Vacuum pumps
Vacuum pumps consist of a cylinder and a vacuum pump which is
either hand operated or motorized. The cylinder is placed over
the flaccid
penis and the user applies an external vacuum to cause blood
to enter the penis and produce an erection. Once a satisfactory
erection is obtained and before removing the vacuum cylinder,
the user often places a constriction ring around the base of
the erect penis to maintain the erection during intercourse.
The vacuum cylinder includes a quick release mechanism to relieve
vacuum suction and/or a separate automatic vacuum mechanism
to limit vacuum strength as listed in the design features section
of this guidance.
Constriction rings
Constriction rings are devices that are placed around the base
of the erect penis for the duration of sexual intercourse to
restrict venous blood flow leaving the penis. Constriction rings
generally consist of loops of flexible, elastic material and
a quick release mechanism to release constriction and remove
the ring. When an erection can be achieved but not maintained
constriction rings can be used alone, or when creating an erection
is not possible, they are used in conjunction with vacuum pumps.
Penile splints
Penile splints are flexible support structures intended to be attached
to or placed along the penis to hold the penis erect during sexual
intercourse. Penile splints include a quick release mechanism
to enable quick removal.
External penile rigidity devices do not include intended uses
such as:
· mechanical penile extenders
· foreskin remodeling or restoration
· penile enhancement, such as penis enlargement
· treatment of diseases or conditions of the penis with
respect to curvature and other penis deformities, e.g., Peyronie’s
Disease.
· prevention or reversal of erectile dysfunction/impotence
· retaining a condom on the penis.
Devices intended for the uses listed above raise new questions
of safety and effectiveness and we believe they can not be found
substantially equivalent to external penile rigidity devices that
are described in this guidance document. The Urology and Lithotripsy
Devices Branch is available to discuss any questions you may have
concerning such devices.
3. Risks to Health
FDA has identified the following risks to health associated with
the use of the external penile rigidity devices in the table below.
FDA recommends the following measures to mitigate the identified
risks in this guidance, as shown in the table below.
Table 1. Identified Risks and Recommended Mitigation Measures
Identified risks Recommended mitigation measures
Tissue injury, trauma, or infection (user and user’s partner)
Design Features (Section 4)Labeling (Section 5)
Aggravation of existing medical conditions such as Peyronie’s
disease, priapism, and urethral strictures Labeling (Section 5)
FDA believes that conformance with the recommendations in this
guidance document, when combined with the general controls of the
Act, will provide reasonable assurance of the safety and effectiveness
of the external penile rigidity devices. We recommend that manufacturers
evaluate their devices as described below and, where appropriate,
document the results in their design history files as a part of
the Quality Systems Requirements (21 CFR 820.20).
4. Design Features
We recommend that external penile rigidity devices have the design
features described below. We believe these features will minimize
the potential risk of injury to the user.
Design Features for Vacuum Pumps
Manual Safety Mechanism – A vacuum device should include
a manually operated mechanism to quickly release the vacuum pressure.
The design should not include design features for extended continuous
use.
Vacuum Level – Vacuum pumps typically draw a vacuum of less
than 17 inches of mercury. If the vacuum range of a new device
differs substantially from that specification, manufacturers should
conduct studies to establish the acceptability of the vacuum drawn
by their device. Tests should be performed to verify the maximum
vacuum level. The device should include an automatic safety valve
to limit vacuum pressure to safe levels.
Shape and Surface Design – Vacuum pumps should have smooth
surfaces and shapes. Vacuum pumps should not include design features
that promote extended application and use of the device beyond
the limited time needed to draw a vacuum and to create an erection.
Electrical Safety – An electrically powered vacuum device
should have adequate electrical isolation between the user and
the power source of the device. The device leakage current should
not exceed a safe limit according to the standard IEC 60601 1,
Medical Electrical Equipment - Part 1: General Requirements for
Safety (General).
