(387 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical performance of a standard condom, with no mention of AI or ML technologies.
No.
A therapeutic device is typically used to treat or manage a disease or condition, whereas condoms are used for contraception and protection against STIs (prophylactic purposes).
No
The device is a contraceptive and prophylactic product, designed to prevent pregnancy and the transmission of sexually transmitted infections, not to diagnose a condition.
No
The device description explicitly states the device is a "natural latex sheath" and describes its physical characteristics and materials, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraceptive and prophylactic purposes (preventing pregnancy and STIs). This is a direct physical barrier function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a physical barrier device made of latex.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on physical properties (slippage, breakage, biocompatibility, shelf-life) and clinical effectiveness as a barrier, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Titan Condoms are indicated for use for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
Indicated Patient Age Range
Not Found
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
A prospective clinical study was conducted 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
§ 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.
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 ( 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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3
510(k) Summary – K210208
| Submitter
Address: | Titan Condoms LLC
1950 Elkhorn Ct. Apt. 210
San Mateo, CA 94403 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Contact
Person: | Mr. Neville Muringayi, CEO
neviilemuringayi@gmail.com
(951) 746-6130 |
| Date Prepared: | February 16, 2022 |
| Device Name: | Titan Condoms |
| Common name: | Male Natural Rubber Latex Condom |
| Regulation Name: | Condom |
| Regulation
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
Description: | 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 |
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
Condom Size
(mm) | Condom
Thickness
(mm) | Lubricant | Reservoir Tip | Texture
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
Use: | The Titan Condoms are indicated for use for contraceptive and prophylactic
purposes (to help prevent pregnancy and the transmission of sexually
transmitted infections). |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Intended Use and
Technological
Characteristics: | A comparison of the intended use and technological features of the subject
and predicate devices are described in Table 2 below: |
| | Subject Device
Titan Condoms
K210208 | Predicate Device
TheyFit Male Condoms
K122219 | Comparison |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HIS | HIS | Same |
| Indications for Use | The Titan Condoms are
indicated for use for
contraceptive and prophylactic
purposes (to help prevent
pregnancy the transmission of
sexually transmitted infections. | The TheyFit Male
Condom is used for
contraceptive and for
prophylactic purposes (to
help prevent pregnancy
and the transmission of
sexually transmitted
infections) | The indications for use
and intended use of the
subject and predicate
devices are the same. |
| Condom Material | Natural Rubber Latex | Natural Rubber Latex | Same |
| Design | Varied sizes with different length,
width, and thickness
combinations.
Cylindrical with reservoir end
Smooth, dotted, and ribbed
surface textures. | Varied sizes with different
length/width combinations.
Cylindrical with reservoir
end
Surface texture
information not known as
not stated in the
predicate 510(k)
Summary. | Different: The subject
and predicate devices are
both provided in different
length and width
configurations. Versions
of the subject device are
also provided with varying
thickness and surface
texture. These differences
do not raise different
questions of S&E. |
| Fitting Kit to
Determine Correct
Size | Yes | Yes | Same |
| Maximum Length | 180 - 223 mm | 163 - 208 mm | Different: The subject
and predicate devices
have different maximum
lengths. The subject
devices are within the
range of maximum lengths
of the predicate with the
exception of subject
device versions with
maximum lengths of 223
mm. This difference in |
| Maximum Width | 49 - 69 mm | 49 - 64 mm | maximum length does not
raise different questions of
safety and effectiveness
(S&E).
Different: The subject
and predicate devices
have different maximum
widths. The subject
device includes one
version with a maximum
width of 69 mm. This
difference in maximum
width does not raise
different questions of
safety 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