[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Rules and Regulations]
[Pages 58603-58607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24624]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2015-N-3165]


Medical Devices; Cardiovascular Devices; Classification of the 
Steerable Cardiac Ablation Catheter Remote Control System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
steerable cardiac ablation catheter remote control system 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 steerable cardiac ablation catheter remote control system'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 September 30, 2015. The classification 
was applicable on December 18, 2014.

FOR FURTHER INFORMATION CONTACT: Deborah Castillo, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1321, Silver Spring, MD 20993-0002, 301-
796-4908.

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) of the FD&C Act, to a predicate

[[Page 58604]]

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) of 
the FD&C Act. 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 will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On February 14, 2014, Catheter Robotics, Inc. submitted a request 
for classification of the AMIGO Remote Catheter System under section 
513(f)(2) of the FD&C Act. The manufacturer recommended that the device 
be classified into class II (Ref. 1).
    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 December 18, 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 870.5700.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a steerable 
cardiac ablation catheter remote control system will need to comply 
with the special controls named in this final order. The device is 
assigned the generic name steerable cardiac ablation catheter remote 
control system, and it is identified as a prescription device that is 
external to the body and interacts with the manual handle of a 
steerable cardiac ablation catheter to remotely control the 
advancement, retraction, rotation, and deflection of a compatible, 
steerable ablation catheter used for the treatment of cardiac 
arrhythmias in the right side of the heart. The device allows reversion 
to manual control of the steerable cardiac ablation catheter without 
withdrawal of the catheter and interruption of the procedure.
    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--Steerable Cardiac Ablation Catheter Remote Control System Risks
                         and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Device Failure, Resulting in Patient     Non-Clinical Mechanical
 Injury or Interruption of Procedure.     Performance Testing
                                         Non-Clinical Electrical
                                          Testing:
                                         Electromagnetic Compatibility
                                          (EMC), Electrical Safety,
                                          Electrical System,
                                          Performance, Shelf Life
                                          Testing, Sterilization
                                          Testing, In Vivo Testing,
                                          Labeling, Training.
Device Alters Catheter Functionality     Non-Clinical Mechanical
 (Advance/Withdrawal, Rotation,           Performance Testing
 Deflection) Resulting in Patient        Non-Clinical Electrical
 Injury (e.g., Perforation) or Improper   Testing: EMC, Electrical
 Catheter Performance (Positioning and    Safety, Electrical System,
 Contact) or Interruption of Procedure.   Performance, In Vivo Testing,
                                          Labeling, Post Market
                                          Surveillance.
Adverse Tissue Reaction................  Sterilization Testing.
Improper Device Use/Use Error..........  Labeling, Training, In Vivo
                                          Testing, Post Market
                                          Surveillance.
Interference with Other Electrical       Non-Clinical Mechanical
 Equipment/Devices (e.g., Device          Performance Testing
 Malfunction).                           Non-Clinical Electrical
                                          Testing: EMC, Electrical
                                          Safety, Electrical System,
                                          Performance, Labeling.
Electrical Shock.......................  Non-Clinical Electrical
                                          Testing: Electrical Safety
                                          Testing, Labeling.
Device Malfunction Resulting in          Non-Clinical Mechanical
 Unanticipated Operation (e.g., Device    Performance Testing
 Stoppage, Unintended Movement).         Non-Clinical Electrical
                                          Testing: EMC, Electrical
                                          Safety, Electrical System,
                                          Performance, In Vivo Testing,
                                          Labeling, Training.
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination 
with the general controls, address these risks to health and provide 
reasonable assurance of safety and effectiveness:
     Non-clinical mechanical performance testing must 
demonstrate that the device performs as intended under anticipated 
conditions of use. The following performance testing must be performed:
    [cir] Mechanical performance of the system (without catheter 
connected);
    [cir] mechanical performance of the system with compatible 
catheters connected to verify that the system does not impact catheter 
function or

[[Page 58605]]

