(134 days)
Conductivity/TDS Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells and instruments. The Conductivity/TDS Calibrator Solutions may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the equipment, and do not come into contact with the patient.
The device consists of salt dissolved in purified water. The proportion of salt determines the solution's conductivity. The solution is packaged into sealed polyethylene bottles.
The provided text describes the 510(k) summary for the "Conductivity/TDS Calibrator Solution." Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of specific numerical thresholds for conductivity or TDS. However, the implicit acceptance criterion is that the device demonstrates sufficient accuracy and reliability for its intended use as a calibrator solution. | "The test results demonstrated that the device exceeded the acceptance specifications by greater than one order of magnitude." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "production lots" were used for validation.
- Data Provenance: The validation was performed by the "Danish Institute of Fundamental Metrology." This indicates an international (Denmark) origin for the testing. The study was likely prospective as it was performed on "production lots" to validate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The validation was performed by an institute, not explicitly by individual experts establishing ground truth in a clinical context.
4. Adjudication Method for the Test Set
- This information is not provided in the document. The study does not appear to involve human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is a calibrator solution for instruments, not an AI-based diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance study was done. The device itself is the "algorithm" (in the sense of a physical reference standard) and its performance was evaluated independently by the Danish Institute of Fundamental Metrology. There is no human-in-the-loop component for this type of device's primary function.
7. The Type of Ground Truth Used
- The ground truth for the performance validation was established by the "Danish Institute of Fundamental Metrology." This implies a metrological standard or reference measurement as the ground truth. They are an institute specializing in fundamental metrology, which concerns the scientific study of measurement.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The device is a calibrator solution, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided. As mentioned above, there is no training set for this type of device.
§ 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.