Guidance for Industry and for FDA
Reviewers/Staff
Guidance for the Content of
Premarket Notifications for
Penile Rigidity Implants
Document issued on:  January 16, 2000
This document supersedes document Draft Guidance for the Content of Premarket Notifications
for Penile Rigidity Implants (dated 5/30/95).
U.S. Department Of Health And Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Urology and Lithotripsy Devices Branch
Division of Reproductive, Abdominal, Ear, Nose
and Throat, and Radiological Devices
Office of Device Evaluation
Page i Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency consideration to
Chief, Urology and Lithotripsy Devices Branch, HFZ-470, 9200 Corporate Blvd.,
Rockville, Maryland  20850.  Comments may not be acted upon by the Agency until the
document is next revised or updated.  For questions regarding the use or interpretation of
this guidance, please contact John H. Baxley at (240) 276-4161 or by electronic mail at
john.baxley@fda.hhs.gov.
Additional Copies
World Wide Web/CDRH home page:  http://www.fda.gov/cdrh/ode/guidance/177.pdf, or
CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 177 when
prompted for the document shelf number.
Page ii Table of Contents
Page
1.  Introduction .......................................................................................   1
A.  Background ............................................................................   1
B.  Device Design/Principle of Operation ......................................   1
C.  Regulatory History .............................................................   1
D.  Devices Not Included .................................................................   1
E.  Additional Sources of Information .............................................   2
2.  Sponsor/Device Identification ............................................................   2
A.  Sponsor/Manufacturer Information ...........................................   2
B.  Proposed Device .........................................................................  2
C.  Predicate Device ......................................................................   2
3.  Classification/Product Code ..............................................................   3
4.  Special Controls .............................................................................   3
5.  Device Description .............................................................................   3
A.  Reason for 510(k) .......................................................................   3
B.  Intended Use .............................................................................   3
C.  Technical Characteristics ......................................................   4
D.  Sterilization ..............................................................................   4
6.  Claim of Substantial Equivalence ........................................................   4
Page iii 7.  Performance Testing ..............................................................   5
A.  General Considerations ..............................................................   5
B.  Simulated Life/Fatigue Testing .................................................   5
C.  Positioning/Concealability Testing ..........................................   5
D.  Buckling Testing .......................................................................   6
E.  Tip Extender Joint Strength Testing ..........................................   6
F.  Biocompatibility Testing ...........................................................   6
G.  Clinical Testing ..........................................................................   6
8.  Labeling .............................................................................................   8
A.  General Labeling Considerations ................................................   8
B.  Physician Labeling ...........................................................   8
C.  Patient Labeling ...............................................................  10
D.  Promotional Literature ........................................................... 12
9.  Other Administrative Requirements .....................................................  12
10.  Device Modifications ............................................................................ 12
Page iv 1. Introduction
A. Background
The purpose of this guidance document is to identify information that should be provided to
the Food and Drug Administration (FDA) in a premarket notification (510(k)) to support a
determination of substantial equivalence for a penile rigidity implant.
B. Device Design/Principle of Operation
A penile rigidity implant consists of a pair of  semirigid rods or cylinders that are surgically
implanted in the corpora cavernosa of the penis in patients diagnosed as having erectile
dysfunction.  The purpose of this device is to provide adequate penile rigidity for vaginal
intercourse.  Several different noninflatable designs are included under this device
classification:
  rod prostheses, which typically consist of a flexible, solid cylinder of polymer material;
  malleable prostheses, which typically consist of a flexible polymer cylinder that
incorporates an internal metal core;
  single hinged prostheses, in which each rod incorporates a highly flexible segment of
material to enable the patient to position the penis downward for concealment under
his clothes; and
  multiple hinged prostheses, which typically consist of a series of hinged segments,
encapsulated in a polymer sheath.
C. Regulatory History
Penile rigidity implants are preamendments devices which were originally classified into
class III.  Based on new information known regarding these devices, FDA published a
proposed rule on December 16, 1997 proposing reclassification of the penile rigidity implant
to class II (62 FR 65770).  On February 2, 2000, FDA published a final rule in the Federal
Register reclassifying penile rigidity implants into class II (65 FR 4881).
