Medical Devices; Orthopedic Devices; Classification of the Screw Sleeve Bone Fixation Device

CourtFood And Drug Administration
Published date01 March 2022
Record Number2022-04154
Federal Register, Volume 87 Issue 40 (Tuesday, March 1, 2022)
[Federal Register Volume 87, Number 40 (Tuesday, March 1, 2022)]
                [Rules and Regulations]
                [Pages 11293-11295]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2022-04154]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                21 CFR Part 888
                [Docket No. FDA-2022-N-0114]
                Medical Devices; Orthopedic Devices; Classification of the Screw
                Sleeve Bone Fixation Device
                AGENCY: Food and Drug Administration, HHS.
                ACTION: Final amendment; final order.
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                SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
                classifying the screw sleeve bone fixation 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 screw sleeve bone fixation 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 March 1, 2022. The classification was
                applicable on May 1, 2020.
                FOR FURTHER INFORMATION CONTACT: Jesse Muir, Center for Devices and
                Radiological Health, Food and Drug Administration, 10903 New Hampshire
                Ave., Bldg. 66, Rm. 4508, Silver Spring, MD 20993-0002, 240-402-6679,
                [email protected].
                SUPPLEMENTARY INFORMATION:
                I. Background
                 Upon request, FDA has classified the screw sleeve bone fixation
                device 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, 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 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. 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.
                 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 section 513(i) of the FD&C Act,
                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 13, 2018, FDA received Woven Orthopedic Technologies,
                LLC's request for De Novo classification of the OGmend[supreg] Implant
                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 May 1, 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
                888.3043.\1\ We have named the generic type of device ``screw sleeve
                bone fixation device,'' and it is intended to be implanted in
                conjunction with a non-resorbable, metallic bone screw where the screw
                has lost purchase due to loosening, backout, or breakage. The device
                fits between the screw threads and surrounding bone and provides
                increased surface area to create an
                [[Page 11294]]
                interference fit to restore stability of the implant construct.
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                 \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.
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                 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--Screw Sleeve Bone Fixation Device Risks and Mitigation Measures
                ------------------------------------------------------------------------
                 Identified risks Mitigation measures
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                Loss of function/mechanical integrity In vivo performance testing;
                 resulting from: Non-clinical performance
                [ssquf] Device malposition. testing; Shelf life testing;
                [ssquf] Device breakage. and Labeling.
                [ssquf] Damage to screw during
                 insertion.
                [ssquf] Deterioration due to aging.
                [ssquf] Insufficient restoration of
                 screw fixation.
                Revision............................... In vivo performance testing;
                 Non-clinical performance
                 testing; and Labeling.
                Adverse tissue reaction................ Biocompatibility evaluation; In
                 vivo performance testing; Non-
                 clinical performance testing;
                 and Labeling.
                Infection.............................. Sterilization validation; and
                 Shelf life testing.
                Febrile response due to endotoxins..... Pyrogenicity testing.
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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. 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. We encourage sponsors to consult with us if they wish to
                use a non-animal testing method that they believe is suitable,
                adequate, validated, and feasible. We will consider if such an
                alternative method could be assessed for equivalency to an animal test
                method. 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 21 CFR 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. 888.3043 to subpart D to read as follows:
                Sec. 888.3043 Screw sleeve bone fixation device.
                 (a) Identification. A screw sleeve bone fixation device is intended
                to be implanted in conjunction with a non-resorbable, metallic bone
                screw where the screw has lost purchase due to loosening, backout, or
                breakage. The device fits between the screw threads and surrounding
                bone and provides increased surface area to create an interference fit
                to restore stability of the implant construct.
                 (b) Classification. Class II (special controls). The special
                controls for this device are:
                 (1) In vivo performance testing under anticipated conditions of use
                must demonstrate:
                 (i) The device provides sufficient stability to allow for fracture
                healing; and
                 (ii) A lack of adverse biologic response to the implant through
                histopathological and histomorphometric assessment.
                 (2) Non-clinical performance testing must demonstrate that the
                device performs as intended under anticipated conditions of use.
                Testing must:
                 (i) Assess the stability of the device in a rescue screw scenario;
                 (ii) Demonstrate that the device can be inserted and removed
                without damage to the implant or associated hardware;
                 (iii) Demonstrate the device can withstand dynamic loading without
                device failure; and
                 (iv) Characterize wear particle generation.
                 (3) The device must be demonstrated to be biocompatible.
                 (4) The device must be demonstrated to be non-pyrogenic.
                 (5) Performance data must demonstrate the sterility of the device.
                 (6) Performance data must support the labeled shelf life of the
                device by demonstrating continued sterility, package integrity, and
                device functionality over the established shelf life.
                 (7) Labeling must include:
                 (i) A detailed summary of the device technical parameters;
                 (ii) Information describing all materials of the device;
                 (iii) Instructions for use, including device removal; and
                 (iv) A shelf life.
                [[Page 11295]]
                 Dated: February 22, 2022.
                Lauren K. Roth,
                Associate Commissioner for Policy.
                [FR Doc. 2022-04154 Filed 2-28-22; 8:45 am]
                BILLING CODE 4164-01-P
                

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