[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Rules and Regulations]
[Pages 30722-30724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12297]



[[Page 30722]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2014-N-0430]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of Pancreatic Drainage Stent and Delivery System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
pancreatic drainage stent and delivery system 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 pancreatic drainage stent and delivery system 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 June 30, 2014. The classification was 
applicable beginning December 18, 2013.

FOR FURTHER INFORMATION CONTACT: Jeffrey Cooper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G228, Silver Spring, MD 20993-0002, 301-796-6517.

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) of the FD&C Act, 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, July 9, 2012, 126 Stat. 1054), provides two procedures by which a 
person may request FDA to classify a device under the criteria set 
forth in section 513(a)(1). 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) of the FD&C Act, 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) of the FD&C 
Act 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 February 15, 2013, Xlumena, Inc., submitted a request for 
classification of the AXIOS Stent and Delivery System 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) of the FD&C Act. 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 de novo 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 December 18, 2013, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding Sec.  876.5015.
    Following the effective date of this final classification 
administrative order, any firm submitting a premarket notification 
(510(k)) for a pancreatic drainage stent and delivery system will need 
to comply with the special controls named in the final administrative 
order.
    The device is assigned the generic name pancreatic drainage stent 
and delivery system, and it is identified as a prescription device that 
consists of a self-expanding, covered, metallic stent, intended for 
placement to facilitate transmural endoscopic drainage of pancreatic 
pseudocysts. This stent is intended to be removed upon confirmation of 
pseudocyst resolution. This device may also include a delivery system.
    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--Pancreatic Drainage Stent and Delivery System Risks and
                           Mitigation Measures
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           Identified risk                     Mitigation measure
------------------------------------------------------------------------
Adverse tissue reaction or infection.  Biocompatibility testing.
                                       Sterility testing.
                                       Labeling.
Partial expansion of stent...........  Clinical experience.
                                       In-vitro (bench) testing.
                                       Labeling.

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Failure to deliver stent.............  Clinical experience.
                                       In-vitro (bench) testing.
                                       Labeling.
Stent occlusion......................  Clinical experience.
                                       Labeling.
Stent ingrowth/failure to remove       Clinical experience.
 stent.                                Labeling.
Stent migration (passive dislocation)  Clinical experience.
                                       In-vitro (bench) testing.
                                       Labeling.
Stent dislodgement (active             Clinical experience.
 dislocation).                         In-vitro (bench) testing.
                                       Labeling.
Tissue ulceration....................  Clinical experience.
                                       In-vitro (bench) testing.
                                       Labeling.
Procedural complications.............  Clinical experience.
                                       Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to 
the general controls, address these risks to health and provide 
reasonable assurance of safety and effectiveness:
    1. The device and elements of the delivery device that may contact 
the patient must be demonstrated to be biocompatible.
    2. Performance data must demonstrate the sterility of patient-
contacting components of the device.
    3. Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the requested shelf life.
    4. Non-clinical testing data must demonstrate that the stent and 
delivery system perform as intended under anticipated conditions of 
use. The following performance characteristics must be tested:
     Deployment testing of the stent and delivery system must 
be conducted under simulated use conditions.
     Removal force testing must be conducted. The removal force 
testing must demonstrate that the stent can be safely removed, and that 
the stent will remain in place when subjected to forces encountered 
during use.
     Expansion force testing must be conducted. The expansion 
force must demonstrate that the forces exerted by the stent will not 
damage the tissue surrounding the stent.
     Compression force testing must be conducted. The 
compression force must demonstrate that the stent will withstand the 
forces encountered during use.
     Dimensional verification testing must be conducted.
     Tensile testing of joints and materials must be conducted. 
The minimum acceptance criteria must be adequate for its intended use.
     Fatigue testing must be conducted. Material strength must 
demonstrate that the stent will withstand forces encountered during 
use.
     Corrosion testing must be conducted. Corrosion resistance 
must demonstrate that the stent will withstand conditions encountered 
during use.
    5. Non-clinical testing must evaluate the compatibility of the 
stent in a magnetic resonance environment.
    6. Well-documented clinical experience must demonstrate safe and 
effective use, and capture any adverse events observed during clinical 
use.
    7. Labeling must include the following:
     Appropriate instructions, warnings, cautions, limitations, 
and information related to the safe use of the device, including 
deployment of the device, maintenance of the drainage lumen, and 
removal of the device.
     A warning that the safety and patency of the stent has not 
been established beyond the duration of the documented clinical 
experience.
     Specific instructions and the qualifications and clinical 
training needed for the safe use of the device, including deployment of 
the device, maintenance of the drainage lumen, and removal of the 
device.
     Information on the patient population for which the device 
has been demonstrated to be effective.
     A detailed summary of the clinical experience pertinent to 
use of the device.
     A detailed summary of the device technical parameters.
     A detailed summary of the device- and procedure-related 
complications pertinent to use of the device.
     An expiration date/shelf life.
    Pancreatic drainage stents and delivery systems are prescription 
devices restricted to patient use only upon the authorization of a 
practitioner licensed by law to administer or use the device. (Proposed 
Sec.  876.5015(a); see section 520(e) of the FD&C Act (21 U.S.C. 
360j(e)) and 21 CFR 801.109 (Prescription devices).) Prescription-use 
restrictions are a type of general controls as defined in section 
513(a)(1)(A)(i) of the FD&C Act.
    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) of the FD&C Act 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 pancreatic drainage stent and 
delivery system they intend to market.