D. Devices Not Included
This guidance document does not address penile inflatable implants, which are class III
devices for which a proposed rule to require the submission of premarket approval (PMA)
applications was published on April 28, 1993.
Page 1 E.  Additional Sources of Information
General guidance concerning the information required to be in a 510(k) may be obtained from
the Center for Devices and Radiological Healths Division of Small Manufacturers Assistance
(DSMA) at (800) 638-2041 or (301) 443-6597, or at it Internet address
(http://www.fda.gov/cdrh/dsma/dsmamain.html#contents).
For further information, please contact DSMA or:
Urology and Lithotripsy Devices Branch (ULDB)
Division of Reproductive, Abdominal, Ear, Nose
  and Throat, and Radiological Devices
Center for Devices and Radiological Health
9200 Corporate Boulevard (HFZ-470)
Rockville, Maryland  20850
(301) 594-2194  (phone)
(301) 594-2339  (fax)
2.  Sponsor/Device Identification
FDA regulations (21 CFR 807.87) prescribe information that must appear in each 510(k)
submission.  This information includes:
A.  Sponsor/Manufacturer Information
The name, contact person, address, telephone number, and (if available) facsimile number of
both the sponsor of the 510(k) application and (if different from the sponsor) the device
manufacturer.
B.  Proposed Device
The trade or proprietary name of the device proposed for marketing, as well as the common
device name, i.e., penile rigidity implant.
C.  Predicate Device
The legally marketed device(s) to which the new device is being compared.  To be as specific
as possible, the 510(k) should include the following information to identify each predicate
device and support the claim substantial equivalence:
  Trade/proprietary name,
  Model number,
  Manufacturer,
  510(k) reference number (if known) or preamendments status,
Page 2   Intended use,
  Technological characteristics/performance specifications, and
  Labeling.
3. Classification/Product Code
The Code of Federal Regulations (CFR) number, class, and product code applicable to the
penile rigidity implant (listed below) should be provided in the 510(k):
  CFR Number: 21 CFR 876.3630
  Regulatory Class: Class II (special controls)
  Product Codes: 78 FAE (penile prosthesis)  or  78 FTQ (rigid rod penis prosthesis)
Product code 78 FAE refers to the malleable and hinged prostheses, whereas 78 FTQ refers to
simple, solid cylinders.
4. Special Controls
As stated in the final rule reclassifying the penile rigidity implant into class II, this guidance
document is the special control for this device.
 This guidance document describes a means by which penile rigidity implants may comply
with the requirement of special controls for class II devices.  Designation of this
guidance document as a special control means that manufacturers attempting to establish
that their device is substantially equivalent to a predicate device should demonstrate that
the proposed device complies with either the specific recommendations of this guidance
or some alternative control that provides equivalent assurances of safety and
effectiveness.
5. Device Description
A. Reason for 510(k)
The sponsor should clearly state the reason for the submission of the 510(k), e.g., new device
model, change in intended use, or design modifications to an existing penile rigidity implant.
B. Intended Use
The 510(k) should provide a clear statement of the proposed devices intended use, such as:
Page 3 The [device trade name] is intended for implantation into the corpora cavernosa of
the penis in men who are diagnosed as having erectile dysfunction.  The prosthesis is
implanted to provide adequate penile rigidity for sexual intercourse.
The intended use should be identically worded in the following sections of the 510(k):
  the physicians labeling,
  the Indications for Use form, and
  (if provided) the 510(k) Summary.
C. Technical Characteristics
The sponsor should provide a technical summary of the device (or device modification, if
applicable).  This section of the 510(k) should include, but not be necessarily limited to, the
following information:
  General description of the entire device, detailing its principle of operation.
  Listing of all available sizes.
  Description of the devices constituent components/subassemblies.
  Listing of all device materials, identifying those that are patient-contacting.
  List of all accessories.
  Diagrams of the device and accessories, with all key dimensions and component materials
well-marked and sufficient cross section or magnified diagrams to show adequate detail.
  Description of the devices implantation instructions.
  Description of the devices activation/deactivation instructions (i.e., patients instruction
for device operation).
