FDA Sets a Class II Path for Spinal-Imaging Devices

FDA has formally opened a 510(k) pathway for a device category that, until this week, had exactly one member. A final order published October 30, 2026 classifies "spinal imaging system for neuraxial procedures" devices — sensor-and-software systems that help clinicians locate the interspinous space before epidurals and related procedures — as Class II, with special controls, codified at 21 CFR 868.1985. The classification originated with a single De Novo grant to IntuiTap Medical's VerTouch device two years ago; the new order makes that regulatory path generally available.

What the order actually does

Before this order, a novel device of this type defaulted to Class III — the FD&C Act's automatic classification for any device type with no existing classification regulation or predicate, regardless of actual risk. IntuiTap avoided that outcome for its own device by filing a De Novo request, which FDA's Center for Devices and Radiological Health granted on August 6, 2024, more than two years after IntuiTap submitted it. A De Novo grant classifies the specific device under review, but it does not, by itself, create a regulation that other sponsors can cite. The October 30 final order closes that gap: it establishes a standing classification regulation, 21 CFR 868.1985, under the anesthesiology devices part, so that a second or third company building a similar device can now seek 510(k) clearance using that regulation and its special controls directly, without repeating IntuiTap's multi-year De Novo review.

The special controls

FDA's order lists the special controls a device must meet to qualify for Class II rather than defaulting back to Class III: clinical performance testing demonstrating the device performs as intended under anticipated conditions of use (or a documented clinical justification if that testing is not performed), software verification and validation, electromagnetic compatibility and electrical safety testing, biocompatibility testing of any patient-contacting components, sterility testing where applicable, and specified labeling, including a statement that the device is not intended as a standalone diagnostic and is meant to assist, not replace, clinical judgment and standard technique.

The device behind the classification

IntuiTap's VerTouch, the device that prompted this classification, is a handheld system that generates a real-time image of lumbar spinal anatomy to help clinicians — including those with less experience or facing patients where palpation is difficult, such as higher body-mass-index or scoliosis cases — locate the interspinous space before needle insertion for labor epidurals, epidural steroid injections and epidural blood patches. IntuiTap has run multiple clinical studies on the device, including comparisons against ultrasound and manual palpation for labor-epidural site identification. The company, founded in Houston in 2016, has raised Series A financing to fund its clinical program and FDA submission.

What RA/QA teams should watch

• A classification final order is a category-opening event, not a single clearance. Device developers in adjacent spaces — ultrasound-guided neuraxial localization, AI-assisted landmark identification — should check whether their device fits this new generic type before assuming they need their own De Novo request.
• Special controls are the actual compliance bar. The regulation's value to a follow-on sponsor depends entirely on being able to meet the enumerated clinical performance, software, EMC, biocompatibility and labeling requirements; treat the special-controls list as the design-verification checklist, not a formality.
• De Novo-to-final-order timelines run long. More than two years passed between IntuiTap's De Novo submission and FDA's grant, and over two more years between that grant and this generic classification order — a useful data point for any sponsor estimating how long a first-in-category De Novo pathway takes end to end.

Frequently asked questions

What did FDA do on October 30, 2026?

Published a final order classifying spinal imaging systems for neuraxial procedures as Class II with special controls, codified at 21 CFR 868.1985, effective the same day.

What is a spinal imaging system for neuraxial procedures?

A sensor and software system that helps identify the interspinous space before neuraxial anesthesia, epidural steroid injections and epidural blood patches.

Where did this classification come from?

A De Novo request from IntuiTap Medical for its VerTouch device, granted August 6, 2024; the October 30 order codifies that into a generic regulation other sponsors can use.

What does this mean for other device makers?

They can now pursue 510(k) clearance against the new regulation and special controls instead of filing their own De Novo request or defaulting to Class III/PMA review.