Document ID: FDA-2011-N-0650-0006
Agency: fda
Document Type: Proposed Rule
Title: Cardiovascular Devices; Reclassification of External Pacemaker
Pulse Generator Devices; Reclassification of Pacing System Analyzers
Posted Date: 2014-09-15T04:00Z

[Federal Register Volume 79, Number 178 (Monday, September 15, 2014)]
[Proposed Rules]
[Pages 54927-54936]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21814]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0650]

Cardiovascular Devices; Reclassification of External Pacemaker 
Pulse Generator Devices; Reclassification of Pacing System Analyzers

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is proposing in this 
administrative order to reclassify the external pacemaker pulse 
generator (EPPG) devices, a preamendments class III device into class 
II (special controls), and to amend the device identification and 
reclassify the pacing system analyzers (PSAs) into class II (special 
controls). Specifically, single and dual chamber PSAs, which are 
currently classified with EPPG devices, and triple chamber PSAs 
(TCPSAs), which are postamendments class III devices, are proposed to 
be reclassified to class II devices. FDA is proposing this 
reclassification based on new information pertaining to the device. 
This proposed action would implement certain statutory requirements.

DATES: Submit either electronic or written comments on the proposed 
order by December 15, 2014. See section XII for the effective date of 
any final order that may publish based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0650, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

[[Page 54928]]

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2011-N-0650 for this order. All comments received 
may be posted without change to http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Hina Pinto, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1652, Silver Spring, MD 20993, 301-796-6351.

SUPPLEMENTARY INFORMATION: 

I. Background--Regulatory Authorities

    The Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the 
Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-
295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food 
and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), 
the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-
250), the Medical Devices Technical Corrections Act of 2004 (Public Law 
108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. 
L. 110-85), and the Food and Drug Administration Safety and Innovation 
Act (FDASIA) (Pub. L. 112-144) establishes a comprehensive system for 
the regulation of medical devices intended for human use. Section 513 
of the FD&C Act (21 U.S.C. 360c) established three categories (classes) 
of devices, reflecting the regulatory controls needed to provide 
reasonable assurance of their safety and effectiveness. The three 
categories of devices are class I (general controls), class II (special 
controls), and class III (premarket approval).
    Section 513(a)(1) of the FD&C Act defines class II devices as those 
devices for which the general controls by themselves are insufficient 
to provide reasonable assurance of safety and effectiveness, but for 
which there is sufficient information to establish special controls to 
provide such assurance.
    Under section 513 of the FD&C Act, devices that were in commercial 
distribution before the enactment of the 1976 amendments, May 28, 1976 
(generally referred to as preamendments devices), are classified after 
FDA has: (1) Received a recommendation from a device classification 
panel (an FDA advisory committee); (2) published the panel's 
recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976 (generally referred to as postamendments devices), are 
automatically classified by section 513(f) of the FD&C Act into class 
III without any FDA rulemaking process. Those devices remain in class 
III and require premarket approval unless, and until, the device is 
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).
    A preamendments device that has been classified into class III and 
devices found substantially equivalent by means of premarket 
notification (510(k)) procedures to such a preamendments device or to a 
device within that type may be marketed without submission of a 
premarket approval (PMA) application until FDA issues a final order 
under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring 
premarket approval or until the device is subsequently reclassified 
into class I or class II.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA 
amended the device reclassification procedures under section 513(e) of 
the FD&C Act, changing the process for reclassifying a device from 
rulemaking to an administrative order. Prior to the enactment of 
FDASIA, FDA published a proposed rule under section 513(e) of the FD&C 
Act proposing the reclassification of EPPG devices (76 FR 64223, 
October 17, 2011). Three sets of comments were received on the proposed 
rule. The three sets of comments submitted in response to the proposed 
rule on EPPG devices will be considered under this proposed 
administrative order and do not need to be resubmitted. FDA is issuing 
this proposed administrative order to comply with the new procedural 
requirement created by FDASIA when reclassifying a preamendments class 
III device, as well as to reclassify a postamendments class III device. 
Also, as required by section 513(e) of the FD&C Act for preamendment 
devices, FDA convened a device classification panel meeting which 
discussed the proposed reclassification on September 11, 2013 (78 FR 
49272). This action is intended solely to fulfill the procedural 
requirements for reclassification implemented by FDASIA.
    Section 513(e) of the FD&C Act provides that FDA may, by 
administrative order, reclassify a device based upon ``new 
information.'' FDA can initiate a reclassification under section 513(e) 
or an interested person may petition FDA to reclassify a preamendments 
device. The term ``new information,'' as used in section 513(e) of the 
FD&C Act, includes information developed as a result of a reevaluation 
of the data before the Agency when the device was originally 
classified, as well as information not presented, not available, or not 
developed at that time. (See, e.g., Holland-Rantos Co. v. United States 
Dep't of Health, Educ., & Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 
1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 
366 F.2d 177 (7th Cir. 1966).)
    A postamendments device that has been initially classified in class 
III under section 513(f)(1) of the FD&C Act may be reclassified later 
into class I or class II under section 513(f)(3) of the FD&C Act. 
Section 513(f)(3) provides that FDA acting by administrative order can 
reclassify the device into class I or class II on its own initiative 
under section 513(f)(1) of the FD&C Act, or in response to the petition 
of the manufacturer or importer of the device. FDA's regulations in 21 
CFR 860.134 set forth the procedures for the filing and review of a 
petition for reclassification of these class III devices. To change the 
classification of the device, the proposed new class must have 
sufficient regulatory controls to provide reasonable assurance of the 
safety and effectiveness of the device for its intended use.
    Reevaluation of the data previously before the Agency is an 
appropriate

