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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations
68399

TABLE 1ESOPHAGEAL TISSUE CHARACTERIZATION SYSTEM RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Device malfunction related to:
Breaking Fractures Unintentional separation of components Inaccurate reading Failure to sense Endoscope incompatibility Adverse tissue reaction
Electrical shock and electrical interference from other devices

Nonclinical performance testing; Shelf life testing; Software verification, validation, and hazard analysis; and Labeling.

Procedural risks which may include procedures of endoscopy with sedation.
Infection/cross-contamination

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 510k of the FD&C Act.

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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 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. 35013521. 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 09100844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 09100231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 09100120; the collections of information in 21 CFR

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Biocompatibility evaluation.
Electrical safety testing, Electromagnetic compatibility EMC testing, and Labeling.
Labeling.
Reprocessing validation, Labeling.

part 820, regarding quality system regulation, have been approved under OMB control number 09100073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control number 09100485.
List of Subjects in 21 CFR Part 876
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 876 is amended as follows:
PART 876GASTROENTEROLOGYUROLOGY DEVICES
1. The authority citation for part 876
continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

2.Add 876.1450 to subpart B to read as follows:

thermal safety of the device must be performed.
6 Performance data must validate the reprocessing instructions for any reusable components of the device.
7 Labeling must include:
i Specific instructions regarding the proper placement and use of the device;
ii Instructions for reprocessing of any reusable components; and iii An expiration date for single use components.
Dated: November 26, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202126200 Filed 12121; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration

Docket No. FDA2021N0261

876.1450 Esophageal tissue characterization system.

a Identification. An esophageal tissue characterization system is a device intended for obtaining measurements of electrical properties within esophageal tissue.
b Classification. Class II special controls. The special controls for this device are:
1 All patient contacting components of the device must be demonstrated to be biocompatible.
2 Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.
3 Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.
4 Software verification, validation, and hazard analysis must be performed.
5 Electromagnetic compatibility and electrical safety, mechanical safety, and
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21 CFR Part 882

Medical Devices; Neurological Devices; Classification of the Trunk and Limb Electrical Stimulator To Treat Headache Food and Drug Administration, Department of Health and Human Services HHS.
ACTION: Final amendment; final order.
AGENCY:

The Food and Drug Administration FDA or we is classifying the trunk and limb electrical stimulator to treat 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 trunk and limb electrical stimulator to treat headaches 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
SUMMARY:

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