(387 days)
The Titan Condoms are indicated for use for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Titan Condoms are made of a natural latex sheath which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and a cylinder shape. Titan condoms are available in a range 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.
The provided text describes the acceptance criteria and a clinical study conducted for Titan Condoms, but it does not pertain to an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how training ground truth was established) are not applicable.
Below is the information specifically related to the acceptance criteria and the study as presented in the document for the physical device, Titan Condoms.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Failure Rate < 5% | 64 mm condom: 0% clinical failure rate69 mm condom: 3.1% clinical failure rate |
| Biocompatibility | All tested subject devices were biocompatible. |
| Compliance with ISO 4074:2015 | All Titan Condom versions met all requirements. |
| Shelf-life | 5 years |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of number of condoms or participants for the clinical study. It mentions that "Each couple was to use three condoms."
- Data Provenance: Prospective clinical study. The country of origin of the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable, as this is a clinical study for a physical device, not an AI/ML device requiring expert ground truth for image or data interpretation. The ground truth (clinical failure) was observed directly during use.
4. Adjudication Method for the Test Set
Not applicable, as this is a clinical study for a physical device, not an AI/ML device requiring adjudication for result interpretation. The clinical endpoints were clinical condom slippage and breakage during use, participant's satisfaction, and genitourinary adverse events, reported via an online individual condom use case report form.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable, as this is a clinical study for a physical device, not an AI/ML device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable, as this is a clinical study for a physical device, not an AI/ML algorithm.
7. Type of Ground Truth Used
The ground truth for the clinical study was based on observed clinical outcomes: clinical condom slippage, breakage during use, participant satisfaction, and genitourinary adverse events, as reported by the users themselves.
8. Sample Size for the Training Set
Not applicable, as this is a clinical study for a physical device. There is no AI/ML model to train.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model.
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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.
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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
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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 ( Select one or both, as applicable ) | |
|---|---|
| ---------------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary – K210208
| SubmitterAddress: | Titan Condoms LLC1950 Elkhorn Ct. Apt. 210San Mateo, CA 94403 |
|---|---|
| Submitter ContactPerson: | Mr. Neville Muringayi, CEOneviilemuringayi@gmail.com(951) 746-6130 |
| Date Prepared: | February 16, 2022 |
| Device Name: | Titan Condoms |
| Common name: | Male Natural Rubber Latex Condom |
| Regulation Name: | Condom |
| RegulationNumber: | 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. | |
| DeviceDescription: | Titan Condoms are made of a natural latex sheath which completely coversthe penis with a closely fitted membrane. The condom is shaped with areservoir 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.
| CorrespondingCondom Size(mm) | CondomThickness(mm) | Lubricant | Reservoir Tip | TextureFeatures |
|---|---|---|---|---|
| 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 |
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| Indications forUse: | The Titan Condoms are indicated for use for contraceptive and prophylacticpurposes (to help prevent pregnancy and the transmission of sexuallytransmitted infections). |
|---|---|
| Comparison ofIntended Use andTechnologicalCharacteristics: | A comparison of the intended use and technological features of the subjectand predicate devices are described in Table 2 below: |
| Subject DeviceTitan CondomsK210208 | Predicate DeviceTheyFit Male CondomsK122219 | Comparison | |
|---|---|---|---|
| Product Code | HIS | HIS | Same |
| Indications for Use | The Titan Condoms areindicated for use forcontraceptive and prophylacticpurposes (to help preventpregnancy the transmission ofsexually transmitted infections. | The TheyFit MaleCondom is used forcontraceptive and forprophylactic purposes (tohelp prevent pregnancyand the transmission ofsexually transmittedinfections) | The indications for useand intended use of thesubject and predicatedevices are the same. |
| Condom Material | Natural Rubber Latex | Natural Rubber Latex | Same |
| Design | Varied sizes with different length,width, and thicknesscombinations.Cylindrical with reservoir endSmooth, dotted, and ribbedsurface textures. | Varied sizes with differentlength/width combinations.Cylindrical with reservoirendSurface textureinformation not known asnot stated in thepredicate 510(k)Summary. | Different: The subjectand predicate devices areboth provided in differentlength and widthconfigurations. Versionsof the subject device arealso provided with varyingthickness and surfacetexture. These differencesdo not raise differentquestions of S&E. |
| Fitting Kit toDetermine CorrectSize | Yes | Yes | Same |
| Maximum Length | 180 - 223 mm | 163 - 208 mm | Different: The subjectand predicate deviceshave different maximumlengths. The subjectdevices are within therange of maximum lengthsof the predicate with theexception of subjectdevice versions withmaximum lengths of 223mm. This difference in |
| Maximum Width | 49 - 69 mm | 49 - 64 mm | maximum length does notraise different questions ofsafety and effectiveness(S&E).Different: The subjectand predicate deviceshave different maximumwidths. The subjectdevice includes oneversion with a maximumwidth of 69 mm. Thisdifference in maximumwidth does not raisedifferent questions ofsafety and effectiveness(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
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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.
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| 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.
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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.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.