Rule2025-21217
Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath
Primary source
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Published
November 26, 2025
Effective
November 26, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is classifying the anchored esophageal sheath 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 the classification of the anchored esophageal sheath. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of 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 90 Issue 226 (Wednesday, November 26, 2025)</title>
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[Federal Register Volume 90, Number 226 (Wednesday, November 26, 2025)]
[Rules and Regulations]
[Pages 54230-54232]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21217]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2025-N-4645]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Anchored Esophageal Sheath
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying the anchored esophageal sheath 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
the classification of the anchored esophageal sheath. We are taking
this action because we have determined that classifying the device into
class II (special controls) will
[[Page 54231]]
provide a reasonable assurance of 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 November 26, 2025. The classification
was applicable on April 16, 2019.
FOR FURTHER INFORMATION CONTACT: Anthony Lee, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4549, Silver Spring, MD 20993-0002, 240-402-5935,
<a href="/cdn-cgi/l/email-protection#40012e34282f2e396e0c252571002624216e2828336e272f36"><span class="__cf_email__" data-cfemail="34755a405c5b5a4d1a78515105745250551a5c5c471a535b42">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the anchored esophageal sheath as
class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness for its intended use.
In addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into the appropriate device class based on risk and
the regulatory controls sufficient to provide reasonable assurance of
safety and effectiveness.
FDA may classify a device through an accessory classification
request under section 513(f)(6) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360c(f)(6)), established by section 707 of
the FDA Reauthorization Act of 2017 (Pub. L. 115-52). The provision
allows manufacturers or importers to request classification of an
accessory distinct from another device upon written request. The
classification is based on the risks of the accessory when used as
intended as well as the level of regulatory controls necessary to
provide a reasonable assurance of safety and effectiveness,
notwithstanding the classification of any other device with which such
accessory is intended to be used. Until an accessory is reclassified by
FDA, the classification of any accessory distinct from another device
by regulation or written order issued prior to December 13, 2016, will
continue to apply.
Under section 513(f)(6)(D)(ii) of the FD&C Act, a manufacturer or
importer may request appropriate classification of an accessory that
has been granted marketing authorization as part of a premarket
approval application (PMA), premarket notification (510(k)), or De Novo
classification request. FDA must grant or deny the request not later
than 85 days after receipt and, if granting, publish a notice in the
Federal Register within 30 days of announcing the classification.
Alternatively, under section 513(f)(6)(C) of the FD&C Act, a person
filing a PMA or 510(k) may include a written request for the proper
classification of an accessory that has not been classified distinctly
from another device based on the risks of the accessory when used as
intended and the level of regulatory controls necessary to provide a
reasonable assurance of safety and effectiveness. When the written
request is included in a submission for marketing authorization, FDA
must grant or deny the request along with the response to the PMA or
510(k). Upon granting, FDA will publish a notice in the Federal
Register within 30 days of announcing the classification.
II. Accessory Classification
On July 9, 2018, FDA received BAROnova, Inc.'s request for
accessory classification of the BAROnova Access Sheath. 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 safety and
effectiveness, 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 April 16, 2019, 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
876.1510.\1\ We have named the generic type of device ``anchored
esophageal sheath,'' and it is identified as a device used to provide
an endoluminal pathway to facilitate insertion of an endoscope or other
compatible device into the upper gastrointestinal tract. A distal
anchor assists in keeping the sheath in place to facilitate positioning
of the endoscope or other compatible device.
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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 following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--Anchored Esophageal Sheath Risks and Mitigation Measures
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Identified risks to health Mitigation measures
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Adverse tissue reaction................ Biocompatibility evaluation.
Mechanical injury to esophagus and/or Non-clinical performance
gastroesophageal junction (GEJ) testing; Simulated use
related to: testing; Shelf life testing;
<bullet> Insertion/removal of anchored and Labeling.
esophageal sheath.
<bullet> Insertion/removal of
endoscope or other compatible
device through anchored esophageal
sheath.
<bullet> Actuation of anchoring
component into anchored
configuration within esophagus.
<bullet> Retraction of anchoring
component against GEJ.
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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 safety and effectiveness. For a device to fall within this
classification, and
[[Page 54232]]
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. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act (21 U.S.C. 360(k)).
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) if, after notice of our intent to exempt and consideration of
comments, we determine that premarket notification is not necessary to
provide reasonable assurance of safety and effectiveness of the device.
At a future date, we may publish a separate notice in the Federal
Register announcing our intent to exempt this device type.
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 individually or cumulatively 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 21 CFR part 860, subpart D, regarding De Novo
classification have been approved under OMB control number 0910-0844;
the collections of information in the guidance document ``Medical
Device Accessories--Describing Accessories and Classification
Pathways'' have been approved under OMB control number 0910-0823; the
collections of information in part 814, subparts A through E, regarding
premarket approval have been approved under OMB control number 0910-
0231; the collections of information in part 820 regarding quality
system regulation have been approved under OMB control number 0910-
0073; the collections of information in part 807, subpart E, regarding
premarket notification submissions have been approved under OMB control
number 0910-0120; and the collections of information in part 801
regarding labeling have been approved under OMB control number 0910-
0485.
List of Subjects in 21 CFR Part 876
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
876 is amended as follows:
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
0
1. The authority citation for part 876 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 876.1510 to subpart B to read as follows:
Sec. 876.1510 Anchored esophageal sheath.
(a) Identification. An anchored esophageal sheath is a device used
to provide an endoluminal pathway to facilitate insertion of an
endoscope or other compatible device into the upper gastrointestinal
tract. A distal anchor assists in keeping the sheath in place to
facilitate positioning of the endoscope or other compatible device.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be demonstrated:
(i) Testing must verify all dimensions;
(ii) Testing must demonstrate that insertion and removal of any
device from the anchored esophageal sheath does not damage the shaft
wall or exert force that would cause tissue injury;
(iii) Testing must demonstrate that the anchoring component can be
reliably actuated;
(iv) Testing must demonstrate compatibility with any other device
that the anchored esophageal sheath is intended to be used with; and
(v) Testing must demonstrate device integrity and functionality in
simulated gastric conditions under clinically anticipated forces.
(3) Simulated use testing using an anatomically accurate
gastrointestinal model must demonstrate that:
(i) The device can be inserted and removed safely;
(ii) The device remains anchored in place;
(iii) The device can be safely withdrawn after releasing the
anchor; and
(iv) The device location and anchoring status can be observed by
the intended user.
(4) Performance data must demonstrate continued device
functionality over the identified shelf life.
(5) Labeling must include:
(i) Information as to whether the device can be used for foreign
body removal or with instruments alongside the endoscope;
(ii) Steps needed to prevent injury to the esophagus or
gastroesophageal junction (GEJ) during placement, anchoring, and use of
the device;
(iii) Any visualization steps required to confirm the device's
placement prior to and after actuating the anchoring component at the
GEJ;
(iv) A precaution to avoid excessive force during insertion;
(v) Identification of any endoscopes or other devices that have
been validated for use with the anchored esophageal sheath; and
(vi) An expiration date or shelf life.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-21217 Filed 11-25-25; 8:45 am]
BILLING CODE 4164-01-P
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