Rule2026-18433
Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
Primary source
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Published
September 10, 2026
Effective
September 10, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the mechanical deviation device for esophageal protection during cardiac ablation 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 mechanical deviation device for esophageal protection during cardiac ablation 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 174 (Thursday, September 10, 2026)</title>
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[Federal Register Volume 91, Number 174 (Thursday, September 10, 2026)]
[Rules and Regulations]
[Pages 57495-57497]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18433]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2026-N-9905]
Medical Devices; Cardiovascular Devices; Classification of the
Mechanical Deviation Device for Esophageal Protection During Cardiac
Ablation 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
mechanical deviation device for esophageal protection during cardiac
[[Page 57496]]
ablation 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
mechanical deviation device for esophageal protection during cardiac
ablation 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 September 10, 2026. The classification
was applicable on September 6, 2023.
FOR FURTHER INFORMATION CONTACT: Aneesh Deoras, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5540, Silver Spring, MD 20993-0002, 240-402-4363,
<a href="/cdn-cgi/l/email-protection#b4f5dad1d1c7dc9af0d1dbc6d5c7f4d2d0d59adcdcc79ad3dbc2"><span class="__cf_email__" data-cfemail="2a6b444f4f5942046e4f45584b596a4c4e4b04424259044d455c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the mechanical
deviation device for esophageal protection during cardiac ablation
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. 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 January 24, 2023, FDA received S4 Medical Corp.'s request for De
Novo classification of the esolution Esophageal Retractor. 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 September 6, 2023, 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
870.5710.\1\ We have named the generic type of device ``mechanical
deviation device for esophageal protection during cardiac ablation
procedures,'' and it is identified as a device that is placed in the
lumen of the esophagus to reduce the likelihood of esophageal injury or
a specific adverse event during cardiac ablation procedures. The device
uses mechanical means to deviate the esophagus away from the source of
ablation energy.
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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.
[[Page 57497]]
Table 1--Risks to Health and Mitigation Measures for Mechanical
Deviation Devices for Esophageal Protection During Cardiac Ablation
Procedures
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Identified risks to health Mitigation measures
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Failure to protect the esophagus during Clinical performance testing;
ablation leading to esophageal animal performance testing;
perforating complications. non-clinical performance
testing; and labeling.
Device malfunction leading to Non-clinical performance
esophageal injury. testing; and shelf life and
packaging testing.
Adverse tissue reaction................ Biocompatibility evaluation.
Infection.............................. Sterilization validation; shelf
life and packaging testing;
and labeling.
Mechanical injury to esophageal or oral Clinical performance testing;
structures. animal performance testing;
and labeling.
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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. FDA supports the
principles of the ``3Rs,'' to replace, reduce, and/or refine animal use
in testing when feasible. We encourage sponsors to consult with us if
they wish to use a non-animal testing method they believe is suitable,
adequate, validated, and feasible. We will consider whether such an
alternative method could be assessed for equivalency to an animal test
method.
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 mechanical deviation
devices for esophageal protection during cardiac ablation procedures.
This device is therefore subject to premarket notification requirements
under section 510(k) of the FD&C Act.
III. Analysis of Environmental Impact
The Agency has 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 870
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
870 is amended as follows:
PART 870--CARDIOVASCULAR DEVICES
0
1. The authority citation for part 870 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 870.5710 to subpart F to read as follows:
Sec. 870.5710 Mechanical deviation device for esophageal protection
during cardiac ablation procedures.
(a) Identification. This device is placed in the lumen of the
esophagus to reduce the likelihood of esophageal injury or a specific
adverse event during cardiac ablation procedures. The device uses
mechanical means to deviate the esophagus away from the source of
ablation energy.
(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 include
the following:
(i) Evaluation of reduction of the incidence of esophageal injury
during cardiac ablation procedures; and
(ii) Evaluation of any esophageal or oral injury from use of the
device.
(2) Animal performance testing must demonstrate that the device
performs as intended under the anticipated conditions of use and
include the following:
(i) Evaluation of the device's capability to adequately deviate the
esophagus, including its trailing edge, away from the source of
ablation energy; and
(ii) Evaluation of any esophageal injury from use of the device.
(3) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use and
include the following:
(i) Mechanical integrity testing using clinically relevant forces;
and
(ii) Compatibility testing with accessory devices.
(4) Performance data must demonstrate the sterility of any device
components intended to be provided sterile.
(5) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(6) Performance data must support the shelf life of the device by
demonstrating package integrity and device functionality over the
identified shelf life.
(7) Labeling must include the following:
(i) A summary of clinical performance testing with the device; and
(ii) A shelf life.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-18433 Filed 9-9-26; 8:45 am]
BILLING CODE 4164-01-P
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