(217 days)
WaterCleck™ CP Reagent Strip is intended to be used in detecting residual chlorine or peroxide in dialysis water. It also is used for detection of effective high level of chlorine in the disinfecting solution.
WaterCleck™ CP Reagent 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. The chemistry of the regent strip allows the same single reagent pad to react with either chlorine or peroxide. It is self-contained and is ready to use as a dip-and-read reagent strip without other additional reagent.
The provided text describes a medical device called "WaterCheck™ CP Reagent Strip for Chlorine and Peroxide." It focuses on its intended use, technological comparison to existing products, and a statement of substantial equivalence. However, the document does not contain the detailed acceptance criteria and study information typically found in a comprehensive medical device submission that would allow for a complete answer to your request.
Specifically, the document lacks:
- A table of acceptance criteria with reported device performance values.
- Details on sample sizes for test sets, data provenance, or information about training sets.
- Information on experts used to establish ground truth, adjudication methods, or MRMC studies.
- Data regarding standalone algorithm performance or the type of ground truth used in a formal study.
Therefore, I cannot fully answer your request with the provided information.
However, based on the limited information about performance claims, I can infer what might be considered acceptance criteria based on its comparison to predicate devices, but this is a reconstruction and not explicitly stated in the document.
Inferred Potential Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence Claims):
| Parameter | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (from text) |
|---|---|---|
| Residual Chlorine Detection | Detect 0.5 ppm or less of chlorine | Detect 0.5 ppm or less of chlorine. Can extend detection range to 1000 ppm or more (for high-level disinfection monitoring). |
| Hydrogen Peroxide Detection | Detect 1.0 ppm of hydrogen peroxide | Detect 1.0 ppm of hydrogen peroxide. More sensitive to 0.5 ppm or less of hydrogen peroxide (compared to Renalin Strip). |
| Hydrogen Peroxide Stability | Stable at room temperature (compared to predicate) | Stable at room temperature. |
Missing Information (Cannot be extracted from the provided text):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
- 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 is not an AI device or an imaging study requiring human reader performance).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this is a chemical reagent strip, not an algorithm).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated, but for chemical detection, the "ground truth" would typically be established by laboratory methods using known concentrations of chlorine or peroxide.
- The sample size for the training set: Not applicable (this is a chemical reagent strip, not a machine learning model requiring a training set).
- How the ground truth for the training set was established: Not applicable.
§ 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.