(234 days)
High Range Peroxide™ Test Strip is intended for use as an efficacy test strip for measuring effective levels of peroxide in Renalin® disinfectant solution. Each time when the kidney unit is reprocessed with peroxide disinfectant solution such as Renalin® , the reprocessing solution should be monitored with the High Range Peroxide™ Test Strip to assure that Renaline concentration is 3% as it is intended to be. After the kidney is placed under storage until next use, the Renaling concentration in the disinfectant solution should be checked again before rinsing with the strip to assure that Renalins concentration has been maintained at 1% or higher. If the Renaling concentration drops below 1%, the kidney unit has to be either reprocessed or discarded.
High Range Peroxide™ Strip is a paper based dry chemistry reagent strip. It consists of a single reagent pad, 0.2x0.2 inch square, adhered to one end of a 0.2x2.5 inch plastic handle with a double sided adhesive. It is a self-contained, ready to use dip-andread reagent strip without additional reagent. The strip is packaged in 50 or 100's in bottles. Color blocks corresponding to Renalin8 concentrations of 0.2, 0.5, 1.0, 2.0 and 3.0 % are printed on the bottle label. Quantitative estimation of Renalink concentration can be made by comparing the strip color to the color blocks.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Qualitative detection of ≥1% Renalin concentration (equivalent to predicate device). | "[The IBT High Range Peroxide™ Test and Renalin Perassay™ 500 Test are] equally effective in detecting Positive, i.e., 1 % or higher, of Renalin® concentration in the kidney reprocessing solution." |
| Quantitative measurement of Renalin concentration from 0.2% to 3.0%. | "The strip reactivity is modulated to provide a continuous reaction range with Renalin from 0.2 to 3.0 % or equivalent peroxide levels from 100 to 1,500 ppm. It can be used as a quantitative test for Renalink or other peroxide disinfectants." "Color blocks corresponding to Renalin® concentrations of 0.2, 0.5, 1.0, 2.0 and 3.0 % are printed on the bottle label. Quantitative estimation of Renalin® concentration can be made by comparing the strip color to the color blocks." |
| Indication of effective Renalin concentration for kidney reprocessing (initially 3%, maintained at ≥1%). | Implied by intended use: The device is used "to assure that Renalin® concentration is 3% as it is intended to be" initially, and then "to assure that Renalin® concentration has been maintained at 1% or higher" during storage. The successful granting of 510(k) suggests the device meets this intended use. |
Note: The provided document is a 510(k) summary for a reagent strip, not a detailed clinical study report. Therefore, the "reported device performance" is described qualitatively as part of a substantial equivalency argument rather than with specific statistical metrics (e.g., sensitivity, specificity, accuracy percentages) which would be typical for more complex devices or software.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state a quantitative sample size for a "test set" in the context of a formal study with statistical reporting. The evaluation appears to be based on the chemical principle and a comparison to a predicate device.
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The comparison is a direct technological comparison and statement of equivalence rather than a field test with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. Given the nature of a chemical reagent strip, "ground truth" would likely refer to known, prepared concentrations of Renalin® solution, verified by analytical chemistry methods, rather than expert interpretation of clinical data.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation of medical images or other complex data is involved. For a dip-and-read chemical strip, the "reading" is a visual comparison to color blocks.
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
- No, an MRMC study was not conducted. This type of study is relevant to imaging devices or software where human readers interpret results, often with and without AI assistance. This device is a simple chemical reagent strip.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable in the usual sense. The device is a "dip-and-read" reagent strip, meaning there is an inherent human "in-the-loop" visual comparison to color blocks. There is no automated algorithm that performs a standalone reading. The performance is the "human-in-the-loop" performance based on visual comparison.
7. The Type of Ground Truth Used
- The ground truth would be based on known, prepared concentrations of Renalin® solution (or equivalent peroxide levels). These concentrations would be analytically verified to ensure accuracy. The document refers to "Renalin® concentrations of 0.2, 0.5, 1.0, 2.0 and 3.0 %" as the basis for the color blocks, implying these are the known target values for the comparison.
8. The Sample Size for the Training Set
- This information is not provided and is generally not applicable for a simple chemical reagent strip of this nature. "Training set" typically refers to data used to train machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no "training set" in the context of machine learning. The "ground truth" for the development of the device (i.e., establishing the color scale for different concentrations) would have involved preparing solutions of known Renalin® concentrations and observing the color development on the strip.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.