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[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Rules and Regulations]
[Pages 27895-27898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12829]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2018-N-1894]

Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Fluid Jet System for Prostate Tissue Removal

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the fluid jet system for prostate tissue removal 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 fluid jet

[[Page 27896]]

system for prostate tissue removal'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 June 15, 2018. The classification was 
applicable on December 21, 2017.

FOR FURTHER INFORMATION CONTACT: Jessica Cades, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G246, Silver Spring, MD, 20993-0002, 240-402-3900, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the fluid jet system for prostate 
tissue removal 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 to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). 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 (21 U.S.C. 360c(f)(2)). 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 shall 
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 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 PMA in order 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 April 17, 2017, PROCEPT BioRobotics Inc. submitted a request for 
De Novo classification of the AQUABEAM System. 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 December 21, 2017, 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 876.4350. We have named 
the generic type of device fluid jet system for prostate tissue 
removal, and it is identified as a prescription device intended for the 
resection and removal of prostatic tissue for the treatment of benign 
prostatic hyperplasia. The device cuts tissue by using a pressurized 
jet of fluid delivered to the prostatic urethra. The device is able to 
image the treatment area, or pairs with an imaging modality, to monitor 
treatment progress.
    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--Fluid Jet System for Prostate Tissue Removal Risks and
                           Mitigation Measures
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             Identified risks                    Mitigation measures
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Injury from device operation causing one    Clinical performance
 or more of the following:                   testing, Animal testing,
                                             Labeling, and Training.
     Bleeding
     Bruising
     Penile or pelvic pain

[[Page 27897]]

 
     Dysuria
     Incontinence
     Bladder or prostate capsule
     perforation
     Sexual dysfunction, including
     ejaculatory and erectile dysfunction
     Transurethral resection
     syndrome
     Urethral damage causing false
     passage or stricture
     Rectal incontinence/
     perforation
     Embolism
Adverse tissue reaction...................  Biocompatibility evaluation.
Infection.................................  Sterilization validation,
                                             Reprocessing validation,
                                             Shelf life testing, and
                                             Labeling.
Failure to remove target tissue or removal  Clinical performance
 of non-target tissue.                       testing, Animal testing,
                                             Software verification,
                                             validation, and hazard
                                             analysis, Non-clinical
                                             performance testing,
                                             Labeling, and Training.
Electrical shock or electromagnetic         Electrical safety testing,
 interference.                               Electromagnetic
                                             compatibility testing, and
                                             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. 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. 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.
    At the time of classification, fluid jet systems for prostate 
tissue removal 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 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

    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. 3501-3520). 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 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 part 
801, regarding labeling, have been approved under OMB control number 
0910-0485.

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 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

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

0
2. Add Sec.  876.4350 to subpart E to read as follows:

Sec.  876.4350  Fluid jet system for prostate tissue removal.

    (a) Identification. A fluid jet system for prostate tissue removal 
is a prescription device intended for the resection and removal of 
prostatic tissue for the treatment of benign prostatic hyperplasia. The 
device cuts tissue by using a pressurized jet of fluid delivered to the 
prostatic urethra. The device is able to image the treatment area, or 
pairs with an imaging modality, to monitor treatment progress.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must evaluate the following:
    (i) All adverse events associated with the device, and
    (ii) Improvement in lower urinary tract symptoms (LUTS).
    (2) Physician training must be provided that includes:
    (i) Information on key aspects and use of the device, and
    (ii) Information on how to override or stop resection.
    (3) Animal testing must demonstrate that the device resects 
targeted tissue in a controlled manner without injury to adjacent non-
target tissues.
    (4) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Measurement of targeting accuracy and reproducibility of high 
velocity fluid jet, and
    (ii) High pressure fluid jet verification testing at target and 
non-target tissues.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) The patient-contacting elements of the device must be 
demonstrated to be biocompatible.
    (7) Performance data must demonstrate the electrical safety and 
electromagnetic compatibility of the device.
    (8) Performance data must demonstrate the sterility of the patient-
contacting components of the device.

[[Page 27898]]

    (9) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (10) Performance data must validate the instructions for 
reprocessing and reliability of reusable components.
    (11) Labeling must include the following:
    (i) A section that summarizes the clinical testing results, 
including the adverse event profile and improvement in LUTS;
    (ii) A shelf life for single use components;
    (iii) A use life for reusable components; and
    (iv) Reprocessing instructions for reusable components.

    Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12829 Filed 6-14-18; 8:45 am]
 BILLING CODE 4164-01-P
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