(58 days)
No
The summary describes a physical condom with warming lubricant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The intended uses listed are for contraception and preventing the transmission of sexually transmitted infections, which are not considered therapeutic actions.
No
Explanation: The device is a condom used for contraception and prophylactic purposes, not for diagnosing any medical conditions.
No
The device description clearly states it is a natural rubber latex condom, which is a physical hardware device. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TROJAN™ Her Pleasure Warming condom is a physical barrier device used for contraception and preventing the transmission of STIs. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states "for contraception and for prophylactic purposes," which are not diagnostic functions.
- Device Description: The description focuses on the physical characteristics of the condom and lubricant, not on any analytical or testing components.
The information provided describes a medical device, specifically a condom, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
Product codes
HIS
Device Description
The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a warming lubricant applied directly to the condom to create a perception of warming. The condom is a bulbous shaped condom with 11 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant meets the specifications of ASTM D3492-16. The condom has a nominal length of 185 mm and a nominal flat width of 54 mm, measured 30 mm from the open end. The bulbous part at the closed end of the condom has a flat width of 65 mm.
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
Over-The-Counter Use (21 CFR 801 Subpart C)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Physical Testing Data: Three (3) lots of TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant were tested at baseline and met airburst specifications of ASTM D3492-16 Standard Specifications for Rubber Contraceptives (Male Condoms).
Shelf Life: Stability of the TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant was established from results of physical testing data using a protocol that followed 21 CFR §801.435 and met the requirements of both ASTM D3492-16 and ISO 4074:2015. Based on the evaluation of the results of the physical testing data, the expiration date has been initially set at 36 months (about 3 years) and will be then verified through real-time stability through five (5) years in compliance with FDA expiration labeling requirements in 21 CFR §801.435.
Biocompatibility: Biocompatibility evaluations were performed on the TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant in accordance with ISO 10993-1:2018, Biological Evaluation of Medical Devices. Biocompatibility tests conducted include Cytotoxicity ISO Elution Method (ISO 10993-5), Rabbit Vaginal Irritation (ISO 10993-10), Rabbit Penile Irritation (ISO 10993-10), Primary Rabbit Skin Irritation (ISO 10993-10), Guinea Pig Maximization Sensitization (ISO 10993-10), and Acute Systemic Toxicity (ISO 10993-11). The results of these evaluations demonstrate that the subject device is biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.
July 14, 2022
Church & Dwight Co., Inc. % Dawn Reilly-O'Dell Principal Full Circle Regulatory Consulting, LLC 107 Casablanca Court Cary, NC 27519
Re: K221431
Trade/Device Name: TROJAN™ Her Pleasure Warming male natural rubber latex condom with warming lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: May 12, 2022 Received: May 17, 2022
Dear Dawn Reilly-O'Dell:
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.
1
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.
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 (OS) 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 medical devices and radiation-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,
Jason R. Roberts, 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221431
Device Name
TROJAN™ Her Pleasure Warming male natural rubber latex condom with warming lubricant
Indications for Use (Describe)
The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant is used for contraception and for prophylactic purposes (to 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
| Submitter Name: | Church & Dwight Co., Inc. |
|---|---|
| Submitter Address: | 500 Charles Ewing Boulevard, Ewing, NJ 08628 |
| Submitter Contact Person: Supreet Sahota-Bhatti | |
| Sr. Manager, Global Regulatory Affairs (US) | |
| Church & Dwight Co., Inc., 469 North Harrison Street, Princeton, NJ 08543 | |
| Tel: (609)806-7893 | |
| Preparer Name: Dawn Reilly-O'Dell, RAC, MPH | |
| Principal, Full Circle Regulatory Consulting, LLC | |
| Email: dreilly@fullcirclereg.com | |
| Date Prepared: | May 12, 2022 |
| Trade Name: | TROJAN™ Her Pleasure Warming male natural rubber latex condom with |
| warming lubricant | |
| Common Name: | Natural Rubber Latex Condom |
| Product Code: | HIS (condom) |
| Regulatory Class: | Class II |
| Classification Name: | Condom (21 CFR § 884.5300) |
| Predicate Device: | K131887: TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming |
| and Tingling Lubricant | |
| The predicate device has not been subject to a design related recall. | |
| Reference Devices: | K120249: TROJAN™ MAGNUM Male Latex Condom with Warming Lubricant |
| K092586: Male Natural Latex Condom |
Description of Device:
The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a warming lubricant applied directly to the condom to create a perception of warming. The condom is a bulbous shaped condom with 11 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant meets the specifications of ASTM D3492-16. The condom has a nominal length of 185 mm and a nominal flat width of 54 mm, measured 30 mm from the open end. The bulbous part at the closed end of the condom has a flat width of 65 mm.
4
Intended Use of the Device:
The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
Predicate Device Comparison:
The subject and predicate device have the same intended use and indications for use. The subject and predicate device share the same product code, indications for use, dimensions, shelf-life, and primary packaging. Both are lubricated natural rubber latex condoms, but the formulations of their natural rubber latex and lubricant differ. These differences in technological characteristics do not raise different questions of safety and effectiveness, and both the natural rubber latex and lubricant formulations of the subject device are the same as the natural rubber latex and lubricant formulations of legally marketed, 510(k) cleared reference devices.
Summary of Performance Testing
Physical Testing Data: Three (3) lots of TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant were tested at baseline and met airburst specifications of ASTM D3492-16 Standard Specifications for Rubber Contraceptives (Male Condoms).
Shelf Life: Stability of the TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant was established from results of physical testing data using a protocol that followed 21 CFR §801.435 and met the requirements of both ASTM D3492-16 and ISO 4074:2015. Based on the evaluation of the results of the physical testing data, the expiration date has been initially set at 36 months (about 3 years) and will be then verified through real-time stability through five (5) years in compliance with FDA expiration labeling requirements in 21 CFR §801.435.
Summary of Safety Testing
Biocompatibility: Biocompatibility evaluations were performed on the TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant in accordance with ISO 10993-1:2018, Biological Evaluation of Medical Devices.
| Evaluation (biological endpoint) | ISO Standard |
|---|---|
| Cytotoxicity ISO Elution Method | ISO 10993-5 |
| Rabbit Vaginal Irritation | ISO 10993-10 |
| Rabbit Penile Irritation | ISO 10993-10 |
| Primary Rabbit Skin Irritation | ISO 10993-10 |
| Guinea Pig Maximization Sensitization | ISO 10993-10 |
| Acute Systemic Toxicity | ISO 10993-11 |
Table 1: Biocompatibility Evaluations Conducted
The results of these evaluations demonstrate that the subject device is biocompatible.
5
Conclusion:
Based on the results of the testing and data described above, the TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant is as safe and effective as the predicate device. The performance data support a determination of substantial equivalence.