D. Sterilization
The following information regarding the devices sterilization process should be provided:
(i) the method of sterilization; (ii) the protocol used to validate the sterilization cycle; (iii) a
description of the packaging materials; (iv) the residual levels of ethylene oxide (  25 ppm),
ethylene chlorohydrin (  25 ppm), and ethylene glycol (  500 ppm) remaining on the device
after the sterilization quarantine period (if ethylene oxide sterilization is used); and (v) the
radiation dose (if gamma radiation sterilization is used).  Additionally, the method used to
routinely evaluate this device for pyrogenicity (e.g., LAL or rabbit test) should be stated.
6. Claim of Substantial Equivalence
In order to permit a determination of substantial equivalence, all intended uses and
technological characteristics, including performance test results and labeling, should be
compared to a legally marketed device.  It is recommended that such comparisons be
presented in tabular format.
Page 4 7. Performance Testing
A. General Considerations
During its functional lifetime, a penile rigidity implant will be subjected to a variety of stresses.
These stresses occur during typical daily activities, during the act of intercourse, and at rest.
To determine if a proposed device design can withstand these stresses, performance testing
should be performed.  This testing (i) should be conducted using an appropriate number of
final, sterilized samples, (ii) should separately evaluate the performance of the largest and
smallest device sizes being proposed, and (iii) should be compared to those of a legally
marketed predicate device whenever possible.
Based on the general design requirements of a penile rigidity implant, FDA believes that the
following tests should be considered.  However, 510(k) sponsors should be aware that
modifications or additions to this test plan may be needed for unique device designs.
B. Simulated Life/Fatigue Testing
The purpose of Simulated Life/Fatigue Testing is to determine whether the proposed device
can withstand the cyclical forces that occur when a patient alters the position of his penis over
the expected lifetime of the device.  The following information should be considered when
designing this test:
  Test design should simulate, as closely as possible, the actual environment and stresses
experienced by the device post-implantation.  The maximum test stresses should be at least
equal to the anticipated use stresses, and should be applied to those sections of the device
that will experience the highest stresses in use.
  The devices should be cycled until either failure occurs or a predetermined cycle limit is
reached.  Any predetermined limit should be justified to be at least equal to the anticipated
number of cycles of the devices expected service life.
  The length of the device should be measured periodically during this testing, with any
changes reported.
  The maximum bend angle should be measured periodically during this testing, with any
changes reported.
  The outer covering of the device should be examined periodically during this testing for
any evidence of wear, voids, tears, crazing, or other evidence of physical damage.
C. Positioning/Concealability Testing
The purpose of Positioning/Concealability Testing is to determine the ease and consistency
with which the proposed device can be bent and positioned over its expected lifetime.  The
following information should be considered when designing this test:
  Both the force required to bend the device and the ability of the device to be positioned
and remain at particular angles (representative of actual rigid and flaccid states)
should be measured.
Page 5   These measurements should be taken at periodic intervals during the Simulated
Life/Fatigue Testing.
D. Buckling Testing
The purpose of Buckling Testing is to determine if the device has sufficient column strength to
allow the device to be used as intended (i.e., for vaginal penetration/intercourse).  The test
should quantitatively measure the buckling strength of the device at periodic intervals during
the Simulated Life/Fatigue Testing, and be compared to a justified, predetermined,
performance requirement.
E. Tip Extender Joint Strength Testing
Tip Extender Joint Strength Testing is only applicable to devices that have optional tip
extenders.  The purpose of this testing is to verify that the connection between the tip
extender(s) and the main body of the device will remain intact during the expected life of the
device.
F. Biocompatibility Testing
The 510(k) should contain either results of biocompatibility testing performed on all patient-
contacting materials, or a certification stating that each material formulation used in the
proposed device is identical to that used in another, identified, legally marketed device with a
similar degree of patient contact.  Penile rigidity implants are considered to be permanent,
tissue/bone contacting, implanted devices, and testing should include, but is not limited to,
cytotoxicity, sensitization, irritation (or intracutaneous reactivity), acute systemic toxicity,
genotoxicity, and implantation testing (  90 days).  If the general formulation of the patient-
contacting material has no prior history of use as a long-term implant, the sponsor should also
evaluate the material for chronic toxicity and carcinogenicity.
