(181 days)
Not Found
No
The summary describes a physical medical device (condom) and its performance in clinical studies, with no mention of software, algorithms, AI, or ML.
No
This device is for contraception and prophylaxis against STIs, not for treating a disease or condition for therapeutic purposes.
No
The device, a male condom, is explicitly stated for contraception and prophylactic purposes to reduce the transmission of STIs, not for diagnosing conditions.
No
The device description clearly states it is a "natural rubber latex sheath that completely covers the penis," indicating a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and reducing the transmission of STIs during sexual intercourse. This is a physical barrier method used in vivo (on the body), not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The device is a physical sheath that covers the penis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to detect diseases, conditions, or infections. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The ONE Male Condom is indicated as follows:
The ONE Male Condom is used for contraception to help reduce the risk of pregnancy during vaginal intercourse and for prophylactic purposes to help reduce the transmission of sexually transmitted infections (STIs) during vaginal or anal intercourse. The ONE Male Condom should be used with a condom compatible lubricant when used for anal intercourse.
Product codes (comma separated list FDA assigned to the subject device)
QRZ
Device Description
The ONE Male Condom is a natural rubber latex sheath that completely covers the penis. The condom is straight walled with a reservoir tip and is silicone lubricated. The ONE Male Condom is available in 56 sizes and consists of three different condom types, standard, thin, and fitted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
Indicated Patient Age Range
Age 18-54
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The clinical study to assess condom failures during anal intercourse among MSM (men who have sex with men) and during vaginal intercourse among MSW (men who have sex with women) was conducted in Atlanta, Georgia at two sites of the Rollins School of Public Health at Emory University.
The study enrolled 252 MSM and 252 MSW. Participants reported a total of 4,884 anal or vaginal sex acts using the condoms provided in the study.
Study participants received the three types of the ONE Male Condom: standard condoms, thin condoms, and the fitted condoms (n=5 of each type of condom, n=15 total). All condoms were manufactured from natural rubber latex and had 510(k) clearance.
Study participants were trained on the correct use of condoms. Both the study participants and the study investigators were blinded on condom assignment.
Packets of 10 ml water-based, condom-compatible lubricant were distributed with the condoms. Study participants were instructed to only use study lubricant when using condoms. Based on guidance from the World Health Organization, all MSM study participants were instructed to use the study lubricant for all anal sex acts and MSW were instructed to use the study lubricant for vaginal sex acts as needed or desired.
Study participants were randomized to 1 of 6 orders of condom types to be used sequentially. Each participant was given five of each type of study condom (standard, thin, fitted) and had 2 weeks to use all five condoms of one condom type.
If all five condoms in a set were used by the end of the 2-week period, participants were crossed over to the next condom type. If not, participants were given an additional 2-week period to use the remaining condoms of that type. Therefore, participants were enrolled for a minimum of 6 weeks and a maximum of 12 weeks.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Study
Sample Size: 252 MSM and 252 MSW (total 504 participants), 4,884 anal or vaginal sex acts.
Key Results:
- Anal Intercourse (MSM, n=2351 sex acts): Total clinical failure rate was 0.68% (16/2351). Failure levels ranged from 0.62% to 0.76% across condom types (fitted: 5/813 or 0.62%; standard: 5/750 or 0.67%; thin: 6/788 or 0.76%). No significant differences in failure by condom type.
- Vaginal Intercourse (MSW, n=2533 sex acts): Total clinical failure rate was 1.89% (48/2533). Failure levels ranged from 0.95% to 2.72% across condom types (fitted: 17/847 or 2.01%; standard: 8/839 or 0.95%; thin: 23/847 or 2.72%).
- Overall (all condom types, all sex acts): Total clinical failure (slippage, breakage, or both) was 1.3% (64/4884).
- Adverse Events: Overall AE rate was 1.92%. For anal intercourse, AEs included STI acquisition (0.34%), condom/lubricant discomfort (0.34%), and partner discomfort (0.04%). For vaginal intercourse, AEs included STI acquisition (0.04%), condom/lubricant discomfort (0.27%), and partner UTI (0.04%). All AEs were self-reported and recognized as commonly found in condom-using populations. There were no reported pregnancies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Total Clinical Failure Rates (percentage):
- Anal Intercourse (MSM): 0.68% (16/2351)
- Fitted: 0.62% (5/813)
- Standard: 0.67% (5/750)
- Thin: 0.76% (6/788)
- Vaginal Intercourse (MSW): 1.89% (48/2533)
- Fitted: 2.01% (17/847)
- Standard: 0.95% (8/839)
- Thin: 2.72% (23/847)
- Overall (all condom types, all sex acts): 1.3% (64/4884)
Adverse Event Rates (percentage):
- Overall AEs: 1.92%
- Anal Intercourse AEs:
- STI acquisition: 0.34%
- Condom/lubricant discomfort: 0.34%
- Partner discomfort: 0.04%
- Vaginal Intercourse AEs:
- STI acquisition: 0.04%
- Condom/lubricant discomfort: 0.27%
- Partner UTI: 0.04%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K081886, K122219, K141059, and K150072
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR ONE MALE CONDOM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
External condom for anal intercourse or vaginal intercourse. An external condom for anal intercourse or vaginal intercourse is a barrier device which covers the penis and is used to prevent the transmission of sexually transmitted infections (when used for anal intercourse or vaginal intercourse) and for contraception (when used for vaginal intercourse). This classification does not include condoms intended for vaginal intercourse only.
NEW REGULATION NUMBER: 21 CFR 884.5305
CLASSIFICATION: Class II
PRODUCT CODE: QRZ
BACKGROUND
DEVICE NAME: ONE Male Condom
SUBMISSION NUMBER: DEN210034
DATE DE NOVO RECEIVED: August 26, 2021
SPONSOR INFORMATION:
Global Protection Corp. 12 Channel Street Boston, MA 02210
INDICATIONS FOR USE
The ONE Male Condom is indicated as follows:
The ONE Male Condom is used for contraception to help reduce the risk of pregnancy during vaginal intercourse and for prophylactic purposes to help reduce the transmission of sexually transmitted infections (STIs) during vaginal or anal intercourse. The ONE Male Condom should be used with a condom compatible lubricant when used for anal intercourse.
LIMITATIONS
1
Warnings
- . The condom cannot be used multiple times and is limited to one sex act. One sex act refers to one instance of vaginal intercourse or anal intercourse.
- Make sure there is adequate lubrication. An adequate amount of condom . compatible lubricant should be used during anal intercourse to help reduce the risk of condom failure.
Precautions
- . This product contains natural rubber latex which may cause allergic reactions.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS AND PRECAUTIONS.
DEVICE DESCRIPTION
Bead (Rim)
The ONE Male Condom is a natural rubber latex sheath that completely covers the penis. The condom is straight walled with a reservoir tip and is silicone lubricated.
Image /page/1/Figure/8 description: The image is a schematic of a condom. The condom is a thin, elastic sheath that is used to prevent pregnancy and sexually transmitted infections. It is typically made of latex or polyurethane. The condom is placed over the penis before sexual intercourse. The image shows the basic shape of the condom, which is a long, cylindrical tube with a closed end and an open end.
Figure 1 is an image of the basic schematic of the condom.
Figure 1: Schematic image of the ONE Male Condom
Length
The ONE Male Condom is available in 56 sizes and consists of three different condom types, standard, thin, and fitted. It is identical in size, material composition and manufacturing to condoms cleared in K081886, K122219, K141059, and K150072.
Table 1 provides a list of all sizes available for the One Male Condom and their associated nominal length, width, and thickness.
| Model number | Nominal
length | Nominal width | Nominal
thickness | Condom type |
|--------------|-------------------|---------------|----------------------|-------------|
| O77 | 165mm | 49mm | 0.074mm | Fitted |
| O88 | 165mm | 51mm | 0.074mm | Fitted |
| O99 | 165mm | 53mm | 0.074mm | Fitted |
| O11 | 165mm | 55mm | 0.074mm | Fitted |
| O17 | 165mm | 57mm | 0.074mm | Fitted |
| Model number | Nominal length | Nominal width | Nominal thickness | Condom type |
| O21 | 165mm | 60mm | 0.074mm | Fitted |
| O22 | 165mm | 64mm | 0.074mm | Fitted |
| N88 | 180mm | 51mm | 0.074mm | Fitted |
| N99 | 180mm | 53mm | 0.074mm | Fitted |
| N11 | 180mm | 55mm | 0.074mm | Fitted |
| N17 | 180mm | 57mm | 0.074mm | Fitted |
| N21 | 180mm | 60mm | 0.074mm | Fitted |
| N22 | 180mm | 64mm | 0.074mm | Fitted |
| D11 | 195mm | 55mm | 0.074mm | Fitted |
| D17 | 195mm | 57mm | 0.074mm | Fitted |
| D21 | 195mm | 60mm | 0.074mm | Fitted |
| D22 | 195mm | 64mm | 0.074mm | Fitted |
| Z11 | 210mm | 55mm | 0.074mm | Fitted |
| Z17 | 210mm | 57mm | 0.074mm | Fitted |
| Z21 | 210mm | 60mm | 0.074mm | Fitted |
| Z22 | 210mm | 64mm | 0.074mm | Fitted |
| E55 | 123mm | 45mm | 0.074mm | Fitted |
| E66 | 123mm | 47mm | 0.074mm | Fitted |
| E77 | 123mm | 49mm | 0.074mm | Fitted |
| E88 | 123mm | 51mm | 0.074mm | Fitted |
| E99 | 123mm | 53mm | 0.074mm | Fitted |
| E11 | 123mm | 55mm | 0.074mm | Fitted |
| E17 | 123mm | 57mm | 0.074mm | Fitted |
| E21 | 123mm | 60mm | 0.074mm | Fitted |
| B55 | 133mm | 45mm | 0.074mm | Fitted |
| B66 | 133mm | 47mm | 0.074mm | Fitted |
| B77 | 133mm | 49mm | 0.074mm | Fitted |
| B88 | 133mm | 51mm | 0.074mm | Fitted |
| B99 | 133mm | 53mm | 0.074mm | Fitted |
| B11 | 133mm | 55mm | 0.074mm | Fitted |
| B17 | 133mm | 57mm | 0.074mm | Fitted |
| B21 | 133mm | 60mm | 0.074mm | Fitted |
| B22 | 133mm | 64mm | 0.074mm | Fitted |
| S55 | 143mm | 45mm | 0.074mm | Fitted |
| S66 | 143mm | 47mm | 0.074mm | Fitted |
| S77 | 143mm | 49mm | 0.074mm | Fitted |
| S88 | 143mm | 51mm | 0.074mm | Fitted |
| S99 | 143mm | 53mm | 0.074mm | Fitted |
| S11 | 143mm | 55mm | 0.074mm | Fitted |
| S21 | 143mm | 60mm | 0.074mm | Fitted |
| S22 | 143mm | 64mm | 0.074mm | Fitted |
| M66 | 153mm | 47mm | 0.074mm | Fitted |
| M77 | 153mm | 49mm | 0.074mm | Fitted |
| Model number | Nominal
length | Nominal width | Nominal
thickness | Condom type |
| M88 | 153mm | 51mm | 0.074mm | Fitted |
| M99 | 153mm | 53mm | 0.074mm | Fitted |
| M11 | 153mm | 55mm | 0.074mm | Fitted |
| M17 | 153mm | 57mm | 0.074mm | Fitted |
| M21 | 153mm | 60mm | 0.074mm | Fitted |
| M22 | 153mm | 64mm | 0.074mm | Fitted |
| P53S UT | 180mm | 53mm | 0.058mm | Thin |
| P53S | 185mm | 53mm | 0.074mm | Standard |
2
De Novo Summary (DEN210034)
3
Table 1: ONE Male Condom sizes and dimensions
For the fitted condom type, to determine the appropriate condom size, a fitting tool (Figure 2) is available online. Prior to purchasing the fitted condom, the user measures the length of their erect penis and then its width. Each length and width have an associated letter and number, which translates to a model number corresponding to a size in Table 1. Figure 2 is an image of the fitting kit.
Image /page/3/Figure/3 description: The image shows a sizing guide for condoms. The guide has letters and numbers on it, including the letters E, B, S, M, O, N, D, and Z. The numbers on the guide include 55, 66, 77, 88, 99, 11, 17, 21, and 22. The brand name "MyONE" is also visible on the left side of the guide.
Figure 2: ONE Male Condom fitting tool
To mitigate the risk of condom failure, the ONE Male Condom should be used with a condomcompatible lubricant during anal intercourse.
The ONE Male Condom conforms to ISO 4074-15, Natural rubber latex male condoms -Requirements and test methods and ASTM D3492-16. Standard Specification for Rubber Contraceptives (Male Condoms).
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The ONE Male Condom is categorized as a surface device that contacts both the skin and mucosal membrane for a limited (54 years of age
- 2. Does not live in or near Atlanta metropolitan statistical area
-
- Does not plan to be in Atlanta for the majority of the 12 weeks of enrollment
-
- Unable to independently complete survey instruments in English
-
- Not male sex at birth
-
- Does not currently identify as male
-
- Self-report to have had sex with both men and women in the past four weeks
-
- Self-report transgender sex partners in the past four weeks
-
- Self-report no anal (MSM) or vaginal (MSW) sex act in the past four weeks
-
- Self-report intends to have sex with both men and women in the next 12 weeks
-
- Never the insertive partner for anal sex or not willing to be the insertive partner when using study condoms for anal sex
-
- Not willing or unable to have sex using a latex condom provided by study
-
- Plans to not have sex in the next four weeks
-
- For MSW, report that current partner is currently pregnant
-
- For MSW, report that current partner desires to become pregnant currently or in the next 12 weeks
-
- Unable to consistently maintain an erection while using condoms
-
- Allergic to latex
-
- Current partner(s) allergic to latex
-
- Genital piercings
-
- For MSW, female current partner(s) has (have) vaginal piercings
-
- For MSM, male current partner(s) has (have) anal piercings
-
- Current partner(s) known to be HIV-positive
-
- Self-report presence of sexually transmitted infections, including HIV
8
-
- Confirmed HIV positive at baseline
-
- Not willing to provide at least two means of contact
-
- Not willing to only use lubricant provided by study
-
- Allergic to water-based lubricant
-
- Current partner(s) allergic to water-based lubricant
-
- Not willing to use a fitting tool to determine penile dimensions.
Study Endpoints:
The primary endpoint for the study was total clinical failure as assessed through an electronic daily coital diary. The total condom failure rate was defined as the number of slippage, breakage, or both slippage and breakage events that occurred over the total number of sex acts performed. The primary endpoint was reported separately for the MSM and the MSW study arms. In addition to total clinical failure, the slippage, breakage, and total clinical failure rates were reported for each condom type (standard, thin, and fitted) within the MSM and MSW arms.
The study did not include any pre-specified statistical hypotheses. Descriptive statistics were reported for all endpoints. The sponsor used logistical mixed effects models to account for the crossover study design.
Analysis Populations:
An intention-to-treat (ITT) analysis was utilized for the primary endpoint and included any anal sex acts among MSM and any vaginal sex acts among MSW in which a study condom was used.
A per-protocol analysis was also conducted that used the above criteria but excluded sex acts for which lubricant was used incorrectly, including 1) lubricant inside of the condom, 2) use of condom incompatible lubricant, or 3) not using any lubricant (for the MSM arm only).
Study Results:
Participant Disposition
The study enrolled 252 MSM and 252 MSW. Participants reported a total of 4,884 anal or vaginal sex acts using the condoms provided in the study.
A total of 13.524 individuals were assessed for eligibility through field-based screening. Of the 2,819 initially eligible individuals, 1,037 (36.8%) completed a phone screen to determine eligibility. Of the 1.037 individuals who completed a phone screen, 681 were eligible for the study, and 542 attended a baseline visit. Of the 542 who attended the baseline visit, 504 were enrolled in the trial and received a randomized crossover order (252 MSM arm and 252 MSW arm). Among all enrolled participants in each arm, 200 MSM (79.4%) and 209 MSW (82.9%) were retained until the end of the study.
Of the total enrolled per arm. 43 MSM (17.1%) and 35 MSW (13.9%) were study stopped, and 9 MSM (3.6%) and 8 MSW (3.2%) were lost to follow-up. Among MSM, the most common reasons for study stopping were voluntary withdrawal (n = 27), new HIV positive partner. STI
9
symptoms or recent diagnosis, and moving out of the study area. Among MSW, the most common reasons for study stopping were voluntary withdrawal and moving out of the study area.
Image /page/9/Figure/1 description: This image is a flowchart that shows the progress of participants through a study. At the beginning of the study, 5322 participants completed the field screen, 7664 completed the online screen, and 538 were cross-study panel screeners. 542 participants attended the baseline visit, and 252 participants were enrolled in each of the MSM and MSW arms. The flowchart also shows the number of participants who used at least one study condom and the number of participants who were retained at the end of each period.
Figure 3 summarizes the participant disposition throughout the study.
Figure 3: Participant enrollment summary
Demographic and Baseline Data
The study sample was predominantly single (87.3% never married), identified as homosexual for MSM (90.5%) or heterosexual for MSW (97.2%), and diverse (47.8% White non-Hispanic, 12.3% Hispanic, 26.0% African American non-Hispanic, and 13.7% other, non-Hispanic), Nearly three-quarters (74.0%) of participants in both arms rated themselves as "very experienced" using condoms; however, 36.3% of MSM and 38.1% of MSW reported condom slippage, condom breakage or both in the past 6 months.
Effectiveness Analysis
Table 2 provides total clinical failure, slippage, and breakage rates for the different condom types (standard, thin, and fitted) for each study arm using the ITT population.
10
| | Anal Intercourse (n=2351)
MSM | | | Vaginal Intercourse (n=2533)
MSW | | | |
|---------------------------------------|----------------------------------|----------|----------------------------------------------|-------------------------------------|----------|----------------------------------------------|----------------------------------------------|
| | Slippage | Breakage | Total Clinical Failure | Slippage | Breakage | Total Clinical Failure | Total Failures by Condom Type |
| | n/N, %, (95% CI) | | | | | | |
| Fitted | (b)(4) | (b)(4) | 5/813
0.62%
(0.20%,
1.43%) | (b)(4) | (b)(4) | 17/847
2.01%
(1.17%,
3.19%) | 22/1660
1.33%
(0.83%,
2.0%) |
| Standard | | | 5/750
0.67%
(0.22%,
1.55%) | | | 8/839
0.95%
(0.41%,
1.87%) | 13/1589
0.82%
(0.44%,
1.39%) |
| Thin | | | 6/788
0.76%
(0.28%,
1.65%) | | | 23/847
2.72%
(1.73%,
4.05%) | 29/1635
1.77%
(1.19%,
2.54%) |
| Total Failures by Type of Intercourse | | | 16/2351
0.68%
(0.39%,
1.10%) | | | 48/2533
1.89%
(1.40%,
2.50%) | |
Table 2: Clinical Failure Rates by Condom Type and Study Arm (ITT)
For anal intercourse, there were 16/2,351 (0.68%) condom failures, with failure levels ranging across the three types of condoms from 0.62% to 0.76% (5/813 for the fitted condoms, 5/750 for standard condoms, and 6/788 for thin condoms). There were no significant differences in levels of failure by condom type.
There were a small number of subjects in the MSW arm who used the study condoms outside of the study protocol for anal intercourse. The total clinical failure rate was [bws] jin the MSW arm for anal intercourse.
For vaginal intercourse, there were 48/2533 (1.89%) condom failures, with failure levels ranging across the three types of condoms from 0.95% to 2.72% (17/847 for the fitted condoms, 8/839 for standard condoms, and 23/847 for thin condoms).
Overall, the total clinical failure for vaginal and anal intercourse for all condom types (slippage, breakage, or slippage and breakage) was 1.3% (64/4884).
11
For sex acts in which non-condom compatible lubricant (e.g., oil-based lubricant) was used. failure occurred 2/16 times (12.5%). For sex acts in which condoms were used incorrectly, condoms failed 9/242 times (3.7%).
The results of the per protocol analyses were not substantially different from the ITT results.
The results of the clinical study indicate that slippage, breakage, and total clinical failure for anal intercourse for MSM and vaginal intercourse for MSW for the ONE Male Condom are low.
However, for the limited data available in the pivotal study for anal intercourse in the MSW population (n=7), the total clinical failure rate for anal sex acts is high (1000 %). To ensure that the clinical study supports the safety and effectiveness of the One Male Condom for anal intercourse in both the MSM and MSW population, the sponsor provided additional clinical information to support that the clinical data from the MSM population can be leveraged to support the MSW population.
The sponsor conducted a literature review to identify studies that evaluated total clinical failure during anal intercourse in the MSW population. In the studies identified, the total condom failure ranged from on to to may. These studies also found that additional confounding factors affect anal intercourse failure rates in the MSW population, e.g., emotional, behavioral, inexperience using condoms, concerns about sexual performance, lubricant use, etc. These factors are not related to the biological sex of the receptive partner, relate to the individual condom user and how condoms are used. Therefore, the literature does not support that there are biological differences that would contribute to different failure rates for anal intercourse between the MSM and MSW populations. Because sex based biological differences should not affect condom failure rates, the pivotal study results for the MSM population for anal intercourse can be generalized to the MSW population. Accordingly, the information provided in the pivotal clinical study and the literature review support an anal sex indication for the ONE Male Condom that includes both the MSM and MSW population.
The pivotal clinical study data in the MSM population indicate that if a condom compatible lubricant is used and appropriate condom use instructions are provided and followed, the clinical failure for anal intercourse is low. To mitigate the confounding factors identified in the literature studies, the labeling for the ONE Male Condom includes appropriate and complete instructions for use and warnings related to use of lubricant during anal intercourse (e.g., adequate amount of condom compatible lubricant should be used during anal intercourse to help reduce the risk of condom failure).
Safety Analysis
The overall percentage of adverse events (AEs) was 1.92% for both vaginal and anal intercourse. The adverse event rates for anal intercourse using the ONE Male Condom were 0.34% for STI acquisition, 0.34% for condom/lubricant discomfort and 0.04% for partner discomfort. The adverse event rates for vaginal intercourse using the ONE Male Condom were 0.04% for STI acquisition, 0.27% for condom/lubricant discomfort and 0.04% partner UTI.
12
All AEs were self-reported by the study participants. Regarding STI acquisition, the study did not screen for STIs at baseline, and per the study protocol, the study participants could have sex without the study condoms over the duration of the study. Therefore, the STIs reported in the study may have resulted from unprotected sex prior to the study or during the study.
The AE rates are low, and the AEs observed are commonly found in the real world population using condoms.
Pediatric Extrapolation
For medical devices, the FD&C Act defines patients before their 22nd birthday as pediatric patients. Pediatric patients do not raise additional differences or risks relative to the patient population studied.
LABELING
The ONE Male Condom labeling consists of the primary condom package (individual foil packet), the condom retail package, and the package insert. The labeling includes important information regarding condom use, warnings, precautions, and instructions for use.
The package labeling and directions for use are consistent with "Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300-Class II Special Controls Guidance for Industry and FDA Staff' published in December 2009. While the ONE Male Condom does not fall under 21 CFR 884.5300, the same risks exist between condoms in 21 CFR 884.5300 and this device type, and many of the labeling statements in the special controls document will mitigate those risks for the ONE Male Condom and other devices of the same type.
RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of an external condom for anal intercourse or vaginal intercourse and the measures necessary to mitigate these risks.
| Identified Risks to Health | Mitigation Measures |
|---|---|
| Transmission of Sexually Transmitted | |
| Infection | Acute failure modes clinical study |
| Non-clinical performance testing | |
| Shelf life testing | |
| Labeling | |
| Pregnancy | Acute failure modes clinical study |
| Non-clinical performance testing | |
| Shelf life testing | |
| Labeling |
13
| Adverse tissue reaction | Biocompatibility evaluation
Labeling |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Mechanical injury leading to ulceration,
laceration, trauma | Acute failure modes clinical study
Non-clinical performance testing
Shelf life testing
Labeling |
| Use error/Improper device use leading to the
risks above | Acute failure modes clinical study
Labeling |
SPECIAL CONTROLS
In combination with general controls of the Food Drug & Cosmetic Act, an external condom for anal intercourse or vaginal intercourse is subject to the following special controls:
- Clinical performance data must demonstrate the total rate of clinical failure and rate (1) of individual failure modes of the device based on an acute failure modes study.
- (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The data must include an assessment of mechanical and material integrity, including an evaluation of device failure modes. For devices made of materials other than natural rubber latex. viral penetration testing must be conducted to evaluate barrier effectiveness to sexually transmitted infections.
- (3) The device must be demonstrated to be biocompatible.
- Performance data must support the shelf life of the device by demonstrating device (4) functionality and package integrity over the identified shelf life.
- Labeling must include: (5)
- a. If indicated for vaginal intercourse, a contraceptive effectiveness table comparing typical use and perfect use pregnancy rates with the device to other available methods of birth control;
- b. Statement regarding compatibility with additional lubricant types;
- c. Statement regarding the adverse events associated with the device, including transmission of infection, pregnancy, adverse tissue reaction, mechanical injury, or improper device use;
- d. Expiration date;
- e. The following information, warnings and precautions:
14
- i. The sexually transmitted infections (STIs) for which the device is most protective, the degree of protection the device provides against specific types of STIs. and the STIs the device does not protect against:
- A statement that the device does not completely eliminate the risks of ii. pregnancy and sexually transmitted infections and that risk can be decreased with correct and consistent use;
- iii. A warning regarding the risk of device failure during anal intercourse if adequate lubricant is not used:
- A warning stating that the device cannot be used multiple times and is iv. limited to one sex act;
- A precaution stating not to use the device if the user is at risk for material v. related allergic reactions.
BENEFIT-RISK DETERMINATION
The benefits and risks of the device are based on data collected in the pivotal clinical study described above.
The risks of the device are based on AE data collected in the pivotal clinical study. The overall percentage for AEs is low, with a reported rate of 100 11/6 for both vaginal and anal intercourse. The adverse event rates for anal intercourse using the ONE Male Condom were "MM for STI acquisition, % for condom/lubricant discomfort and [014] % for partner discomfort. The adverse event rates for vaginal intercourse using the ONE Male Condom were 1914 1% STI acquisition. [01] 1% condom/lubricant discomfort and 10101% partner UTI. There were no reported pregnancies.
In the pivotal study, there was a low rate of total clinical failure (0.68% (16/2351)) for the ONE Male Condom when used for anal sex in the MSM population. There was also a low rate of total clinical failure (1.89% (48/2533)) for the ONE Male Condom when used for vaginal sex in the MSW population. The literature does not support that there are biological differences that would contribute to different failure rates for anal intercourse between the MSM and MSW populations. Based on these results, the benefits of the ONE Male Condom are protection against STIs and unplanned pregnancy. Since unprotected anal intercourse carries the greatest sexual exposure risk of transmission of HIV and other STIs, a condom indicated specifically for anal intercourse will be beneficial for both MSM and MSW.
PATIENT PERSPECTIVES
The sponsor provided a brief survey among a sample of MSM. Data were collected from September 2015 through April 2016 through the American Men's Internet Survey (AMIS), an annual Internet survey of MSM in the United States. The survey explored willingness to use condoms under a hypothetical condition of an FDA condom indicated specifically for anal intercourse. In a sample of 2,079 MSM, 69% (95% Confidence Interval: 67%. 71%) reported that they would be more likely to use condoms more frequently if the condoms were indicated for specifically for anal intercourse.
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BENEFIT/RISK CONCLUSION
In conclusion, given the available information above, for the following indication statement: The ONE Male Condom is used for contraception to help reduce the risk of pregnancy during vaginal intercourse and for prophylactic purposes to help reduce the transmission of sexually transmitted infections (STIs) during vaginal or anal intercourse. The ONE Male Condom should be used with a condom compatible lubricant when used for anal intercourse.
The probable benefits outweigh the probable risks for the ONE Male Condom. The device provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo request for the ONE Male Condom is granted and the device is classified as follows:
Product Code: ORZ Device Type: External condom for anal intercourse or vaginal intercourse Class: Class II Regulation Number: 21 CFR 884.5305