[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Rules and Regulations]
[Pages 57321-57323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23304]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2019-N-2675]


Medical Devices; Physical Medicine Therapeutic Devices; 
Classification of the Internal Therapeutic Massager

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 internal therapeutic massager 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 internal 
therapeutic massager'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

[[Page 57322]]

this action will also enhance patients' access to beneficial innovative 
devices, in part by reducing regulatory burdens.

DATES: This order is effective October 25, 2019. The classification was 
applicable on November 20, 2012.

FOR FURTHER INFORMATION CONTACT: Vivek Pinto, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2668, Silver Spring, MD, 20993-0002, 301-796-1136, 
Vivek.Pinto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the internal therapeutic massager 
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), 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 (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 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 (21 U.S.C. 360c(a)(1)). 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 510(k) process, when 
necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on July 27, 2010, finding the 
American Health Insurance Plans (AHIP) Internal Trigger Point Wand not 
substantially equivalent to a predicate not subject to premarket 
approval. Thus, the device remained in class III in accordance with 
section 513(f)(1) of the FD&C Act when we issued the order.
    On August 20, 2010, National Center for Pelvic Pain Research 
Devices, Inc. submitted a request for De Novo classification of the 
AHIP Internal Trigger Point Wand. 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 November 20, 2012, 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 890.5670. We have named 
the generic type of device internal therapeutic massager, and it is 
identified as a hand-held prescription device intended for medical 
purposes to manually provide direct pressure applied to localized areas 
of pain or tenderness in the myofascial tissue associated with chronic 
pelvic pain syndromes. The device is inserted rectally or vaginally and 
provides quantitative feedback to the user of the applied force to the 
target tissue.
    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--Internal Therapeutic Massager Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility evaluation,
                                          and Labeling.
Tissue bruising, abrasion or tearing...  Non-clinical performance
                                          testing, and Labeling.

[[Page 57323]]

 
Microbial contamination from reusable    Labeling.
 components.
Vaginal/rectal cross-contamination.....  Labeling.
Overstretching/weakness of the anal      Non-clinical performance
 sphincter and vagina.                    testing, and Labeling.
Mechanical failure during use..........  Non-clinical performance
                                          testing.
User error.............................  Labeling.
Electrical shock.......................  Electrical safety testing, and
                                          Labeling.
Electromagnetic incompatibility........  Electromagnetic compatibility
                                          testing, and Labeling.
Software failure.......................  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. 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) of the FD&C Act.
    At the time of classification, internal therapeutic massagers 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)).
    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a 
class II device from the premarket notification requirements under 
section 510(k) if, after notice of our intent to exempt and 
consideration of comments, we determine by order that premarket 
notification is not necessary to provide reasonable assurance of safety 
and effectiveness of the device. We believe this may be such a device. 
The notice of intent to exempt the device from premarket notification 
requirements is published elsewhere in this issue of the Federal 
Register.

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 part 820, regarding quality system regulation, have been 
approved under OMB control number 0910-0073; the collections of 
information in 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 890

    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 
890 is amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. Add an authority citation for part 890 to read as follows:

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


0
2. Add Sec.  890.5670 to subpart F to read as follows:


Sec.  890.5670  Internal therapeutic massager.

    (a) Identification. A hand-held internal therapeutic massager 
device is a prescription device intended for medical purposes to 
manually provide direct pressure applied to localized areas of pain or 
tenderness in the myofascial tissue associated with chronic pelvic pain 
syndromes. The device is inserted rectally or vaginally and provides 
quantitative feedback to the user of the applied force to the target 
tissue.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Labeling must include adequate directions for use.
    (2) Non-clinical performance testing must demonstrate 
electromagnetic compatibility (EMC), electrical safety and mechanical 
safety.
    (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) Mechanical durability; and
    (ii) Accuracy of the feedback mechanism.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) The patient-contacting components of the device must be 
demonstrated to be biocompatible.

    Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23304 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P


