[Federal Register Volume 83, Number 4 (Friday, January 5, 2018)]
[Rules and Regulations]
[Pages 600-602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00051]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. FDA-2017-N-6539]


Medical Devices; Radiology Devices; Classification of the 
Absorbable Perirectal Spacer

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 absorbable perirectal spacer 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 absorbable 
perirectal spacer'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 January 5, 2018. The classification was 
applicable on April 1, 2015.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the absorbable perirectal spacer 
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 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.

[[Page 601]]

II. De Novo Classification

    On October 1, 2014, Augmenix, Inc. submitted a request for De Novo 
classification of the SpaceOAR 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 general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on April 1, 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 892.5725. We have named 
the generic type of device absorbable perirectal spacer, and it is 
identified as a device composed of biodegradable material that 
temporarily positions the anterior rectal wall away from the prostate 
during radiotherapy for prostate cancer with the intent to reduce the 
radiation dose delivered to the anterior rectum. The absorbable spacer 
maintains space for the entire course of prostate radiotherapy 
treatment and is completely absorbed by the patient's body over time.
    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--Absorbable Perirectal Spacer Risks and Mitigation Measures
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                                            Mitigation measures/21 CFR
            Identified risks                         section
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Device functional failure or the device  Special Controls (1)(i) (21 CFR
 is unable to maintain space stability    892.5725(b)(1)(i)), (1)(ii)
 during the course of radiation therapy.  (21 CFR 892.5725(b)(1)(ii)),
                                          (1)(iv) (21 CFR
                                          892.5725(b)(1)(iv)), and
                                          (1)(vi) (21 CFR
                                          892.5725(b)(1)(vi)).
Prolonged or delayed procedure.........  Special Controls (1)(iii) (21
                                          CFR 892.5725(b)(1)(iii)),
                                          (1)(iv) (21 CFR
                                          892.5725(b)(1)(iv)), (2) (21
                                          CFR 892.5725(b)(2)), and (3)
                                          (21 CFR 892.5725(b)(3)).
Needle penetration and/or spacer         Special Controls (1)(iv) (21
 material injection into bloodstream,     CFR 892.5725(b)(1)(iv)), (2)
 bladder, prostate, rectal wall,          (21 CFR 892.5725(b)(2)), and
 rectum, or urethra.                      (3) (21 CFR 892.5725(b)(3)).
Incomplete absorption..................  Special Controls (1)(iii) (21
                                          CFR 892.5725(b)(1)(iii)),
                                          (1)(iv) (21 CFR
                                          892.5725(b)(1)(iv)), and
                                          (1)(vii) (21 CFR
                                          892.5725(b)(1)(vii)).
Infection or local tissue inflammatory   Special Controls (1)(iv) (21
 reactions.                               CFR 892.5725(b)(1)(iv)),
                                          (1)(v) (21 CFR
                                          892.5725(b)(1)(v)), (1)(vi)
                                          (21 CFR 892.5725(b)(1)(vi)),
                                          (1)(vii) (21 CFR
                                          892.5725(b)(1)(vii)), and (3)
                                          (21 CFR 892.5725(b)(3)).
Pain or discomfort associated with       Special Controls (1)(iv) (21
 spacer.                                  CFR 892.5725(b)(1)(iv)) and
                                          (3) (21 CFR 892.5725(b)(3)).
Urine retention, bleeding, rectal        Special Controls (1)(iii) (21
 mucosal damage, ulcers, necrosis,        CFR 892.5725(b)(1)(iii)),
 constipation, or rectal urgency.         (1)(iv) (21 CFR
                                          892.5725(b)(1)(iv)), (1)(vii)
                                          (21 CFR 892.5725(b)(1)(vii)),
                                          (2) (21 CFR 892.5725(b)(2)),
                                          and (3) (21 CFR
                                          892.5725(b)(3)).
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    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. In order 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.

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. 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; the collections of 
information in part 820 have been approved under OMB control number 
0910-0073; 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 892

    Medical devices, Radiation protection, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
892 is amended as follows:

PART 892--RADIOLOGY DEVICES

0
1. The authority citation for part 892 continues to read as follows:

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


0
2. Add Sec.  892.5725 to subpart F to read as follows:


Sec.  892.5725  Absorbable perirectal spacer.

    (a) Identification. An absorbable perirectal spacer is composed of 
biodegradable material that temporarily positions the anterior rectal 
wall away from the prostate during radiotherapy for prostate cancer 
with the intent to

[[Page 602]]

reduce the radiation dose delivered to the anterior rectum. The 
absorbable spacer maintains space for the entire course of prostate 
radiotherapy treatment and is completely absorbed by the patient's body 
over time.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The premarket notification submission must include methodology 
and results of the following non-clinical and clinical performance 
testing. For all clinical investigations used to support premarket 
notification submissions for this type of device, line listings of the 
study data must be provided.
    (i) Performance bench testing must demonstrate appropriate 
perirectal space creation and maintenance for the duration of prostate 
radiotherapy.
    (ii) Performance bench testing must demonstrate that therapeutic 
radiation levels do not alter the performance of the device.
    (iii) Performance in vivo testing must demonstrate appropriate 
deployment of spacer as indicated in the accompanying labeling, and 
demonstrate appropriate expansion and absorption characteristics in a 
clinically relevant environment.
    (iv) Clinical study must demonstrate appropriate spacer stability 
and lack of migration for the entire course of radiotherapy, complete 
absorption, and lack of long term toxicity.
    (v) Sterility testing must demonstrate the sterility of the device 
and the effects of the sterilization process on the physical 
characteristics of the spacer.
    (vi) Shelf-life testing must demonstrate the stability of the 
physical characteristics of the spacer throughout the shelf-life as 
indicated in the accompanying labeling.
    (vii) The device must be demonstrated to be biocompatible.
    (2) The risk management activities performed as part of the 
manufacturer's Sec.  820.30 design controls must document an 
appropriate end user initial training program which will be offered as 
part of efforts to mitigate the risk of failure to correctly operate 
the device, including, but not limited to, documentation of an 
appropriate end user initial training program on the proper spacer 
deployment technique.
    (3) The device labeling must include the following:
    (i) A detailed summary of reported or observed complications 
related to the use of the device;
    (ii) Appropriate warnings;
    (iii) Detailed instructions for system preparations and detailed 
implant procedure instructions; and
    (iv) An expiration date that is supported by performance data as 
specified in paragraph (b)(1)(vi) of this section.

    Dated: January 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00051 Filed 1-4-18; 8:45 am]
 BILLING CODE 4164-01-P