[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Rules and Regulations]
[Pages 71157-71159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19726]



[[Page 71157]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2024-N-3994]


Medical Devices; Orthopedic Devices; Classification of the 
Intervertebral Body Graft Containment Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the intervertebral body graft containment device 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 intervertebral body graft containment device'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.

DATES: This order is effective September 3, 2024. The classification 
was applicable on September 18, 2020.

FOR FURTHER INFORMATION CONTACT: Aakash Jain, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4566, Silver Spring, MD 20993-0002, 240-402-7531, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the intervertebral body graft 
containment device as class II (special controls), which we have 
determined will provide a reasonable assurance of safety and 
effectiveness.
    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 (see 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 device 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 (see also part 860, subpart D (21 CFR part 860, subpart D)). 
Section 207 of the Food and Drug Administration Modernization Act of 
1997 (Pub. L. 105-115) established the first procedure for De Novo 
classification. Section 607 of the Food and Drug Administration Safety 
and Innovation Act (Pub. L. 112-144) modified the De Novo application 
process by adding a second procedure. 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 is required 
to 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 section 513(f)(2)(B)(i) of the 
FD&C Act). As a result, other device sponsors do not have to submit a 
De Novo request or premarket approval application to market a 
substantially equivalent device (see 513(i) of the FD&C Act, defining 
``substantial equivalence''). Instead, sponsors can use the 510(k) 
process, when necessary, to market their device.

II. De Novo Classification

    On February 19, 2020, FDA received Spineology, Inc.'s request for 
De Novo classification of the Spineology Interbody Fusion 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 September 18, 2020, FDA issued an order to the 
requester classifying the device into class II. In this final order, 
FDA is codifying the classification of the device by adding 21 CFR 
888.3085.\1\ We have named the generic type of device intervertebral 
body graft containment device, and it is identified as a non-rigid, 
implanted spinal device that is designed to contain bone graft within 
its internal cavity. The device is inserted into the intervertebral 
body space of the spine and is intended as an adjunct to intervertebral 
body fusion.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated 
specifically with

[[Page 71158]]

this type of device and the measures required to mitigate these risks 
in table 1.

     Table 1--Intervertebral Body Graft Containment Device Risks and
                           Mitigation Measures
------------------------------------------------------------------------
         Identified risks to health              Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction....................  Design characteristics,
                                              Biocompatibility
                                              evaluation, Sterilization/
                                              reprocessing validation,
                                              and Labeling.
Infection..................................  Sterilization/reprocessing
                                              validation and Labeling.
Loosening/migration due to device failure    Design characteristics,
 or failure at the bone-implant interface.    Clinical performance
                                              testing, Non-clinical
                                              performance testing,
                                              Biocompatibility
                                              evaluation, and Labeling.
Tissue injury..............................  Labeling.
Pseudarthrosis due to device failure or      Clinical performance
 failure at the bone-implant interface.       testing, Non-clinical
                                              performance testing,
                                              Biocompatibility
                                              evaluation, and Labeling.
Adverse clinical sequelae..................  Clinical performance
                                              testing and Labeling.
Use error/Improper device use..............  Labeling.
------------------------------------------------------------------------

    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.

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. 3501-3521). The collections 
of information in part 860, subpart D, regarding De Novo classification 
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 21 CFR part 
820, regarding quality system regulation, 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 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 continues to read as follows:

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


0
2. Add Sec.  888.3085 to read as follows:


Sec.  888.3085   Intervertebral body graft containment device.

    (a) Identification. An intervertebral body graft containment device 
is a non-rigid, implanted spinal device that is designed to contain 
bone graft within its internal cavity. The device is inserted into the 
intervertebral body space of the spine and is intended as an adjunct to 
intervertebral body fusion.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must include an assessment of any 
adverse events observed during clinical use, as well as intervertebral 
body fusion, and compare this to a clinically acceptable fusion rate.
    (2) Non-clinical performance testing must demonstrate the 
mechanical function and durability of the implant, as well as the 
ability of the device to be inserted, deployed, and filled with bone 
graft consistently.
    (3) Device must be demonstrated to be biocompatible.
    (4) Validation testing must demonstrate the cleanliness and 
sterility of, or the ability to clean and sterilize, the device 
components, and device-specific instruments.
    (5) Design characteristics of the device, including engineering 
schematics, must ensure that the geometry and material composition are 
consistent with the intended use.
    (6) Labeling must bear all information required for the safe and 
effective use of the device, specifically including the following:
    (i) A clear description of the technological features of the device 
including identification of device materials, compatible components in 
the fusion construct, and the principles of device operation;
    (ii) Intended use and indications for use, including levels of 
fixation;
    (iii) Identification of magnetic resonance (MR) compatibility 
status;
    (iv) Cleaning and sterilization instructions for devices and 
instruments that are provided nonsterile to the end user; and
    (v) Detailed instructions of each surgical step, including device 
removal.


[[Page 71159]]


    Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19726 Filed 8-30-24; 8:45 am]
BILLING CODE 4164-01-P