(90 days)
The Frese ،ius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the انان od flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement.
The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure.
It may be used in conjunction with access devices, such as; the Fresenius Online Clearance Monitor", the CritLine® from HemaMetrics, or the HD01 Hemodialysis Monitor from Transonic Systems when flow reversal is required.
The Fresenius Access Flow Reversing Connector is designed to be used during hemodialysis when an access flow measurement is required. The AFRC facilitates the test procedure by eliminating the need to disconnect the arterial and venous lines and reconnecting them to facilitate the switch in flow direction. The device contains a valve that allows reverse blood flow to and from vascular access sites. The device is manually operated and turns 180° to reverse the blood flow communication. The Fresenius Access Flow Reversing Connector will be available as both a standalone and as a component in the Combilines Hemodialysis bloodline tubing sets.
This is a submission for a medical device (Fresenius Access Flow Reversing Connector), not an AI/ML device. Therefore, the typical "acceptance criteria and study that proves device meets acceptance criteria" for AI/ML devices, including details on test sets, ground truth, expert opinions, and training sets, are not applicable here.
However, I can still extract information related to the device's safety and performance and what the submission states about meeting those criteria, based on the provided text.
1. Acceptance Criteria and Reported Device Performance
The submission does not explicitly list acceptance criteria in a quantitative table as one might find for an AI/ML diagnostic device with performance metrics like sensitivity, specificity, etc. Instead, it relies on the concept of substantial equivalence to a predicate device.
The "Safety and Performance" section states:
"The intended use, technological characteristics, design features, and material are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the Fresenius Access Flow Reversing Connector is supported by the substantial equivalence information, materials data, device description, and performance testing."
This means the primary "acceptance criterion" is that the device is substantially equivalent to a previously cleared predicate device, and thus considered safe and effective for its intended use. The performance is "reported" implicitly through this claim of substantial equivalence and general safety/effectiveness.
Table of (Implicit) Acceptance Criteria and Reported Performance:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The device is deemed "substantially equivalent" to Medisystems Blood Tubing Set Accessories (Revers~™); K994306. |
| Safe for Intended Use | The safety of the device is "supported by the substantial equivalence information, materials data, device description, and performance testing." The FDA's 510(k) clearance confirms this. |
| Effective for Intended Use | The effectiveness of the device is "supported by the substantial equivalence information, materials data, device description, and performance testing." The FDA's 510(k) clearance confirms this. The device "facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure" for access flow measurement during hemodialysis. |
| Technological Characteristics (e.g., flow reversal mechanism) | Described as "manually operated and turns 180° to reverse the blood flow communication." Implied to be equivalent or similar to predicate. |
| Material Compatibility | "Materials data" reviewed to support safety and effectiveness. Implied to be compatible with blood and hemodialysis procedures. |
| Functionality (eliminating bloodline disconnection) | The device fulfills its intended function: "eliminating the need to disconnect the arterial and venous lines and reconnecting them to facilitate the switch in flow direction." |
Since this is not an AI/ML device, the following points are not applicable or cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML "test set" for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is the established safety and efficacy of the predicate device and the new device's ability to perform its mechanical function safely.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.