performance. Assessments must include the following:
    [ssquf] Side-by side remote control and manual comparisons of 
catheter manipulation (including all ranges of motion of catheter 
deflection and tip curl) for all compatible catheters; must include 
testing for worst-case conditions, and
    [ssquf] evaluation of the accuracy and function of all device 
control safety features; and
    [cir] simulated-use testing in a bench anatomic model or animal 
model.
     Non-clinical electrical testing must include validation of 
EMC, electrical safety, thermal safety, and electrical system 
performance. The following performance testing must be performed:
    [cir] Electrical performance of the system with compatible 
catheters connected to verify that the system does not impact catheter 
function or performance. Assessments must include the following:
    [ssquf] Side-by side remote control and manual comparisons of 
catheter manipulation (including all ranges of motion of catheter 
deflection and tip curl) for all compatible catheters; must include 
testing for worst-case conditions, and
    [ssquf] evaluation of the accuracy and function of all device 
control safety features; and
    [cir] electrical safety between the device and ablation catheter 
system and with other electrical equipment expected in the catheter lab 
or operating room.
     In vivo testing must demonstrate that the device performs 
as intended under anticipated conditions of use, including an 
assessment of the system impact on the functionality and performance of 
compatible catheters, and documentation of the adverse event profile 
associated with clinical use. Evidence must be submitted to address the 
following:
    [cir] Manipulation and positioning: Ability to manipulate 
compatible catheters to pre-specified cardiac locations and confirm 
proper anatomic placement and tissue contact, in accordance with the 
system indications for use and the compatible catheter indications for 
use;
    [cir] Safety: Assess device-related complication rate and major 
procedural complication rate (regardless of device relatedness) in 
comparison to literature and/or a manual comparison group for 
compatible ablation catheters to support the indications for use;
    [cir] Efficacy: Assess ablation success in comparison to literature 
and/or a manual comparison group for compatible ablation catheters to 
support the indications for use; and
    [cir] User assessment of device remote controls and safety 
features.
     Post-market surveillance (PMS) must be conducted and 
completed in accordance with FDA-agreed upon PMS protocol.
     A training program must be included with sufficient 
educational elements that, upon completion of the training program, the 
clinician and supporting staff can
    [cir] Identify the safe environments for device use,
    [cir] use all safety features of device, and
    [cir] operate the device in simulated or actual use environments 
representative of indicated environments and use for the indication of 
compatible catheters.
     Performance data must demonstrate the sterility of the 
sterile disposable components of the system.
     Performance data must support shelf life by demonstrating 
continued sterility of the device (of the sterile disposable 
components), package integrity, and device functionality over the 
requested shelf life.
     Labeling must include the following:
    [cir] Appropriate instructions, warnings, cautions, limitations, 
and information related to the intended patient population, compatible 
ablation catheters, and the device safeguards for the safe use of the 
device;
    [cir] specific instructions and the clinical training needed for 
the safe use of the device, which includes:
    [ssquf] instructions on assembling the device in all available 
configurations, including installation and removal of compatible 
catheters;
    [ssquf] instructions and explanation of all controls, inputs, and 
outputs;
    [ssquf] instructions on all available modes or states of the 
device;
    [ssquf] instructions on all safety features of the device; and
    [ssquf] validated methods and instructions for reprocessing/
disinfecting any reusable components;
    [cir] a detailed summary of the mechanical compatibility testing 
including:
    [ssquf] A table with a complete list of compatible catheters tested 
(manufacturer trade name and model number), and
    [ssquf] a table with detailed test results, including type of test, 
acceptance criteria, and test results (i.e., pass for meeting 
acceptance criteria);
    [cir] a detailed summary of the in vivo testing including:
    [ssquf] a table with a complete list of compatible catheters used 
during testing (manufacturer trade name and model number);
    [ssquf] adverse events encountered pertinent to use of the device 
under use conditions;
    [ssquf] a detailed summary of the device- and procedure-related 
complications; and
    [ssquf] a summary of study outcomes and endpoints. Information 
pertinent to the fluoroscopy times/exposure for the procedure, patient 
and operator fluoroscopic exposure;
    [cir] other labeling items:
    [ssquf] a detailed summary of pertinent non-clinical testing 
information: EMC, mechanical, electrical, and sterilization of device 
and components;
    [ssquf] a detailed summary of the device technical parameters; and
    [ssquf] an expiration date/shelf life and storage conditions for 
the sterile accessories; and
    [cir] when available, and according to the timeframe included in 
the PMS protocol agreed upon with FDA, provide a detailed summary of 
the PMS data including:
    [ssquf] Updates to the labeling to accurately reflect outcomes or 
necessary modifications based upon data collected during the PMS 
experience, and
    [ssquf] inclusion of results and adverse events associated with 
utilization of the device during the PMS.
    The steerable cardiac ablation catheter remote control system is a 
prescription device restricted to patient use only upon the 
authorization of a practitioner licensed by law to administer or use 
the device; 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 
steerable cardiac ablation catheter remote control system they intend 
to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.33(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

[[Page 58606]]

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 21 
CFR 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 801, regarding labeling, have been 
approved under OMB control number 0910-0485; and the collections of 
information in 21 CFR part 820, regarding postmarket surveillance, have 
been approved under OMB control number 0910-0449.

IV. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and is available electronically at http://www.regulations.gov.

1. DEN140009: De Novo Request from Catheter Robotics, Inc., dated 
February 14, 2014.

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 21 CFR part 870 continues to read as 
follows:


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


0
2. Add Sec.  870.5700 to subpart F to read as follows:


Sec.  870.5700  Steerable cardiac ablation catheter remote control 
system.

