(93 days)
Conductivity/pH Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS and pH measurement instruments. The conductivity /TDS cells and instruments may be indicated for calibrating the conductivity and pH 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 hemodialysis machine or water purification equipment, and does not come into contact with the patient.
The device consists of salts (Sodium Chloride, Sodium Phosphate Dibasic, and Potassium Phosphate Monobasic) dissolved in de-ionized water. The proportion of total salt determines the solution's conductivity. The proportions of Sodium Phosphate Dibasic and Potassium Phosphate Monobasic determine the solution's pH. The solution is packaged into sealed polyethylene bottles. The performance specifications of the device are a pH value of pH 7.0 ± 0.03 pH units and a conductivity value of 14.00 mS/cm ± 0.03 mS/cm. The solution should maintain these values for 18 months stored in a sealed bottle. The solution should also maintain these values for 30 days within an opened but recapped bottle. There will be two bottle sizes of this solution, a 32-oz bottle and a 16-oz bottle.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Conductivity/pH Calibrator Solution
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Specifications) | Reported Device Performance |
|---|---|
| pH value of pH 7.0 ± 0.03 pH units | New Device (2013): 7.0 pH ± 0.03 pH @ 25°C. |
| Study Results: The "PQ-RM017 pH and Conductivity Solution Manufacturing Process" validated production to specification. The "PQ-RM019 pH and Conductivity Solution Storage Stability" demonstrated pH values remain within specification for 18 months, with extrapolation from 13-41 weeks. The "PQ-RM018 pH and Conductivity Solution Open Bottle Stability" demonstrated pH values remain within specification for 30 days after opening. | |
| Conductivity value of 14.00 mS/cm ± 0.03 mS/cm | New Device (2013): 14.0 millisiemen ±0.03 millisiemen @ 25°C. |
| Study Results: The "PQ-RM017 pH and Conductivity Solution Manufacturing Process" validated production to specification. The "PQ-RM019 pH and Conductivity Solution Storage Stability" demonstrated conductivity values remain within specification for 18 months, with extrapolation from 13-41 weeks. The "PQ-RM018 pH and Conductivity Solution Open Bottle Stability" demonstrated conductivity values remain within specification for 30 days after opening. | |
| Shelf life: 18 months (sealed bottle) | New Device (2013): 18 months. |
| Study Results: The "PQ-RM019 pH and Conductivity Solution Storage Stability" demonstrated that values remain within specification for 18 months. Results were extrapolated from data taken between 13 and 41 weeks. | |
| Shelf life: 30 days (opened but recapped bottle) | New Device (2013): 30 days. |
| Study Results: The "PQ-RM018 pH and Conductivity Solution Open Bottle Stability" demonstrated the device is within specification after 30 days of the bottle being opened and recapped several times. | |
| Independence of measurement instrument | Study Results: The "PQ-RM020 pH and Conductivity Solution Instrument Independence" demonstrated that the new device's conductivity measurements are independent of the type of measurement instrument, similar to the predicate. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes (number of bottles, measurements, etc.) for each validation test (PQ-RM017, PQ-RM018, PQ-RM019, PQ-RM020). It refers to "production lots" for the initial manufacturing process validation.
The data provenance is retrospective, as the studies were performed on "production lots" and involved testing for stability over time. The country of origin of the data is Mesa Laboratories, Inc., located in Lakewood, CO, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device. The ground truth for calibrator solutions is established through comparison to N.I.S.T. (National Institute of Standards and Technology) SRM's (Standard Reference Materials), which are highly precise and certified standards. It does not involve human expert interpretation or consensus.
4. Adjudication Method for the Test Set
This information is not applicable. As discussed above, the validation involves objective measurement against NIST standards, not human interpretation that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where human readers' performance is evaluated and compared with and without AI assistance. This device is a calibrator solution, not an interpretive medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This concept is not directly applicable in the traditional sense of an "algorithm only" performance for an AI/ML device. However, the performance of the calibrator solution itself, independent of the user, is assessed in the various validation studies (e.g., manufacturing process, storage stability, open bottle stability, instrument independence). The device's performance characteristics (pH, conductivity) are measured directly using instrumentation.
7. The Type of Ground Truth Used
The ground truth used for these studies is N.I.S.T. SRM's (Standard Reference Materials). These are primary calibration standards produced in accordance with NIST instructions, providing highly accurate and traceable reference values.
8. The Sample Size for the Training Set
This information is not applicable. This device is a chemical calibrator solution, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this 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.