Rule2025-16041
Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool
Primary source
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Published
August 21, 2025
Effective
August 21, 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 laparoscopic gastrointestinal sizing tool 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 laparoscopic gastrointestinal sizing tool. We are taking this action because we have determined that classifying the device into class II 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 160 (Thursday, August 21, 2025)</title>
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[Federal Register Volume 90, Number 160 (Thursday, August 21, 2025)]
[Rules and Regulations]
[Pages 40728-40730]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16041]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2025-N-2823]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Laparoscopic Gastrointestinal Sizing Tool
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 laparoscopic gastrointestinal sizing tool 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 laparoscopic gastrointestinal sizing
tool. We are taking this action because we have determined that
classifying the device into class II 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.
DATES: This order is effective August 21, 2025. The classification was
applicable on February 4, 2020.
FOR FURTHER INFORMATION CONTACT: Pramodh Kariyawasam, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 2536, Silver Spring, MD 20993-0002,
301-348-1911, <a href="/cdn-cgi/l/email-protection#89d9fbe8e4e6ede1a7c2e8fbe0f0e8fee8fae8e4c9efede8a7e1e1faa7eee6ff"><span class="__cf_email__" data-cfemail="1a4a687b77757e7234517b6873637b6d7b697b775a7c7e7b34727269347d756c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the laparoscopic gastrointestinal
sizing tool as class II (special controls), which we have determined
will provide a
[[Page 40729]]
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), 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 November 12, 2019, FDA received Torax Medical Inc.'s request for
accessory classification of the LINX Reflux Management System--
Esophagus Sizing Tool. 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 February 4, 2020, 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
876.5360.\1\ We have named the generic type of device ``laparoscopic
gastrointestinal sizing tool,'' and it is identified as a prescription
use device intended for laparoscopically measuring an extraluminal
dimensional parameter of the indicated gastrointestinal organs.
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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--Laparoscopic Gastrointestinal Sizing Tool Risks and Mitigation
Measures
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Identified risks to health Mitigation measures
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Longer procedure time due to: Non-clinical performance
testing;
<bullet> Use error Shelf life testing; and
<bullet> Inaccuracy of the size Labeling.
markers
<bullet> Breaking ............................
<bullet> Unintentional separation of ............................
components
Adverse tissue reaction Biocompatibility evaluation;
and
Labeling.
Retained foreign body due to: Non-clinical performance
testing;
<bullet> Breaking Shelf life testing; and
<bullet> Unintentional separation of Labeling.
components
Infection Non-clinical performance
testing;
Shelf life testing;
Sterility and/or
reprocessing validation;
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 safety and effectiveness. 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. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act (21 U.S.C. 360(k)).
At the time of classification, laparoscopic gastrointestinal sizing
tools are for prescription use only. Prescription devices are exempt
from the requirement for adequate directions
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for use for the layperson under section 502(f)(1) of the FD&C Act (21
U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR
801.109 are met.
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 21 CFR part 820 regarding
quality system regulation have been approved under OMB control number
0910-0073; the collections of information in 21 CFR 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. 876.5360 to subpart F to read as follows:
Sec. 876.5360 Laparoscopic gastrointestinal sizing tool.
(a) Identification. A laparoscopic gastrointestinal sizing tool is
a prescription use device intended for laparoscopically measuring an
extraluminal dimensional parameter of the indicated gastrointestinal
organs.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Performance testing must demonstrate that the sizing tool
performs as intended under anticipated conditions of use. Performance
testing must include the following:
(i) Trocar compatibility, which includes shaft bending force
characterization;
(ii) Joint strength tensile testing;
(iii) Distal loop extension/retraction force characterization;
(iv) Material selection analysis, which includes corrosion and
visual inspection; and
(v) Accuracy of the dimensional measurement.
(2) Performance testing must support the sterility and/or
reprocessing and shelf life of the patient-contacting components of the
device.
(3) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(4) Labeling of the device must include the following:
(i) A statement regarding metal allergies if the device is made
from metallic components;
(ii) Specific instructions for proper device use including
information regarding the following:
(A) Inspection of device prior to use;
(B) Surgical access techniques or methodologies;
(C) Instructions for avoiding structural damage to vagus nerve
bundle;
(D) Trocar compatibility;
(E) Sizing methodology; and
(F) Minimum and maximum dimensional parameters that the device is
capable of measuring.
(iii) Identification of the associated parent device with which the
sizing tool has been demonstrated to be compatible; and
(iv) An expiration date.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16041 Filed 8-20-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on August 21, 2025.
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