CAREline Twister: The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the responsibility of the physician. The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The Fresenius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood 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. Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K2 and T Hemodialysis Machines. CAREline Standard: The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the resonsiblity of the physician. The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K.2 and T Hemodialysis Machines.
The CAREline bloodlines are intended for use in acute and chronic hemodialysis therapy. The bloodline is part of the hemodialysis extracorporeal circuit, which transports arterial blood from the patient's arterial access (e.g., fistula or catheter) through a hemodialyzer and back to the patient's venous access.
The provided text describes the 510(k) premarket notification for the CAREline Airless Hemodialysis Blood Tubing Sets. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove device performance against specific acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not explicitly available in the provided document. The document outlines performance testing conducted to support substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it lists various performance tests conducted to support substantial equivalence. The "reported device performance" is implied to have met the requirements of these tests, as the FDA concluded substantial equivalence.
| Performance Test Type | Reported Device Performance |
|---|---|
| Performance testing of connectors (hemodialyzer, vascular access device, and ancillary components) | Results support determination of substantial equivalence (specific outcomes not detailed). |
| Structural integrity testing | Results support determination of substantial equivalence (specific outcomes not detailed). |
| Biological safety testing (biocompatibility) | Passed: Chemical analysis (extractables and leachables), Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Material Mediated Pyrogenicity, Genotoxicity, Hemocompatibility. Toxicological risk assessment performed. |
| Sterility and pyrogenicity testing | Results support determination of substantial equivalence (specific outcomes not detailed). |
| Structural integrity - Pressure and pull testing | Results support determination of substantial equivalence (specific outcomes not detailed). |
| Pressure testing Access ports and pressure output devices (PODs) | Results support determination of substantial equivalence (specific outcomes not detailed). |
| Endurance testing | Conducted with Fresenius Medical Care 2008® Series K, K2, and T Hemodialysis Machines. Results support determination of substantial equivalence (specific outcomes not detailed). |
| Clamp testing (Ability to occlude and effects of repeated use) | Results support determination of substantial equivalence (specific outcomes not detailed). |
| Usability evaluation | Results support determination of substantial equivalence (specific outcomes not detailed). |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each of the performance tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The testing was conducted in accordance with ISO 8638:2010.
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)
This information is not provided. The performance tests described are primarily engineering and biological safety tests, which typically rely on standardized protocols and instrumental measurements rather than human expert interpretation for "ground truth" in the way a diagnostic AI might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for these performance tests.
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
No such study was conducted. The device is a physical medical device (blood tubing set) and does not involve AI or human readers in an interpretative capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the listed performance tests, the "ground truth" would be established by the physical and chemical properties measured according to international standards (e.g., ISO 8638:2010) and established biological safety testing methods. For instance:
- Biocompatibility: Ground truth is based on the results of validated assays (e.g., cytotoxicity, sensitization, genotoxicity tests) against predetermined pass/fail criteria specific to those tests, often compared to controls.
- Structural Integrity: Ground truth is based on whether the device withstands specified pressures, pulls, or cycles without failure, as defined by engineering specifications.
8. The sample size for the training set
Not applicable. This is a physical medical device undergoing performance testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical 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.