[[Page 54929]]

basis for subsequent regulatory action where the reevaluation is made 
in light of newly available regulatory authority (see Bell v. Goddard, 
supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 
(D.D.C. 1991)), or in light of changes in ``medical science.'' (See 
Upjohn v. Flinch supra, 422 F.2d at 951.) Whether data before the 
Agency are old or new data, the ``new information'' to support 
reclassification under section 513(e) must be ``valid scientific 
evidence,'' as defined in section 513(a)(3) of the FD&C Act and Sec.  
860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. 
Cir. 1985); Contact Lens Manufacturers Association v. FDA, 766 F.2d 592 
(D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. To be 
considered in the reclassification process, the valid scientific 
evidence upon which the Agency relies must be publicly available. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
premarket approval application (PMA). (See section 520(c) of the FD&C 
Act (21 U.S.C. 360j(c)).
    Section 513(e)(1) of the FD&C Act sets forth the process for 
issuing a final order. Specifically, prior to the issuance of a final 
order reclassifying a device, the following must occur: (1) Publication 
of a proposed order in the Federal Register; (2) a meeting of a device 
classification panel described in section 513(b) of the FD&C Act; and 
(3) consideration of comments from all affected stakeholders, including 
patients, payors, and providers. In addition, the proposed order must 
set forth the proposed reclassification, and a substantive summary of 
the valid scientific evidence concerning the proposed reclassification, 
including the public health benefits of the use of the device, and the 
nature and incidence (if known) of the risk of the device. (See section 
513(e)(1)(A)(i) of the FD&C Act.)
    Section 510(m) of the FD&C Act provides that a class II device may 
be exempted from the premarket notification requirements under section 
510(k) of the FD&C Act if the Agency determines that premarket 
notification is not necessary to assure the safety and effectiveness of 
the device. FDA has determined that premarket notification is necessary 
to reasonably assure the safety and effectiveness of EPPG and PSA 
devices.

II. Regulatory History of the Device

A. EPPG Devices

    On March 9, 1979, FDA published a proposed rule in the Federal 
Register for classification of EPPG devices into class III based on the 
recommendation of the Cardiovascular Devices Panel (the Panel) (44 FR 
13284 at 13372). The Panel meeting recommended EPPG devices be 
classified into class III because the device provided temporary life 
support and that certain kinds of failures could cause this device to 
emit inappropriate electrical signals, which could cause cardiac 
irregularities and death. The Panel indicated that general controls 
alone would not be sufficient and that there was not enough information 
to establish a performance standard. Consequently, the Panel believed 
that premarket approval was necessary to reasonably assure the safety 
and effectiveness of the device. In 1980, FDA classified EPPG into 
class III under Sec.  870.3600 (21 CFR 870.3600) after receiving no 
comments on the proposed rule (45 FR 7907, February 5, 1980). In 1987, 
FDA published a clarification by inserting language in the codified 
language stating that no effective date had been established for the 
requirement for premarket approval for EPPG devices (52 FR 17732, May 
11, 1987).
    In 2009, FDA published an order in the Federal Register under 
section 515(i) of the FD&C Act to call for information on the remaining 
class III 510(k) preamendment devices, including EPPG devices (74 FR 
16214, April 9, 2009). In response to that order, FDA received two 
reclassification petitions from one device manufacturer who requested 
that EPPG devices be reclassified into class II. The manufacturers 
stated that safety and effectiveness of these devices may be assured by 
performance standards, the intended use environment, postmarket 
surveillance to include Medical Device Reporting (MDRs), FDA 
inspections of manufacturing facilities, and premarket review of 
performance testing in a 510(k) submission. The manufacturers 
specifically noted that the FDA recognized consensus standard, 
International Electrotechnical Commission (IEC) 60601-2-31: 'Particular 
requirements for the basic safety and essential performance of external 
cardiac pacemakers with internal power source' provides adequate design 
and testing parameters for EPPG devices.
    On October 17, 2011, FDA published a proposed rule proposing the 
reclassification of EPPG devices from class III to class II (76 FR 
64223) and announcing the availability of a draft Special Controls 
Guidance Document that, if finalized, would serve as a special control, 
if FDA reclassified these devices. FDA believed that the special 
controls described in the draft special controls guidance document 
entitled ``Class II Special Controls Guidance Document: External 
Pacemaker Pulse Generator'' would be sufficient to mitigate the risks 
to health associated with EPPG (Ref. 1).
    The proposed rule provided for a comment period that was open until 
January 17, 2012. FDA received three sets of comments. These comments 
stated that: (1) FDA should retain EPPG in class III, (2) FDA's 
reclassification proposed rule was not adequately supported by new 
publicly valid scientific evidence, (3) MDR data showed that existing 
performance standards are insufficient, (4) there were no publicly 
available performance standards that would apply to EPPG, (5) FDA 
should convene an advisory committee (the Panel) to seek a 
recommendation on the classification of EPPG, and (6) the recall 
process after reclassification of EPPG would need to be clarified. 
These comments were considered by FDA in drafting this proposed order.

B. PSA Devices

    Single and dual chamber PSAs have historically been classified with 
EPPG devices. These devices combine the functionality of a single or 
dual chamber EPPG, which is currently class III and the functionality 
of a pacemaker electrode function tester, which is regulated as a class 
II device (under Sec.  870.3720 (21 CFR 870.3720)). Single and dual 
chamber PSA devices have been found substantially equivalent to EPPG 
devices through the 510(k) process. Triple chamber PSA (TCPSA) devices 
have not been determined to be substantially equivalent through the 
510(k) process, and since this technology was not on the market in 
1976, TCPSAs have been reviewed through the PMA process as 
postamendment class III devices.
    On July 9, 2012, FDASIA was enacted, which amended the device 
reclassification procedures under sections 513 and 515 of the FD&C Act. 
Accordingly, FDA is issuing a proposed administrative order to comply 
with the new procedural requirement created by FDASIA when 
reclassifying a preamendments class III device. Further, FDA intends to 
codify the proposed special controls within the Sec.  870.3600 
classification regulation for EPPG and to create a separate

[[Page 54930]]

classification regulation for PSA devices.
    As explained further in section VII, a meeting of the Circulatory 
System Devices Panel (the 2013 Panel) took place on September 11, 2013, 
to discuss whether EPPG and TCPSA devices should be reclassified or 
remain in class III (Ref. 2). FDA included a discussion of TCPSA 
devices in the 2013 Panel discussion because the risks to health and 
proposed special controls were very similar to those being proposed for 
the EPPG devices already under consideration. The 2013 Panel 
recommended that EPPG devices be reclassified to class II with special 
controls when intended for cardiac rate control or prophylactic 
arrhythmia prevention. The 2013 Panel also recommended that TCPSA 
devices be reclassified to class II with special controls when intended 
for use during the pulse generator implant procedure. FDA is not aware 
of new information that would provide a basis for a different 
recommendation or finding.

