[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Rules and Regulations]
[Pages 26577-26580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12339]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2018-N-1863]


Medical Devices; Orthopedic Devices; Classification of the In 
Vivo Cured Intramedullary Fixation Rod

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the in vivo cured intramedullary fixation rod into class II (special 
controls). The special controls that apply to the device type are 
identified in this order and will be part of the codified language for 
the in vivo cured intramedullary fixation rod's classification. We are 
taking this action because we have determined that classifying the 
device into class II (special controls) will provide a reasonable 
assurance of safety and effectiveness of the device. We believe this 
action will also enhance patients' access to beneficial innovative 
devices, in part by reducing regulatory burdens.

DATES: This order is effective June 8, 2018. The classification was 
applicable on December 19, 2017.

FOR FURTHER INFORMATION CONTACT: Peter Allen, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1512, Silver Spring, MD 20993-0002, 301-796-6402, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the in vivo cured intramedullary 
fixation rod as class II (special controls), which we have determined 
will provide a reasonable assurance of safety and effectiveness. In 
addition, we believe this action will enhance patients' access to 
beneficial innovation, in part by

[[Page 26578]]

reducing regulatory burdens by placing the device into a lower device 
class than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that 
does not require premarket approval. We determine whether a new device 
is substantially equivalent to a predicate by means of the procedures 
for premarket notification under section 510(k) of the FD&C Act (21 
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall 
classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval application in order to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial 
equivalence''). Instead, sponsors can use the less burdensome 510(k) 
process, when necessary, to market their device.

II. De Novo Classification

    On December 28, 2016, IlluminOss Medical, Inc. submitted a request 
for De Novo classification of the IlluminOss Photodynamic Bone 
Stabilization System. 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.
    We classify 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 that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on December 19, 2017, FDA issued an order to the 
requester classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 888.3023. We have named 
the generic type of device in vivo cured intramedullary fixation rod, 
and it is identified as a prescription implanted device consisting of a 
balloon that is inserted into the medullary canal of long bones for the 
fixation of fractures. The balloon is infused with, and completely 
encapsulates, a liquid monomer that is exposed to a curing agent that 
polymerizes the monomer within the balloon creating a hardened rigid 
structure.
    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--In Vivo Cured Intramedullary Fixation Rod Risks and Mitigation
                                Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
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Adverse tissue reaction resulting from:  Biocompatibility evaluation and
                                          Labeling.
     Balloon leakage...........
     Device materials..........
Infection, including wound               Sterilization validation,
 complications.                           Reprocessing validation, Shelf
                                          life testing, Pyrogenicity
                                          testing, and Labeling.
Bone fracture resulting from:..........  Non-clinical performance
                                          testing and Labeling.
     Device bending, cracking,
     or fracture.
     Device migration or
     instability, including initial
     inadequate fixation.
     Inability to properly
     deploy or remove device.
Soft tissue damage including             Non-clinical performance
 transection or laceration of neural,     testing and Labeling.
 vascular, or muscular structures.
Pain and/or loss of function resulting   Non-clinical performance
 from:.                                   testing and Labeling.
     Balloon leakage...........
     Device bending, cracking,
     or fracture.

[[Page 26579]]

 
     Device migration or
     instability, including initial
     inadequate fixation.
     Inability to properly
     deploy or remove device.
Revision...............................  Non-clinical performance
                                          testing and Labeling.
Electric shock or interference with      Electrical safety testing,
 other electrical devices.                Electromagnetic compatibility
                                          testing, and Labeling.
Exothermic reaction leading to tissue    Non-clinical performance
 injury.                                  testing.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. For a device to fall within this 
classification, and thus avoid automatic classification in class III, 
it would have to comply with the special controls named in this final 
order. The necessary special controls appear in the regulation codified 
by this order. This device is subject to premarket notification 
requirements under section 510(k) of the FD&C Act.
    At the time of classification, in vivo cured intramedullary 
fixation rods are for prescription use only. Prescription devices are 
exempt from the requirement for adequate directions for use for the 
layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) 
and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met 
(referring to 21 U.S.C. 352(f)(1)).

III. 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations and guidance. 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 the guidance document ``De Novo Classification 
Process (Evaluation of Automatic Class III Designation)'' have been 
approved under OMB control number 0910-0844; the collections of 
information in 21 CFR part 814, subparts A through E, regarding 
premarket approval, have been approved under OMB control number 0910-
0231; 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 888

    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 
888 is amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for part 888 is revised to read as follows:

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

0
2. Add Sec.  888.3023 to subpart D to read as follows:


Sec.  888.3023  In vivo cured intramedullary fixation rod.

    (a) Identification. An in vivo cured intramedullary fixation rod is 
a prescription implanted device consisting of a balloon that is 
inserted into the medullary canal of long bones for the fixation of 
fractures. The balloon is infused with, and completely encapsulates, a 
liquid monomer that is exposed to a curing agent which polymerizes the 
monomer within the balloon creating a hardened rigid structure.
    (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 tested:
    (i) Mechanical testing must be conducted on the final device to 
assess burst, abrasion, bending, and torsion in static and dynamic 
conditions.
    (ii) Mechanical testing must demonstrate the integrity of the 
balloon including testing for leaks, ruptures, and release of cured/
uncured material.
    (iii) Performance testing must demonstrate that the device can be 
inserted and removed.
    (iv) Performance testing must demonstrate the ability, in the event 
of a leak, to remove the uncured material from its in vivo location.
    (v) Performance testing must demonstrate the reliability and 
accuracy of the curing method used.
    (vi) Thermal safety testing must be conducted to evaluate the 
temperature rise during curing.
    (2) Electrical safety, electromagnetic compatibility (EMC) testing, 
and electromagnetic interference (EMI) testing must be conducted for 
all electrical components.
    (3) All patient-contacting components must be demonstrated to be 
biocompatible.
    (4) Performance data must demonstrate the sterility and 
pyrogenicity of patient contacting components of the device that are 
provided sterile.
    (5) Performance data must validate the reprocessing instructions 
for any reusable components or instruments.
    (6) Performance data must support the shelf life of the system by 
demonstrating continued sterility, package integrity, and system 
functionality over the established shelf life.
    (7) Technological characterization of the device must include 
materials, curing agents, and a description of the operating principles 
of the device, including the delivery system and devices which initiate 
the curing process.
    (8) Labeling must include the following:
    (i) A detailed summary of the device technical parameters.
    (ii) Information describing all materials of the device.
    (iii) Information describing how to perform the procedure and use 
the device, including the delivery system and devices which initiate 
the curing process, as well as how to remove the device and any uncured 
materials.
    (iv) A shelf life.
    (v) Validated methods and instructions for reprocessing any 
reusable components or instruments.


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    Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12339 Filed 6-7-18; 8:45 am]
BILLING CODE 4164-01-P