Design Features for Constriction Rings
Manual Safety Release Mechanism – The device should have
a simple and quick method to manually release the device. Quick
release mechanisms for constrictive devices should include a sufficiently
wide tab, handle, loop, or other means for the user to eliminate
continued application of constrictive pressure and remove the device.
The design should not include design features for extended continuous
use.
Pliable Materials – The materials used in constriction rings
should minimize the potential for injury to the user or partner
by using soft and pliable materials. The materials used should
not cause adverse tissue reaction with respect to cytotoxicity,
sensitization, or irritation conforming to International Standard
Organization Standard (ISO) Standard ISO-10993, "Biological
Evaluation of Medical Devices Part 1: Evaluation and Testing" for
a limited duration, skin contacting device.
Shape and Surface Design – Constriction rings should include
a smooth shape and surface design to minimize protrusions and pressure
points to the user and partner. Constriction rings should avoid
design features that promote use of the device beyond 30 minutes.
Design Features for Penile Splints
Manual Safety Mechanism – The device should have a simple
and quick method to easily release and remove the device manually.
The design should not include design features for extended continuous
use.
Pliable Materials – Soft and pliable materials should be
used in penile splints to help minimize the potential for injury
to the user or partner. The materials used should not cause adverse
tissue reaction with respect to cytotoxicity, sensitization, or
irritation conforming to International Standard Organization Standard
(ISO) Standard ISO-10993, "Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing" for a limited duration,
skin contacting device.
Shape and Surface Design– Penile splints should include
a smooth shape and surface design. Penile splints should be designed
to not constrict the penis.
5. Labeling
The following suggestions are aimed at assisting manufacturers
in preparing labeling that satisfies the requirements of 21 CFR
Part 801.
Instructions for Use
The instructions for use should contain comprehensive instructions
with adequate illustrations regarding how to size, place, operate,
remove, and clean the device. The instructions should also include
a general descriptive overview of the entire system, including
diagrams of the system and its major components and a description
of each safety feature. The first page of the instructions for
use should include a statement that the user should read the
instructions before using the device. Please see also Attachment
1 for an example of patient information.
The instructions for use should be written and formatted so as
to be easily read and understood by the layman (i.e., 8th grade
reading level) with any medical or technical words either replaced
with terms understood by the layman or defined in a glossary. We
recommend that the instructions for use include the following sections:
· a table of contents
· a brief description of the device and its intended use
· a section that lists all potential risks and hazards
associated with using the device
· a list of warning statements and their consequences to
emphasize the importance of following them
· an instructions for use section
· a troubleshooting section (Attachment 1 provides a suggested
content and format)
· a glossary of any medical or technical terms used in
the instructions.
Warnings
In addition to the information above, FDA recommends that labeling
address the warnings as given in the examples below.
Delayed Diagnosis of Other Conditions
If you have symptoms of erectile dysfunction, i.e., inability to
achieve an erection that is sufficient for sexual intercourse,
consult your physician prior to using this device to avoid a
potentially harmful delay in diagnosing any of the most common
causes of this condition, such as diabetes, multiple sclerosis,
cirrhosis of the liver, chronic renal failure, or alcoholism.
Use with Impaired Pain Perception
Do not use the device if you have decreased sensation of pain in
the area of the penis. (This warning should inform the user that
if he cannot feel pain, he may not know whether or not he is
being injured by the device.)
Use with Decreased Hand Strength
Do not use the device if you have decreased hand strength, as this
would make removal of the device difficult.
The labeling should also describe the alternative treatments such
as counseling, drug therapy, hormonal therapy, vascular surgery,
and implanted prosthetic devices. The labeling should advise the
device user to contact his physician for more information regarding
these alternate treatments.
