[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Rules and Regulations]
[Pages 71144-71145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27135]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2021-N-0590]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Endoscopic Transhepatic Venous Access Needle

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 transhepatic venous access needle 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 transhepatic venous access needle'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 December 15, 2021. The classification 
was applicable on November 20, 2019.

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 transhepatic venous 
access needle as class II (special controls), which we have determined 
will provide a reasonable assurance of safety and effectiveness. In 
addition, we believe this action will enhance patients' access to 
beneficial innovation.
    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 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 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. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). 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.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation. 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 
21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not 
have to submit a De Novo request or premarket approval application in 
order to market a substantially equivalent device (see 21 U.S.C. 
360c(i), defining ``substantial equivalence''). Instead, sponsors can 
use the less-burdensome 510(k) process, when necessary, to market their 
device.

II. De Novo Classification

    On November 19, 2018, Cook Ireland Ltd. submitted a request for De 
Novo classification of the EchoTip[supreg] InsightTM 
Portosystemic Pressure Gradient Measuring System. 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 November 20, 2019, FDA issued an order to the 
requester classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 876.1050. \1\ We have 
named the generic type of device Endoscopic transhepatic venous access 
needle, and it is identified as a device that is inserted through the 
liver into the

[[Page 71145]]

patient's portal/hepatic venous system under endoscopic ultrasound 
guidance. It is connected to a separate device intended to measure a 
physiological parameter.
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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 Transhepatic Venous Access Needle Risks and
                           Mitigation Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility testing.
                                         Pyrogenicity testing.
Infection..............................  Sterilization validation.
                                         Pyrogenicity testing.
                                         Shelf life testing.
                                         Package integrity testing.
Use error leading to:
     Access site hemorrhage/
     thrombosis.
     Portal vein penetration     Labeling.
     leading to intrahepatic bleeding.
Improper patient management due to       Non-clinical performance
 inaccurate measurement.                  testing.
                                         Labeling.
------------------------------------------------------------------------

    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. In order 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).
    At the time of classification, Endoscopic transhepatic venous 
access needles are for prescription use only. Prescription devices are 
exempt from the requirement for adequate directions 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.

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 the guidance document ``De Novo Classification 
Process (Evaluation of Automatic Class III Designation)'' 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 collection 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.  876.1050 to subpart B to read as follows:


Sec.  876.1050  Endoscopic transhepatic venous access needle.

    (a) Identification. An endoscopic transhepatic venous access needle 
is inserted through the liver into the patient's portal/hepatic venous 
system under endoscopic ultrasound guidance. It is connected to a 
separate device intended to measure a physiological parameter.
    (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) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (3) The patient-contacting components of the device must be 
demonstrated to be non-pyrogenic.
    (4) Performance testing must support the shelf life of device 
components provided sterile by demonstrating continued sterility and 
package integrity over the labeled shelf life.
    (5) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following must be tested:
    (i) Needle crumple testing;
    (ii) Tensile testing;
    (iii) Dimensional verification for all components; and
    (iv) Simulated use testing.
    (6) Labeling must include the following:
    (i) Instructions for use, including specific instructions regarding 
device preparation;
    (ii) The recommended training for safe use of the device; and
    (iii) A shelf life for any sterile components.

    Dated: December 10, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27135 Filed 12-14-21; 8:45 am]
BILLING CODE 4164-01-P