II. 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.

[[Page 30724]]

III. Paperwork Reduction Act of 1995

    This final administrative 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. K123250: De Novo Request per section 513(f)(2) of the Federal 
Food, Drug, and Cosmetic Act From Xlumena, Inc., dated February 15, 
2013.

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 21 CFR part 876 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  876.5015 to subpart F to read as follows:


Sec.  876.5015  Pancreatic drainage stent and delivery system.

    (a) Identification. A pancreatic drainage stent is a prescription 
device that consists of a self-expanding, covered, metallic stent, 
intended for placement to facilitate transmural endoscopic drainage of 
pancreatic pseudocysts. This stent is intended to be removed upon 
confirmation of pseudocyst resolution. This device may also include a 
delivery system.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The device and elements of the delivery device that may contact 
the patient must be demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of patient-
contacting components of the device.
    (3) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the requested shelf life.
    (4) Non-clinical testing data must demonstrate that the stent and 
delivery system perform as intended under anticipated conditions of 
use. The following performance characteristics must be tested:
    (i) Deployment testing of the stent and delivery system must be 
conducted under simulated use conditions.
    (ii) Removal force testing must be conducted. The removal force 
testing must demonstrate that the stent can be safely removed, and that 
the stent will remain in place when subjected to forces encountered 
during use.
    (iii) Expansion force testing must be conducted. The expansion 
force must demonstrate that the forces exerted by the stent will not 
damage the tissue surrounding the stent.
    (iv) Compression force testing must be conducted. The compression 
force must demonstrate that the stent will withstand the forces 
encountered during use.
    (v) Dimensional verification testing must be conducted.
    (vi) Tensile testing of joints and materials must be conducted. The 
minimum acceptance criteria must be adequate for its intended use.
    (vii) Fatigue testing must be conducted. Material strength must 
demonstrate that the stent will withstand forces encountered during 
use.
    (viii) Corrosion testing must be conducted. Corrosion resistance 
must demonstrate that the stent will withstand conditions encountered 
during use.
    (5) Non-clinical testing must evaluate the compatibility of the 
stent in a magnetic resonance (MR) environment.
    (6) Well-documented clinical experience must demonstrate safe and 
effective use, and capture any adverse events observed during clinical 
use.
    (7) Labeling must include the following:
    (i) Appropriate instructions, warnings, cautions, limitations, and 
information related to the safe use of the device, including deployment 
of the device, maintenance of the drainage lumen, and removal of the 
device.
    (ii) A warning that the safety and patency of the stent has not 
been established beyond the duration of the documented clinical 
experience.
    (iii) Specific instructions and the qualifications and clinical 
training needed for the safe use of the device, including deployment of 
the device, maintenance of the drainage lumen, and removal of the 
device.
    (iv) Information on the patient population for which the device has 
been demonstrated to be effective.
    (v) A detailed summary of the clinical experience pertinent to use 
of the device.
    (vi) A detailed summary of the device technical parameters.
    (vii) A detailed summary of the device- and procedure-related 
complications pertinent to use of the device.
    (viii) An expiration date/shelf life.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12297 Filed 5-28-14; 8:45 am]
BILLING CODE 4160-01-P