(225 days)
The Fresenius iCare Monitoring System is a computer-based hemodialysis treatment monitoring system for adjunctive use with the Fresenius 2008 series dialysate delivery system when the patient is attended by trained personnel.
This monitoring system is contraindicated as the sole method of monitoring a patient during hemodialysis.
The Fresenius iCare Monitoring System is a computer-based hemodialysis treatment monitoring system. It is an updated version of the Fresenius FDS08.
The provided text is a 510(k) Premarket Notification for the "Fresenius iCare Monitoring System". This document focuses on establishing substantial equivalence to a predicate device (Fresenius FDS08) rather than detailing a study that proves the device meets specific performance acceptance criteria through quantitative metrics.
Therefore, many of the requested categories cannot be filled as the information is not present in the provided text. The document primarily asserts "equivalence" and "safety and effectiveness" without providing the underlying data from studies that would demonstrate these claims in a detailed, quantitative manner.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document states that "The iCare Monitoring System validation rigorously tested the features of the Fresenius iCare System. The results of this testing indicate that the iCare System is safe and effective for its intended use." However, it does not provide any specific quantitative acceptance criteria or the measured performance of the device against those criteria (e.g., accuracy, precision, sensitivity, specificity, or specific tolerances for monitored parameters). The focus is on demonstrating substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified
- Data provenance: Not specified
Explanation: The document refers to "validation" and "rigorous testing" but does not detail the protocols, sample sizes, or nature of the test data used for these activities.
3. 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)
- Number of experts: Not specified
- Qualifications of experts: Not specified
Explanation: There is no mention of experts being used to establish a "ground truth" in the context of performance evaluation for this monitoring system. The validation activities are generally expected to compare the device's output against known inputs or established reference methods, but the document does not elaborate on this.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not specified
Explanation: Since no details on expert-based ground truth establishment or comparative evaluations are provided, there is no mention of an adjudication method.
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
- MRMC study done: No
- Effect size of improvement: Not applicable
Explanation: The device is described as a "computer-based hemodialysis treatment monitoring system for adjunctive use." It is not an AI-assisted diagnostic or interpretation system that would typically undergo an MRMC study comparing human performance with and without AI. It monitors parameters, and its safety relies on it being "attended by trained personnel" and not being the "sole method of monitoring."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance study done: Not explicitly detailed, but implied by the "validation rigorously tested the features" statement. However, no performance metrics are given.
Explanation: The document asserts the system's "safety and effectiveness for its intended use" based on its validation. This validation would inherently involve evaluating the algorithm's performance in monitoring. However, specific standalone performance metrics (e.g., accuracy of measurement, speed, or reliability under various conditions) are not disclosed in this summary. The device's intended use is adjunctive, meaning it's not designed to operate without human oversight.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not specified
Explanation: The document does not detail how the accuracy or reliability of the monitoring system's measurements or alerts (which would constitute its "ground truth") were established during validation tests.
8. The sample size for the training set
- Sample size for training set: Not applicable (or not specified if the system involves machine learning).
Explanation: The device is described as a "computer-based hemodialysis treatment monitoring system." While computer-based systems can involve algorithms, the document doesn't indicate it's a machine learning or AI system that requires a distinct "training set" in the modern sense. It appears to be an update to an existing monitoring system, implying rule-based or deterministic algorithms rather than data-driven learning.
9. How the ground truth for the training set was established
- How ground truth was established for training set: Not applicable.
Explanation: As above, if a training set was not explicitly used (as in an ML model), then the establishment of its ground truth is not relevant to this document.
§ 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.