Labeling for external penile rigidity devices should include:
· indications for use
· identification of the population(s) for whom the device
is appropriate
· warning advising the user and his partner to consult
a physician if any complications occur and discontinue use of the
device if complications continue
· warning against using lubricants that may adversely affect
the materials of the device along with examples of such lubricants
· other contraindications, warnings, and precautions relevant
to your device (See the example in Attachment 1. Sample patient
handout for vacuum devices and constriction rings, December 1991,
Contemporary Urology reprint)
· disposable or single use status (if applicable).
Additional Labeling for Vacuum Pumps
In addition to the information for all external penile rigidity
devices, FDA recommends that labeling for vacuum pumps address
the warnings and precautions given in the examples below.
Warnings
· stop using the vacuum pump if pain occurs
· do not use under the influence of alcohol or drugs, since
such use may impair the user’s judgment and increase the
risk of injury to the penis.
· do not use if the user has sickle cell disease, has a
history of prolonged erections, or is taking large quantities of
aspirin or other blood thinners, as these conditions increase the
risk of bruising and hematoma.
· misuse of the vacuum pump could injure the penis.
Precautions
· apply only the minimum amount of vacuum pressure necessary
to achieve an erection; excessive vacuum pressure may bruise or
injure the penis.
· limit use of the constriction ring to no longer than
30 minutes per use. (You should box or otherwise make this precaution
more prominent than others.)
· use of a vacuum pump may bruise or rupture the blood
vessels within the penis or scrotum, resulting in petechiae, hemorrhage,
or the formation of a hematoma.
· use of a vacuum pump may aggravate already existing conditions
such as Peyronies disease, priapism, and urethral strictures.
· if appropriate, the labeling should instruct patients
not to use an electrically powered vacuum pump in or near water.
Additional Labeling for Constriction Rings
In addition to the information above for all external penile rigidity
devices, FDA recommends that labeling for constriction rings address
the warnings and precautions given in the examples below.
Warnings
· do not fall asleep while wearing the constriction ring,
since prolonged use of the constriction ring may cause permanent
injury to the penis.
· allow at least 60 minutes between uses, as more frequent
use may increase the risk of injury to the penis.
· do not use constriction rings under the influence of
alcohol or drugs, since such use may impair your judgment and increase
the risk of injury to the penis.
· misuse of a constriction ring may cause bruising, painful
injury, or permanent damage to the penis.
· constriction rings do not prevent pregnancy.
Precautions
· use of a constriction ring may aggravate already existing
medical conditions such as Peyronie's disease (the formation of
hardened tissue in the penis that causes pain, curvature, and distortion,
usually during erection); priapism (persistent, usually painful
erection of the penis as a consequence of disease and not related
to sexual arousal); and urethral strictures (urethral stricture
is an area of hardened tissue, which narrows the urethra sometimes
making it difficult to urinate).
· limit use of the constriction ring to no longer than
30 minutes per use (You should box or otherwise make this precaution
more prominent than others.)
· prolonged use of the constriction ring (i.e., without
removal) may cause permanent injury to the penis (You should box
or otherwise make this precaution more prominent than others.)
· device use may bruise or rupture the blood vessels within
the penis or scrotum, resulting in petechiae (a small purplish
spot on a body surface, such as the skin or a mucous membrane,
caused by a minute hemorrhage), hemorrhage (flow of blood from
ruptured blood vessels), or the formation of a hematoma (localized
swelling filled with blood resulting from a break in a blood vessel).
· use the least constrictive ring size that maintains an
erection, since excessive constriction could injure the penis.
6. Limitations of Exemption from Premarket Notification
FDA's decision to exempt a Class II device from the requirement
of 510(k) is based on the existing and reasonably foreseeable
characteristics of devices within that generic type that currently
are, or have been, in commercial distribution. Section 21 CFR
876.9 specifies the limitations to exemption. A device classified
as exempt from 510(k) requirements is not exempt, if the device:
· is for an intended use that is different from the intended
use of a legally marketed device in that generic type
· operates using a different fundamental scientific technology
than that used by a legally marketed device in that generic type.
If any of these limitations apply, your device is not exempt and
you must submit a 510(k).
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