[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Rules and Regulations]
[Pages 45725-45727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2017-N-5153]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the High Intensity Ultrasound System for Prostate Tissue Ablation

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 high intensity ultrasound system for prostate tissue ablation 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 high intensity ultrasound system for prostate 
tissue ablation'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 October 2, 2017. The classification was 
applicable on October 9, 2015.

FOR FURTHER INFORMATION CONTACT: John Baxley, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G210, Silver Spring, MD 20993-0002, 301-796-6549, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the high intensity ultrasound 
system for prostate tissue ablation 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

[[Page 45726]]

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 (the 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 and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    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 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 premarket approval application 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 March 23, 2015, SonaCare Medical, LLC submitted a request for De 
Novo classification of the Sonablate[supreg] 450. 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 general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on October 9, 2015, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 876.4340. We have named 
the generic type of device high intensity ultrasound system for 
prostate tissue ablation, and it is identified as a prescription device 
that transmits high intensity therapeutic ultrasound energy into the 
prostate to thermally ablate a defined, targeted volume of tissue, 
performed under imaging guidance. This classification does not include 
devices that are intended for the treatment of any specific prostate 
disease and does not include devices that are intended to ablate non-
prostatic tissues/organs.
    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--High Intensity Ultrasound System for Prostate Tissue Ablation
                      Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Thermal injury from high intensity       Non-clinical performance
 ultrasound exposure to non-target        testing; Software
 tissue:                                  verification, validation, and
  Erectile dysfunction            hazard analysis; In vivo
  Urinary incontinence            testing; Clinical testing;
  Rectal fistula                  Labeling; and Physician
  Osteomyelitis pubis             training.
Thermal injury from high intensity       Clinical testing, Labeling, and
 ultrasound exposure to target tissue:    Physician training.
  Urethral stricture
  Bladder neck contracture
  Urinary retention
  Tissue debris/obstruction
  Voiding dysfunction
  Dysuria
  Hematuria
  Ejaculation disorder
Mechanical injury from unintentional     Software verification,
 movement of ultrasound components:       validation, and hazard
  Patient rectal injury           analysis; Clinical testing;
  Operator hand injury            Labeling; and Physician
                                          training.

[[Page 45727]]

 
Infection..............................  Sterilization validation,
                                          Reprocessing validation, Shelf
                                          life validation, and Labeling.
Electrical shock/electromagnetic         Electrical safety testing,
 interference.                            Electromagnetic compatibility
                                          testing, and Labeling.
Adverse tissue reaction................  Biocompatibility testing.
------------------------------------------------------------------------

    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 510(k).
    At the time of classification, high intensity ultrasound systems 
for prostate tissue ablation 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 (21 U.S.C. 352(f)(1)) 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 25.34(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 administrative order establishes special controls that 
refer to previously approved collections of information found in other 
FDA regulations. 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 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.  876.4340 to subpart E to read as follows:


Sec.  876.4340  High intensity ultrasound system for prostate tissue 
ablation.

    (a) Identification. A high intensity ultrasound system for prostate 
tissue ablation is a prescription device that transmits high intensity 
therapeutic ultrasound energy into the prostate to thermally ablate a 
defined, targeted volume of tissue, performed under imaging guidance. 
This classification does not include devices that are intended for the 
treatment of any specific prostate disease and does not include devices 
that are intended to ablate non-prostatic tissues/organs.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) 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) Characterization of acoustic pressure and power output at 
clinically relevant levels;
    (ii) Measurement of targeting accuracy and reproducibility of high 
intensity ultrasound output;
    (iii) Ultrasound-induced heating verification testing at target and 
non-target tissues;
    (iv) Electrical safety testing; and
    (v) Electromagnetic compatibility testing.
    (2) Software verification, validation, and hazard analysis must be 
performed.
    (3) The elements of the device that may contact the patient's 
mucosal tissue must be demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components that contact the patient's mucosal tissue.
    (5) Performance data must support shelf life by demonstrating 
continued sterility of the device or the sterile components, package 
integrity, and device functionality over the identified shelf life.
    (6) Performance data must support the instructions for reprocessing 
all reusable components.
    (7) In vivo testing must demonstrate that the device thermally 
ablates targeted tissue in a controlled manner without thermal injury 
to adjacent, non-target tissues.
    (8) Clinical testing must document the adverse event profile, 
provide evidence of prostatic ablation, and demonstrate that the device 
performs as intended under anticipated conditions of use.
    (9) Training must be provided so that upon completion of the 
training program, the physician can:
    (i) Use all safety features of the device;
    (ii) Accurately target the high intensity ultrasound energy within 
the desired region of the prostate; and
    (iii) Perform the ablation procedure in a manner that minimizes 
damage to non-target tissues.
    (10) Labeling must include:
    (i) A section that summarizes the clinical testing results, 
including the adverse event profile and evidence of prostate ablation 
achieved; and
    (ii) An expiration date or shelf life for single use components.

    Dated: September 25, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21074 Filed 9-29-17; 8:45 am]
 BILLING CODE 4164-01-P