For additional information on the above recommendations for biocompatibility testing, please
refer to the document entitled Use of International Standard ISO-10993, Biological
Evaluation of Medical Devices Part-1:  Evaluation and Testing (5/1/95).  A copy of this
guidance document may be obtained from DSMA.
G. Clinical Testing
Clinical testing is only recommended for penile rigidity implants that are significantly
different in design, materials, control method, operating principle, or intended use as
compared to devices already on the market.  In such circumstances, the results of clinical
testing of the device should be submitted to evaluate whether the proposed implant is as safe
and as effective as predicate penile rigidity implants.
FDA recommends that the following information should be considered when designing a
clinical study for a penile rigidity implant:
Page 6   The objectives of this clinical study should be (i) to evaluate the potential of the device to
fail or cause other complications that necessitate either surgical removal or medical
intervention (e.g., infection, erosion, migration, extrusion, mechanical malfunction, patient
dissatisfaction, prolonged or intractable pain, urinary obstruction, etc.); and (ii) to assess
the ability of the device to provide adequate penile rigidity for sexual intercourse.
  The study should enroll a minimum of 50 patients using appropriate inclusion/exclusion
criteria, and evaluate the effects of repeated device use post-implantation.  Each patient
should be adequately screened using standard methods as having erectile dysfunction prior
to receiving the implant.  Furthermore, each subject should complete an appropriate sexual
function questionnaire, for later comparison to the post-treatment results for evaluation of
device performance.  Prior to device implantation, the subject should be provided with
detailed patient labeling, as described in Section 8.B. of this document.
  The investigators should record appropriate data during the implantation procedure, such
as:  insertion site, accessories and tools used (if any are sold with the device), implant size
used, and assessment of device function/anatomical outcome.
  Follow-up examinations should be scheduled to allow the investigating physician to
physically assess for the incidence of any complications, as well as the anatomical
placement of the prosthesis.  Additionally, if the patient has begun to use his prosthesis for
sexual intercourse, he should fill out the post-treatment sexual function questionnaire at
the exam.  These follow-up exams should occur at the following time frames:  (i) at the
time that the patient is instructed to begin sexual intercourse (e.g., 6 weeks post-surgery);
and (ii) 6 months post-surgery.  Furthermore, the protocol should inform study subjects to
immediately notify the investigator if any problems are encountered with the use of the
device, and to receive additional follow-up exams if deemed necessary.  Lastly, at the end
of the follow-up period, each patient should be questioned regarding his level of
satisfaction with the various qualities of the device (i.e., concealability, rigidity, length,
girth, flaccidity, etc.).  Detailed case report forms should be developed to encourage the
collection of all data specified in the protocol.
  Outcomes should be analyzed according to the following variables:  etiology of erectile
dysfunction, whether or not this is the patient's first penile implant, frequency of device
usage post-implantation, investigational site, implant size, and incision site.
Any U.S. clinical investigation of a penile rigidity implant that is not legally marketed must be
conducted in accordance with the investigational device exemptions (IDE) regulations for a
significant risk device.  Reports of foreign clinical experience are acceptable provided that the
investigation was conducted in accordance with the provisions of the IDE regulations
regarding the protection of human research subjects (commonly referred to as the
Declarations of Helsinki), and the data are applicable to the U.S. population and medical
practice.  When planning a clinical trial, consult the Urology and Lithotripsy Devices Branch
Page 7 prior for guidance on the appropriate study design to address the particular technological
characteristics offered by the proposed penile rigidity implant.
8.  Labeling
A.  General Labeling Considerations
Proposed labels, labeling, and any promotional information sufficient to describe the proposed
penile rigidity implant, its intended use, and its directions for use should be submitted in the
510(k), consistent with 21 CFR 807.87(e).  The label of the device packaging must bear the
prescription device statement in accordance with 21 CFR 801.109(b)(1) under the authority of
section 520(e) of the Federal Food, Drug and Cosmetic Act:
CAUTION:  Federal law restricts this device to sale by or on the order of a
physician.
