpreting results.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of a semi-quantitative chemical test strip, the adjudication method would likely involve comparing the color change on the strip to a color chart provided with the device, and subsequently comparing that reading to the known concentration of the prepared water sample.
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 manual chemical test strip, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device requires human interpretation of the color change on the test strip against a color chart. It is not an automated algorithm.
7. The Type of Ground Truth Used
The ground truth for the test set was established by prepared water samples with known concentrations of total chlorine. These known concentrations would have been determined through precise chemical methods, making it an analytical truth.
8. The Sample Size for the Training Set
This information is not provided in the document. As a chemical test strip, it's unlikely to have a "training set" in the sense of machine learning algorithms. The design and calibration of the test strip's chemical formulation and color chart would be based on chemical principles and experimental validation, but the term "training set" is not applicable here.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8. The "ground truth" for developing such a device would reside in the chemical reactions and the correlation of color intensity to chlorine concentration, established through laboratory experiments and chemical analysis during the product's R&D phase.
§ 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.