[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Rules and Regulations]
[Pages 57090-57092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24026]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2015-N-3044]


Medical Devices; Ophthalmic Devices; Classification of the Oral 
Electronic Vision Aid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the oral 
electronic vision aid 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 oral electronic vision 
aid'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 September 22, 2015. The classification 
was applicable on June 18, 2015.

FOR FURTHER INFORMATION CONTACT: Dexiu Shi, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2246, Silver Spring, MD, 20993-0002, 301-796-6470, 
[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 (21 U.S.C. 360c(f)(2)), 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), 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 7, 2013, Wicab Inc., submitted a request for 
classification of the BrainPort V100 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

[[Page 57091]]

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 18, 2015, 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 886.5905.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for an oral 
electronic vision aid will need to comply with the special controls 
named in this final order. The device is assigned the generic name oral 
electronic vision aid, and it is identified as a battery-powered 
prescription device that contains an electrode stimulation array to 
generate electrotactile stimulation patterns that are derived from 
digital object images captured by a camera. It is intended to aid 
profoundly blind patients in orientation, mobility, and object 
recognition as an adjunctive device to other assistive methods such as 
a white cane or a guide dog.
    FDA has identified the following risks to health associated 
specifically with this type of device, as well as the mitigation 
measures required to mitigate these risks in table 1.

    Table 1--Oral Electronic Vision Aid Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation method
------------------------------------------------------------------------
Irritation, Discomfort or Adverse        Clinical Testing.
 Events Involving the Mouth, Tongue, or  Labeling.
 Gums.
Adverse Tissue Reaction................  Biocompatibility Testing.
                                         Labeling.
Unit (Hardware) Malfunction, Functional  Non-Clinical Performance
 Reliability.                             Testing.
                                         Clinical Testing.
                                         Labeling.
Software Malfunction...................  Software Verification,
                                          Validation, and Hazard
                                          Analysis.
Use Error..............................  Clinical Testing.
                                         Healthcare Professional
                                          Training.
                                         Patient Training.
                                         Labeling.
Interference with Other Devices........  Electromagnetic Compatibility
                                          and Electromagnetic
                                          Interference Testing.
                                         Wireless Coexistence Testing.
                                         Labeling.
Electrical Shock.......................  Electrical Safety Testing.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination 
with the general controls, address these risks to health and provide 
reasonable assurance of the safety and effectiveness:
     Clinical performance testing must demonstrate an 
acceptable adverse event profile, including adverse events involving 
the mouth, tongue, and gums and demonstrate the effect of the 
stimulation to provide clinically meaningful outcomes. The clinical 
performance testing must also investigate the anticipated conditions of 
use, including potential use error, intended environment of use, and 
duration of use.
     Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including simulated moisture ingress, device durability, and battery 
reliability.
     Software verification, validation, and hazard analysis 
must be performed.
     Analysis/testing must validate electromagnetic 
compatibility.
     Analysis/testing must validate electrical safety.
     Analysis/testing must assess and validate wireless 
coexistence concerns.
     Any elements of the device that contact the patient must 
be demonstrated to be biocompatible.
     Training must include elements to ensure that the 
healthcare provider and user can identify the safe environments for 
device use, use all safety features of the device, and operate the 
device in the intended environment of use.
     Labeling for the trainer and user must include a summary 
of the clinical testing including adverse events encountered under use 
conditions, summary of study outcomes and endpoints, and information 
pertinent to use of the device including the conditions under which the 
device was studied (e.g., level of supervision or assistance, and 
environment of use).
    Oral electronic vision aid devices are prescription devices 
restricted to patient use only upon the authorization of a practitioner 
licensed by law to administer or use the device; 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) 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 oral electronic vision aid 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 57092]]

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. DEN130039: De Novo Request per 513(f)(2) from Wicab Inc., dated 
August 7, 2013.

List of Subjects in 21 CFR Part 886

    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 
886 is amended as follows:

PART 886--OPHTHALMIC DEVICES

0
1. The authority citation for 21 CFR part 886 continues to read as 
follows:

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


0
2. Add Sec.  886.5905 to subpart F to read as follows:


Sec.  886.5905  Oral electronic vision aid.

    (a) Identification. An oral electronic vision aid is a battery-
powered prescription device that contains an electrode stimulation 
array to generate electrotactile stimulation patterns that are derived 
from digital object images captured by a camera. It is intended to aid 
profoundly blind patients in orientation, mobility, and object 
recognition as an adjunctive device to other assistive methods such as 
a white cane or a guide dog.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate an acceptable 
adverse event profile, including adverse events involving the mouth, 
tongue, and gums and demonstrate the effect of the stimulation to 
provide clinically meaningful outcomes. The clinical performance 
testing must also investigate the anticipated conditions of use, 
including potential use error, intended environment of use, and 
duration of use.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including simulated moisture ingress, device durability, and battery 
reliability.
    (3) Software verification, validation, and hazard analysis must be 
performed.
    (4) Analysis/testing must validate electromagnetic compatibility.
    (5) Analysis/testing must validate electrical safety.
    (6) Analysis/testing must assess and validate wireless coexistence 
concerns.
    (7) Any elements of the device that contact the patient must be 
demonstrated to be biocompatible.
    (8) Training must include elements to ensure that the healthcare 
provider and user can identify the safe environments for device use, 
use all safety features of the device, and operate the device in the 
intended environment of use.
    (9) Labeling for the trainer and user must include a summary of the 
clinical testing including adverse events encountered under use 
conditions, summary of study outcomes and endpoints, and information 
pertinent to use of the device including the conditions under which the 
device was studied (e.g., level of supervision or assistance, and 
environment of use).

    Dated: September 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24026 Filed 9-21-15; 8:45 am]
 BILLING CODE 4164-01-P