(88 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological safety of a latex condom, with no mention of AI or ML technology.
No.
A therapeutic device is typically used to treat a disease, injury, or medical condition. This device is described for contraception and prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections), not for treating an existing condition.
No
The device, a condom, is intended for contraception and prevention of sexually transmitted infections, not for diagnosing any medical condition.
No
The device description clearly states it is a physical condom made of natural rubber latex with silicone lubricant, and it undergoes physical performance testing and biocompatibility studies. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Intended Use: The intended use of the Trojan™ Ultra Ribbed Ecstasy condom is for contraception and prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections). This is a physical barrier method used externally on the body.
- No Specimen Examination: The device description and performance studies do not involve the examination of any specimens from the human body. The testing described is related to the physical properties, biocompatibility, and shelf life of the condom itself.
Therefore, based on the provided information, the Trojan™ Ultra Ribbed Ecstasy condom is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) is made of a natural rubber latex sheath, which covers the penis with a fitted membrane. A silicone-based lubricant is applied directly to the condom during packaging. The condom is a bulbous shaped condom with 7 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The condom meets the specifications of ASTM D3492-16. The condom has a nominal length of 200 mm, a nominal thickness of 0.095 mm, nominal flat widths of 53 mm measured 30 mm from the open end and 71 mm at the bulbous, closed end, and 800 mg of silicone lubricant per condom.
The condoms are packaged in individually sealed laminate (plastic inner layer, foil middle layer, and cellophane outer layer). The foils are packaged in an outer consumer cardboard carton. The Trojan™ Ultra Ribbed Ecstasy condoms are intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
Biocompatibility studies were performed in accordance with the 2023 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" as follows:
- Cytotoxicity (ISO 10993-5:2009/R 2014)
- Sensitization (ISO 10993-10:2010/R 2014)
- Vaginal Irritation (ISO 10993-23:2021)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The results of testing demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Physical Performance Testing:
The Trojan™ ultra ribbed ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) was tested and met all the requirements of ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms).
Shelf Life:
The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) has a three-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
§ 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 21, 2025
Church & Dwight Co., Inc. % Dawn Reilly-O'Dell Principal Full Circle Regulatory Consulting, LLC 107 Casablanca Court Cary, North Carolina 27519
Re: K243640
Trade/Device Name: Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: November 25, 2024 Received: November 25, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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,
Michael T. Bailey -S
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
3
Indications for Use
510(k) Number (if known) K243640
Device Name
Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy)
Indications for Use (Describe)
The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) 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)
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."
4
510(k) Summary K243640 Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy)
1. Submitter Information
| Applicant: | Church & Dwight Co., Inc. |
|---|---|
| Address: | 500 Charles Ewing Boulevard |
| Ewing, NJ 08628 | |
| Contact: | Lori Kordyban |
| Sr. Manager, Regulatory Affairs | |
| 469 North Harrison Street | |
| Princeton, NJ 08543 | |
| Phone: | (920) 815-9345 |
| Email: | lori.kordyban@churchdwight.com |
2. Correspondent Information
| Full Circle Regulatory Consulting, | |
|---|---|
| LLC | |
| Dawn Reilly-O'Dell, RAC, MPH | |
| dreilly(@fullcirclereg.com | |
February 19, 2025 3. Date prepared:
4. Device Information
| Device Name: | Trojan™ Ultra Ribbed Ecstasy latex condom with silicone
lubricant (Trojan™ Ultra Ribbed Ecstasy) |
|--------------------|-----------------------------------------------------------------------------------------------------|
| Common Name: | Male Natural Rubber Latex Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | HIS (Condom) |
| Regulatory Class: | Class II |
5. Predicate Device Information
| Device Name: | TROJAN™ Her Pleasure (Ribbed) Ecstasy latex condom with
silicone lubricant |
|----------------|-------------------------------------------------------------------------------|
| 510(k) Number: | K120286 |
| Sponsor: | Church & Dwight Co., Inc. |
The predicate device has not been subject to a design-related recall.
6. Device Description
The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) is made of a natural rubber latex sheath, which covers the penis with a fitted membrane. A silicone-based lubricant is applied directly to the condom during packaging. The condom is a bulbous shaped condom with 7 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The condom meets the specifications of ASTM D3492-16. The condom has a nominal length of 200
5
mm, a nominal thickness of 0.095 mm, nominal flat widths of 53 mm measured 30 mm from the open end and 71 mm at the bulbous, closed end, and 800 mg of silicone lubricant per condom.
