[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 [www.gpo.gov]
[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, 
[email protected].

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,
 Injury to pancreas or       and hazard analysis; Non-clinical
 other non-target tissue..           performance testing; Labeling; and
 Stent dislodgement.......   Training.
Injury due to procedure or device:  Clinical performance testing,
 Hemorrhage/                 Labeling, and Training.
 gastrointestinal (GI) bleeding..
 Pneumoperitoneum.........
 Sepsis/multiorgan
 failure..
 Morcellation of malignant
 tissue..
------------------------------------------------------------------------

    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