Rule2024-20248
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Pancreatic Debridement Device
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 9, 2024
Effective
September 9, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is classifying the endoscopic pancreatic debridement device 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 endoscopic pancreatic debridement device's classification. 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.
Full Text
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<title>Federal Register, Volume 89 Issue 174 (Monday, September 9, 2024)</title>
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[Federal Register Volume 89, Number 174 (Monday, September 9, 2024)]
[Rules and Regulations]
[Pages 72984-72986]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20248]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2024-N-4059]
Medical Devices; Gastroenterology-Urology Devices; Classification
of the Endoscopic Pancreatic Debridement Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the endoscopic pancreatic debridement device 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 endoscopic pancreatic debridement device's classification. 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.
DATES: This order is effective September 9, 2024. The classification
was applicable on December 23, 2020.
FOR FURTHER INFORMATION CONTACT: Thelma Valdes, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2610, Silver Spring, MD 20993-0002, 301-796-9621,
<a href="/cdn-cgi/l/email-protection#ffab979a93929ed1a99e939b9a8cbf999b9ed197978cd1989089"><span class="__cf_email__" data-cfemail="184c707d747579364e79747c7d6b587e7c793670706b367f776e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the endoscopic pancreatic
debridement device as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness.
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 as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 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
[[Page 72985]]
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 (see 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 application
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 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.
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
510(k) process, when necessary, to market their device.
II. De Novo Classification
On March 16, 2020, FDA received Interscope, Inc's request for De
Novo classification of the EndoRotor. 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 21 U.S.C. 360c(a)(1)(B)). 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 December 23, 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
876.4330.\1\ We have named the generic type of device endoscopic
pancreatic debridement device, and it is identified as a device
intended to be inserted via an endoscope and placed through a
cystogastrostomy fistula into the pancreatic cavity. It is intended for
removal of necrotic tissue from a walled off pancreatic necrosis (WOPN)
cavity.
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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--Endoscopic Pancreatic Debridement Device Risks and Mitigation
Measures
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Identified risks to health Mitigation measures
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Adverse tissue reaction........... Biocompatibility evaluation, and
Pyrogenicity testing.
Infection......................... Sterilization validation,
Pyrogenicity testing, Shelf life
testing, Package integrity testing,
and Labeling.
Electrical shock/electromagnetic Electrical safety testing, and
interference. Electromagnetic compatibility
testing.
Injury due to device malfunction Clinical performance testing;
or device misuse: Software validation, verification,
<bullet> Injury to pancreas or and hazard analysis; Non-clinical
other non-target tissue.. performance testing; Labeling; and
<bullet> Stent dislodgement....... Training.
Injury due to procedure or device: Clinical performance testing,
<bullet> Hemorrhage/ Labeling, and Training.
gastrointestinal (GI) bleeding..
<bullet> Pneumoperitoneum.........
<bullet> Sepsis/multiorgan
failure..
<bullet> Morcellation of malignant
tissue..
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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 order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
[[Page 72986]]
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 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 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 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. 876.4330 to subpart E to read as follows:
Sec. 876.4330 Endoscopic pancreatic debridement device.
(a) Identification. An endoscopic pancreatic debridement device is
inserted via an endoscope and placed through a cystogastrostomy fistula
into the pancreatic cavity. It is intended for removal of necrotic
tissue from a walled off pancreatic necrosis (WOPN) cavity.
(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, including
evaluation of debridement of walled off pancreatic necrosis and all
adverse events.
(2) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(3) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
(4) The patient-contacting components of the device must be
demonstrated to be non-pyrogenic.
(5) Performance testing must support the shelf life of device
components provided sterile by demonstrating continued sterility,
package integrity, and device functionality over the labeled shelf
life.
(6) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
(i) Testing of rotational speeds and vacuum pressure;
(ii) Functional testing including testing with all device
components and the ability to torque the device; and
(iii) Functional testing in a relevant tissue model to demonstrate
the ability to resect and remove tissue.
(7) Performance data must demonstrate the electromagnetic
compatibility (EMC) and electrical safety of the device.
(8) Software verification, validation, and hazard analysis must be
performed.
(9) Training must be provided so that upon completion of the
training program, the user can resect and remove tissue of interest
while preserving non-target tissue.
(10) Labeling must include the following:
(i) A summary of the clinical performance testing conducted with
the device;
(ii) Instructions for use, including the creation of a conduit for
passage of endoscope and device into a walled off pancreatic necrotic
cavity;
(iii) Unless clinical performance data demonstrates that it can be
removed or modified, a boxed warning stating that the device should not
be used in patients with known or suspected pancreatic cancer;
(iv) The recommended training for safe use of the device; and
(v) A shelf life for any sterile components.
Dated: September 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20248 Filed 9-6-24; 8:45 am]
BILLING CODE 4164-01-P
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