(a) Identification. A pediatric continuous renal replacement therapy hemodialysis system is a device intended for use as an artificial kidney system for the management of pediatric patients with acute kidney injury and/or fluid overload by performing such therapies as hemodialysis, hemofiltration, hemodiafiltration, and isolated ultrafiltration. Using a hemodialyzer with a semipermeable membrane, the hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via ultrafiltration) and/or diffusion (via a concentration gradient in dialysate). The hemodialysis delivery machine, with an automated ultrafiltration controller, controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. During treatment, a patient's blood is circulated through the blood tubing set connected to the hemodialyzer's blood compartment. Blood access devices and accessories for hemodialysis required for the prescribed treatment are regulated under § 876.5540.

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

(1) Clinical performance testing must confirm the safety and the accuracy, precision, and reproducibility of the non-clinical performance data under anticipated conditions of use.

(2) Usability testing must demonstrate that a user can correctly use the hemodialysis delivery device based solely on reading the instructions for use.

(3) 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) Hemodialysis delivery system performance testing must include:

(A) Fluid flow accuracy testing; and

(B) Functional testing of system components including sensors, pumps, and scales to acceptance criteria.

(ii) Hemodialyzer performance testing must include:

(A) Ultrafiltration;

(B) Blood and dialysate pressure drop;

(C) Clearance rates;

(D) Sieving coefficients;

(E) Mechanical hemolysis;

(F) Structural integrity;

(G) Blood compartment integrity;

(H) Volume of the blood compartment; and

(I) Chemical analysis of the dialyzer membrane.

(iii) Blood tubing set performance testing must include:

(A) Pressure leak testing;

(B) Worst-case endurance testing;

(C) Priming volume assessment;

(D) Tensile testing of joints and materials of all tubing segments;

(E) Pressure transducer leak testing;

(F) Clamp occlusion;

(G) Mechanical hemolysis; and

(H) Kink testing.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and wireless compatibility of the device.

(6) The tissue-contacting components of the device must be demonstrated to be biocompatible.

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

(8) Performance data must validate the reprocessing instructions for the reusable components of the device.

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

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

(11) Device labeling must include:

(i) Hemodialysis delivery system labeling must provide detailed information regarding the safe use of the dialysis machine, including:

(A) Overall description of the device and individual components or accessories labeled for use with the delivery system;

(B) Description of the safety-related components included in the system;

(C) Identification of operational parameters;

(D) Alarms and troubleshooting information;

(E) Cleaning, disinfection, and preventative maintenance procedures; and

(F) A statement that the device is intended for use by operators trained in the administration of continuous renal replacement therapy and in the management of its complications.

(ii) Hemodialyzer labeling must include:

(A) Description of compatibility;

(B) Shelf life;

(C) Storage conditions;

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

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

(F) Summary of the in vitro performance data; and

(G) A non-pyrogenic statement.

(iii) Blood tubing set labeling must provide detailed information regarding the safe use of the device, including:

(A) Description of compatibility;

(B) Shelf life;

(C) Storage conditions;

(D) Identification of the components in the package;

(E) Total length of the arterial and venous tubing sets;

(F) Outer diameter (OD) of the pump segment;

(G) Priming volume;

(H) Identification of the hemodialysis delivery systems which are compatible with the blood tubing set;

(I) Identification of the largest gauge needle that can be used with the injection port, if applicable; and

(J) Identification of the maximum operating pressures for the transducer protectors.