III. Device Description

A. EPPG Devices

    An EPPG is a device that has a power supply and electronic circuits 
that produce a periodic electrical pulse to stimulate the heart. This 
device, which is used outside the body, is used as a temporary 
substitute for the heart's intrinsic pacing system until a permanent 
pacemaker can be implanted, or to control irregular heartbeats in 
patients following events such as cardiac surgery or a myocardial 
infarction. The device may have adjustments for pacing rate, pulse 
amplitude, pulse width (duration), R-wave sensitivity, and other pacing 
variables.
    An EPPG device is designed to be used with cardiac pacing lead 
systems for temporary atrial and/or ventricular pacing. An EPPG system 
generally includes the pulse generator, extension cables, and adaptors 
which connect the extension cable to the implanted pacing lead and are 
critical to the functionality of the EPPG system. The pacing leads for 
use with EPPG may be for temporary or permanent use for either 
tranvenous or epicardial uses. The pacing leads are not considered part 
of the EPPG device because they have their own regulatory designations 
(21 CFR 870.3680) depending on their design and intended use.
    EPPG devices are used exclusively in hospital environments with the 
patients supervised by qualified medical personnel. The electrical and 
heart rhythm of patients are continuously monitored using EPPG-
independent electrocardiogram (ECG) monitors usually with alarm 
functions. Independent ECG monitoring requirements are identified in 
international standards, such as IEC 60601-2-31 for device design.
    FDA is also proposing in this order to slightly modify the 
identification language from the way it is presently written in Sec.  
870.3600(a) to clarify that these are prescription devices in 
accordance with Sec.  801.109 (21 CFR 801.109).

B. PSA Devices

    A PSA combines the functionality of a pacemaker electrode function 
tester (under Sec.  870.3720) and an EPPG. A pacemaker electrode 
function tester is a device that is connected to an implanted pacemaker 
lead that supplies an accurately calibrated, variable pacing pulse for 
measuring the patient's pacing threshold and intracardiac R-wave 
potential. A PSA can temporarily take over pacing functions while 
simultaneously testing one or more implanted pacing leads. PSA devices 
can be single, dual, or triple chamber, translating into the 
measurement capabilities/functionalities of the device. Single chamber 
PSAs typically measure pacing capture threshold, whereas in the case of 
dual chamber PSAs, the device can also measure conduction times or 
intrinsic atrioventricular delay. In the case of a TCPSA, the device 
can also function as a biventricular external pacemaker and measure the 
intrinsic intra-ventricular (VV) interval.

IV. Proposed Reclassification

A. EPPG Devices

    FDA is proposing that EPPG devices be reclassified from class III 
to class II. In this proposed order, the Agency has identified special 
controls under section 513(a)(1)(B) of the FD&C Act that, together with 
general controls (including prescription-use restrictions) applicable 
to the devices, would provide reasonable assurance of their safety and 
effectiveness. Absent the special controls identified in this proposed 
order, general controls applicable to the device are insufficient to 
provide reasonable assurance of the safety and effectiveness of the 
device. Since the time of the 1979 classification, new information 
about use and pacing technology for this device has become sufficiently 
available to establish special controls. FDA believes that this new 
information is sufficient to demonstrate that the proposed special 
controls, when finalized, can effectively mitigate the risks to health 
identified in section V, and that these special controls, together with 
general controls, will provide a reasonable assurance of safety and 
effectiveness for EPPG devices.

B. PSA Devices

    FDA is proposing to create a separate classification regulation for 
PSA devices, including single, dual, and triple chamber PSA devices 
that will be reclassified from class III to class II. In this proposed 
order, the Agency has identified special controls under section 
513(a)(1)(B) of the FD&C Act that, together with general controls 
(including prescription-use restrictions) applicable to the devices, 
would provide reasonable assurance of their safety and effectiveness. 
Absent the special controls identified in this proposed order, general 
controls applicable to the device are insufficient to provide 
reasonable assurance of the safety and effectiveness of the device. 
Since the 1979 classification of temporary external pacing devices, new 
information about device use and pacing technology has become available 
to establish special controls. FDA believes that this new information 
is sufficient to demonstrate that the proposed special controls can 
effectively mitigate the risks to health identified in section V, and 
that these special controls, together with general controls, will 
provide a reasonable assurance of safety and effectiveness for PSA 
devices.
    Section 510(m) of the FD&C Act authorizes the Agency to exempt 
class II devices from premarket notification (510(k)) submission. FDA 
has considered EPPG and PSA devices in accordance with the reserved 
criteria set forth in section 513(a) and determined that both devices 
require premarket notification (510(k) of the FD&C Act). Therefore, the 
Agency does not intend to exempt these proposed class II devices from 
premarket notification (510(k)) submission as provided under section 
510(m) of the FD&C Act.

V. Risks to Health

A. EPPG Devices

    After considering available information for the classification of 
these devices, including the recommendations of the advisory committees 
(panels) for the classification of these devices, FDA has evaluated the 
risks to health associated with the use of EPPG devices and determined 
the following risks to health are associated with its use:
     Failure to pace: Improper settings, electromagnetic 
interference, or failure

[[Page 54931]]

of mechanical/electrical components of the device can prevent pacing of 
the patient's heart.
     Improperly high pacing rate: Undersensing during demand 
pacing, unintended asynchronous pacing, or improper use of burst/
overdrive pacing can cause harmful acceleration of heart rate or induce 
harmful arrhythmias such as ventricular tachycardia.
     Improperly low pacing rate: Oversensing or use error can 
result in stimulation pulses being delivered at an unwanted low pacing 
rate, which can result in untreated symptomatic bradycardia.
     Improper pacing leading to unwanted stimulation: Pacing 
during vulnerable periods of the cardiac cycle or at higher than 
programmed amplitude can induce arrhythmias.
     Micro/macro shock: Uncontrolled leakage currents or 
patient auxiliary currents can cause an electric shock resulting in an 
arrhythmia or cardiac tissue damage.

