| Device |
non-coring (huber) needle |
| Regulation Description |
Hypodermic single lumen needle. |
| Definition |
The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums. |
| Physical State |
Sterile medical grade stainless steel hollow needle which may be straight or bent at a 90 degrees, with a hub that is only compatible with other luer type devices. The needle tip angles so the bevel opening provides a clean entry into the port’s septra without damage. The hub may include; an anti-stick safety feature, integrated extension set, or luer activated valve. |
| Technical Method |
A sterile non-coring (Huber) needle used under sterile conditions to pierce the skin above a subcutaneous implanted intravascular infusion port. Once the port is accessed, the needle is pushed through the septum into the port reservoir body that has an integrated catheter. |
| Target Area |
Various subcutaneous locations; upper arms, chest and abdomen. Indirectly effects the central venous vascular system by facilitating the delivery of intravenous fluids, medications, contrast media and the withdrawal of blood for laboratory sampling. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | PTI |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.5570
|
|---|
| 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? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
