9240 Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Rules and Regulations 

1FDA notes that the ‘‘ACTION’’ caption for this 

final order is styled as ‘‘Final amendment; final 

order,’’ rather than ‘‘Final order.’’ Beginning in 

December 2019, this editorial change was made to 

indicate that the document ‘‘amends’’ the Code of 

Federal Regulations. The change was made in 

accordance with the Office of Federal Register’s 

(OFR) interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the Document 

Drafting Handbook. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2021–N–1029] 

Medical Devices; Cardiovascular 

Devices; Classification of the 

Percutaneous Catheter for Creation of 

an Arteriovenous Fistula for 

Hemodialysis Access 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the percutaneous catheter for 

creation of an arteriovenous fistula for 

hemodialysis access 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 percutaneous 

catheter for creation of an arteriovenous 

fistula for hemodialysis access’ 

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. 

DATES: This order is effective February 

18, 2022. The classification was 

applicable on June 22, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Carmen Gacchina Johnson, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 2120, 

Silver Spring, MD 20993–0002, 240– 

402–5244, Carmen.Gacchina@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

percutaneous catheter for creation of an 

arteriovenous fistula for hemodialysis 

access 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, 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 

device 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 established the first procedure 

for De Novo classification (Pub. L. 105– 

115). Section 607 of the Food and Drug 

Administration Safety and Innovation 

Act modified the De Novo application 

process by adding a second procedure 

(Pub. L. 112–144). 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. 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 

section 513(f)(2)(B)(i) of the FD&C Act). 

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 section 513(i) of the FD&C Act, 

defining ‘‘substantial equivalence’’). 

Instead, sponsors can use the lessburdensome 510(k) process, when 

necessary, to market their device. 

II. De Novo Classification 

On February 3, 2016, FDA received 

TVA Medical, Inc.’s request for De Novo 

classification of the everlinQ endoAVF 

System. Subsequently, on January 10, 

2017, FDA received Avenu Medical, 

Inc.’s similar request for De Novo 

classification of the Ellipsys Vascular 

Access System. FDA reviewed both 

requests in order to classify the devices 

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 requests, 

we determined that the devices 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 devices. 

Therefore, on June 22, 2018, FDA 

issued orders to both requesters 

classifying their devices into class II. In 

this final order, FDA is codifying the 

classification of the devices by adding 

21 CFR 870.1252.1 We have named the 

generic type of device percutaneous 

catheter for creation of an arteriovenous 


jspears on DSK121TN23PROD with RULES1
Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Rules and Regulations 9241 

fistula for hemodialysis access, and it is 

identified as a single use percutaneous 

catheter system that creates an 

arteriovenous fistula in the arm of 

patients with chronic kidney disease 

who need hemodialysis. 

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. 

TABLE 1—PERCUTANEOUS CATHETER FOR CREATION OF AN ARTERIOVENOUS FISTULA FOR HEMODIALYSIS ACCESS RISKS

AND MITIGATION MEASURES

Identified risks Mitigation measures 

Unintended vascular or tissue injury ........................................................ Non-clinical performance testing, Animal testing, Clinical performance 

testing, and Labeling. 

Adverse hemodynamic effects ................................................................. Non-clinical performance testing, Animal testing, Clinical performance 

testing, and Labeling. 

Failure to create a durable fistula that is usable for hemodialysis .......... Animal testing and Clinical performance testing. 

Use of the device adversely impacts future vascular access sites ......... Clinical performance testing and Labeling. 

Adverse tissue reaction ............................................................................ Biocompatibility evaluation and Labeling. 

Infection .................................................................................................... Sterilization validation, Shelf life testing, and Labeling. 

Electrical malfunction or interference leading to electrical shock, device 

failure, or inappropriate activation.

Non-clinical performance testing, Electrical safety testing, and Electromagnetic compatibility (EMC) testing. 

Software malfunction leading to device failure or inappropriate activation.Software verification, validation, and hazard analysis. 

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. 