B. PSA Devices

    After considering available information for the classification of 
these devices, including the recommendations of the advisory committees 
(panels) for the classification of these devices, FDA has evaluated the 
risks to health associated with the use of PSA devices and determined 
the following risks to health are associated with its use:
     Failure to pace: Improper settings, electromagnetic 
interference, or failure of mechanical/electrical components of the 
device can prevent pacing of the patient's heart.
     Improperly high pacing rate: Undersensing during demand 
pacing, unintended asynchronous pacing, or improper use of burst/
overdrive pacing can cause harmful acceleration of heart rate or induce 
harmful arrhythmias such as ventricular tachycardia.
     Improperly low pacing rate: Oversensing or use error can 
result in stimulation pulses being delivered at an unwanted low pacing 
rate, which can result in untreated symptomatic bradycardia.
     Improper pacing leading to unwanted stimulation: Pacing 
during vulnerable periods of the cardiac cycle or at higher than 
programmed amplitude can induce arrhythmias. For TCPSAs, this risk 
includes VV dyssynchrony.
     Micro/macro shock: Uncontrolled leakage currents or 
patient auxiliary currents can cause an electric shock resulting in an 
arrhythmia or cardiac tissue damage.
     Misdiagnosis: If the zero or calibration of the device is 
inaccurate or unstable the device may generate inaccurate diagnostic 
data. If inaccurate diagnostic data are used in managing the patient, 
the physician may prescribe a course of treatment that places the 
patient at risk unnecessarily.

VI. Summary of Reasons for Reclassification

    FDA believes that EPPG devices and PSA devices should be 
reclassified from class III to class II because special controls, in 
addition to general controls, can be established to provide reasonable 
assurance of the safety and effectiveness of the devices, and because 
general controls themselves are insufficient to provide reasonable 
assurance of their safety and effectiveness. In addition, there is now 
sufficient information to establish special controls to provide such 
assurance. FDA also believes that TCPSA devices--as a subset of PSA 
devices--can achieve a reasonable assurance of safety and effectiveness 
using the same special controls proposed for EPPG and PSA devices with 
the addition of limiting use to the duration of the implant procedure 
in order to mitigate the risk of unwanted interventricular stimulation 
leading to arrhythmia (captured as misdiagnosis and improper pacing 
leading to unwanted stimulation in the list of risks to health in 
section V).

VII. Summary of Data Upon Which the Reclassification Is Based

A. EPPG Devices

    FDA believes that the identified special controls, in addition to 
general controls, are necessary to provide reasonable assurance of 
safety and effectiveness of these devices. Therefore, in accordance 
with sections 513(e) and 515(i) of the FD&C Act and Sec.  860.130, 
based on new information with respect to the device and taking into 
account the public health benefit of the use of the device and the 
nature and known incidence of the risk of the device, FDA, on its own 
initiative, is proposing to reclassify this preamendments class III 
device into class II. The Agency has identified special controls that 
would provide reasonable assurance of their safety and effectiveness. 
EPPG are prescription devices restricted to patient use only upon the 
authorization of a practitioner licensed by law to administer or use 
the device. Since 1979 when FDA classified EPPG devices into class III, 
sufficient evidence has been developed to support a reclassification to 
class II with the establishment of special controls. FDA has been 
reviewing these devices for many years and their risks are well known. 
The risks to health are identified in section V, and FDA believes these 
risks can be adequately mitigated by special controls.
    EPPG devices that use temporary cardiac pacing for the purposes of 
rate control or treatment of bradycardia use mature technology with 
well-established evidence of effectiveness (Refs. 3, 8, 9, 11, 13). A 
review of 14 clinical studies published over four decades shows that 
temporary external pacing is generally safe and has an 
electrophysiologic as well as hemodynamic benefit when used as 
indicated (Refs. 3 to 17).
    The low frequency of serious adverse events as evidenced through 
FDA's Manufacturer and User Facility Device Experience (MAUDE) 
database, the low rate of postmarket recalls, the established 
scientific evidence to support pacing for specific indications, the 
hospital use environment, and FDA's review experience with these 
devices, all support the reclassification of these devices to class II. 
In addition, several key performance standards (such as IEC 60601-1 and 
IEC 60601-2-31) that address various aspects of design and performance 
have been developed and used to support marketing applications since 
the original classification. In light of these considerations, FDA has 
tentatively concluded that the identified special controls, in addition 
to general controls, provide reasonable assurance of the safety and 
effectiveness of EPPG devices.
    FDA's presentation to the 2013 Panel included a summary of the 
available safety and effectiveness information for EPPG devices, 
including adverse event reports from FDA's MAUDE database and available 
literature. Based on the available scientific literature, which 
supports that use of EPPG devices may be beneficial for patients 
needing temporary atrial and/or ventricular pacing, FDA recommended to 
the 2013 Panel that EPPG devices be reclassified to class II (special 
controls). The 2013 Panel discussed and made recommendations regarding 
the regulatory classification of EPPG devices to either reconfirm to 
class III (subject to premarket approval application) or reclassify to 
class II (subject to special controls). The 2013 Panel agreed with 
FDA's conclusion that the available scientific evidence is adequate to 
support the safety and effectiveness of EPPG devices. The 2013 Panel 
also acknowledged that EPPG devices are life-supporting devices and 
provided the following rationale per

[[Page 54932]]

