Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial Procedures

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is classifying the spinal imaging system for neuraxial procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the spinal imaging system for neuraxial procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Full Text

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<title>Federal Register, Volume 91 Issue 209 (Friday, October 30, 2026)</title>
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[Federal Register Volume 91, Number 209 (Friday, October 30, 2026)]
[Rules and Regulations]
[Pages 68460-68462]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22181]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. FDA-2026-N-12255]


Medical Devices; Anesthesiology Devices; Classification of the 
Spinal Imaging System for Neuraxial Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
spinal imaging system for neuraxial procedures into class II (special 
controls). The special controls that apply to the device type are 
identified in this order and will be part of the codified language for 
classification of the spinal imaging system for neuraxial procedures. 
We are taking this action because we have determined that classifying 
the device into class II will provide a reasonable assurance of the 
safety and effectiveness of the device. We believe this action will 
also enhance patients' access to beneficial innovative devices, in part 
by reducing regulatory burdens.

DATES: This order is effective October 30, 2026. The classification was 
applicable on January 19, 2024.

FOR FURTHER INFORMATION CONTACT: Bradley Quinn, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1220, Silver Spring, MD 20993-0002, 301-796-5575, 
<a href="/cdn-cgi/l/email-protection#6b29190a0f070e12453a1e0205052b0d0f0a45030318450c041d"><span class="__cf_email__" data-cfemail="aae8d8cbcec6cfd384fbdfc3c4c4eacccecb84c2c2d984cdc5dc">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA (the Agency or we) has classified the spinal 
imaging system for neuraxial procedures into class II (special 
controls), which we have determined will provide a reasonable assurance 
of the safety and effectiveness of the device. In addition, we believe 
this action will enhance patients' access to beneficial innovation, in 
part by reducing regulatory burdens by placing the device into a lower 
device class than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified into, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that 
does not require premarket approval.

[[Page 68461]]

We determine whether a new device is substantially equivalent to a 
predicate device by means of the procedures for premarket notification 
under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 
(21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). 
Section 207 of the Food and Drug Administration Modernization Act of 
1997 (Pub. L. 105-115) established the first procedure for De Novo 
classification. Section 607 of the Food and Drug Administration Safety 
and Innovation Act (Pub. L. 112-144) modified the De Novo 
classification process by adding a second procedure. A device sponsor 
may utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a premarket 
notification (510(k)) for a device that has not previously been 
classified. After receiving an order from FDA classifying the device 
into class III under section 513(f)(1) of the FD&C Act, the person then 
requests a classification under section 513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the 
FD&C Act). As a result, other device sponsors do not have to submit a 
De Novo request or premarket approval application to market a 
substantially equivalent device (see section 513(i) of the FD&C Act, 
defining ``substantial equivalence''). Instead, sponsors can use the 
less burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On February 1, 2022, FDA received IntuiTap Medical, Inc.'s request 
for De Novo classification of the VerTouch Spinal Imaging Device. FDA 
reviewed the request in order to classify the device under the criteria 
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves 
are insufficient to provide reasonable assurance of the safety and 
effectiveness of the device, but there is sufficient information to 
establish special controls that, in combination with the general 
controls, provide reasonable assurance of the safety and effectiveness 
of the device for its intended use (see section 513(a)(1)(B) of the 
FD&C Act). After review of the information submitted in the request, we 
determined that the device can be classified into class II with the 
establishment of special controls. FDA has determined that these 
special controls, in addition to the general controls, will provide 
reasonable assurance of the safety and effectiveness of the device.
    Therefore, on January 19, 2024, FDA issued an order to the 
requester classifying the device into class II. In this final order, 
FDA is codifying the classification of the device by adding 21 CFR 
868.1985.\1\ We have named the generic type of device ``spinal imaging 
system for neuraxial procedures,'' and it is identified as is a sensor 
and software system that is used to assist in identification of the 
interspinous space for neuraxial procedures.
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the risks to health associated with this type of 
device and the measures required to mitigate these risks in table 1.

   Table 1--Risks to Health and Mitigation Measures for Spinal Imaging
                    Systems for Neuraxial Procedures
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       Identified risks to health              Mitigation measures
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Inaccurate interspinous space            Clinical performance testing;
 identification leading to:               Non-clinical performance
<bullet> Increased pain.                  testing; Human factors
<bullet> Bleeding.                        testing; Software
<bullet> Unintended dural puncture.       verification, validation, and
<bullet> Injury to other deeper           hazard analysis; and Labeling.
 structures.
Increased procedure time due to          Clinical performance testing;
 improper device use.                     Human factors testing;
                                          Software verification,
                                          validation, and hazard
                                          analysis; and Labeling.
Electrical shock or interference with    Electrical safety testing; and
 other devices.                           Electromagnetic compatibility
                                          testing.
Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness of the device. For a device 
to fall within this classification, and thus avoid automatic 
classification in class III, it would have to comply with the special 
controls named in this final order. The necessary special controls 
appear in the regulation codified by this final order.
    Under the FD&C Act, submission of a premarket notification under 
section 510(k) is required to reasonably assure the safety and 
effectiveness of class II devices unless FDA determines that the device 
type should be exempt under section 510(m) of the FD&C Act. At this 
time FDA has not made this determination for spinal imaging systems for 
neuraxial procedures. This device is therefore subject to premarket 
notification requirements under section 510(k) of the FD&C Act.

[[Page 68462]]

III. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a 
type that does not normally have a significant effect on the human 
environment. Therefore, neither an environmental assessment nor an 
environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations and guidance. These collections of information are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections 
of information in part 860, subpart D, regarding De Novo classification 
have been approved under OMB control number 0910-0844; the collections 
of information in 21 CFR part 814, subparts A through E, regarding 
premarket approval have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding 
premarket notification submissions have been approved under OMB control 
number 0910-0120; the collections of information in 21 CFR part 820 
regarding quality management system regulation have been approved under 
OMB control number 0910-0073; and the collections of information in 21 
CFR part 801 regarding labeling have been approved under OMB control 
number 0910-0485.

List of Subjects in 21 CFR Part 868

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
868 is amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

0
1. The authority citation for part 868 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  868.1985 to subpart B to read as follows:


Sec.  868.1985  Spinal imaging system for neuraxial procedures.

    (a) Identification. 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.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use and must 
evaluate:
    (i) Rate of neuraxial procedure success across the intended use 
population;
    (ii) Procedure time;
    (iii) Adverse events, including pain, bleeding, unintended dural 
puncture, and injury to other spinal structures; and
    (iv) Comparison of performance to manual palpation or alternative 
method of determination of the target insertion site.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use and 
must evaluate the accuracy, repeatability, and resolution of imaging of 
the underlying anatomy representative of intended use populations.
    (3) Human factors testing must demonstrate that the user can 
correctly use the device based solely on the directions for use.
    (4) Software verification, validation, and hazard analysis must be 
performed. Validation testing must verify and validate proper image 
construction.
    (5) Electromagnetic compatibility and electrical, mechanical, and 
thermal safety testing must be performed.
    (6) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (7) Performance testing must demonstrate the sterility of any 
device components intended to be labeled sterile.
    (8) Labeling must include a warning that risks inherent to 
neuraxial procedures under standard of care conditions are still 
present with use of the device.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-22181 Filed 10-29-26; 8:45 am]
BILLING CODE 4164-01-P


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