54006 Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Rules and Regulations 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 868 
[Docket No. FDA–2018–N–3729] 
Medical Devices; Anesthesiology 
Devices; Classification of the High Flow Humidified Oxygen Delivery Device 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final order. 
SUMMARY : The Food and Drug 
Administration (FDA or we) is classifying the high flow humidified oxygen delivery device 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 high flow humidified oxygen delivery device’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 
26, 2018. The classification was applicable on April 10, 2018. 
FOR FURTHER INFORMATION CONTACT : 
Derya Coursey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2563, Silver Spring, MD 20993–0002, 240–402–6130, Derya.Coursey@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : 
I. Background 
Upon request, FDA has classified the 
high flow humidified oxygen delivery device 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 (see 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 January 3, 2017, Vapotherm, Inc. 
submitted a request for De Novo 
classification of the Precision Flow
® 
HVNI. 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 April 10, 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 868.5454. We have named the generic type of device high flow humidified oxygen delivery device, and it is identified as a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia. 
FDA has identified the following risks 
to health associated specifically with this type of device and the measures required to mitigate these risks in table 1. 
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TABLE 1—H IGHFLOW HUMIDIFIED OXYGEN DELIVERY DEVICE RISKS AND MITIGATION MEASURES  
Identified risks Mitigation measures 
Adverse tissue reaction ............................................................................ Biocompatibility evaluation, Non-clinical performance testing, and La-
beling. 
Interference with other devices ................................................................ Electromagnetic compatibility testing, Radiofrequency identification test-
ing, and Labeling. 
Infection .................................................................................................... Cleaning validation and Labeling. 
Device software failure leading to delayed initiation of therapy .............. Software verification, validation, and hazard analysis; and Labeling. 
Device failure/malfunction leading to ineffective treatment ...................... Non-clinical performance testing and Labeling. 
Electrical shock injury from device failure ................................................ Electrical safety, thermal safety, and mechanical safety testing. 
Use error/improper device use leading to hypoxia or worsening 
hypercarbia.Labeling. 
FDA has determined that special 
controls, in combination with the 
general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act. 
At the time of classification, high flow 
humidified oxygen delivery devices 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 820, 
regarding quality system regulation, have been approved under OMB control number 0910–0073; 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 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 868 
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 868 is amended as follows: 
PART 868—ANESTHESIOLOGY 
DEVICES 
■1. The authority citation for part 868 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 360l, 371. 
■2. Add § 868.5454 to subpart F to read 
as follows: 
§ 868.5454 High flow humidified oxygen 
delivery device. 
(a) Identification. A high flow 
humidified oxygen delivery device is a 
prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia. 
(b) Classification. Class II (special 
controls). The special controls for this device are: 
(1) The patient-contacting 
components of the device must be demonstrated to be biocompatible. 
(2) Non-clinical performance testing 
must demonstrate that the device performs as intended under anticipated conditions for use, including the following: 
(i) Alarm testing must be performed; (ii) Continuous use thermal stability 
testing must be performed; 
(iii) Humidity output testing must be 
performed; and 
(iv) Blender performance testing must 
evaluate fraction of inspired oxygen (FiO
2) blending accuracy. 
(3) Performance data must validate 
cleaning instructions for any reusable components of the device. 
(4) Electrical safety, thermal safety, 
mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed. 
(5) Software verification, validation, 
and hazard analysis must be performed. 
(6) Labeling must include: 
(i) A description of available FiO
2 
ranges for different flowrates and inlet 
gas pressures; 
(ii) Instructions for applicable 
flowrates for all intended populations; 
(iii) A warning that patients on high 
flow oxygen are acute and require appropriate monitoring, to include pulse oximetry; 
(iv) A warning regarding the risk of 
condensation at low set temperatures and certain flows; and 
(v) A description of all alarms and 
their functions. 
Dated: October 22, 2018. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2018–23409 Filed 10–25–18; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 874 
[Docket No. FDA–2018–N–3772] 
Medical Devices; Ear, Nose, and Throat 
Devices; Classification of the Active Implantable Bone Conduction Hearing System 
AGENCY : Food and Drug Administration, 
HHS. 
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