Sec.  860.93 for recommending that EPPG devices be reclassified to 
class II: (1) These devices are used exclusively in the hospital 
environment where backup monitoring is available, hazards can be 
recognized and treated immediately, and where there is a reasonable 
expectation that users are adequately trained; (2) there is sufficient 
clinical experience that attests to the benefit of the device; and (3) 
the recommended special controls will mitigate the health risks 
associated with the device.
    The 2013 Panel also agreed with the identified risks to health 
presented at the meeting; however, it recommended that FDA consider 
rewording some of the language for clarity and also to ensure that 
certain hazards, such as asynchronous pacing and arrhythmia induction, 
are included in the risks to health. FDA agrees with the 2013 Panel's 
recommendations and modified the risks to health accordingly as 
outlined in section V. The 2013 Panel also agreed with FDA's proposed 
special controls outlined in section VIII; however, the 2013 Panel 
further recommended that FDA add labeling requirements for proper 
training, proper maintenance of the device, and remedial actions for 
failures due to lead connections. FDA agrees with the 2013 Panel and 
the proposed special controls have been modified to reflect more 
specific labeling requirements.
    The 2013 Panel transcript and other meeting materials are available 
on FDA's Web site (Ref. 2).

B. PSA Devices

    FDA believes that the identified special controls, in addition to 
general controls, are necessary to provide reasonable assurance of 
safety and effectiveness of these devices. Therefore, in accordance 
with sections 513(e) and 515(i) of the FD&C Act and Sec.  860.130, 
based on new information with respect to the device and taking into 
account the public health benefit of the use of the device and the 
nature and known incidence of the risks of the device, FDA, on its own 
initiative, is proposing to reclassify these class III devices into 
class II. The Agency has identified special controls that would provide 
reasonable assurance of their safety and effectiveness.
    Single and dual chamber PSA devices combine the functions of a 
pacemaker electrode function tester (class II) and an EPPG device 
(proposed class II). No new risks have been identified from the 
combination of these devices and the 2013 Panel likewise did not 
identify new concerns with regulating single and dual chamber PSAs in a 
manner consistent with EPPG devices. The low frequency of serious 
adverse events as evidenced through FDA's MAUDE database, the low rate 
of postmarket recalls, the established scientific evidence to support 
pacing for specific indications, the hospital use environment, and 
FDA's review experience with these devices, all supports the 
reclassification of these devices to class II. These devices are 
prescription devices restricted to patient use only upon the 
authorization of a practitioner licensed by law to administer or use 
the device.
    Sufficient evidence has been developed to support a 
reclassification of single and dual chamber PSA devices, to class II 
with special controls. FDA has been reviewing these devices for many 
years and their risks are well known. The risks to health are 
identified in section V, and FDA believes these risks can be adequately 
mitigated by general and special controls.
    Sufficient evidence has also been developed to support a 
reclassification of TCPSA devices. FDA has not identified any 
additional risks to the patient due to the availability to pace three 
chambers in terms of failure to pace or improper pacing rate during the 
implant procedure. The longer-term hemodynamic issues associated with 
biventricular pacing are not relevant to the acute implant procedure. 
The use of TCPSAs is limited by labeling to use only during implant of 
a pacemaker or implantable cardioverter defibrillator (ICD). 
Accordingly, the proposed special controls for TCPSA devices contain 
the same requirements as EPPG devices with the addition of labeling 
that indicates TCPSA use only during the implant procedure.
    FDA's presentation to the 2013 Panel included a summary of the 
available safety and effectiveness information for TCPSA devices, 
including adverse event reports from FDA's MAUDE database and a search 
of the available literature. The searches did not identify any safety 
issues for this device type.
    Based on the available evidence, FDA recommended to the 2013 Panel 
that TCPSA devices be reclassified to class II (special controls). The 
2013 Panel discussed and made recommendations regarding the regulatory 
classification of TCPSA devices to either reconfirm to class III 
(subject to premarket approval application) or reclassify to class II 
(subject to special controls) as directed by section 513(e) of the FD&C 
Act. The 2013 Panel agreed with FDA's conclusion that the available 
scientific evidence is adequate to support the safety and effectiveness 
of TCPSA devices and reclassify them to class II. The 2013 Panel also 
acknowledged that TCPSA devices are life-supporting devices and 
provided the following rationale per Sec.  860.93 for recommending that 
TCPSA devices be reclassified to class II: (1) These devices are used 
only during the implant procedure where backup monitoring is 
continuous, hazards can be recognized and treated immediately, and 
where there is a reasonable expectation that users are adequately 
trained; (2) these devices are not intended to provide the long-term 
hemodynamic benefit of biventricular pacing or cardiac 
resynchronization therapy; and (3) the recommended special controls 
will mitigate the health risks associated with the device.
    The 2013 Panel also agreed with the identified risks to health 
presented at the meeting; however, the 2013 Panel recommended that FDA 
consider the same modifications as recommended for EPPG devices. FDA 
agrees with the 2013 Panel's recommendations and modified the risks to 
health accordingly as outlined in section V. The 2013 Panel also agreed 
with FDA's proposed special controls outlined in section VIII; however, 
the 2013 Panel further recommended that FDA add labeling requirements 
for proper training, proper maintenance of the device, and remedial 
actions for failures due to lead connections. FDA agrees with the 2013 
Panel.
    The 2013 Panel transcript and other meeting materials are available 
on FDA's Web site (Ref. 2).

