(a) Identification. A hemodialyzer with expanded solute removal profile is a device intended for use a part of an artificial kidney system for the treatment of patients with renal failure by performing such therapies as hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer with expanded solute removal profile includes modifications to the semipermeable membrane that allows for increased removal of uremic retention solutes compared with standard high-flux hemodialyzers of the high permeability hemodialysis system classification (§ 876.5860), including solutes at the upper end of the “middle” molecular weight range (0.5 kDa to 60 kDa). This device is intended to be used with the extracorporeal hemodialysis delivery systems, blood tubing sets, blood access devices, and accessories regulated under §§ 876.5820, 876.5860, 876.5540, and/or 876.5600.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing under anticipated conditions of use must evaluate the solute removal profile and document all adverse events.

(2) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Ultrafiltration;

(ii) Blood and dialysate pressure drop;

(iii) Clearance rates;

(iv) Sieving coefficients;

(v) Mechanical hemolysis;

(vi) Structural integrity;

(vii) Blood compartment integrity;

(viii) Volume of the blood compartment; and

(ix) Endotoxin retention of the dialyzer membrane.

(3) The tissue-contacting components of the device must be demonstrated to be biocompatible. Biocompatibility evaluation must include a chemical analysis of the dialyzer membrane.

(4) Performance data must demonstrate the sterility of the patient-contacting components of the device.

(5) The patient-contacting components of the device must be demonstrated to be non-pyrogenic.

(6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(7) Device labeling must include:

(i) Shelf life;

(ii) Storage conditions;

(iii) Instructions for the preparation of the hemodialyzer, initiation of dialysis, troubleshooting, and discontinuance of dialysis;

(iv) Membrane surface area, priming (blood) volume, maximum transmembrane pressure, maximum blood flow and maximum dialysate rate for each model;

(v) A non-pyrogenic statement;

(vi) A summary of the in vitro performance data, provided in tabular form; and

(vii) A summary of the clinical performance data.

[89 FR 72716, Sept. 6, 2024]