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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations
lotter on DSK11XQN23PROD with RULES1

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.
360ca1B. 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 14, 2019, FDA
issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21
CFR 868.5480.1 We have named the generic type of device isocapnic ventilation device, and it is identified as a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags 21 CFR
868.5320, oxygen cannulas 21 CFR
868.5340, masks 21 CFR 868.5550, valves 21 CFR 868.5870, resuscitation bags 21 CFR 868.5915, and/or tubing 21 CFR 868.5925.
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.

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. In order 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 510k.
At the time of classification, isocapnic ventilation devices are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502f1 of the FD&C Act 21 U.S.C. 352f1 and 21
CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
III. Analysis of Environmental Impact The Agency has determined under 21
CFR 25.34b 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 TABLE 1ISOCAPNIC VENTILATION DEfound in other FDA regulations and VICE RISKS AND MITIGATION MEASguidance. These collections of information are subject to review by the URES
Office of Management and Budget Identified risks Mitigation measures OMB under the Paperwork Reduction Act of 1995 44 U.S.C. 35013521. The Hypocapnia Nonclinical performance testcollections of information in the lacking ing, and Labeling.
guidance document De Novo CO2.
Hypercapnia Nonclinical performance testClassification Process Evaluation of Automatic Class III Designation have excess ing, and Labeling.
been approved under OMB control CO2.
Hypoxemia Nonclinical performance testnumber 09100844; the collections of lacking O2.
ing, and Labeling.
information in 21 CFR part 814, High airway Nonclinical performance testsubparts A through E, regarding pressure ing, and Labeling.
premarket approval, have been e.g., approved under OMB control number barotrauma.
09100231; the collections of Adverse tissue Biocompatibility evaluation.
information in part 807, subpart E, reaction.
regarding premarket notification submissions, have been approved under 1 FDA notes that the ACTION caption for this OMB control number 09100120; the final order is styled as Final amendment; final collections of information in 21 CFR
order, rather than Final order. Beginning in part 820, regarding quality system December 2019, this editorial change was made to regulation, have been approved under indicate that the document amends the Code of Federal Regulations. The change was made in OMB control number 09100073; and accordance with the Office of Federal Registers the collections of information in 21 CFR
OFR interpretations of the Federal Register Act 44
part 801, regarding labeling, have been U.S.C. chapter 15, its implementing regulations 1
approved under OMB control number CFR 5.9 and parts 21 and 22, and the Document Drafting Handbook.
09100485.

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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 868ANESTHESIOLOGY
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 868.5480 to subpart F to read as follows:

868.5480

Isocapnic ventilation device.

a Identification. An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags 868.5320, oxygen cannulas 868.5340, masks 868.5550, valves 868.5870, resuscitation bags 868.5915, and/or tubing 868.5925.
b Classification. Class II special controls. The special controls for this device are:
1 Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use, including the following performance characteristics:
i Gas concentration accuracy testing for the range of intended concentrations;
ii Airway pressure delivery accuracy testing;
iii Supplemental O2 flowrate accuracy testing;
iv Alarm testing; and v Use life testing.
2 The patient-contacting components of the device must be demonstrated to be biocompatible.
3 Labeling must include the following:
i Instructions for use;
ii A precaution that monitoring of capnography is necessary during treatment with non-spontaneously breathing patients; and iii Use life specification.
Dated: November 29, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202126201 Filed 12121; 8:45 am BILLING CODE 416401P

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