[Federal Register Volume 81, Number 134 (Wednesday, July 13, 2016)]
[Rules and Regulations]
[Pages 45229-45232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16530]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2016-N-1813]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Metallic Biliary Stent System for Benign Strictures

AGENCY: Food and Drug Administration, HHS.

[[Page 45230]]


ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
metallic biliary stent system for benign strictures into class II 
(special controls). The special controls that will apply to the device 
are identified in this order and will be part of the codified language 
for the metallic biliary stent system for benign strictures' 
classification. The Agency is classifying the device into class II 
(special controls) in order to provide a reasonable assurance of safety 
and effectiveness of the device.

DATES: This order is effective July 13, 2016. The classification was 
applicable on June 3, 2016.

FOR FURTHER INFORMATION CONTACT: April Marrone, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240-402-6510, 
april.marrone@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i), to a predicate device that does not 
require premarket approval. The Agency determines whether new devices 
are substantially equivalent to predicate devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1) of 
the FD&C Act. Under the first procedure, the person submits a premarket 
notification under section 510(k) of the FD&C Act for a device that has 
not previously been classified and, within 30 days of receiving an 
order classifying the device into class III under section 513(f)(1), 
the person requests a classification under section 513(f)(2). Under the 
second procedure, rather than first submitting a premarket notification 
under section 510(k) and then a request for classification under the 
first procedure, the person determines that there is no legally 
marketed device upon which to base a determination of substantial 
equivalence and requests a classification under section 513(f)(2) of 
the FD&C Act. If the person submits a request to classify the device 
under this second procedure, FDA may decline to undertake the 
classification request if FDA identifies a legally marketed device that 
could provide a reasonable basis for review of substantial equivalence 
with the device or if FDA determines that the device submitted is not 
of ``low-moderate risk'' or that general controls would be inadequate 
to control the risks and special controls to mitigate the risks cannot 
be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On August 27, 2015, Boston Scientific Corporation submitted a 
request for classification of the WallFlex Biliary RX Fully Covered 
Stent System RMV under section 513(f)(2) of the FD&C Act. The 
manufacturer recommended that the device be classified into class II 
(Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1). FDA classifies 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 to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use. After review of the information submitted in the 
request, FDA determined that the device can be classified into class II 
with the establishment of special controls. FDA believes these special 
controls, in addition to general controls, will provide reasonable 
assurance of the safety and effectiveness of the device.
    Therefore, on June 3, 2016, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 876.5011.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a metallic 
biliary stent system for benign strictures will need to comply with the 
special controls named in this final order. The device is assigned the 
generic name metallic biliary stent system for benign strictures, and 
it is identified as a prescription device intended for the treatment of 
benign biliary strictures. The biliary stents are intended to be left 
indwelling for a limited amount of time and subsequently removed. The 
device consists of a metallic stent and a delivery system intended to 
place the stent in the bile duct. This device type is not intended for 
use in the vasculature.
    FDA has identified the following risks to health associated with 
this type of device, and the measures required to mitigate these risks, 
in table 1.

 Table 1--Metallic Biliary Stent System for Benign Strictures Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility Evaluation.
                                         Labeling.
Infection..............................  Sterilization Validation.
                                         Shelf Life Validation.
                                         Labeling.
Bile duct obstruction..................  Clinical Performance Testing.
  Stent migration......................  Non-clinical Performance
                                          Testing.
  Stent does not resolve obstruction...  Shelf Life Validation.
  Stent cannot be placed...............  Labeling.
  Expansion/compression forces.
  Foreshortening.......................
Trauma to bile ducts...................  Clinical Performance Testing.

[[Page 45231]]

 
  During stent deployment..............  Non-clinical Performance
                                          Testing.
  During removal.......................  Shelf Life Validation.
  Due to stent migration...............  Labeling.
  During stent indwell.
  Inability to safely remove stent.....
  Expansion/compression forces.........
------------------------------------------------------------------------

    FDA believes that the special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness.
    A metallic biliary stent system for benign strictures is not safe 
for use except under the supervision of a practitioner licensed by law 
to direct the use of the device. As such, the device is a prescription 
device and must satisfy prescription labeling requirements (see 21 CFR 
801.109, Prescription devices).
    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 FDA determines that premarket notification is not necessary 
to provide reasonable assurance of the safety and effectiveness of the 
device. For this type of device, FDA has determined that premarket 
notification is necessary to provide reasonable assurance of the safety 
and effectiveness of the device. Therefore, this device type is not 
exempt from premarket notification requirements. Persons who intend to 
market this type of device must submit to FDA a premarket notification, 
prior to marketing the device, which contains information about the 
metallic biliary stent system for benign strictures they intend to 
market.

II. 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.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. 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. 3501-3520). 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 21 CFR part 801, regarding labeling, have been 
approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and is available electronically at http://www.regulations.gov.
    1. DEN150040: De Novo request from Boston Scientific Corporation, 
dated August 27, 2015.

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.  876.5011 to subpart F to read as follows:


Sec.  876.5011  Metallic biliary stent system for benign strictures.

    (a) Identification. A metallic biliary stent system for benign 
strictures is a prescription device intended for the treatment of 
benign biliary strictures. The biliary stents are intended to be left 
indwelling for a limited amount of time and subsequently removed. The 
device consists of a metallic stent and a delivery system intended to 
place the biliary stent in the bile duct. This device type is not 
intended for use in the vasculature.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate or provide the 
following:
    (i) The ability to safely place and subsequently remove the stent 
after the maximum labeled indwell period.
    (ii) All adverse event data including bile duct obstruction and 
trauma to the bile duct.
    (iii) The stent resolves strictures during the maximum labeled 
indwell period.
    (iv) Stricture resolution is maintained post-stent removal.
    (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) Corrosion testing to demonstrate that the stent maintains its 
integrity during indwell and does not release potentially toxic levels 
of leachables.
    (ii) Stent dimensional testing supports the intended use.
    (iii) Compression and expansion forces must be characterized.
    (iv) The delivery catheter must deliver the stent to the intended 
location and the stent must not be adversely impacted by the delivery 
catheter during deployment and catheter withdrawal.
    (v) The delivery system must withstand clinically anticipated 
forces.
    (vi) Compatibility in a magnetic resonance environment.
    (3) All patient contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components intended to be provided sterile.
    (5) Shelf life testing must demonstrate that the device maintains 
its performance characteristics and that packaging maintains sterility 
for the duration of the labeled shelf life.
    (6) Labeling for the device must include:
    (i) A detailed summary of the clinical testing including device 
effectiveness, and device- and procedure-related adverse events.
    (ii) Appropriate warning(s) to accurately ensure usage of the 
device for the intended patient population.

[[Page 45232]]

    (iii) Shelf life.
    (iv) Compatibility information for use in the magnetic resonance 
environment.
    (v) Stent foreshortening information supported by dimensional 
testing.

    Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16530 Filed 7-12-16; 8:45 am]
 BILLING CODE 4164-01-P