52970 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations 
Dated: October 15, 2018. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2018–22786 Filed 10–18–18; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 878 
[Docket No. FDA–2018–N–3595] 
Medical Devices; General and Plastic 
Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final order. 
SUMMARY : The Food and Drug 
Administration (FDA or we) is classifying the hemostatic device for intraluminal gastrointestinal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hemostatic device for intraluminal gastrointestinal use’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens. 
DATES : This order is effective October 
19, 2018. The classification was applicable on May 7, 2018. 
FOR FURTHER INFORMATION CONTACT : 
Maegen Colehour, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G423, Silver Spring, MD, 20993–0002, 301–796–6436, Maegen.Colehour@fda.hhs.gov . 
SUPPLEMENTARY INFORMATION : 
I. Background 
Upon request, FDA has classified the 
hemostatic device for intraluminal gastrointestinal use as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III 
occurs by operation of law and without 
any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as ‘‘postamendments devices’’ because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
FDA may take a variety of actions in 
appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). 
FDA may also classify a device 
through ‘‘De Novo’’ classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105–115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112–144) 
modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification. 
Under the first procedure, the person 
submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). 
Under the second procedure, rather 
than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. 
Under either procedure for De Novo 
classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. 
We believe this De Novo classification 
will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining ‘‘substantial equivalence’’). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device. 
II. De Novo Classification 
On March 9, 2017, Wilson-Cook 
Medical, Inc. submitted a request for De 
Novo classification of the Hemospray
® 
Endoscopic Hemostat. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. 
We classify devices into class II if 
general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. 
Therefore, on May 7, 2018, FDA 
issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 878.4456. We have named the generic type of device hemostatic device for intraluminal gastrointestinal use, and it is identified as a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other means. 
FDA has identified the following risks 
to health associated specifically with this type of device and the measures 
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required to mitigate these risks in table 
1. 
TABLE 1—H EMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USERISKS AND MITIGATION MEASURES  
Identified risks Mitigation measures 
Bleeding: 
•Inability to achieve hemostasis 
•Recurrence of bleeding In vivo performance testing, Non-clinical performance testing, and Labeling. 
Infection ....................................................................... Sterilization validation, Shelf life testing, and Labeling. 
Adverse tissue reaction ............................................... In vivo performance testing, Non-clinical performance testing, Biocompatibility evaluation, 
and Labeling. 
Obstruction of gastrointestinal (GI) tract ..................... In vivo performance testing and Labeling. 
GI distension or perforation ......................................... In vivo performance testing and Labeling. 
Vascular obstruction: 
•Ischemia 
•Emboli formation In vivo performance testing, Non-clinical performance testing, and Labeling. 
Tissue trauma .............................................................. In vivo performance testing, Non-clinical performance testing, and Labeling. 
Improper device use .................................................... In vivo performance testing and Labeling. 
FDA has determined that special 
controls, in combination with the 
general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act. 
At the time of classification, 
hemostatic devices for intraluminal gastrointestinal use are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)). 
III. Analysis of Environmental Impact 
We have determined under 21 CFR 
25.34(b) that this action is of a type that 
does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 
IV. Paperwork Reduction Act of 1995 
This final order establishes special 
controls that refer to previously 
approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in the guidance document ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ have been approved under OMB control number 0910–0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910–0231; the collections of information in 21 CFR part 820, regarding quality system regulations, have been approved under OMB control number 0910–0073; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910–0485. 
List of Subjects in 21 CFR Part 878 
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 878 is amended as follows: 
PART 878—GENERAL AND PLASTIC 
SURGERY DEVICES 
■1. The authority citation for part 878 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 360l, 371. 
■2. Add § 878.4456 to subpart E to read 
as follows: § 878.4456 Hemostatic device for 
intraluminal gastrointestinal use. 
(a) Identification. A hemostatic device 
for intraluminal gastrointestinal use is a 
prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means. 
(b) Classification. Class II (special 
controls). The special controls for this device are: 
(1) The device must be demonstrated 
to be biocompatible. 
(2) Performance data must support the 
sterility and pyrogenicity of the device. 
(3) Performance data must support the 
shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. 
(4) In vivo performance testing must 
demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following: 
(i) The ability to deliver the 
hemostatic material to the bleeding site; 
(ii) The ability to achieve hemostasis 
in a clinically relevant model of gastrointestinal bleeding; and 
(iii) Safety endpoints, including 
thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation. 
(5) Non-clinical performance testing 
must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: 
(i) Materials characterization of all 
components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of 
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impurities, physical characteristics, and 
reactivity with fluids. 
(ii) Performance testing must 
demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems. 
(6) Labeling must include: 
(i) Information identifying and 
explaining how to use the device and its 
components; and 
(ii) A shelf life. 
Dated: October 15, 2018. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2018–22784 Filed 10–18–18; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 882 
[Docket No. FDA–2018–N–3690] 
Medical Devices; Neurological 
Devices; Classification of the Thermal Vestibular Stimulator for Headache 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final order. 
SUMMARY : The Food and Drug 
Administration (FDA or we) is classifying the thermal vestibular stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the thermal vestibular stimulator for headache’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens. 
DATES : This order is effective October 
19, 2018. The classification was applicable on March 26, 2018. 
FOR FURTHER INFORMATION CONTACT : 
Stacie Gutowski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993–0002, 240–402–6032, Stacie.Gutowski@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : I. Background 
Upon request, FDA has classified the 
thermal vestibular stimulator for headache as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. 
The automatic assignment of class III 
occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as ‘‘postamendments devices’’ because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
FDA may take a variety of actions in 
appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). 
FDA may also classify a device 
through ‘‘De Novo’’ classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105–115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112–144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification. 
Under the first procedure, the person 
submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather 
than first submitting a 510(k) and then 
a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. 
Under either procedure for De Novo 
classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. 
We believe this De Novo classification 
will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket application to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), defining ‘‘substantial equivalence’’). Instead, sponsors can use the less- burdensome 510(k) process, when necessary, to market their device. 
II. De Novo Classification 
On April 18, 2017, Scion NeuroStim, 
LLC submitted a request for De Novo 
classification of the ThermoNeuroModulation Device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. 
We classify devices into class II if 
general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. 
Therefore, on March 26, 2018, FDA 
issued an order to the requester classifying the device into class II. FDA 
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