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510(k) Data Aggregation
K Number
DEN220009Device Name
VerTouch Spinal Imaging Device
Manufacturer
Date Cleared
2024-01-19
(717 days)
Regulation Number
868.1985Why did this record match?
Applicant Name (Manufacturer) :
IntuiTap Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
VerTouch is indicated to aid in the localization of a lumbar interspinous space, and the marking of an identified insertion site, for diagnostic and therapeutic neuraxial procedures.
VerTouch is indicated for use in hospital facilities and clinics by right- and left-handed emergency medicine, neurology, anesthesiology, and pain medicine professionals for assistance with spinal punctures.
The VerTouch handle is intended to be held with the left hand. Imaging and marking are intended to be performed with the right hand.
VerTouch is indicated for use on patients at least 18 years of age with BMI <42 kg/m2 undergoing the following procedures in the seated or lateral positions:
- . Lumbar punctures
- . Neuraxial anesthesia (spinals, epidurals, and combined spinal-epidurals)
- . Epidural steroid injections
- Epidural blood patches .
VerTouch can only be used with the marker included in the VerTouch Kit.
Device Description
IntuiTap's VerTouch™ Spinal Imaging Device ("VerTouch" or "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, for diagnostic and therapeutic neuraxial procedures, including lumbar punctures, neuraxial anesthesia (spinals, and combined spinalepidurals), epidural steroid injections, and epidural blood patches. The Device includes functionality to guide a marking tool.
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