Listed below are available sources that may provide useful information regarding the
information to be included in the labeling of medical devices:  (1) Device Labeling
Guidance, ODE Blue Book Memorandum #G91-1; (2) Labeling:  Regulatory Requirements
for Medical Devices, HHS Publication FDA 89-4203; and (3) Write It Right:
Recommendations for Developing User Instruction Manuals for Medical Devices Used in
Home Health Care, HHS Publication FDA 93-4258.  This information is available from
DSMA.
B.  Physician Labeling
The following information should be included in the physician labeling for penile rigidity
implants:
Device labeling for the penile rigidity implant should include the device name;
manufacturers name, address, and telephone number; the prescription device statement;
intended use; and a description of the device (including dimensional specifications).  Penile
rigidity implants should be labeled as sterile, non-pyrogenic, single use implants.
Physicians should be instructed not to resterilize the device.
The intended use statement should include the specific indications for use and
identification of the target populations for whom this device is appropriate.
The labeling should include warnings describing the known and potential risks of penile
rigidity implants, such as infection, erosion, migration, extrusion, mechanical malfunction,
patient dissatisfaction, adverse tissue reaction, prolonged or intractable pain, urinary
obstruction, silicone particle migration, and other complications (e.g., post-operative
bleeding, hematoma, penile edema, penile necrosis/gangrene, perforation of the corpora or
Page 8 the urethra, inability to adequately dilate the corpora, incorrect sizing of the implant, and
tearing or ripping of the device during implantation).
The warnings section of the physician labeling should include a list of existing medical
conditions which may increase the risk of infection (i.e., diabetes, spinal cord injuries,
open sores or skin infections in the region of the surgery, or urinary tract infection).
The physician labeling should warn that infection that fails to respond to antibiotic therapy
may result in removal of the implant, that implantation of a new device may be
contraindicated at that time, and that infection followed by explantation of the device may
result in scarring which may make subsequent reimplantation more difficult.
The labeling should describe the types of mechanical malfunctions that could occur with
the device.
The labeling should recommend that physicians counsel patients on the expected post-
operative course of  pain, including severity and duration, to give patients a sense of the
normal healing process.
The labeling should state that since penile rigidity implants are subject to wear, eventual
failure is expected over time and they should not be considered lifetime implants.  Where
possible, the labeling should state the anticipated surgical revision rate of the implant.
The directions for use should contain comprehensive instructions regarding the pre-
operative, peri-operative and post-operative procedures to be followed, and include
information on how to minimize anticipated complications (i.e., infection, erosion,
migration, extrusion, mechanical malfunction, urinary obstruction, silicone particle
migration, and other complications).  This information includes but is not necessarily
limited to:
  a description of any training necessary for the surgical team;
  a description of the appropriate measures to reduce the likelihood of infection,
including the use of sterile techniques and antibiotic prophylaxis to prepare the patient,
the operating room, and the implant;
  instructions for implantation, including possible surgical approaches, implant sizing,
device handling, and intraoperative test procedures to ensure implant functionality and
proper placement/fit; and
  instructions for follow-up, including recommendations about patient antibiotic
prophylaxis during the post-implant period or during any subsequent dental or other
surgical procedures, proper care for the surgical site during the healing period,
determining when patients are ready to attempt intercourse, and evaluating proper
functionality and anatomical placement/fit.
The physician labeling should instruct the urologist or implanting surgeon to provide the
implant candidate with the patient labeling prior to surgery, to allow each patient
Page 9 sufficient time to review the information about the device and the procedure and discuss
this information with his physician and sexual partner.
C. Patient Labeling
The following information should be included in the physician labeling for penile rigidity
implants:
Patient labeling should be provided which includes the information needed to give
prospective patients realistic expectations of the benefits and risks of device implantation.
This information should aid potential recipients in making informed decisions prior to
implantation, as well as educate patients on how to recognize and minimize the potential
risks of penile rigidity implants.  Such information should be written and formatted so as
to be easily read and understood by most patients (i.e.,   7th grade reading level), and
should be provided to patients prior to scheduling implantation so that each patient has
sufficient time to review the information and discuss it with his physician and sexual
partner.  Technical terms should be kept to a minimum and should be defined if they must
be used.