VIII. Proposed Special Controls

A. EPPG Devices

    FDA believes that the following special controls, together with 
general controls (including applicable prescription-use restrictions 
and continuing 510(k) notification requirements), are sufficient to 
mitigate the risks to health described in section V for EPPG devices:
    1. Appropriate analysis/testing must validate electromagnetic 
compatibility (EMC) within a hospital environment.
    2. Electrical bench testing must demonstrate device safety during 
intended use. This must include testing with the specific power source 
(i.e., battery power, AC mains connections, or both).
    3. Non-clinical performance testing data must demonstrate the 
performance characteristics of the device. Testing must include the 
following:
     Testing must demonstrate the accuracy of monitoring 
functions, alarms, measurement features, therapeutic features, and all 
adjustable

[[Page 54933]]

or programmable parameters as identified in labeling;
     mechanical bench testing of material strength must 
demonstrate that the device and connection cables will withstand forces 
or conditions encountered during use;
     simulated use analysis/testing must demonstrate adequate 
user interface for adjustable parameters, performance of alarms, 
display screens, interface with external devices (e.g. data storage, 
printing), and indicator(s) functionality under intended use 
conditions; and
     methods and instructions for cleaning the pulse generator 
and connection cables must be validated.
    4. Appropriate software verification, validation, and hazard 
analysis must be performed.
    5. Labeling must include the following:
     The labeling must clearly state that these devices are 
intended for use in a hospital environment and under the supervision of 
a clinician trained in its use;
     connector terminals should be clearly, unambiguously 
marked on the outside of the EPPG device. The markings should identify 
positive (+) and negative (-) polarities. Dual chamber devices should 
clearly identify atrial and ventricular terminals;
     the labeling must list all pacing modes available in the 
device;
     labeling must include a detailed description of any 
special capabilities (e.g., overdrive pacing or automatic mode 
switching); and
     appropriate electromagnetic compatibility information must 
be included.
    Table 1 shows how FDA believes that the risks to health identified 
in section V can be mitigated by the proposed special controls.

     Table 1--Health Risks and Mitigation Measures for EPPG Devices
------------------------------------------------------------------------
           Identified risk                    Mitigation measures
------------------------------------------------------------------------
Failure to Pace......................  Use Environment.
                                       EMC Testing.
                                       Electrical Safety Testing.
                                       Non-Clinical Performance
                                        Evaluation.
                                       Software Verification, Validation
                                        & Hazards Analysis.
                                       Labeling.
Improper High Rate Pacing............  Use Environment.
                                       EMC Testing.
                                       Electrical Safety Testing.
                                       Non-Clinical Performance
                                        Evaluation.
                                       Software Verification, Validation
                                        & Hazards Analysis.
                                       Labeling.
Pacing at an Improperly Low Rate.....  Use Environment.
                                       EMC Testing.
                                       Electrical Safety Testing.
                                       Non-Clinical Performance
                                        Evaluation.
                                       Software Verification, Validation
                                        & Hazards Analysis.
                                       Labeling.
Improper Pacing Leading to Unwanted    Non-Clinical Performance
 Stimulation.                           Evaluation.
                                       Software Verification, Validation
                                        & Hazards Analysis.
                                       Labeling.
Micro/Macro Shock....................  Electrical Safety Testing.
                                       Non-Clinical Performance
                                        Evaluation.
                                       Labeling.
------------------------------------------------------------------------

    In addition, under Sec.  801.109, the sale, distribution, and use 
of EPPG devices are restricted to prescription use. Prescription use 
restrictions are a type of general control in section 513(a)(1)(A)(i) 
of the FD&C Act. Also, under Sec.  807.81, the device would continue to 
be subject to 510(k) notification requirements.

B. PSA Devices

    FDA believes that the following special controls, together with 
general controls (including applicable prescription-use restrictions 
and continuing 510(k) notification requirements), are sufficient to 
mitigate the risks to health described in section V for single, dual, 
and triple chamber PSA devices:
    1. Appropriate analysis/testing must validate EMC within a hospital 
environment.
    2. Electrical bench testing must demonstrate device safety during 
intended use. This must include testing with the specific power source 
(i.e., battery power, AC mains connections, or both).
    3. Non-clinical performance testing data must demonstrate the 
performance characteristics of the device. Testing must include the 
following:
     Testing must demonstrate the accuracy of monitoring 
functions, alarms, measurement features, therapeutic features, and all 
adjustable or programmable parameters as identified in labeling;
     mechanical bench testing of material strength must 
demonstrate that the device and connection cables will withstand forces 
or conditions encountered during use;
     simulated use analysis/testing must demonstrate adequate 
user interface for adjustable parameters, performance of alarms, 
display screens, interface with external devices (e.g. data storage, 
printing), and indicator(s) functionality under intended use 
conditions; and
     methods and instructions for cleaning the pulse generator 
and connection cables must be validated.
    4. Appropriate software verification, validation, and hazard 
analysis must be performed.
    5. Labeling must include the following:
     The labeling must clearly state that these devices are 
intended for use in a hospital environment and under the supervision of 
a clinician trained in its use;
     connector terminals should be clearly, unambiguously 
marked on the outside of the EPPG device. The markings should identify 
positive (+) and negative (-) polarities. Dual

[[Page 54934]]

chamber devices should clearly identify atrial and ventricular 
terminals. Triple chamber devices should clearly identify atrial, right 
ventricular, and left ventricular terminals;
     the labeling must list all pacing modes available in the 
device;
     labeling must include a detailed description of any 
special capabilities (e.g., overdrive pacing or automatic mode 
switching);
     labeling must limit the use of external pacing to the 
implant procedure; and
     appropriate electromagnetic compatibility information must 
be included.
    Table 2 shows how FDA believes that the risks to health identified 
in section V can be mitigated by the proposed special controls.