    (a) Identification. A steerable cardiac ablation catheter remote 
control system is a prescription device that is external to the body 
and interacts with the manual handle of a steerable cardiac ablation 
catheter to remotely control the advancement, retraction, rotation, and 
deflection of a compatible, steerable ablation catheter used for the 
treatment of cardiac arrhythmias in the right side of the heart. The 
device allows reversion to manual control of the steerable cardiac 
ablation catheter without withdrawal of the catheter and interruption 
of the procedure.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical mechanical performance testing must demonstrate 
that the device performs as intended under anticipated conditions of 
use. The following performance testing must be performed:
    (i) Mechanical performance of the system (without catheter 
connected);
    (ii) Mechanical performance of the system with compatible catheters 
connected to verify that the system does not impact catheter function 
or performance. Assessments must include the following:
    (A) Side-by-side remote control and manual comparisons of catheter 
manipulation (including all ranges of motion of catheter deflection and 
tip curl) for all compatible catheters; must include testing for worst-
case conditions, and
    (B) Evaluation of the accuracy and function of all device control 
safety features; and
    (iii) Simulated-use testing in a bench anatomic model or animal 
model.
    (2) Non-clinical electrical testing must include validation of 
electromagnetic compatibility (EMC), electrical safety, thermal safety, 
and electrical system performance. The following performance testing 
must be performed:
    (i) Electrical performance of the system with compatible catheters 
connected to verify that the system does not impact catheter function 
or performance. Assessments must include the following:
    (A) Side-by-side remote control and manual comparisons of catheter 
manipulation (including all ranges of motion of catheter deflection and 
tip curl) for all compatible catheters; must include testing for worst-
case conditions, and
    (B) Evaluation of the accuracy and function of all device control 
safety features; and
    (ii) Electrical safety between the device and ablation catheter 
system and with other electrical equipment expected in the catheter lab 
or operating room.
    (3) In vivo testing must demonstrate that the device performs as 
intended under anticipated conditions of use, including an assessment 
of the system impact on the functionality and performance of compatible 
catheters, and documentation of the adverse event profile associated 
with clinical use. Evidence must be submitted to address the following:
    (i) Manipulation and Positioning: Ability to manipulate compatible 
catheters to pre-specified cardiac locations and confirm proper 
anatomic placement and tissue contact, in accordance with the system 
indications for use and the compatible catheter indications for use;
    (ii) Safety: Assess device-related complication rate and major 
procedural complication rate (regardless of device relatedness) in 
comparison to literature and/or a manual comparison group for 
compatible ablation catheters to support the indications for use;
    (iii) Efficacy: Assess ablation success in comparison to literature 
and/or a manual comparison group for compatible ablation catheters to 
support the indications for use; and
    (iv) User assessment of device remote controls and safety features.
    (4) Post-market surveillance (PMS) must be conducted and completed 
in accordance with FDA agreed upon PMS protocol.
    (5) A training program must be included with sufficient educational 
elements that, upon completion of the training program, the clinician 
and supporting staff can:
    (i) Identify the safe environments for device use,
    (ii) Use all safety features of device, and
    (iii) Operate the device in simulated or actual use environments 
representative of indicated environments and use for the indication of 
compatible catheters.
    (6) Performance data must demonstrate the sterility of the sterile 
disposable components of the system.
    (7) Performance data must support shelf life by demonstrating 
continued sterility of the device (of the sterile disposable 
components), package integrity, and device functionality over the 
requested shelf life.
    (8) Labeling must include the following:
    (i) Appropriate instructions, warnings, cautions, limitations, and 
information related to the intended patient population, compatible 
ablation catheters, and the device safeguards for the safe use of the 
device;
    (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, including installation and removal of compatible 
catheters;
    (B) Instructions and explanation of all controls, inputs, and 
outputs;

[[Page 58607]]

    (C) Instructions on all available modes or states of the device;
    (D) Instructions on all safety features of the device; and
    (E) Validated methods and instructions for reprocessing/
disinfecting any reusable components;
    (iii) A detailed summary of the mechanical compatibility testing 
including:
    (A) A table with a complete list of compatible catheters tested 
(manufacturer trade name and model number), and
    (B) A table with detailed test results, including type of test, 
acceptance criteria, and test results (i.e., pass for meeting 
acceptance criteria);
    (iv) A detailed summary of the in vivo testing including:
    (A) A table with a complete list of compatible catheters used 
during testing (manufacturer trade name and model number);
    (B) Adverse events encountered pertinent to use of the device under 
use conditions;
    (C) A detailed summary of the device- and procedure-related 
complications; and
    (D) A summary of study outcomes and endpoints. Information 
pertinent to the fluoroscopy times/exposure for the procedure, patient, 
and operator fluoroscopic exposure;
    (v) Other labeling items:
    (A) A detailed summary of pertinent non-clinical testing 
information: EMC, mechanical, electrical, and sterilization of device 
and components;
    (B) A detailed summary of the device technical parameters; and
    (C) An expiration date/shelf life and storage conditions for the 
sterile accessories; and
    (vi) When available, and according to the timeframe included in the 
PMS protocol agreed upon with FDA, provide a detailed summary of the 
PMS data including:
    (A) Updates to the labeling to accurately reflect outcomes or 
necessary modifications based upon data collected during the PMS 
experience, and
    (B) Inclusion of results and adverse events associated with 
utilization of the device during the PMS.

    Dated: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24624 Filed 9-29-15; 8:45 am]
 BILLING CODE 4164-01-P