The indications for use and relevant contraindications, warnings, precautions and adverse
effects/complications should be described using terminology well known and understood
by the average layperson.
The anticipated benefits and risks associated with the device should be provided to give
the patient realistic expectations of device performance and potential complications.  The
known, suspected, and potential risks of device implantation should be identified, and the
consequences of these risks and possible methods of resolution should be described.
Known and potential complications associated with penile rigidity implants include:
infection, erosion, migration, extrusion, mechanical malfunction, patient dissatisfaction,
adverse tissue reaction, temporary and chronic pain, urinary obstruction, silicone particle
migration, and other complications (e.g., post-operative bleeding, hematoma, penile
edema, penile necrosis/gangrene, perforation of the corpora or the urethra, inability to
adequately dilate the corpora, incorrect sizing of the implant, and tearing or ripping of the
device during implantation).
The patient labeling should inform the patient of the following information regarding the
risk of infection:
  As with any surgical implantation, an infection may develop after surgery.  The
physician will take steps to reduce the likelihood of infection.  These steps may include
using antibiotics to flush the surgical site during surgery, as well as appropriate
antibiotics given before and after the surgery.  Men with diabetes, spinal cord injuries,
open sores or skin infections in the region of surgery, or urinary tract infections may
have an increased risk of an infection associated with the device.
  If the infection cannot be treated by antibiotics, it may be necessary to remove the
prosthesis.  In this case, it may not be possible to implant a new device.  In addition,
Page 10 infection that causes the device to be removed may also cause scarring which may
make implanting a new device difficult or impossible.
Patients should be warned that failure to obtain timely medical evaluation and treatment
for erosion, migration, or extrusion may result in substantial worsening of the condition,
infection, and/or loss of tissue.
The patient labeling should describe the types of mechanical malfunction that could occur
with the device.
The patient labeling should inform the patient of the following information regarding the
potential outcome of a penile rigidity implant:
  Implantation of a penile prosthesis may result in penile shortening, curvature, or
scarring.
  The prosthetic erection may differ from the patients original, natural erection in that it
may be shorter, less firm, have less girth, or have reduced sensation.
  Realistic cosmetic expectations should include the potential for skin scarring, lack of
concealability (due to the constant presence of the rigid/semirigid rods), and lack of
rigidity to the glans.
  The implant will not enhance or restore libido, penile sensation, or the ability to have
an orgasm and ejaculate.
  The device implantation procedure is likely to damage or destroy any previous erectile
capability.
The patient labeling should include a brief description of the available alternative therapies
for the patients condition, including less invasive treatments and the associated benefits
and risks of each.  The patient should be advised to contact his physician for more
information on whether any of these alternatives might be appropriate given the patients
specific condition.
The patient labeling should include instructions on how to care for and use the device.
This information should include the expected duration of recovery from surgery, when to
resume intercourse following implantation, how to urinate and care for the implant and
surgical site during the healing period, warnings against certain actions that could damage
the device, the conditions that require physician intervention, who to contact if questions
arise, and any other relevant information.
Patients should be informed that penile rigidity implants are subject to wear due to normal
daily activities, and that eventual failure is expected over time.  Therefore, these implants
should not be considered lifetime prostheses.  Where possible, the labeling should state the
anticipated surgical revision rate of the implant.
Page 11 D.  Promotional Literature
Any promotional literature regarding the proposed device should be submitted in the 510(k)
for review.
9.  Other Administrative Requirements
Each 510(k) submission should contain the following administrative items:
  a completed Indications for Use form;
  a signed Truthful and Accurate Statement; and
  either a 510(k) Summary or 510(k) Statement.
Information regarding each of the above items is available from DSMA.
10.  Device Modifications
Guidance concerning the premarket notification requirements for device modifications is
available in the document entitled Deciding When to Submit a 510(k) for Change to an
Existing Device (1/10/97).  A copy is available from DSMA or CDRHs Internet address
(http://www.fda.gov/cdrh/ode/510kmod.html).
Page 12