[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Rules and Regulations]
[Pages 94251-94253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2016-N-4165]


Medical Devices; Neurological Devices; Classification of the 
Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke 
Treatment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
neurovascular mechanical thrombectomy device for acute ischemic stroke 
treatment 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 neurovascular mechanical thrombectomy 
device for acute ischemic stroke treatment's 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 December 23, 2016. The classification 
was applicable on September 2, 2016.

FOR FURTHER INFORMATION CONTACT: Leigh Anderson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 301-796-5613, 
leigh.anderson@fda.hhs.gov.

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

[[Page 94252]]

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) of the FD&C Act, 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) of the 
FD&C Act, the person requests a classification under section 513(f)(2). 
Under the second procedure, rather than first submitting a premarket 
notification under section 510(k) of the FD&C Act 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.
    On October 26, 2015, Concentric Medical, Inc., submitted a request 
for classification of the Trevo ProVue and XP ProVue Retrievers (Trevo 
Retrievers) 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 September 2, 2016, 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 882.5600.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a 
neurovascular mechanical thrombectomy device for acute ischemic stroke 
treatment will need to comply with the special controls named in this 
final order.
    The device is assigned the generic name neurovascular mechanical 
thrombectomy device for acute ischemic stroke treatment, and it is 
identified as a prescription device used in the treatment of acute 
ischemic stroke to improve clinical outcomes. The device is delivered 
into the neurovasculature with an endovascular approach, mechanically 
removes thrombus from the body, and restores blood flow in the 
neurovasculature.
    FDA has identified the following risks to health associated 
specifically with this type of device, as well as the measures required 
to mitigate these risks in table 1.

Table 1--Neurovascular Mechanical Thrombectomy Device for Acute Ischemic
             Stroke Treatment Risks and Mitigation Measures
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          Identified risk                    Mitigation measure
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Adverse Tissue Reaction...........  Biocompatibility Evaluation.
Infection.........................  Sterility Testing, Shelf-Life
                                     Testing, Labeling.
Tissue or Vessel Damage:
     Dissection...........  Non-clinical Performance Testing.
     Perforation..........  Clinical Performance Testing.
     Hemorrhage...........  Labeling.
Stroke Progression................  Non-clinical Performance Testing,
                                     Clinical Performance Testing,
                                     Labeling.
Emboli............................  Non-clinical Performance Testing,
                                     Clinical Performance Testing,
                                     Labeling.
------------------------------------------------------------------------

    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.
    Neurovascular mechanical thrombectomy device for acute ischemic 
stroke treatment devices are 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) 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 
neurovascular mechanical thrombectomy device for acute ischemic stroke 
treatment they intend to market.

[[Page 94253]]

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 882

    Medical devices, Neurological devices.

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

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

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


0
2. Add Sec.  882.5600 to subpart F to read as follows:


Sec.  882.5600   Neurovascular mechanical thrombectomy device for acute 
ischemic stroke treatment.

    (a) Identification. A neurovascular mechanical thrombectomy device 
for acute ischemic stroke treatment is a prescription device used in 
the treatment of acute ischemic stroke to improve clinical outcomes. 
The device is delivered into the neurovasculature with an endovascular 
approach, mechanically removes thrombus from the body, and restores 
blood flow in the neurovasculature.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including:
    (i) Mechanical testing to demonstrate the device can withstand 
anticipated tensile, torsional, and compressive forces.
    (ii) Mechanical testing to evaluate the radial forces exerted by 
the device.
    (iii) Non-clinical testing to verify the dimensions of the device.
    (iv) Non-clinical testing must demonstrate the device can be 
delivered to the target location in the neurovasculature and retrieve 
simulated thrombus under simulated use conditions.
    (v) Non-clinical testing must demonstrate the device is radiopaque 
and can be visualized.
    (vi) Non-clinical testing must evaluate the coating integrity and 
particulates under simulated use conditions.
    (vii) Animal testing must evaluate the safety of the device, 
including damage to the vessels or tissue under anticipated use 
conditions.
    (3) Performance data must support the sterility and pyrogenicity of 
the patient contacting components of the device.
    (4) Performance data must support the shelf-life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the specified shelf-life.
    (5) Clinical performance testing of the device must demonstrate the 
device performs as intended for use in the treatment of acute ischemic 
stroke and must capture any adverse events associated with the device 
and procedure.
    (6) The labeling must include:
    (i) Information on the specific patient population for which the 
device is intended for use in the treatment of acute ischemic stroke, 
including but not limited to, specifying time from symptom onset, 
vessels or location of the neurovasculature that can be accessed for 
treatment, and limitations on core infarct size.
    (ii) Detailed instructions on proper device preparation and use for 
thrombus retrieval from the neurovasculature.
    (iii) A summary of the clinical testing results, including a 
detailed summary of the device- and procedure-related complications and 
adverse events.
    (iv) A shelf life.

    Dated: December 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31007 Filed 12-22-16; 8:45 am]
BILLING CODE 4164-01-P