• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
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 CodeQXD
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
-
-