[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Rules and Regulations]
[Pages 71610-71612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25001]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA-2016-N-2829]
Medical Devices; Physical Medicine Devices; Classification of the
Upper Extremity Prosthesis Including a Simultaneously Powered Elbow
and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of
Freedom and Controlled by Non-Implanted Electrical Components
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
Upper Extremity Prosthesis Including a Simultaneously Powered Elbow
and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of
Freedom and Controlled by Non-Implanted Electrical Components 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 upper extremity prosthesis including a
simultaneously powered elbow and/or shoulder with greater than two
simultaneous powered degrees of freedom and controlled by non-implanted
electrical components' 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 October 18, 2016. The classification was
applicable on May 9, 2014.
FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2640, Silver Spring, MD, 20993-0002, 301-
796-6476, [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, 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) of the FD&C
Act. 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 shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device. In
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order
on May 18, 2012, classifying the DEKA Arm System into class III,
because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II.
On June 15, 2012, DEKA Integrated Solutions Corporation submitted a
request for classification of the DEKA Arm System under section
513(f)(2) of the FD&C Act. 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 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 May 9, 2014, 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 890.3450.
Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for an upper
extremity prosthesis including a simultaneously powered elbow and/or
shoulder with greater than two simultaneous powered degrees of freedom
and controlled by non-implanted electrical components will need to
comply with the special controls named in this final order. The device
is assigned the generic name upper extremity prosthesis including a
simultaneously powered elbow and/or shoulder with greater than two
simultaneous powered degrees of freedom and controlled by non-implanted
electrical components, and it is identified as a prescription device
intended for medical purposes, and intended to replace a partially or
fully amputated or congenitally absent upper extremity. It uses
electronic inputs (other than simple, manually controlled electrical
components such as switches) to provide greater than two independent
and simultaneously powered degrees of freedom and includes a
simultaneously
[[Page 71611]]
powered elbow and/or shoulder. Prosthetic arm components that are
intended to be used as a system with other arm components must include
all degrees of freedom of the total upper extremity prosthesis system.
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--Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than
Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components Risks and
Mitigation Measures
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Identified risk Mitigation measures
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Unintended Motion................................. Electronic Input Testing.
Software Verification, Validation, and Hazards Analysis.
Wireless Testing.
Electromagnetic Compatibility (EMC) Testing.
Non-clinical Performance Testing.
Water/Particle Ingress Testing.
Durability Testing.
Battery Testing.
Labeling.
Adverse Tissue Reaction........................... Biocompatibility Assessment.
Battery Failure................................... Battery Testing.
Water/Particle Ingress Testing.
Labeling.
Electromagnetic Incompatibility................... EMC testing.
Labeling.
Electrical Safety Issues (e.g., shock)............ Electrical Safety Testing.
Labeling.
Gripping Malfunction.............................. Non-clinical Performance Testing.
Software Verification, Validation, and Hazards Analysis.
Labeling.
High Risk Activities (e.g., driving).............. Labeling.
Malfunction Due to Environmental Conditions....... Non-clinical Performance Testing.
Battery Testing.
Water/Particle Ingress Testing.
Wireless Testing.
EMC Testing.
Flammability Testing.
Labeling.
Use Error......................................... Clinical Studies.
Human Factors Studies.
Labeling.
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FDA believes that the special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of the safety and effectiveness.
An upper extremity prosthesis including a simultaneously powered
elbow and/or shoulder with greater than two simultaneous powered
degrees of freedom and controlled by non-implanted electrical
components is not safe for use except under the supervision of a
practitioner licensed by law to direct the use of the device. As such,
the device is a prescription device and must satisfy prescription
labeling requirements (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 upper extremity prosthesis
including a simultaneously powered elbow and/or shoulder with greater
than two simultaneous powered degrees of freedom and controlled by non-
implanted electrical components they intend to market.
II. 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.
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.
List of Subjects in 21 CFR Part 890
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
890 is amended as follows:
[[Page 71612]]
PART 890--PHYSICAL MEDICINE DEVICES
0
1. The authority citation for part 890 is revised to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 890.3450 to subpart D to read as follows:
Sec. 890.3450 Upper extremity prosthesis including a simultaneously
powered elbow and/or shoulder with greater than two simultaneous
powered degrees of freedom and controlled by non-implanted electrical
components.
(a) Identification. A upper extremity prosthesis including a
simultaneously powered elbow and/or shoulder with greater than two
simultaneous powered degrees of freedom and controlled by non-implanted
electrical components, is a prescription device intended for medical
purposes, and is intended to replace a partially or fully amputated or
congenitally absent upper extremity. It uses electronic inputs (other
than simple, manually controlled electrical components such as
switches) to provide greater than two independent and simultaneously
powered degrees of freedom and includes a simultaneously powered elbow
and/or shoulder. Prosthetic arm components that are intended to be used
as a system with other arm components must include all degrees of
freedom of the total upper extremity prosthesis system.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Appropriate analysis/testing must validate electronic
compatibility, electrical safety, thermal safety, mechanical safety,
battery performance and safety, and wireless performance, if
applicable.
(2) Appropriate software verification, validation, and hazard
analysis must be performed.
(3) Non-clinical performance data must demonstrate that the device
performs as intended under anticipated conditions of use. Performance
testing must include:
(i) Mechanical bench data, including durability testing, to
demonstrate that the device will withstand forces, conditions, and
environments encountered during use.
(ii) Simulated use testing to demonstrate performance of arm
commands and available safeguard(s) under worst case conditions and
after durability testing.
(iii) Verification and validation of force sensors and hand release
button, if applicable, are necessary.
(iv) Device functionality in terms of flame retardant materials,
liquid/particle ingress prevention, sensor and actuator performance,
and motor and brake performance.
(v) The accuracy of the device features and safeguards.
(4) Non-clinical and clinical performance testing must demonstrate
the accuracy of device features and safeguards.
(5) Elements of the device that may contact the patient must be
demonstrated to be biocompatible.
(6) Documented clinical experience and human factors testing must
demonstrate safe and effective use, capture any adverse events observed
during clinical use and demonstrate the accuracy of device features and
safeguards.
(7) Labeling for the Prosthetist and User Guide must include:
(i) Appropriate instructions, warning, cautions, limitations, and
information related to the necessary safeguards of the device,
including warning against activities that may put the user at greater
risk (e.g., driving).
(ii) Specific instructions and the clinical training needed for the
safe use of the device, which includes:
(A) Instructions on assembling the device in all available
configurations,
(B) Instructions on fitting the patient,
(C) Instructions and explanations of all available programs and how
to program the device,
(D) Instructions and explanation of all controls, input, and
outputs,
(E) Instructions on all available modes or states of the device,
(F) Instructions on all safety features of the device, and
(G) Instructions for maintaining the device.
(iii) Information on the patient population for which the device
has been demonstrated to be effective.
(iv) A detailed summary of the non-clinical and clinical testing
pertinent to use of the device.
Dated: October 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25001 Filed 10-17-16; 8:45 am]
BILLING CODE 4164-01-P