| Device |
robotic peripheral venous blood collection system |
| Definition |
A robotic peripheral venous blood collection system is an electromechanical device used to obtain blood samples from peripheral veins for diagnostic purposes. The device uses robotic systems to assist with the blood collection procedure, including vessel identification, targeting, and/or needle insertion, and may perform its functions in an automated or autonomous manner. |
| Physical State |
The device is stationary. It may be battery or mains powered. |
| Technical Method |
The patient aligns the approximate venipuncture location with a laser and initiates the procedure. The device then autonomously scans the patient’s limb using ultrasound and/or other imaging modalities to identify a suitable venipuncture site. If an acceptable site is located, it then uses a robotic arm to insert a needle into the vein and collect blood into a compatible container for subsequent diagnostic testing. |
| Target Area |
Peripheral veins only. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | SIW |
|---|
| Premarket Review |
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6975
|
|---|
| 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 |