The condoms are packaged in individually sealed laminate (plastic inner layer, foil middle layer, and cellophane outer layer). The foils are packaged in an outer consumer cardboard carton. The Trojan™ Ultra Ribbed Ecstasy condoms are intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
Device specifications are listed in Table 1 below.
7. Indications for Use Statement
The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.
| Subject Device | Predicate Device | |
|---|---|---|
| Trojan™ Ultra Ribbed | ||
| Ecstasy latex condom with | ||
| silicone lubricant (Trojan™ | ||
| Ultra Ribbed Ecstasy) | TROJAN™ Her Pleasure | |
| (Ribbed) Ecstasy latex | ||
| condom with silicone | ||
| lubricant | ||
| K243640 | K120286 | |
| Device & Predicate Device | Trojan™ Ultra Ribbed | |
| Ecstasy latex condom with | ||
| silicone lubricant (Trojan™ | ||
| Ultra Ribbed Ecstasy) | TROJAN™ Her Pleasure | |
| (Ribbed) Ecstasy latex | ||
| condom with silicone | ||
| lubricant | ||
| 510(K) Number | K243640 | K120286 |
| Product Code | HIS | HIS |
| Regulation Number | 21 CFR 884.5300 | 21 CFR 884.5300 |
| Regulation Name | Condom | Condom |
| Indications for Use | The Trojan™ ultra ribbed | |
| ecstasy latex condom with | ||
| silicone lubricant (trojan™ | ||
| ultra ribbed ecstasy) is used | ||
| for contraception and for | ||
| prophylactic purposes (to | ||
| prevent pregnancy and the | ||
| transmission of sexually | ||
| transmitted infections). | TROJAN® HER | |
| PLEASURE™ (Ribbed) | ||
| ECSTASY® Latex Condom | ||
| with Lubricant is used for | ||
| contraception and for | ||
| prophylactic purposes (to | ||
| help prevent pregnancy and | ||
| the transmission of sexually | ||
| transmitted infections) | ||
| Prescription or Over-The- | ||
| Counter Use | Over-The-Counter | Over-The-Counter |
| Condom Material | Natural Rubber Latex | Natural Rubber Latex |
Table 1. Comparison of Intended Use and Technological Characteristics
6
| Width | 53 ± 2 mm (30 mm from | 53 mm (30 mm from open |
|---|---|---|
| open end) | end) | |
| 71 ± 2 mm (75 ± 5 mm from | 73 mm (bulbous, closed end) | |
| closed end) | ||
| Nominal Length | 200 ± 10 mm | 200 ± 10 mm |
| Nominal Thickness | 0.095 ± 0.010 mm | 0.094 ± 0.010 mm |
| Lubricant | Silicone | Silicone |
| Lubricant Quantity | 800 ± 200 mg | Not specified |
| Air Burst Pressure | > 1.0 kPa | Not specified |
| Air Burst Volume | 28.0 L | Not specified |
| Sterilization | Non-Sterile | Non-sterile |
| Texture | Ribbed | Ribbed |
| Shelf Life | 3 Years | 3 Years |
| Color Additives | N/A | N/A |
| Flavor Additives | N/A | N/A |
The subject and predicate device have similar indications for use and have the same intended use. The technological characteristics of the subject device and predicate device are similar in that they are natural rubber latex-based, are lubricated with silicone, and have the same shelf-life duration. The subject and predicate devices do have different technological characteristics. including different dimensions and specifications. However, the different technological characteristics of the subject devices do not raise different questions of safety and effectiveness.
9. Summary of Non-Clinical Performance Testing
Biocompatibility:
Biocompatibility studies were performed in accordance with the 2023 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" as follows:
- · Cytotoxicity (ISO 10993-5:2009/R 2014)
- · Sensitization (ISO 10993-10:2010/R 2014)
- · Vaginal Irritation (ISO 10993-23:2021)
- · Acute Systemic Toxicity (ISO 10993-11:2017)
The results of testing demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Physical Performance Testing:
The Trojan™ ultra ribbed ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) was tested and met all the requirements of ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods and ASTM D3492-16 - Standard Specification for Rubber Contraceptives (Male Condoms).
Shelf Life:
The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy)
7
K243640 Page 4 of 4
has a three-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria.
10. Conclusion
The results of the performance testing described above demonstrate that the Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) is as safe and effective as the predicate device and supports a determination of substantial equivalence.