| Device |
spinal imaging system for neuraxial procedures |
| Definition |
A spinal imaging system for neuraxial procedures is a sensor and software system that is used to assist in identification of the interspinous space for neuraxial procedures. |
| Physical State |
A handheld device, capable of assembly and use by a single operator, and requires no connection with peripheral systems or software during clinical use. The Applicator is the primary component that facilitates scanning-based tactile imaging. A calibrated, piezoresistive sensor array is mounted to the patient-contacting surface of the Applicator, which is designed to optimize feature resolution with minimal application of force. When the user presses the Applicator at a first location, a linear positioning system is used to display the corresponding 2D pressure data at that location within the imaging range on the screen. The user then slides the Applicator to a new location and rep |
| Technical Method |
The device is intended to provide a two dimensional (2D) pressure map of posterior spinal anatomy to help the physician plan and approach his/her needle placement during neuraxial procedures. The Device is intended to aid in the localization of an interspinous space, and the placement of a needle at the identified site, for diagnostic and therapeutic spinal punctures, including lumbar punctures, neuraxial anesthesia (spinals, epidurals, and combined spinal-epidurals), epidural steroid injections, and epidural blood patches. The Device includes functionality to guide a marking tool or needle. |
| Target Area |
interspinous space |
| Regulation Medical Specialty |
Anesthesiology |
| Review Panel |
Anesthesiology |
|---|
| Product Code | QXD |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
868.1985
|
|---|
| 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 |
|
|
