| Device |
piston syringe with neuraxial connector – epidural, peripheral, and/or indirect cerebral spinal fluid contact |
| Regulation Description |
Piston syringe. |
| Definition |
A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections. |
| Physical State |
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. |
| Technical Method |
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. The connector may be compliant with ANSI/AAMI/ISO 80369-6: 2016: “Small bore connectors for liquids and gases in healthcare applications – Part 6 Connectors for neuraxial applications” |
| Target Area |
Sites for the neuraxial application include the epidural, peripheral nerve, subarachnoid/spinal block, intrathecal and/or intracerebroventricular locations. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | QEH |
|---|
| 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 |
880.5860
|
|---|
| 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
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
