[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Rules and Regulations]
[Pages 73028-73030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25602]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. FDA-2016-N-3287]


Medical Devices; Ear, Nose, and Throat Devices; Classification of 
the Eustachian Tube Balloon Dilation System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
Eustachian tube balloon dilation 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 Eustachian tube balloon dilation system's 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 October 24, 2016. The classification was 
applicable on September 16, 2016.

FOR FURTHER INFORMATION CONTACT: Joyce Lin, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2462, Silver Spring, MD, 20993-0002, 301-796-5544, 
[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) 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), 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 shall 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On December 17, 2015, Acclarent, Inc. submitted a request for 
classification of the ACCLARENT AERATM Eustachian Tube 
Balloon Dilation System under section 513(f)(2) of the FD&C Act.
    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

[[Page 73029]]

believes these special controls, in addition to general controls, will 
provide reasonable assurance of the safety and effectiveness of the 
device.
    Therefore, on September 16, 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 874.4180.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a Eustachian 
tube balloon dilation system will need to comply with the special 
controls named in this final administrative order.
    The device is assigned the generic name Eustachian tube balloon 
dilation system, and it is identified as a prescription device that 
includes a flexible catheter attached to an inflatable balloon. The 
system is intended for use in dilating the cartilaginous portion of the 
Eustachian tube for treating persistent Eustachian tube dysfunction.
    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--Eustachian Tube Balloon Dilation System Risks and Mitigation
                                Measures
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              Identified risk                    Mitigation measure
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Introduction of false passages and rupture  Non-clinical performance
 or damage to carotid artery.                testing.
                                            Simulated use testing.
                                            Training.
                                            Labeling.
Injury to mucosal tissue:                   Non-clinical performance
                                             testing.
 due to misuse of device on         Simulated use testing.
 patulous Eustachian tube or following
 skull base surgery
 due to catheter mechanical         Shelf life validation.
 failure
 due to balloon rupture             Training.
 due to mishandling of device with  Labeling.
 respect to excessive force and/or
 incorrect positioning
Adverse tissue reaction...................  Biocompatibility evaluation.
Infection.................................  Sterilization validation.
                                            Shelf life validation.
                                            Labeling.
------------------------------------------------------------------------

    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.
    Eustachian tube balloon dilation system devices are 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 
Eustachian tube balloon dilation system 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 administrative order establishes special controls that 
refer to previously approved collections of information found in 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.

List of Subjects in 21 CFR Part 874

    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 
874 is amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

0
1. The authority citation for part 874 continues to read as follows:

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


0
2. Add Sec.  874.4180 to subpart E to read as follows:


Sec.  874.4180  Eustachian tube balloon dilation system.

    (a) Identification. A Eustachian tube balloon dilation system is a 
prescription device that includes a flexible catheter attached to an 
inflatable balloon. The system is intended for use in dilating the 
cartilaginous portion of the Eustachian tube for treating persistent 
Eustachian tube dysfunction.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be evaluated:
    (i) Mechanical testing, including tensile and flexural testing of 
catheter joints and materials.
    (ii) Durability testing, including fatigue and burst pressure 
testing of the balloon materials and components.
    (iii) Inflation and deflation characterization testing, including 
time and pressure measurements, and leak testing of the balloon.
    (iv) Verification testing of safety features built into the device 
must be performed, including the characterization of catheter 
geometries

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and distal tip insertion limitation mechanisms.
    (2) Simulated use testing in a clinically relevant model must 
demonstrate the reliability of the device to remain mechanically 
functional throughout the anticipated conditions of use, and validate 
that the design features limit access to only the cartilaginous portion 
of the Eustachian tube.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device.
    (5) Performance data must support shelf life by demonstrating 
continued sterility of the device, package integrity, and device 
functionality over the identified shelf life.
    (6) Training must include simulated use on cadavers to ensure users 
can follow the instructions for use to allow safe use of the device.
    (7) Labeling must include:
    (i) Detailed instructions for use.
    (ii) A detailed summary of the device technical parameters, 
including maximum allowed inflation pressure, allowable catheter 
geometries, and available balloon sizes.
    (iii) A shelf life.

    Dated: October 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25602 Filed 10-21-16; 8:45 am]
 BILLING CODE 4164-01-P