      Table 2--Health Risks and Mitigation Measures for PSA Devices
------------------------------------------------------------------------
           Identified risk                    Mitigation measures
------------------------------------------------------------------------
Misdiagnosis.........................  Non-Clinical Performance
                                        Evaluation.
                                       Labeling.
Failure to Pace......................  Use Environment.
                                       EMC Testing.
                                       Electrical Safety Testing.
                                       Non-Clinical Performance
                                        Evaluation.
                                       Software Verification, Validation
                                        & Hazards Analysis.
                                       Labeling.
Improper High Rate Pacing............  Use Environment.
                                       EMC Testing.
                                       Electrical Safety Testing.
                                       Non-Clinical Performance
                                        Evaluation.
                                       Software Verification, Validation
                                        & Hazards Analysis.
                                       Labeling.
Pacing at an Improperly Low Rate.....  Use Environment.
                                       EMC Testing.
                                       Electrical Safety Testing.
                                       Non-Clinical Performance
                                        Evaluation.
                                       Software Verification, Validation
                                        & Hazards Analysis.
                                       Labeling.
Improper Pacing Leading to Unwanted    Non-Clinical Performance
 Stimulation.                           Evaluation.
                                       Software Verification, Validation
                                        & Hazards Analysis.
                                       Labeling.
Micro/Macro Shock....................  Electrical Safety Testing.
                                       Non-Clinical Performance
                                        Evaluation.
                                       Labeling.
------------------------------------------------------------------------

    In addition, under Sec.  801.109, the sale, distribution, and use 
of these single and dual chamber PSA devices are restricted to 
prescription use. Prescription use restrictions are a type of general 
controls in section 513(a)(1)(A)(i) of the FD&C Act. Also, under Sec.  
807.81, the device would continue to be subject to 510(k) notification 
requirements.

IX. 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.

X. Paperwork Reduction Act of 1995

    This proposed order refers to currently approved collections of 
information found in 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, have been approved 
under OMB control number 0910-0120; the collections of information in 
21 CFR part 814, subpart B, have been approved under OMB control number 
0910-0231; and the collections of information under 21 CFR part 801 
have been approved under OMB control number 0910-0485.

XI. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act 
provided for FDA to issue regulations to reclassify devices. Although 
section 513(e) as amended authorizes FDA to issue orders rather than 
regulations, FDASIA also provides for FDA to revoke previously issued 
regulations by order. FDA will continue to codify classifications and 
reclassifications in the Code of Federal Regulations (CFR). Changes 
resulting from final orders will appear in the CFR as changes to 
codified classification determinations or as newly codified orders. 
Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by 
FDASIA, in this proposed order we are proposing to: (1) Revoke the 
requirements in Sec.  870.3600 related to the classification of EPPG 
devices as class III devices and to codify the reclassification of EPPG 
devices into class II (special controls) and (2) codify the 
reclassification of PSA devices into class II (special controls).

XII. Proposed Effective Date

    FDA is proposing that any final order based on this proposed order 
become effective on the date of its publication in the Federal Register 
or at a later date if stated in the final order.

XIII. Comments

    Comments already submitted to the docket (FDA-2011-N-0650) have 
been officially noted and do not need to be resubmitted. FDA will 
consider previous docket comments in issuing any final orders for these 
devices. Interested persons may submit either electronic comments 
regarding this document or the associated guidance to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received

[[Page 54935]]

comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday, and will be posted to the 
docket at http://www.regulations.gov.

XIV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES), and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified all the Web site addresses in this reference section, but 
we are not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)

1. Class II Special Controls Draft Guidance Document: External 
Pacemaker Pulse Generator, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM275703.pdf.
2. The panel transcript and other meeting materials for the 
September 11, 2013, Circulatory System Devices Panel are available 
on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm342357.htm.
3. ``ACC/AHA Guidelines for the Management of Patients with ST-
Elevation Myocardial Infarction,'' Circulation, 110:e82-e292, 2004.
4. Beland, M. J., P. S. Hesslein, C. D. Finlay, et al., 
``Noninvasive Transcutaneous Cardiac Pacing in Children,'' Pacing 
and Clinical Electrophysiology, 10:1262-1270, 1987.
5. Braun, M. U., T. Rauwolf, M. Bock, et al., ``Percutaneous Lead 
Implantation Connected to an External Device in Stimulation-
Dependent Patients With Systemic Infection--A Prospective and 
Controlled Study,'' Pacing and Clinical Electrophysiology, August; 
29(8):875-879, 2006.
6. Ceresnak, S. R., R. H. Pass, T. J. Starc, et al., ``Predictors 
for Hemodynamic Improvement With Temporary Pacing After Pediatric 
Cardiac Surgery,'' Journal of Thoracic Cardiovascular Surgery, 
January; 141(1):183-187, 2011.
7. Dunn, D. L. and J. J. Gregory, ``Noninvasive Temporary Pacing: 
Experience in a Community Hospital,'' Heart and Lung, January; 
18(1):23-28, 1989.
8. Eberhardt, F., T. Hanke, M. Heringlake, et al., ``Feasibility of 
Temporary Biventricular Pacing in Patients With Reduced Left 
Ventricular Function After Coronary Artery Bypass Grafting,'' Pacing 
and Clinical Electrophysiology, January; 30 Suppl 1:S50-53, 2007.
9. Ferguson, T. B. Jr. and J. L. Cox, ``Temporary External DDD 
Pacing After Cardiac Operations,'' The Annals of Thoracic Surgery, 
May; 51(5):723-732, 1991.
10. Halldorsson, A. O., W. T. Vigneswaran, F. J. Podbielski, and D. 
M. Evans, ``Electrophysiological and Clinical Comparison of Two 
Temporary Pacing Leads Following Cardiac Surgery,'' Pacing and 
Clinical Electrophysiology, August; 22(8):1221-1225, 1999.
11. Hindman, M. C., G. S. Wagner, M. JaRo, et al., ``The Clinical 
Significance of Bundle Branch Block Complicating Acute Myocardial 
Infarction. Indications for Temporary and Permanent Pacemaker 
Insertion,'' Circulation, October; 58(4):689-699, 1978.
12. Janousek J., P. Vojtovic, and R. A. Gebauer, ``Use of a 
Modified, Commercially Available Temporary Pacemaker for R Wave 
Synchronized Atrial Pacing in Postoperative Junctional Ectopic 
Tachycardia,'' Pacing and Clinical Electrophysiology, February; 26(2 
Pt. 1):579-586, 2003.
13. Kratz, J. and J. Tyler, ``Clinical Experience with a New DDD 
External Pacemaker,'' Pacing and Clinical Electrophysiology, 
December; 16(12):2227-2234, 1993.
14. Nimetz, A. A., S. J. Shubrooks, A. M. Hutter, and R. W. 
DeSanctis, ``The Significance of Bundle Branch Block During Acute 
Myocardial Infarction,'' American Heart Journal, October; 90(4):439-
444, 1975.
15. Pinneri, F., S. Frea, K. Najd, et al., ``Echocardiography-Guided 
Versus Fluoroscopy-Guided Temporary Pacing in the Emergency Setting: 
An Observational Study,'' Journal of Cardiovascular Medicine 
(Hagerstown), March; 14(3):242-246, 2013.
16. Siddons, H., ``Transvenous Long-Term Pacing With an External 
Pacemaker. What Are the Risks?'', Pacing and Clinical 
Electrophysiology, April; 1(2):163-165, 1978.
17. Voigtl[auml]nder T., B, Nowak, P. B[auml]renf[auml]nger, et al., 
``Feasibility and Sensing Thresholds of Temporary Single-Lead VDD 
Pacing in Intensive Care,'' American Journal of Cardiology, May 15; 
79(10):1360-1363, 1997.

