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Federal Register / Vol. 86, No. 236 / Monday, December 13, 2021 / Rules and Regulations This device is subject to premarket notification requirements under section 510k of the FD&C Act.
At the time of classification, temporary coil embolization assist 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

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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
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 882
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 882 is amended as follows:

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PART 882NEUROLOGICAL DEVICES
1. The authority citation for part 882
continues to read as follows:

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

2. Add 882.5955 to subpart F to read as follows:

882.5955 Temporary coil embolization assist device.

a Identification. A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.
b Classification. Class II special controls. The special controls for this device are:
1 Clinical performance testing of the device must demonstrate the device performs as intended for temporary use as an endovascular device to assist in the coil embolization of intracranial aneurysms and must evaluate all adverse events, including tissue or vessel damage that could lead to dissection, perforation, hemorrhage, or vasospasm, thrombo-embolic events, and coil entanglement.
2 The patient-contacting components of the device must be demonstrated to be biocompatible.
3 Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use, including:
i Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, compressive, and tip deflection forces;
ii Mechanical testing to evaluate the radial forces exerted by the device;
iii Simulated use testing to demonstrate the device can be delivered to the target location in the neurovasculature and is compatible with embolic coils;
iv Dimensional verification testing;
v Radiopacity testing; and vi Performance testing to evaluate the coating integrity and particulates under simulated use conditions.
4 Animal testing under anticipated use conditions must evaluate all adverse events, including damage to vessels or tissues.
5 Performance data must support the sterility and pyrogenicity of the device.
6 Performance data must support the shelf life of the device by demonstrating
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continued sterility, package integrity, and device functionality over the labeled shelf life.
7 The labeling must include:
i Instructions for use;
ii A detailed summary of the device technical parameters, including compatible delivery catheter dimensions and device sizing information;
iii A summary of the clinical testing results, including a detailed summary of the deviceand procedure-related complications and adverse events; and iv A shelf life.
Dated: December 6, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202126926 Filed 121021; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 876
Docket No. FDA2021N0898

Medical Devices; GastroenterologyUrology Devices; Classification of the Pressure Ulcer Management Tool AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Final amendment; final order.

The Food and Drug Administration FDA or we is classifying the pressure ulcer management tool into class I. We are taking this action because we have determined that classifying the device into class I 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.
DATES: This order is effective December 13, 2021. The classification was applicable on December 20, 2018.
FOR FURTHER INFORMATION CONTACT:
Gema Gonzalez, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2530, Silver Spring, MD 209930002, 3017966519, Gema.Gonzalez@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:

I. Background Upon request, FDA has classified the pressure ulcer management tool as class I, which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance
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