80 FR 49895 - Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 159 (August 18, 2015)

The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation device 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 esophageal thermal regulation device'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.

[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Rules and Regulations]
[Pages 49895-49897]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20317]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2015-N-2723]


Medical Devices; Cardiovascular Devices; Classification of the 
Esophageal Thermal Regulation Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
esophageal thermal regulation device 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 esophageal 
thermal regulation device'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 August 18, 2015. The classification was 
applicable on June 23, 2015.

FOR FURTHER INFORMATION CONTACT: Lydia Glaw, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1102, Silver Spring, MD 20993-0002, 301-796-1456, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1). 
Under the first procedure, the person submits a premarket notification 
under section 510(k) of the FD&C Act for a device that has not 
previously been classified and, within 30 days of receiving an order 
classifying the device into class III under section 513(f)(1), the 
person requests a classification under section 513(f)(2) of the FD&C 
Act. Under the second procedure, rather than first submitting a 
premarket notification under section 510(k) 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 May 
8, 2014, Advanced Cooling Therapy, LLC, submitted a request for 
classification of the Esophageal Cooling Device 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 could be classified into class 
II with the

[[Page 49896]]

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 June 23, 2015, 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 870.5910.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for an esophageal 
thermal regulation device will need to comply with the special controls 
named in this final order. The device is assigned the generic name 
esophageal thermal regulation device, and it is identified as a 
prescription device used to apply a specified temperature to the 
endoluminal surface of the esophagus via an external controller. This 
device may incorporate a mechanism for gastric decompression and 
suctioning. The device is used to regulate patient temperature.
    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--Esophageal Thermal Regulation Device Risks and Mitigation
                                Measures
------------------------------------------------------------------------
              Identified risk                    Mitigation measure
------------------------------------------------------------------------
Adverse tissue reaction...................  Biocompatibility testing.
Gastric distension........................  Non-clinical performance
                                             evaluation.
                                            Labeling.
Injury to the esophagus...................  Non-clinical performance
                                             evaluation.
                                            Animal testing.
                                            Labeling.
Harmful hypo/hyperthermia.................  Non-clinical performance
                                             evaluation.
                                            Animal testing.
                                            Labeling.
Injury to the trachea.....................  Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination 
with the general controls, address these risks to health and provide 
reasonable assurance of the safety and effectiveness:
     The patient contacting materials must be demonstrated to 
be biocompatible.
     Non-clinical performance evaluation must demonstrate that 
the device performs as intended under anticipated conditions of use. 
The following performance characteristics must be tested:
    [cir] Mechanical integrity testing;
    [cir] Testing to determine temperature change rate(s);
    [cir] Testing to demonstrate compatibility with the indicated 
external controller; and
    [cir] Shelf life testing.
     Animal testing must demonstrate that the device does not 
cause esophageal injury and that body temperature remains within 
appropriate boundaries under anticipated conditions of use.
     Labeling must include the following:
    [cir] Detailed insertion instructions;
    [cir] Warning against attaching the device to unintended 
connections, such as external controllers for which the device is not 
indicated, or pressurized air outlets instead of vacuum outlets for 
those devices, including gastric suction;
    [cir] The operating parameters, name, and model number of the 
indicated external controller; and
    [cir] The intended duration of use.
    Esophageal thermal regulation devices are prescription devices 
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 
esophageal thermal regulation device they intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
part 807, subpart E, regarding premarket notification submissions have 
been approved under OMB control number 0910-0120, and the collections 
of information in 21 CFR part 801, regarding labeling have been 
approved under OMB control number 0910-0485.

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. DEN140018: De Novo Request per 513(f)(2) from Advanced Cooling 
Therapy, LLC, dated May 8, 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.  870.5910 to subpart F to read as follows:


Sec.  870.5910  Esophageal thermal regulation device.

    (a) Identification. An esophageal thermal regulation device is a 
prescription device used to apply a specified temperature to the 
endoluminal surface of the esophagus via an external controller. This 
device may incorporate a mechanism for gastric decompression and 
suctioning. The device is used to regulate patient temperature.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting materials must be demonstrated to be 
biocompatible.
    (2) Non-clinical performance evaluation must demonstrate that the 
device performs as intended under anticipated conditions of use. The

[[Page 49897]]

following performance characteristics must be tested:
    (i) Mechanical integrity testing.
    (ii) Testing to determine temperature change rate(s).
    (iii) Testing to demonstrate compatibility with the indicated 
external controller.
    (iv) Shelf life testing.
    (3) Animal testing must demonstrate that the device does not cause 
esophageal injury and that body temperature remains within appropriate 
boundaries under anticipated conditions of use.
    (4) Labeling must include the following:
    (i) Detailed insertion instructions.
    (ii) Warning against attaching the device to unintended 
connections, such as external controllers for which the device is not 
indicated, or pressurized air outlets instead of vacuum outlets for 
those devices, including gastric suction.
    (iii) The operating parameters, name, and model number of the 
indicated external controller.
    (iv) The intended duration of use.

    Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20317 Filed 8-17-15; 8:45 am]
 BILLING CODE 4164-01-P