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, it is 
proposed that 21 CFR part 870 be 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. Section 870.3600 is revised to read as follows:

Sec.  870.3600  External pacemaker pulse generator.

    (a) Identification. An external pacemaker pulse generator (EPPG) is 
a prescription device that has a power supply and electronic circuits 
that produce a periodic electrical pulse to stimulate the heart. This 
device, which is used outside the body, is used as a temporary 
substitute for the heart's intrinsic pacing system until a permanent 
pacemaker can be implanted, or to control irregular heartbeats in 
patients following cardiac surgery or a myocardial infarction. The 
device may have adjustments for impulse strength, duration, R-wave 
sensitivity, and other pacing variables.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate analysis/testing must validate electromagnetic 
compatibility (EMC) within a hospital environment.
    (2) Electrical bench testing must demonstrate device safety during 
intended use. This must include testing with the specific power source 
(i.e., battery power, AC mains connections, or both).
    (3) Non-clinical performance testing data must demonstrate the 
performance characteristics of the device. Testing must include the 
following:
    (i) Testing must demonstrate the accuracy of monitoring functions, 
alarms, measurement features, therapeutic features, and all adjustable 
or programmable parameters as identified in labeling;
    (ii) Mechanical bench testing of material strength must demonstrate 
that the device and connection cables will withstand forces or 
conditions encountered during use;
    (iii) Simulated use analysis/testing must demonstrate adequate user 
interface for adjustable parameters, performance of alarms, display 
screens, interface with external devices (e.g. data storage, printing), 
and indicator(s) functionality under intended use conditions; and
    (iv) Methods and instructions for cleaning the pulse generator and 
connection cables must be validated.
    (4) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (5) Labeling must include the following:
    (i) The labeling must clearly state that these devices are intended 
for use in a hospital environment and under the supervision of a 
clinician trained in their use; and
    (ii) Connector terminals should be clearly, unambiguously marked on 
the outside of the EPPG device. The markings should identify positive 
(+) and negative (-) polarities. Dual chamber devices should clearly 
identify atrial and ventricular terminals; and
    (iii) The labeling must list all pacing modes available in the 
device;

[[Page 54936]]

    (iv) Labeling must include a detailed description of any special 
capabilities (e.g., overdrive pacing or automatic mode switching); and
    (v) Appropriate electromagnetic compatibility information must be 
included.
0
3. In Subpart D, add Sec.  870.3605 to read as follows:

Sec.  870.3605  Pacing system analyzer.

    (a) Identification. A pacing system analyzer (PSA) is a 
prescription device that combines the functionality of a pacemaker 
electrode function tester (Sec.  870.3720) and an external pacemaker 
pulse generator (EPPG) (Sec.  870.3600). It is connected to a pacemaker 
lead and uses a power supply and electronic circuits to supply an 
accurately calibrated, variable pacing pulse for measuring the 
patient's pacing threshold and intracardiac R-wave potential. A PSA may 
be a single, dual, or triple chamber system and can simultaneously 
deliver pacing therapy while testing one or more implanted pacing 
leads.
    (b) Classification. Class II (special controls) for PSAs. The 
special controls for this device are:
    (1) Appropriate analysis/testing must validate electromagnetic 
compatibility (EMC) within a hospital environment.
    (2) Electrical bench testing must demonstrate device safety during 
intended use. This must include testing with the specific power source 
(i.e., battery power, AC mains connections, or both).
    (3) Non-clinical performance testing data must demonstrate the 
performance characteristics of the device. Testing must include the 
following:
    (i) Testing must demonstrate the accuracy of monitoring functions, 
alarms, measurement features, therapeutic features, and all adjustable 
or programmable parameters as identified in labeling;
    (ii) Mechanical bench testing of material strength must demonstrate 
that the device and connection cables will withstand forces or 
conditions encountered during use;
    (iii) Simulated use analysis/testing must demonstrate adequate user 
interface for adjustable parameters, performance of alarms, display 
screens, interface with external devices (e.g. data storage, printing), 
and indicator(s) functionality under intended use conditions; and
    (iv) Methods and instructions for cleaning the pulse generator and 
connection cables must be validated.
    (4) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (5) Labeling must include the following:
    (i) The labeling must clearly state that these devices are intended 
for use in a hospital environment and under the supervision of a 
clinician trained in their use;
    (ii) Connector terminals should be clearly, unambiguously marked on 
the outside of the EPPG. The markings should identify positive (+) and 
negative (-) polarities. Dual chamber devices should clearly identify 
atrial and ventricular terminals. Triple chamber devices should clearly 
identify atrial, right ventricular, and left ventricular terminals;
    (iii) The labeling must list all pacing modes available in the 
device;
    (iv) Labeling must include a detailed description of any special 
capabilities (e.g., overdrive pacing or automatic mode switching);
    (v) Labeling must limit the use of external pacing to the implant 
procedure; and
    (vi) Appropriate electromagnetic compatibility information must be 
included.

    Dated: September 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21814 Filed 9-12-14; 8:45 am]
BILLING CODE 4164-01-P