(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a condom, with no mention of AI or ML.
Yes
The device is described as being used "for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections)", which are therapeutic uses.
No
Explanation: The device is indicated for contraception and prevention of sexually transmitted infections, which are prophylactic purposes, not diagnostic.
No
The device description clearly states it is a "natural rubber latex sheath" and describes physical characteristics and testing related to a physical product (condom). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prevention of sexually transmitted infections. This is a physical barrier method used in vivo (on the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a physical product (a condom) designed to be used externally on the penis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a disease or condition.
The information provided clearly describes a medical device used for physical barrier contraception and disease prevention, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The TROJAN™ Fire & Ice male natural rubber latex condom with lubricant 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™ Fire & Ice lubricated male natural rubber latex condom is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane, and a lubricant applied directly to the exterior of the condom that creates a perception of warming and cooling. The condom is bulbous shaped and smooth (no ribs) with a reservoir tip and 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
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)
Physical Testing: Three (3) lots of TROJAN™ Fire & Ice lubricated male natural rubber latex condoms were tested at baseline and met 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: Stability of the TROJAN™ Fire & Ice lubricated male natural rubber latex condom 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 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 studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing were 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" and ISO 10993-1:2009 as follows:
- Cytotoxicity ISO Elution Method: ISO 10993-5
- Rabbit Vaginal Irritation: ISO 10993-10
- Guinea Pig Maximization Sensitization: ISO 10993-10
- Acute Systemic Toxicity: ISO 10993-11
The results of this testing demonstrated that the subject devices are non-cytotoxic, non-irritating, nonsensitizing, and not systemically toxic.
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 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 along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.
September 28, 2022
Church & Dwight Co., Inc. % Dawn Reilly-O'Dell Principal Full Circle Regulatory Consulting, LLC 107 Casablanca Court Cary, NC 27519
Re: K221906
Trade/Device Name: TROJAN™ Fire & Ice lubricated male natural rubber latex condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: June 22, 2022 Received: June 30, 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.
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,
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) K221906
Device Name
TROJAN™ Fire & Ice lubricated male natural rubber latex condom
Indications for Use (Describe)
The TROJAN™ Fire & Ice male natural rubber latex condom with 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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510(k) Summary – K221906
| Submitter Name: | Church & Dwight Co., Inc. |
|---|---|
| Submitter Address: | 500 Charles Ewing Boulevard, Ewing, NJ 08628 |
| 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 | |
| Date Prepared: | September 15, 2022 |
| Trade Name: | TROJAN™ Fire & Ice lubricated male natural rubber latex condom |
| Common Name: | Male Natural Rubber Latex Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | HIS (condom) |
| 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. |
Description of Device:
The TROJAN™ Fire & Ice lubricated male natural rubber latex condom is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane, and a lubricant applied directly to the exterior of the condom that creates a perception of warming and cooling. The condom is bulbous shaped and smooth (no ribs) with a reservoir tip and 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.
Indications for Use:
The TROJAN™ Fire & Ice male natural rubber latex condom with lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
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Predicate Device Comparison:
The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.
| Subject Device | Predicate Device | |
|---|---|---|
| TROJAN™ Fire & Ice | TROJAN™ Jaguar male natural | |
| lubricated male natural | rubber latex condom with | |
| rubber latex condom | Warming and Tingling Lubricant | |
| 510(k) Number | K221906 | K131887 |
| Product Code | HIS | HIS |
| Regulation | 21 CFR 884.5300 | 21 CFR 884.5300 |
| Indications for Use | For contraception and for | For contraception and for |
| prophylactic purposes (to | prophylactic purposes (to | |
| prevent pregnancy and the | prevent pregnancy and the | |
| transmission of sexually | transmission of sexually | |
| transmitted infections). | transmitted infections). | |
| Prescription or Over-the-Counter | Over-the-counter | Over-the-counter |
| Condom Material | Natural rubber latex | Natural rubber latex |
| Nominal Length | 185 mm | 185 mm |
| Nominal Width | 54 mm | 54 mm |
| Nominal Thickness | 0.085 mm | 0.088 mm |
| Texture | Smooth | Ribbed |
| Lubricant | Glycol-based | Glycol-based |
| Air Burst Test Pressure | $\geq$ 1.0 kPa | $\geq$ 1.0 kPa |
| Air Burst Test Volume | $\geq$ 18 L | $\geq$ 18 L |
| Shelf-Life | 3 years | 3 years |
The subject and predicate device have the same intended use and indications for use. The subject and predicate device share the same shape, dimensions, shelf-life, and primary packaging. Both are lubricated natural rubber latex condoms, but the formulations of their natural rubber latex and lubricant
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differ. Additionally, the predicate device is ribbed, the subject device is smooth without ribbing. These differences in technological characteristics do not raise different questions of safety and effectiveness.
Summary of Non-Clinical Performance Testing
Physical Testing: Three (3) lots of TROJAN™ Fire & Ice lubricated male natural rubber latex condoms were tested at baseline and met 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: Stability of the TROJAN™ Fire & Ice lubricated male natural rubber latex condom 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 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 studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing were 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" and ISO 10993-1:2009 as follows:
Table 1: Biocompatibility Evaluations Conducted
| Evaluation (biological endpoint) | ISO Standard |
|---|---|
| Cytotoxicity ISO Elution Method | ISO 10993-5 |
| Rabbit Vaginal Irritation | ISO 10993-10 |
| Guinea Pig Maximization Sensitization | ISO 10993-10 |
| Acute Systemic Toxicity | ISO 10993-11 |
The results of this testing demonstrated that the subject devices are non-cytotoxic, non-irritating, nonsensitizing, and not systemically toxic.
Conclusion:
Based on the results of the testing described above, the TROJAN™ Fire & Ice lubricated male natural rubber latex condom is as safe and effective as the predicate device and supports a determination of substantial equivalence.