(222 days)
The Serim™ Dialysate Monitor™ Test Strip provides semi-quantitative indications of pH, bicarbonate, and glucose (which acts as a tracer for the acid concentrate) concentrations in final bicarbonate dialysate solutions. They can be used to monitor the proper preparation of such dialysate solutions. The Serim™ Dialysate Monitor™ Test Strips are to be used to supplement current methods for testing dialysate.
SERIM Dialysate Monitor Test Strips are firm plastic strips that contain three reagent areas to test for pH, bicarbonate/carbonate ion, and glucose in dialysate. The glucose concentration is a tracer of the amount of acid concentrate added to the dialysate.
Here is a summary of the acceptance criteria and study information for the SERIM™ Dialysate Monitor™ Test Strip, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device performance in terms of its ability to detect misdilutions and its substantial equivalence to predicate devices, rather than explicit numerical acceptance criteria.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Misdilution Detection | Ability to detect significant misdilutions of dialysate concentrates (acid or bicarbonate). | "Significantly misdiluted samples were readily detected by the strips and also provided indications of which component, acid or bicarbonate concentrate was added in the improper amount. We have shown that when solutions were misdiluted by 35% or more, there was a good probability of detecting this misdilution by means of the test strip." |
| Normal Sample Detection | Provide expected values when samples are properly diluted. | "All normal samples gave the expected values as read by the test strips." |
| pH Pad Performance | Substantially equivalent to previously cleared pH strip (K945491) and comparable to pH meters using glass electrodes. | "The pH strip is identical to that which has been previously cleared by the FDA (K945491). In this submission, the pH readings of the strip were compared to that of pH meters using glass electrodes." (Implicitly, the comparison found equivalence, as it's not further discussed as a non-conformance) AND "Each of the pads on the test strips was substantially equivalent to the results of the corresponding predicate devices." |
| Bicarbonate Pad Performance | Correlate with bicarbonate concentration and be substantially equivalent to a conductivity meter (IBP Gmbh Model HDM97, K020908). | "Since both the conductivity and the test strip colors correlate with total ionic concentrations it was expected and was found experimentally that the test strips correlated well with the conductivity of the final dialysate assuming that the concentration of other ions remains about constant." AND "Each of the pads on the test strips was substantially equivalent to the results of the corresponding predicate devices." |
| Glucose Pad Performance | Correlate with known glucose concentrations and be substantially equivalent to the Bayer Multistix® 10SG (glucose pad) K992257. | "Each test strip separately correlated well with known glucose concentrations. Therefore, it was expected and found that the Serim test strip correlated well with the predicate Bayer test strip." AND "The glucose test strip used in this test is similar in composition to the predicate device. It consists of glucose oxidase, peroxidase, buffers, and an indicator." AND "We compared the performance of the Serim glucose test strip against the performance of the glucose pad on the Bayer MultiStix 10 SG test strip using standard glucose solutions prepared in dialysate." (Implicitly, the comparison found equivalence, as it's not further discussed as a non-conformance) AND "Each of the pads on the test strips was substantially equivalent to the results of the corresponding predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "samples obtained from a dialysis clinic" and "normal and intentionally misdiluted samples were prepared." For significantly misdiluted samples, errors of "2X or 0.5X the correct amount of bicarbonate concentrate" were used. There are no specific numerical sample sizes provided for either the clinic samples or the prepared samples.
- Data Provenance: The study used a combination of:
- Retrospective/Prospective (Mixed): Samples "obtained from a dialysis clinic" (likely prospective, but could include some retrospective analysis if pre-existing samples were used).
- Synthetically Prepared: "normal and intentionally misdiluted samples were prepared."
- Country of Origin: Not explicitly stated, but the submission is to the FDA for a US company, implying the study was conducted in the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The document describes comparisons to predicate devices and known concentrations, rather than expert interpretation of the test strips.
4. Adjudication Method for the Test Set:
This information is not provided as the study appears to rely on direct comparison to predicate devices and known concentrations, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The device is a test strip designed for semi-quantitative visual interpretation or comparison to predicate devices/known standards, not an AI system requiring human reader comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
The device itself is a test strip, not an algorithm. Its performance is inherent in its chemical reactions and color changes. The "standalone" performance here refers to the strips' ability to accurately reflect the pH, bicarbonate, and glucose levels as designed, which was evaluated against predicate devices and known concentrations. The study did evaluate the device in a standalone manner by comparing its readings to objective measures (pH meters, conductivity meters, known glucose concentrations).
7. Type of Ground Truth Used:
The ground truth used for the study included:
- Objective Measurement Devices: pH meters (glass electrodes), IBP Gmbh Model HDM97 conductivity meter.
- Known Concentrations: Standard glucose solutions, and intentionally created misdiluted dialysate samples with 2X or 0.5X dilution errors.
- Predicate Device Performance: The performances of the Bayer Multistix® 10SG (glucose pad) and the previously cleared SERIM™ Dialysate Monitor™ Test Pad (pH) served as a comparative ground truth for equivalence.
8. Sample Size for the Training Set:
This information is not applicable as the SERIM™ Dialysate Monitor™ Test Strip is a chemical test strip, not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above; there is no training set for a chemical test 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.