| Device |
pediatric hemodialysis system |
| Definition |
For use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms. |
| Physical State |
The device system consists of blood tubing, a hemodialyzer, and an automated hemodialysis delivery system equipped with an ultrafiltration controller. The delivery system also includes essential life supporting / life sustaining pumps and sensors to achieve the prescribed therapies unique to an individual system supported by performance data. |
| Technical Method |
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. |
| Target Area |
The device is intended to connect to venous blood access devices to create an extracorporeal circuit. |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | QIR |
|---|
| Premarket Review |
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.5861
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
