- Page Type
- Product Code
- 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
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 868.1985
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible