Titan Condoms

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. February 17, 2022 Titan Condoms LLC % George Hattub Senior Project Manager Medicsense USA 291 Hillside Avenue Somerset, MA 02726 Re: K210208 Trade/Device Name: Titan Condoms Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: January 17, 2022 Received: January 20, 2022 Dear George Hattub: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. {1}------------------------------------------------ You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K210208 Device Name Titan Condoms #### Indications for Use (Describe) The Titan Condoms are indicated for use for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). | Type of Use ( <i>Select one or both, as applicable</i> ) | | |----------------------------------------------------------|--| |----------------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary – K210208 | Submitter<br>Address: | Titan Condoms LLC<br>1950 Elkhorn Ct. Apt. 210<br>San Mateo, CA 94403 | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Contact<br>Person: | Mr. Neville Muringayi, CEO<br>neviilemuringayi@gmail.com<br>(951) 746-6130 | | Date Prepared: | February 16, 2022 | | Device Name: | Titan Condoms | | Common name: | Male Natural Rubber Latex Condom | | Regulation Name: | Condom | | Regulation<br>Number: | 21 CFR 884.5300 | | Product Code: | HIS (Condom) | | Regulatory Class: | II | | Predicate Device: | K122219 – TheyFit Male Condom | | | The predicate device has not been subject to a design-related recall. | | Device<br>Description: | Titan Condoms are made of a natural latex sheath which completely covers<br>the penis with a closely fitted membrane. The condom is shaped with a<br>reservoir end and a cylinder shape. Titan condoms are available in a range | D of sizes, with different length and width combinations. Surface textures include smooth, dotted, and ribbed. Titan Condoms are provided prelubricated with a silicone-based lubricant. Table 1 provides the dimensions and features of each condom variant. | Corresponding<br>Condom Size<br>(mm) | Condom<br>Thickness<br>(mm) | Lubricant | Reservoir Tip | Texture<br>Features | |--------------------------------------|-----------------------------|----------------|---------------|---------------------| | 180 x 49 | 0.05 - 0.07 | Silicone-Based | Yes | N/A | | 180 x 52 | 0.05 - 0.07 | Silicone-Based | Yes | Dotted | | 180 x 52 | 0.05 - 0.07 | Silicone-Based | Yes | Ribbed | | 185 x 53 | 0.05 - 0.07 | Silicone-Based | Yes | N/A | | 180 x 53 | 0.05 - 0.06 | Silicone-Based | Yes | N/A | | 180 x 53 | 0.08 | Silicone-Based | Yes | N/A | | 185 x 57 | 0.05 - 0.07 | Silicone-Based | Yes | N/A | | 193 x 60 | 0.05 - 0.07 | Silicone-Based | Yes | N/A | | 223 x 64 | 0.05 - 0.07 | Silicone-Based | Yes | N/A | | 223 x 69 | 0.05 - 0.07 | Silicone-Based | Yes | N/A | {4}------------------------------------------------ | Indications for<br>Use: | The Titan Condoms are indicated for use for contraceptive and prophylactic<br>purposes (to help prevent pregnancy and the transmission of sexually<br>transmitted infections). | |------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison of<br>Intended Use and<br>Technological<br>Characteristics: | A comparison of the intended use and technological features of the subject<br>and predicate devices are described in Table 2 below: | | | Subject Device<br>Titan Condoms<br>K210208 | Predicate Device<br>TheyFit Male Condoms<br>K122219 | Comparison | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | HIS | HIS | Same | | Indications for Use | The Titan Condoms are<br>indicated for use for<br>contraceptive and prophylactic<br>purposes (to help prevent<br>pregnancy the transmission of<br>sexually transmitted infections. | The TheyFit Male<br>Condom is used for<br>contraceptive and for<br>prophylactic purposes (to<br>help prevent pregnancy<br>and the transmission of<br>sexually transmitted<br>infections) | The indications for use<br>and intended use of the<br>subject and predicate<br>devices are the same. | | Condom Material | Natural Rubber Latex | Natural Rubber Latex | Same | | Design | Varied sizes with different length,<br>width, and thickness<br>combinations.<br>Cylindrical with reservoir end<br>Smooth, dotted, and ribbed<br>surface textures. | Varied sizes with different<br>length/width combinations.<br>Cylindrical with reservoir<br>end<br>Surface texture<br>information not known as<br>not stated in the<br>predicate 510(k)<br>Summary. | Different: The subject<br>and predicate devices are<br>both provided in different<br>length and width<br>configurations. Versions<br>of the subject device are<br>also provided with varying<br>thickness and surface<br>texture. These differences<br>do not raise different<br>questions of S&E. | | Fitting Kit to<br>Determine Correct<br>Size | Yes | Yes | Same | | Maximum Length | 180 - 223 mm | 163 - 208 mm | Different: The subject<br>and predicate devices<br>have different maximum<br>lengths. The subject<br>devices are within the<br>range of maximum lengths<br>of the predicate with the<br>exception of subject<br>device versions with<br>maximum lengths of 223<br>mm. This difference in | | Maximum Width | 49 - 69 mm | 49 - 64 mm | maximum length does not<br>raise different questions of<br>safety and effectiveness<br>(S&E).<br>Different: The subject<br>and predicate devices<br>have different maximum<br>widths. The subject<br>device includes one<br>version with a maximum<br>width of 69 mm. This<br>difference in maximum<br>width does not raise<br>different questions of<br>safety and effectiveness<br>(S&E). | | Lubricant | Silicone based | Silicone based | Same | | Color Additives | none | none | Same | | Flavor Additives | none | none | Same | | Single Use Device | Yes | Yes | Same | | Shelf Life | 5 years | 5 years | Same | ## Table 2. Comparison of technological characteristics {5}------------------------------------------------ As shown in the table above, the subject and predicate devices have the same indications for use and intended use. The technological characteristics of the subject and predicate device are different as the subject devices have a larger maximum length and width than the predicate devices, and versions with varying thickness. In addition, versions of the subject device include ribbed or dotted textures that may differ from the predicate device. These differences in technological characteristics do not raise different questions of safety and effectiveness. Summary of A prospective clinical study was conducted to evaluate the slippage and breakage rate of the 64 mm and 69 mm condoms. The clinical study was Clinical Testing: based on ISO 29943-1:2017 Condoms - Guidance on Clinical Studies-Part 1: Male Condoms. > Eligible participants used the Titan Size Guide to determine their penis girth measurements, which was used to determine if they would test the 64 mm or 69 mm condom. Each couple was to use three condoms within two consecutive weeks. Each couple completed an online individual condom use case report form. Clinical endpoints were clinical condom slippage and breakage during use, participant's satisfaction, and genitourinary adverse events. The pre-specified endpoint was a total clinical failure rate <5%. The baseline demographic information for participants in this study are shown in Table 3. {6}------------------------------------------------ | Parameter | Percentage of Participants | |---------------------------|----------------------------| | Age | | | 18 to 24 | 5% | | 25 to 29 | 23% | | 30 to 34 | 19% | | 35 to 39 | 33% | | 40 to 45 | 20% | | Ethnicity | | | White/Caucasian | 48% | | African/American | 22% | | Hispanic/Latino | 20% | | Asian or Pacific Islander | 5% | | More than one | 5% | ### Table 3. Trial participant baseline demographics Study results showed a clinical failure rate for the condom with a width of 64 mm of 0%. The condom with a width of 69 mm had a clinical failure rate of 3.1%. Therefore, Titan Condoms met the pre-defined total clinical failure endpoint of <5%. Summary of Non-The following studies have been performed to support substantial equivalence to the predicate device: Clinical Performance ### Biocompatibility Testing Biocompatibility testing was performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process." Testing included the following assessments: - Cytotoxicity (ISO 10993-5:2009) - . Sensitization (ISO 10993-10:2010) - Irritation (ISO 10993-10:2010) . - Acute Systemic Toxicity (ISO 10993-11:2017) ● The results of this testing demonstrated that the subject devices are biocompatible. ### Physical Testing All Titan Condom versions were tested and met all the requirements of ISO 4074:2015 - Natural rubber latex male condoms – Requirements and test methods. ### Shelf-Life Titian Condoms have a five-year shelf life based on the results of real-time and accelerated stability evaluations conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria. {7}------------------------------------------------ Conclusion: The results of the performance testing described above demonstrate that the Titan Condoms are as safe and effective as the predicate device and supports a determination of substantial equivalence.