III. Analysis of Environmental Impact 

The Agency has 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. 3501–3521). 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 part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; 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 870 

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 870 is 

amended as follows: 

PART 870—CARDIOVASCULAR 

DEVICES 

■ 1. The authority citation for part 870 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 870.1252 to subpart B to read 

as follows: 

§ 870.1252 Percutaneous catheter for 

creation of an arteriovenous fistula for 

hemodialysis access. 

(a) Identification. This device is a 

single use percutaneous catheter system 

that creates an arteriovenous fistula in 

the arm of patients with chronic kidney 

disease who need hemodialysis. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing must 

evaluate: 

(i) The ability to safely deliver, 

deploy, and remove the device; 

(ii) The ability of the device to create 

an arteriovenous fistula; 

(iii) The ability of the arteriovenous 

fistula to attain a blood flow rate and 

diameter suitable for hemodialysis; 

(iv) The ability of the fistula to be 

used for vascular access for 

hemodialysis; 

(v) The patency of the fistula; and 

(vi) The rates and types of all adverse 

events. 

(2) Animal testing must demonstrate 

that the device performs as intended 

under anticipated conditions of use. The 

following performance characteristics 

must be assessed: 

(i) Delivery, deployment, and retrieval 

of the device; 

(ii) Compatibility with other devices 

labeled for use with the device; 

(iii) Patency of the fistula; 

(iv) Characterization of blood flow at 

the time of the fistula creation 

procedure and at chronic followup; and 

(v) Gross pathology and 

histopathology assessing vascular injury 

and downstream embolization. 

(3) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. The following 

performance characteristics must be 

tested: 

(i) Simulated-use testing in a 

clinically relevant bench anatomic 

model to assess the delivery, 

deployment, activation, and retrieval of 

the device; 

(ii) Tensile strengths of joints and 

components; 


jspears on DSK121TN23PROD with RULES1
9242 Federal Register / Vol. 87, No. 34 / Friday, February 18, 2022 / Rules and Regulations 

(iii) Accurate positioning and 

alignment of the device to achieve 

fistula creation; and 

(iv) Characterization and verification 

of all dimensions. 

(4) Electrical performance, electrical 

safety, and electromagnetic 

compatibility (EMC) testing must be 

performed for devices with electrical 

components. 

(5) Software verification, validation, 

and hazard analysis must be performed 

for devices that use software. 

(6) All patient-contacting components 

of the device must be demonstrated to 

be biocompatible. 

(7) Performance data must 

demonstrate the sterility of the device 

components intended to be provided 

sterile. 

(8) Performance data must support the 

shelf life of the device by demonstrating 

continued sterility, package integrity, 

and device functionality over the 

identified shelf life. 

(9) Labeling for the device must 

include: 

(i) Instructions for use; 

(ii) Identification of system 

components and compatible devices; 

(iii) Expertise needed for the safe use 

of the device; 

(iv) A detailed summary of the 

clinical testing conducted and the 

patient population studied; and 

(v) A shelf life and storage conditions. 

Dated: February 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03496 Filed 2–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 886 

[Docket No. FDA–2022–N–0104] 

Medical Devices; Ophthalmic Devices; 

Classification of the Electromechanical 

Tear Stimulator 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the electromechanical tear 

stimulator 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 

electromechanical tear stimulator’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. 

DATES: This order is effective February 

18, 2022 . The classification was 

applicable on May 1, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Leonid Livshitz, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1234, Silver Spring, 

MD 20993–0002, 301–796–6975, 

Leonid.Livshitz@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

electromechanical tear stimulator 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 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 

device 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. 

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 section 513(f)(2)(B)(i) of the 

FD&C Act). 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 section 513(i) of 

the FD&C Act, defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the less-burdensome 510(k) process, 

when necessary, to market their device. 

II. De Novo Classification 

On May 15, 2019, FDA received 

Olympic Ophthalmics, Inc.’s request for 

De Novo classification of the iTEAR100 

Neurostimulator. 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 


jspears on DSK121TN23PROD with RULES1