[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Rules and Regulations]
[Pages 4139-4141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2017-N-6285]


Medical Devices; Cardiovascular Devices; Classification of the 
Temporary Catheter for Embolic Protection During Transcatheter 
Intracardiac Procedures

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 temporary catheter for embolic protection during transcatheter 
intracardiac procedures 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 temporary catheter for 
embolic protection during transcatheter intracardiac procedures' 
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 30, 2018. The classification was 
applicable on June 1, 2017.

FOR FURTHER INFORMATION CONTACT: Sadaf Toor, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1202, Silver Spring, MD 20993-0002, 301-796-6381, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the temporary catheter for embolic 
protection during transcatheter intracardiac procedures 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 and 
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    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.

[[Page 4140]]

    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 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.

II. De Novo Classification

    On September 20, 2016, Claret Medical, Inc., submitted a request 
for De Novo classification of the Sentinel[supreg] Cerebral Protection 
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 June 1, 2017, FDA issued an order to the requester 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 870.1251. We have named 
the generic type of device temporary catheter for embolic protection 
during transcatheter intracardiac procedures, and it is identified as a 
single use percutaneous catheter system that has (a) blood filter(s) at 
the distal end. This device is indicated for use while performing 
transcatheter intracardiac procedures. The device is used to filter 
blood in a manner that may prevent embolic material (thrombus/debris) 
from the transcatheter intracardiac procedure from traveling towards 
the cerebral circulation.
    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--Temporary Catheter for Embolic Protection During Transcatheter
          Intracardiac Procedures Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Device failure leading to debris         Non-clinical performance
 embolization and stroke or death.        testing, Animal testing, and
                                          Clinical performance testing.
Impeded or disrupted blood flow leading  Non-clinical performance
 to peripheral ischemia.                  testing, Animal testing,
                                          Clinical performance testing,
                                          and Labeling.
Device incompatibility with              Non-clinical performance
 transcatheter intracardiac procedure     testing, Animal testing,
 device leading to prolonged treatment    Clinical performance testing,
 time or device failure.                  and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Vascular injury due to device delivery,  Non-clinical performance
 deployment, placement, or retrieval.     testing, Animal testing,
                                          Clinical performance testing,
                                          and 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. 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 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; 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 870

    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 
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 continues to read as follows:

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

0
2. Add Sec.  870.1251 to subpart B to read as follows:

[[Page 4141]]

Sec.  870.1251  Temporary catheter for embolic protection during 
transcatheter intracardiac procedures.

    (a) Identification. This device is a single use percutaneous 
catheter system that has (a) blood filter(s) at the distal end. This 
device is indicated for use while performing transcatheter intracardiac 
procedures. The device is used to filter blood in a manner that may 
prevent embolic material (thrombus/debris) from the transcatheter 
intracardiac procedure from traveling towards the cerebral circulation.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Simulated-use testing in a clinically relevant bench anatomic 
model to assess the following:
    (A) Delivery, deployment, and retrieval, including quantifying 
deployment and retrieval forces, and procedural time; and
    (B) Device compatibility and lack of interference with the 
transcatheter intracardiac procedure and device.
    (ii) Tensile strengths of joints and components, tip flexibility, 
torque strength, torque response, and kink resistance.
    (iii) Flow characteristics.
    (A) The ability of the filter to not impede blood flow.
    (B) The amount of time the filter can be deployed in position and/
or retrieved from its location without disrupting blood flow.
    (iv) Characterization and verification of all dimensions.
    (2) Animal testing must demonstrate that the device performs as 
intended under anticipated conditions of use. The following performance 
characteristics must be assessed:
    (i) Delivery, deployment, and retrieval, including quantifying 
procedural time.
    (ii) Device compatibility and lack of interference with the 
transcatheter intracardiac procedure and device.
    (iii) Flow characteristics.
    (A) The ability of the filter to not impede blood flow.
    (B) The amount of time the filter can be deployed in position and/
or retrieved from its location without disrupting blood flow.
    (iv) Gross pathology and histopathology assessing vascular injury 
and downstream embolization.
    (3) All patient contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components intended to be provided sterile.
    (5) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (6) Labeling for the device must include:
    (i) Instructions for use;
    (ii) Compatible transcatheter intracardiac procedure devices;
    (iii) A detailed summary of the clinical testing conducted; and
    (iv) A shelf life and storage conditions.
    (7) Clinical performance testing must demonstrate:
    (i) The ability to safely deliver, deploy, and remove the device;
    (ii) The ability of the device to filter embolic material while not 
impeding blood flow;
    (iii) Secure positioning and stability of the position throughout 
the transcatheter intracardiac procedure; and
    (iv) Evaluation of all adverse events including death, stroke, and 
vascular injury.

    Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01638 Filed 1-29-18; 8:45 am]
 BILLING CODE 4164-01-P