[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,
[email protected].
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
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Identified risk Mitigation measure
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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