(87 days)
Myron L Company D-6 Dialysate Meter™ is a hand-held, multi-test instruments that is intended for use by trained hemodialysis professionals to verify the characteristics of product water, dialysate and sodium bicarbonate dialysate used with hemodialysis systems as a means of independently verifying functioning of in-line monitors. It may also be used by water purification specialist to verify the suitability of feed water used with hemodialysis systems and to test wastewater created by hemodialysis systems. D-6 Dialysate Meter is intended for the above uses where: a. The measurement of conductivity, resistivity, TDS, pH is needed and; b. The measurement of Oxidation Reduction Potential (ORP) is needed to determine the presence and level of oxidizing or reducing agents in product water or treated wastewater.
The D-6 Dialysate Meter™ is a microprocessor-based, battery powered, handheld, device that measures conductivity, resistivity total dissolved solids (TDS), pH, Temperature, and oxidation-reduction potential (ORP) of water and dialysate fluids associated with hemodialysis delivery systems. It measures and reports multiple ranges of conductivity, resistivity, TDS, pH and ORP. All measurement functions are automatically compensated for temperature. Up to 100 measurements can be stored in the devices memory, including the measured value, temperature and the date/time the measurement was taken. The device comes in a waterproof, chemically resistant case.
The D-6 Dialysate Meter is a medical device intended for use by trained hemodialysis professionals to verify the characteristics of water and dialysate fluids associated with hemodialysis systems. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for each measurement type (conductivity, pH, temperature, resistivity, TDS, ORP). Instead, the performance testing describes a comparative approach against published specifications of the device itself and against predicate devices. The implicit acceptance criterion is that the D-6 Dialysate Meter performs consistently with its own published specifications and comparably to predicate devices.
| Feature/Parameter | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| General | Substantial equivalence to predicate devices regarding safety and effectiveness. | "The D-6 Dialysate Meter™ is substantially equivalent regarding safety and effectivity to other devices already on the market that have the same intended uses." "The D-6 Dialysate Meter™ does not pose any new safety risks or effectivity issues." |
| Measurements | Consistent performance with published specifications and predicate devices for: Conductivity, pH, Temperature, Resistivity, TDS, ORP. | Performance tests were carried out on the D-6 Dialysate Meter™ and three predicate devices (Hydra, 90XL, HDM97). These tests: Were performed on side-by-side using identical solutions and test set-ups.Compared each device to its published specs.Where possible, compared each device to all of the other devices. |
| Temperature Compensation | Automatic temperature compensation for all ranges. | Confirmed: "Automatic All Ranges" |
| Sensors | Built-in, field-replaceable sensors. | Confirmed: "Built In: Field Replaceable" |
| Microprocessor | Microprocessor-based functionality. | Confirmed: "YES" |
| Power Supply | Battery powered. | Confirmed: "Battery" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test solutions or the number of measurements taken during performance testing. It simply states "identical solutions and test set-ups" were used.
- Data Provenance: The data was generated by the manufacturer, Myron L Company, through "performance tests... carried out on the D-6 Dialysate Meter™ and the three predicate devices listed in Table 1". The tests were conducted "side-by-side" using "identical solutions and test set-ups." The document does not specify a country of origin for the data beyond being generated by a US-based company. The study appears to be prospective as it involves actively performing tests on the new device and predicate devices.
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 in the document. The performance tests appear to have been conducted under controlled laboratory conditions, comparing the device's readings against its own specifications and those of predicate devices. There is no mention of experts establishing a ground truth for the test set in the clinical sense (e.g., radiologists interpreting images). The ground truth for the performance testing is implicitly the design specifications of the devices being tested and the known properties of the test solutions.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. As performance testing involved comparing meter readings against established specifications and other meters, there would be no need for an adjudication method in the context of expert review.
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
This information is not applicable. The D-6 Dialysate Meter is a measurement device, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. While the device is "microprocessor-based", it is a physical measurement tool. "Standalone" performance testing refers to the device's ability to accurately measure the specified parameters. The performance tests ("side-by-side using identical solutions and test set-ups") serve as the standalone performance evaluation for this type of device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth used for the performance testing of the D-6 Dialysate Meter was:
- Published specifications of the D-6 Dialysate Meter itself.
- Published specifications of the predicate devices.
- Known properties of the "identical solutions" used in the test set-ups. This implies a reliance on calibrated standards or reference measurements.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The D-6 Dialysate Meter is a hardware-based measurement device, not a machine learning or AI model that requires a "training set" in the traditional sense. Its design and calibration would be based on engineering principles and established measurement standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this type of device. The accuracy and calibration of the device are established through manufacturing processes, quality control, and adherence to measurement standards, rather than a data-driven training paradigm.
§ 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.